Global Medical Device Podcast powered by Greenlight Guru

A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can use to guide product development and marketing submission planning. There is an art to preparing a Pre-submission, though, so it's important to include the necessary contents (and avoid common pitfalls) that will yield the best possible results.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about Pre-submissions. Listen as the two share recommendations about what content to include in a Pre-sub request to FDA as well as costly pitfalls to avoid with this particular Q-submission type.Some highlights of this episode include:A Pre-submission meeting is an opportunity to communicate with FDA prior to a marketing submission.About 3,306 medical device-related Pre-submission requests were made to FDA in 2020. In 2021, more than 1,500 Pre-submission requests have been made so far.Not all Pre-submission requests are made for meetings with FDA. About two-thirds of Pre-subs requested a meeting and one-third requested written email communication only.On average, FDA takes two months to give a written response of approval or denial for a Pre-submission request.A Pre-submission is completely optional and never required, but highly recommended.The only time that Mike does not recommend a Pre-sub is when the marketing submission is a ‘slam dunk’ in terms of the agency's decision. That rarely seems to occur, especially because 75% of 510(k)s and 89% of PMAs are rejected the first time.Unlike 510(k) and PMA submissions, as well as 513(g) requests for information, there is no user fee associated with Pre-submissions.When crafting a Pre-submission, justify reasons for why certain approaches are being taken over others.Memorable Quotes from Mike Drues:“A Pre-submission meeting is an opportunity to talk to the FDA before you actually make your submission.”“Clearly, the popularity of the program is increasing.”“A Pre-sub is purely optional. It is never required. A company can choose to do a Pre-sub or not.” “Unlike 510(k) and PMA submissions, unlike 513(g) requests, and so on, there is no user fee associated with the Pre-sub—although at least not yet.”Links:FDA - Q-Submission Guidance - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission ProgramFDA - Premarket Notification 510(k)FDA - Premarket Approval (PMA)FDA - De Novo ProgramFDA - 513(g) Requests for InformationFDA - Medical Device User Fee Amendments (MDUFA) ReportsFDA - Center for Devices and Radiological Health (CDRH)FDA - Medical Device OverviewMike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

What can you still do to help in response to the COVID-19 pandemic? The National Institute of Biomedical Imaging and Bioengineering (NIBIB) announced that its Point-of-Care Technology Research Network (POCTRN) is soliciting proposals to further advance SARS-CoV-2 testing technologies to fill specific unmet national needs through RADx Tech II, a fast-track program that leverages POCTRN.In this episode of the Global Medical Device Podcast Jon Speer talks to Mark Marino, Vice President of Growth and Strategy Development at VentureWell. VentureWell has been involved with the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Program. Listen to this episode to learn more about the RADx Tech II program to fast-track eligible technologies to market in 2021.Some highlights of this episode include:Under this RADx Tech II solicitation, NIBIB is seeking proposals to accelerate validation, manufacturing scale up, and commercialization of innovative COVID-19 testing capabilities.Capabilities include the full range of COVID testing from antigen to labs and POC to over-the-counter (OTC).Mark is starting to see some rapid evolution with some exciting technologies that are starting to come up in the pipeline of the market.It’s unfortunate that it took COVID-19 to spark innovation and acceleration of bringing products and technologies to the market.Unmet needs still exist, particularly when it comes to screening, surveillance, diagnostics, and prognosis related to at-home and point of care tests.How are tests holding up to variants? Adjust and modify tests to be as fast and responsive to address variant capabilities.RADx Tech I versus Tech II programs will follow a similar phased-based approach for funding, infrastructure, and other systems. Less data is needed, but the data still needs to hold up.Memorable Quotes from Mark Marino:“It’s labs, point of care, it’s antigen, it’s over-the-counter, really the full-range of COVID testing.”“Now, we’re really starting to see some really rapid evolution with some really exciting technologies that are starting to come up in the pipeline of the market.”“Everyone kind of knows, everyone has an expertise. Everyone has the same goal. People are letting go of both ego and showing up with tons of humility about what can I do to help? How can I add value?”“We still understand that there are some unmet needs, particularly when it comes to screening, surveillance, diagnostics, and prognosis related to at-home and point of care tests.”Links:Mark Marino - LinkedInRADx Tech II - POCTRN - CIMITVentureWell Home Page - Welcome to VentureWellNational Institutes of Health (NIH)National Institute of Biomedical Imaging and Bioengineering (NIBIB)FDA - Emergency Use Authorization (EUA)The Manhattan ProjectGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Hungry for medical device industry knowledge? Greenlight Guru has you covered — now, medical device professionals can enjoy additional, sought-after training courses in the already popular educational platform, Greenlight Guru Academy, through a new partnership with Medical Device HQ.In this episode of the Global Medical Device Podcast, Jon Speer talks to Peter Sebelius, the founder and CEO of Medical Device HQ.Together, Peter and Jon discuss the importance of online learning and providing access to relevant, role-based training for medical device professionals. Listen now to understand the true value-add of this partnership and the further learning opportunities it brings the medical device industry.Some highlights of this episode include:Peter finds the process of developing or creating something new is almost as exciting as doing the actual technical work.Also, Peter believes that blended courses are helpful because people get to learn at their own pace and validate their understanding of the content through formative assessments and evaluations.Why are we doing these things? The FDA requires regulations and standards to be met for good reasons. It’s motivation to be meaningful. Peter started his career in the defense industry, which is good at structured product development. However, he transitioned to the medical device industry to go from taking lives to giving life.The COVID-19 pandemic has put more emphasis on online learning, which is useful and remains a trend.Memorable Quotes from Peter Sebelius:“The process of developing something or creating something new is almost as exciting as doing the actual technical work.”“Being able to work in an industry where both those two things are important is such a privilege for me.”“Unfortunately, quite a lot of people that are instructors in this industry will forget all the good things. We’re doing the things that the requirements tell us to do.”Links:Peter Sebelius on LinkedInMedical Device HQMedical Device HQ on YouTubeFDA - Medical DevicesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

What did FDA report as the most-cited issues during medical device inspections for the fiscal year of 2020? Understanding the data can help you prepare against making these common, avoidable mistakes during your next quality system inspection.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues with Vascular Sciences. Together, Mike and Jon discuss the FDA FY2020 data for medical device quality system inspections and evaluate the top three most cited QSR clauses that resulted in 483 observations.Some highlights of this episode include:The volume of inspections and number of findings, such as 483 observations and warning letters, were down - partially due to the COVID pandemic.Other reasons may include whether remote inspections are effective or even allowed. However, the number of 483s issued against medical device quality systems decreased by 50% in 2020.Top 3 Cited Claims: CAPAs, complaints, and design controls made up about 35% of all 483 observations issued by the FDA in 2020.Of the 197 times that CAPAs were issued last year, manufacturers either did not document or cite procedures. Medical device companies must have a quality management system (QMS) and follow a CAPA process to be compliant.CAPA should be changed to preventative and corrective actions (PACA). Put the emphasis on preventing problems, rather than correcting problems and complaints when they happen.Almost 200 complaints were cited because manufacturers didn’t document procedures for maintaining files.Also, 139 complaints were filed due to medical device failures not investigated, not containing required information, or lacking rationale to not conduct an investigation. Every complaint requires some level of investigation.Design validation of design controls gets most 483 observations for not having procedures, not performing or documenting risk analysis, not having software validations, or not using a production equivalent device in validation studies. Memorable quotes from this episode:“When the number of findings is down, is it because we in companies and we as an industry are doing a better job? Or, is it because of something else?” Mike Drues“Apparently, FDA doesn’t have a mandate or I’ll use the word, permission, or something of that nature, to do remote inspections for med device companies.” Jon Speer“Our job as medical device professionals is to make sure that the products that we design, develop, manufacture, sell, so on and so forth, they’re as safe and effective as they can possibly be.” Jon Speer “I have a responsibility, certainly to the patients, to do an investigation when I learn about something.” Jon Speer“Average regulatory professionals know the rules, but the best ones know the exceptions.” Mike DruesLinks:The Top 10 Most-Cited Issues in FDA FY2020 Medical Device InspectionsFDA - Inspection ObservationsFDA - Medical DevicesFDA - Corrective and Preventive Actions (CAPA)FDA - Form 483 Frequently Asked QuestionsFDA - Premarket Notification 510(k)Code of Federal Regulations (CFR) - Title 21 Part 820CFR Part 820:30 - Design ControlsThe Bleeding Edge Documentary on NetflixMike Drues on LinkedInGreenlight Guru AcademyMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Close your eyes, take a deep breath in, and imagine your team operating at peak performance, exceeding goals and each member feeling and working at their best. Now, breathe out, letting out a sigh of relief knowing that's fully within the realm of possibility — through mindset training.In this episode of the Global Medical Device Podcast, Jon Speer talks to Kevin Bailey, mindset coach and founder of Dreamfuel, a mindset coaching solution for high growth companies.Kevin is the mindset coach for Greenlight Guru and has worked with Jon and Greenlight Guru employees over the years by providing mindfulness tools and techniques that teams can use to improve overall mindset. Listen to what Jon has learned from this mindset training and how the medical device community, too, can benefit from engaging in mindset practices at work.Some highlights of this episode include:Being the CEO of a high-growth startup proved to take a whole other level of work that required mental strength and resilience. Kevin used mental models to reframe experiences and have a more positive attitude while leading people.CEO Cues: Feeling motivated or burnt out? How is the business doing? People follow their leaders and want to boost productivity and camaraderie.Working with Kevin from Dreamfuel has changed the world for Jon and his colleagues, as well as other companies trying to do great things, make a difference, and feel better.Mindset is an important practice for success in a company. About 95% of thoughts are subconscious and automatic, like a heartbeat. Also, 70-80% of those thoughts and actions are negative, disempowering, limiting beliefs.A measurable difference, consistency, and alignment of peak performance can be achieved by companies, executives, and staff via neuroscience principles.The stigma around meditation is stopping people who need it from doing it. What’s the goal? There’s no outcome you are going for in meditation.Acknowledge and let go of thoughts spinning in your mind because dopamine (pleasure) and serotonin (joy, happiness, and presence) create a balanced mind.Your breath controls your physiology, and your physiology heavily influences how you feel, how you think, and what you do. If you can control your physiology, it’s easier to control your thinking and behaviors. Breathe rhythmically and smoothly.Memorable quotes by Kevin Bailey:“Mindset is such an important practice for success in a company.”“We’re trying to kind of take these practices that have been utilized for ions to help people be happier and perform better, wrap them with some neuroscience, so that people can accept and understand them, but there’s still that stigma.”“There’s no outcome you’re going for in meditation. You purely do meditation to do meditation.”“Your breath controls your physiology, and your physiology heavily influences how you feel, how you think, what you do.”Links:Kevin Bailey on LinkedInDreamfuel CoachingDr. Diane PowellWhy Greenlight Guru Rewards Employees Who Get the Best SleepThe Beatles’ Meditation Coach - Maharishi Mahesh YogiBreath by James NestorGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What are the pros, cons, and ramifications of the U.S. Department of Health and Human Services’ (HHS) proposal that impacts the medical device industry?In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the HHS proposal, which focuses on down-classifying and exempting more than 80 types of devices such as exam gloves, thermometers, imaging systems, infusion pumps, and ventilators.Some highlights of this episode include:In January 2021, HHS declassified a number of medical devices without first consulting or notifying FDA. As a result, the reclassification initiative is on hold pending a review due to regulatory freeze.The HHS proposal affects seven (7) Class I devices (all gloves) and eighty-three (83) Class II devices, such personal protective equipment (PPE) and thermometers.It’s ironic that regulatory quality requirements apply to products but don’t seem to apply to processes that regulate those products. It’s another example of not practicing what you preach.Some companies want FDA to require feedback before down classifying and exempting changes. Reasons why? Safety, efficacy, and competitive advantage.Design controls, risk management, and quality management systems demonstrate that products are safe, effective, and meet indications for use.Proceduralizing and establishing processes is a way to describe how you operate and run your business. Why are they perceived as bad things and barriers?Recommended approach: begin with biology, engineering, then regulatory requirements. Memorable quotes from this episode:“Changing medical device classification, whether we’re going down or up, doesn’t matter, without notifying or consulting the folks that are responsible for evaluating these medical devices...politics aside, Jon, it’s hard to connect those dots. What sense does that make?” Mike Drues“You don’t have to have a Ph.D. in biomedical engineering...to appreciate that gloves and thermometers and other forms of PPE—these are not the most complicated kind of products in the world.” Mike Drues“It should not take a Ph.D. in biomedical engineering or an RAC after somebody’s name to appreciate that maybe it doesn’t make sense to lump gloves and thermometers into the same category as infusion pumps and ventilators.” Mike Drues“Isn’t evaluating changes or the potential for changes, in this case in a medical device, always a good thing?” Mike Drues“Things like design controls and risk management and establishing a quality management system is all about science. It’s all about demonstrating that the product is safe, that it’s effective, and that it meets the indications for use.” Jon SpeerLinks:Mike Drues on LinkedInVascular SciencesU.S. Department of Health and Human Services (HHS)HHS ProposalFDA - Medical DevicesHHS’ proposed 510(k) exemption proves the need for regulatory scienceDevice, digital health firms oppose HHS’ proposed 510(k) exemptionsFDA walks back Trump-era premarket notification exemptions21st Century Cures ActEmergency Use Authorization (EUA)Overview of the 510(k) ProcessPremarket Approval (PMA)De Novo Classification RequestGreenlight Guru AcademyGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

If you love learning and want to level up your medical device industry knowledge on topics such as audits, document management, design controls, risk management, and more, Greenlight Guru Academy is your education destination.In this episode of the Global Medical Device Podcast, Jon Speer invites colleagues Aaron Lucas, Training and Education Manager, and Jesseca Lyons, Operations and Enablement Guru, to join the show and explain to listeners what Greenlight Guru Academy is and how the eLearning platform is helping users around the world advance their medical device careers.Some highlights of this episode include:Greenlight Guru Academy is a learning management system (LMS) path that allows medical device gurus, customers, and others to share knowledge and educational content and courses to encourage retention and effectiveness.About six years ago, whenever a new customer would come on board with Greenlight Guru, it was a manual process. Fast forward to a few years later, Greenlight Guru Academy has made that process automatic and evergreen.Feedback from some of the thousands of Greenlight Guru Academy users who have completed the various courses help gauge success and types of content.Learner’s Mindset: I want to do the right thing. I want to make it better. I want to help someone, but it’s next to impossible to do. Demystify the medical device space, especially as the industry changes.Greenlight Guru Academy is for anyone getting started to veterans wanting to hone their skills in the medical device industry. Expect to see a lot more audit and inspection courses and content. Also, expect basic regulatory learning.Memorable quotes from this episode:“In the academy, we have all sorts of awesome courses - go at your own pace courses - on topics like document management, design controls, risk management, training, audits, and the list is going to continue to grow and evolve.” Jon Speer“Ultimately, the academy looks to really be this educational kind of beacon in the medical device industry for anything anyone could ever need to know from just getting started to a veteran looking to hone their skills.” Aaron Lucas“There’s something about the medical device industry that breeds these folks who don’t just recognize that they have to learn this stuff but they actually kind of like it.” Aaron Lucas“Why am I making a medical device in the first place? I want to help someone.” Jesseca Lyons“This is an opportunity to get a chance to really impact more and more people.” Jesseca LyonsLinks:Aaron Lucas on LinkedInJesseca Lyons on LinkedInGreenlight Guru Academy - Enroll NowAbout Greenlight Guru AcademyFDA - Medical DevicesInternational Organization for Standardization (ISO)510(k) Premarket NotificationEuropean Union’s Medical Device Regulation (EU MDR)Risk Management True Quality Summit SeriesGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Have you ever had to “sell” your brand to someone? To do this effectively, you must master the art of networking and selling whatever it is that you bring to the table.In this episode of the Global Medical Device Podcast, Jon Speer talks to Chip Helm, a Dental School dropout turned National Sales Manager of a multi-billion-dollar medical device company. Also, Chip is a guest lecturer and bestselling author who is creating a sales revolution.Together, Chip and Jon chat about the importance of a person's brand, which consist of three main types, and how medical device professionals can create new opportunities for growth with intentional self awareness tactics.Some highlights of this episode include:Chip’s Books: It doesn’t matter what career you take and where you go, his books teach basic principles of business and lessons that fit into anybody’s career, any company.Importance of Branding: Whether it’s your personal or professional brand, you have got to have self awareness to build, develop, and write your personal brand.Google your name. What can you do if you don’t like the brand you have? Find five things about yourself and how others you trust perceive you and your brand.Compartmentalize: Perception is reality, it doesn’t matter if you didn’t do something. Your personal brand can take years to build, but it can take only seconds to lose it.Rules of Engagement: There’s three brands—personal, colleague/industry, and customer—observe and listen more, speak less to communicate.Your company must have a great product, but it’s still about networking and building relationships. Help people by offering solutions to solve their problems.Sales Component: If you’re just trying to sell someone something, they can tell if you care about them or not. Commission gets people too close to not doing the right thing for the right person.Memorable quotes by Chip Helm:“It doesn’t matter what career you take and where you go, it teaches five basic principles of business. It fits into anybody’s career, any company, it doesn’t matter.”“Everyone’s in sales.”“Most people say when they think of branding, they think of corporate branding. They really don’t think that there’s a thing called personal branding out there.”“It could take years to build up a personal brand, but it will take seconds to lose it.”“If you want to get promoted, if you want to get a better paycheck, if you want to make advancements...you need to be up on your personal brand. You’ve got to understand it.”Links:Chip Helm’s WebsiteEveryday Sales Wisdom for Your Wealth and Career by Chip HelmBigger Than Sales - How Humility and Relationships Build Career Success by Chip HelmTo Sell is Human by Daniel H. PinkMark Cuban on Shark TankGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Have you ever wondered, what does a medical device guru actually do? What role do they play within Greenlight Guru and what value do they bring medical device companies in the context of the QMS software?In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rish, a senior medical device guru and manager of the guru team at Greenlight Guru.Tom shares his unique insights into the life of a medical device guru at Greenlight Guru, how the guru team engages with customers beyond the software itself, and how the "Guru Edge" has come to be one of Greenlight Guru's most valuable offerings to medical device companies around the world.Some highlights of this episode include:Role of the Medical Device Guru: Collect as much feedback as possible from customers throughout the sales process to determine why they select Greenlight Guru’s QMS over other quality management systems.Medical Device Guru Team Philosophy: Give peace of mind to customers and help them meet their goals, whether it’s to launch a product or pass an audit. Gurus want their customers to succeed the first time.Do you want to be a medical device guru at Greenlight Guru? You are encouraged to be curious, inquisitive, and willing to learn and help because you are exposed to different medical device companies and technologies.The process of setting up a medical device quality system, getting your product to market is much more overwhelming than it actually is. First, focus on design controls and risk management. You can add more later.Build as You Go: Use phased approach to implement a QMS to make paperwork less of a burden and less tedious to add value and improve business efficiencies.Market Research: You need to know your industry and understand your users and their needs. Talk to as many people as possible - clinicians, patients, etc.Memorable quotes by Tom Rish:“Greenlight Guru is more of an experience and not just buying software. We feel like the gurus are a big part of that experience and we want to make sure that we hold up our end of the bargain to that.”“We found early that our customers are coming to us with a lot of different questions.”“It’s very humbling and also encouraging to see how many people out there are just really passionate about their ideas.”“You can do a lot of work to get your product ready to launch knowing that you can add stuff on later.”Links:Tom RishFDA - Medical DevicesFDA - Guidance Documents510(k) Submission ProcessFDA Inspections and ISO Audits: What is the difference?Software as a Medical Device (SaMD)European Union Medical Device Regulation (EU MDR)In Vitro Diagnostics Regulation (IVDR)Global Medical Device Podcast, Episode 177: 5 Actionable Lessons Learned from the RADx Initiative by NIH Global Medical Device Podcast, Episode 205: Global Medical - Things I wish I knew as FDA reviewerGlobal  Medical Device Podcast, Episode 158: Meet a Guru - Tom RishGlobal Medical Device Podcast, Episode 155: Meet a Guru - Jesseca LyonsGlobal Medical Device Podcast, Episode 153: Meet a Guru - Taylor BrownGlobal Medical Device Podcast, Episode 160: Meet a Guru - Wade SchroederGlobal Medical Device Podcast, Episode 188: Meet a Guru - Sara AdamsGlobal Medical Device Podcast, Episode 206: Meet a Guru - Laura CourtGlobal Medical Device Podcast, Episode 207: Meet a Guru - Etienne NicholsGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

The Guru edge: it's what makes Greenlight Guru so unique and valuable to the medical device companies it serves. The Guru team is comprised of industry experts with a knack for helping companies succeed; each of whom have a specific skillset and knowledge base that companies can tap into and leverage throughout their medical device journey.In this episode of the Global Medical Device Podcast, Jon Speer talks to Etienne Nichols, a Medical Device Guru at Greenlight Guru, to learn more about his expansive industry knowledge, experience, and passion, of which he uses in his approach to help customers work through the design and development process to bring safe, high quality products to market.

What makes Greenlight Guru unique? It’s the Guru edge⁠—a team of medical device professionals with a ton of industry experience.In this episode of the Global Medical Device Podcast, Jon Speer talks to Laura Court, a medical device Guru at Greenlight Guru, about her journey in the medical device industry, which ultimately brought her to Greenlight Guru, and Laura shares tips for success she's learned along the way.Some of the highlights of this episode include:Laura gained hands-on manufacturing experience because she believes medical device professionals can’t design a product well if they don’t know how it’s made or what is gone through to get a product made and put on the market.What made Laura move towards Greenlight? Ultimately, it was her love of helping people and getting out on the floor to help people who make products.Laura sought advice and looked to manufacturers for knowledge to validate products because they knew the systems and processes better than anyone and she wanted to help fix problems.Also, Laura learned that people using products can drastically alter what medical device professionals do.Laura likes being a Guru because she has the opportunity to meet companies and customers, as well as collaborate and interact with people doing and coming out with amazing work and new technology.Greenlight Guru Academy offers courses on risk management, design controls, and document management. Laura believes the educational resource features well-written content that makes the transition to a medical device career easier.Most interactions at Greenlight have been virtual and remote. It takes a desire to learn, surround yourself with smart people, and gain experience.Keys to Success: Use and rely on resources that you can find. You don’t need to know everything right now or be an expert on everything you touch and see.Memorable quotes by Laura Court:“I’m a true believer that you can’t design a product well if you don’t know how it’s being made or what you go through to make a product.”“Ultimately, I just loved helping people. I loved getting out on the floor and helping people who are helping us make the products and things like that. That’s what ultimately drew me towards coming towards Greenlight.”“I’ve already met so many different companies and just learned about some amazing technology that people are coming out with.”“I just love the collaborative side of all of it.”Links:Laura Court on LinkedInFDA - Medical DevicesEuropean Union Medical Device Regulation (EU MDR)ISO 13485 - Medical DevicesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

As some veteran FDA reviewers leave and new ones are hired, knowledge is not always passed on seamlessly... To that end, regulatory professionals are often left to their own devices to find the guidance, support, and resources they need to fulfill their important roles in the medical device industry.In this episode of the Global Medical Device Podcast, Jon Speer talks to Allison Komiyama, a former FDA reviewer who is an expert in regulatory submissions, quality systems, and biocompatibility evaluation. Listen to Allison share her thoughts on what she wishes she had known as an FDA reviewer, providing valuable insights for regulatory professionals in the medical device industry.Some highlights of this episode include:New FDA reviewers are trying to navigate what’s important by asking questions because they have been working from home, never been onsite, and haven’t met their manager or other team members.FDA managers are trying to make sure that their teams get the training and mentorship that they need, but it is difficult and challenging.Deficiencies: What is four-part harmony? How are they written? List what was provided, what’s missing, what needs to be provided, and why is it needed?It’s not only the lead reviewer looking at a regulatory submission, but a team of people. Review the deficiencies and manage the additional information (AI) letter to ask relevant questions.To improve the speed of review and the time it takes for files, it’s important to support the reviewers and resources during that process.There’s just not enough time for FDA reviewers to read through and understand all the guidance documents put out by the FDA. Include guidance documents in files to help the reviewers and express how regulations are being followed.Recommendations for new reviewers: There’s what the regulation states, the legal definition, and then people's interpretation of the regulation, what does it mean and how does it apply?There are different risks to different devices. For most questions, there are multiple correct answers that are acceptable by FDA. As a reviewer, you feel a huge burden of wanting to make sure nothing bad happens.Memorable Quotes from Allison Komiyama:“We’re kind of dealing with a lot of new reviewers who are trying to navigate being a new reviewer and what’s actually important. We can see that reflected in some of the questions that we’re getting.” “I think the managers at FDA are doing an amazing job trying to make sure that their teams get the training and the mentorship that they need while they are there. But it’s hard.” “Sometimes that knowledge doesn’t get passed on as seamlessly as we all would want. From the industry perspective, one of the most beneficial things that we can do to improve the speed of review and improve the time that our files take to go through that process is really to support the reviewers.”“One of the things she didn’t realize when she was a new reviewer was how diligent a lot of us in industry are at keeping up on guidance and the changes in regulations because that’s my job. That’s what we do.”Links:Allison Komiyama on LinkedInAcknowledge Regulatory StrategiesRegulatory Science ForumFDA - Medical DevicesFDA - Guidance DocumentsBreakthrough Devices Program (BDP)Safer Technologies Program (STeP)510(k) Submission ProcessPremarket Approval (PMA)Emergency Use Authorization (EUA)David Pudwill (a.k.a. Mr. Regulatory) Code of Federal Regulations (CFR) Title 21Medical Device User Fee Amendments (MDUFA)Use of ISO 10993-1 Biological Evaluation of Medical DevicesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Great uncertainty brings great opportunities for growth...career growth. Currently, regulatory roles are one of the highest in demand in the medical device industry. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mitch Robbins, founder and managing director at The Anthony Michael Group. Listen as Mitch shares his unique insights and perspectives into why there's such a high demand right now for regulatory and quality roles and how you can find your next career opportunity with the help of a regulatory affairs recruitment solution for employers and candidates.Some highlights of this episode include:The COVID-19 pandemic affected everything, including hiring practices. Companies started to shut down progressively and put hiring people on hold. Since April-May 2020, Mitch’s firm has worked non-stop with organizations that need help placing regulatory and quality talent.COVID has caused leaders to look at things differently, if they want to continue their business. Some are uncomfortable, others view it as an opportunity to move forward, adapt, and innovate. Flexibility and autonomy are key reasons why people are interested or not. Necessity is the mother of invention: Being forced to do things in a different way, how many businesses will continue the remote workforce model or go back to a brick-and-mortar office setting?  The high demand for regulatory staff is based on several reasons, including the eventual rollout of EU MDR, unbelievable innovation and hypergrowth in digital health, population continues to age, and more medical technology startups.Career Hunters is an online, step-by-step program for professionals interested in moving their career forward. MedTech Talent Lab is a show that talks about all things talent related to medical technology and features a variety of guests.Recruiting has to change. The employer value proposition differentiates hiring opportunities. Top talent cares about organizations that help save lives or improve quality of life, rewards their talent, and offers meaningful value.     Memorable quotes from Mitch Robbins:“When this pandemic started to happen, as rapidly as it did, in March, I, as the owner of our business, like everybody else was pretty freaked out because I saw things start to shut down and shut down more and more progressively.”“We had some searches going on that a couple had just finished up and a couple that were in the final stages went on hold—just pretty much overnight.” “We have just been non-stop with organizations that need our help to place regulatory and quality talent. So, I would say that the market is on fire and demand is...greater than it’s ever been.”“Be okay being uncomfortable—meaning, especially with hiring practices, so many organizations, never in their wildest dreams thought they would hire on a remote basis, let alone build a remote workforce.”“People that are moving and adapting to what is reality are the ones that are winning. It’s okay to be uncomfortable, especially if you see a way forward to continue to innovate.”Links:Mitch Robbins on LinkedInMitch Robbins EmailThe Anthony Michael GroupThe Career HuntersEuropean Union - Medical Device Regulation (EU MDR)FDA - Classify Your Medical DevicesTony RobbinsRisk Management True Quality Virtual Summit SeriesGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program (BDP) and Safer Technologies Program for Medical Devices (STeP)?In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Director of Regulatory Affairs for Proxima Clinical Research (CRO).Together, Isabella and Jon discuss the FDA’s Breakthrough Devices Program and Safer Technologies Program and how manufacturers can determine if one or either is worth pursuing for their medical device. BDP is popular, STeP has the potential to be, but is not quite there yet given it’s a much newer program.Some highlights of this episode include:BDP designations are for medical devices that treat or diagnose life-threatening or irreversibly debilitating conditions. BDP designations have an improvement over the current standard of care, may be new technology, or modification of existing technology. BDP designations show or have the potential to show that they are more effective and safe.STeP is for medical devices and device-led combination products that improve the safety of currently available treatments or diagnostics that target an underlying disease or condition less serious than those eligible for BDP.FDA hones in on the indication statement for breakthrough devices. A general indication statement of intended use that is not indication specific is more likely along the lines of STeP, then it is a breakthrough device.BDP designation and STeP need to be their own usually distinct q-submissions. It’s a 60-day period between submission and final designation or denial. At day 30, most get a request for more information.Some of the drawbacks of the BDP and STeP process include engagement and interactions with the FDA that do not go as expected. Consider reimbursement early on because it’s important. The Centers for Medicare and Medicaid Services (CMS) has paused the Medicare Coverage of Innovative Technology (MCIT) reimbursement for BDP designation. Memorable quotes from Isabella Schmitt:“When you have more of a general indication statement, it’s more of an intended use and not really indication specific, that’s probably more along the lines of STeP than it is a breakthrough device.”“FDA really hones in on the indication statement for a lot of breakthrough devices.”“Being safer than the current technology out there–having the STeP designation can be beneficial for them because that’s really their selling point.”“The FDA’s bar can get a little bit higher for your clearance or approval because you’re focusing on specific language...and you’re basically making claims that need to be proven.”Links:Isabella SchmittProxima CROBreakthrough Device Designation ReimbursementFDA - BDPFDA - STePSTeP Guidance Document510(k) Premarket NotificationPremarket Approval (PMA)De Novo Classification RequestQ-Submission GuidanceEuropean Union Medical Device Regulation (EU MDR)Emergency Use Authorization (EUA)Centers for Medicare and Medicaid Services (CMS)Medicare Coverage of Innovative Technology (MCIT)Medical Device User Fee and Modernization Act (MDUFMA)Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many device professionals, the one year countdown to the IVDR deadline in May 2022 is almost here, causing much anxiety about whether compliance is even possible.In this episode of the Global Medical Device Podcast, Jon Speer and his guest Joanne LeBrun, VP of Quality Systems at MDC Associates, shine light on EU IVDR transition concerns and the challenges the medical device industry faces, like the notified body shortage.Some highlights of this episode include:Why are some notified bodies not interested? There’s a ton of work, audits, and corrective actions. They don’t view it as necessary to move forward and pursue.First, notified bodies plan a wait-and-see approach to find out how the EU MDR goes on May 27. The notified bodies are overwhelmed and resources are limited.The EU MDR has more constituents involved and is a bit more straightforward to implement than the IVDR. The IVDR has less constituents but more things that are different, such as product classification.The opportunity to self-certify for MDR has passed and certain notified bodies are no longer accepting new clients. You can contact your authorized representative about cut-off dates to get your CE mark.Even if you don’t have to submit a technical documentation file, you still need to have one and review it constantly. Make it part of your change controls,For ISO/MDSAP certifications and audits, do not have duplicates of files and documentation. Only have one source of information or you are setting yourself up for failure and will be out of compliance. Notified bodies are not designed to teach regulatory and quality professionals what they should know to be ready. Prepare and reach out before it is too late.Memorable quotes from Joanne LeBrun:“One of the conditions of going live for the IVDR is that they have seven notified bodies by the time we’re supposed to go live. They have a year to get more notified bodies.”“I think that notified bodies are very overwhelmed.”“While the MDR has more constituents involved, I think that it’s going to be a little more straightforward to implement than the IVDR. The IVDR has less constituents but way more things that are different - particularly product classification.” “That honor system is now gone, and we all have to keep up on it. You really do need to update your technical file all the time.”Links:Joanne LeBrun on LinkedInMDC AssociatesFDA - Medical DevicesEU IVDREU MDRNotified BodiesNew Approach Notified and Designated Organizations (NANDO)ISO 13485:2016ISO 14971:2019 ISO/TR 24971:2020Medical Device Single Audit Program (MDSAP)Overview of the 510(k) ProcessAllison Komiyama from AcKnowledge Regulatory StrategiesGlobal Medical Device Podcast, EP 193: Quality Management for IVD Devices vs Medical Devices with Joanne LeBrun Greenlight Guru AcademyGreenlight Guru AcademyGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

It's easy to get so wrapped up in the risk management of your medical device that you forget about managing your business risk with the same level of diligence and ongoing attention.In this episode of the Global Medical Device Podcast, Jon Speer talks to Michael Cremeans, Life Sciences Industry Practice Leader at Hylant. Together, Mike and Jon talk about how medical device companies should approach and manage business risk, which systems and tools can help, and advice on how to review contracts and terms and conditions.Some highlights of this episode include:Are you ready to grow your company? Is it the right time for a business owner to think about the business, liability, and intellectual property? Time to engage Mike.There are consequences to a company’s distribution model and selling strategy.  Each has a different set of contracts and risks that need to be assessed and receive recommendations.Insurance is there for when you need it, even if you don’t understand it. Contractual liability is usually the biggest risk for entrepreneurs and startups.Mike often says that there are three truths in the insurance business: We have our own language, we like to confuse, and we’re really good at it.Jon defines risk management as a platform with intentionally built workflows related to ISO 14971. Greenlight Guru mitigates risk for companies as they operate quality systems to manage information and handle audits.What you do and don’t do influences and represents your risk profile. Don’t make insurance an afterthought to achieve better outcomes and goals. Do everything you can to be the best company. Don’t just do the minimum, but go above and beyond to change the quality of life.Memorable quotes from Michael Cremeans:“What I’m going to do is help people map out where they’re headed. What could go wrong? Who’s going to be upset at them? What are they going to be upset about? What are the financial damages? What things should you be focused on?”“How can you figure out what they need if you haven’t asked them about their company?”“There’s three truths in the insurance business: We have our own language, we like to confuse, and we’re really good at it.”“Do not sign a contract until you’ve talked to me.”Links:HylantMike Cremeans on LinkedInMike Cremeans: Risk and Insurance ConsultingFDA - Device Approvals, Denials, and ClearancesFDA - GuidancesISO 14971ISO 13485:2016Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice?The waterfall methodology used to be the industry norm for medical device product development until an alternative approach known as the agile methodology emerged, leading to competing opinions over which product development approach is best. In this special 200th episode of the Global Medical Device Podcast, host Jon Speer and his guest Devon Campbell, founder and CEO at Prodct, discuss the waterfall and agile methodologies for medical device product development, how they were first introduced and how they are interpreted and used today, while also dispelling common myths about the two approaches.Listen as the battle between the methodologies is finally laid to rest by Jon and Devon, with one key theme emerging: the name of your chosen methodology is not nearly as important as the defined processes you follow during product development and throughout the course of your medical device project.Some highlights of this episode include:The FDA’s Design Control Guidance for Medical Device Manufacturers is outdated and includes the waterfall design process. However, medical device manufacturers do not have to follow the waterfall approach. Industry norm? Read the entire guidance before making an incorrect assumption. The waterfall approach is one way, but the guidance offers other approaches and best practices to consider or follow. The waterfall approach was not revolutionary, but it did serve a lot of good for a lot of people. It helped companies establish infrastructure and understand how to develop medical devices in a safe and efficacious manner to meet patient needs.The term, ‘agile,’ as far as a product development methodology, didn’t exist until 2001 with the Agile Manifesto. There were huge gains in efficiency, productivity, and customer satisfaction for software companies using this shiny new approach.What does a good prototype look like? It might be a misconception that one approach is slower or faster than the other. Embrace and acknowledge the idea of continuous change and iteration. Document early, revise often.However, a certain order of operation needs to be followed for verification, validation, traceability, and flow of requirements, regulations, and other factors.Memorable quotes from this episode:“The big confusion about medical device product development is exacerbated by the infamous waterfall diagram that’s published in the FDA guidance.” Jon Speer“Incorrect impression: Well, the FDA says we have to do this, and therefore, we shall do this. They’ve given us a model. This is the way we have to do it. It doesn’t say that.”  Devon Campbell“People, they just see this waterfall approach and use it. Kind of blindly, almost.” Devon Campbell“You start seeing huge gains in efficiency and productivity and customer satisfaction for software companies where they are using this approach.” Devon CampbellLinks:FDA - Design Control Guidance for Medical Device Manufacturers (Waterfall Diagram)FDA - Quality System Regulation, Part 820 Agile ManifestoScaled Agile Framework (SAFe)Large-Scale Scrum (LeSS)Software as a Medical Device (SaMD)ISO 13485 - Medical DevicesProdct LLCDevon Campbell’s EmailDevon Campbell on LinkedInDevon Campbell on TwitterProject Medtech Podcast with Duane ManciniEasy Medical Device Podcast with Monir El AzzouziGreenlight Guru AcademyGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Who loves internal auditing? Probably 99.99 percent of medical device professionals answered “not me!” While it may not be everyone’s favorite pastime, internal audits are very important...especially if you have or want a true quality culture and mindset of continuous improvement.  In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru at Greenlight Guru.Sara loves to talk about internal audits. She shares her valuable wisdom of internal audits as well as learnings from leading Corrective and Preventive Action (CAPA) investigations and implementations, process improvements, and supplier and regulatory audits throughout her career in the medical device industry.Some of the highlights of the show include:Internal audits shouldn’t be about checking a box. If you know about problems, fix them first. Internal auditing offers opportunities for improvement. From a risk perspective, where are the trends and weak areas? Find them before someone else does and causes complaints or extra work. It is valuable to be able to look into those problem areas that need to be fixed. More medical device companies need to change their mindset by embracing quality as part of their culture, not as an obstacle or barrier. Collaborate with other departments because everyone has to own their process and procedure.Quality auditors may say there’s no choice, this has to be done. If the company has a CAPA or other options to be compliant, management will offer its buy-in. Misconceptions about internal audits include conducting internal audits on every process and procedure at least once a year, and if there’s any audit finding, you must create a CAPA. Key Tips: Make a plan/schedule, document and follow internal audit process, and realize that CAPA’s are only meant for major, risk-based, systemic issues. Memorable quotes from this episode:“We can always get better. Internal auditing is one method that, done properly, can help us improve our processes and our operations as medical device companies.” Jon Speer“I like rules. I like boundaries. I like guidelines.” Sara Adams“You can fix it and not give someone else an opportunity to find that.” Sara Adams“Your internal audits should be the toughest audits that you ever have.” Jon Speer“Being able to present options that still will take you into compliance, I think, is huge for getting management’s buy-in.” Sara AdamsLinks:Sara AdamsISO 13485:2016FDA - Medical Device Single Audit Program (MDSAP)Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a medical device?  In this episode of the Global Medical Device Podcast, Jon Speer talks to Milton Yarberry, Director of Medical Programs at Integrated Computer Solutions (ICS).Jon and Milton discuss practical pointers for determining and describing the similarities and differences between the two types of devices. Milton also offers some helpful recommendations for IVD manufacturers to consider when it comes to regulatory compliance and their quality system.Some highlights of this episode include:An IVD consists of the agents, instruments, and systems used for the diagnosis of disease or other health conditions, such as HIV, hepatitis, diabetes, and flu.From a patient perspective, the IVD is not invasive. A sample of something, such as saliva, urine, or blood from the patient is taken. Then, the sample is prepared and put through an IVD for analysis to determine the results of a specific test. An IVD is the equipment that analyzes the patient’s sample, not the actual patient. The IVD focuses on the fidelity and accuracy of the tested sample. There’s risk for the patient. Who’s performing the test (lab or licensed clinician), what’s being tested for (non-life threatening disease or not), and if results are inaccurate.Information has to be crystal clear because the user population could be a child, elderly person, or otherwise who takes the wrong action or misinterprets actions that could lead to death. If you have been tested for the coronavirus (COVID), how was the sample collected? How long was the swab that went up your nose? How long was it in?An IVD is a medical device and is subject to the same pre- and post-market controls. It needs a quality system and similar risk-based classification.Treat people and their data in your clinical study well. A lab developed test (LDT) and investigative device should not be perceived as a regulatory path.Memorable quotes from this episode:“That’s the key difference. There’s no patient. There is a sample.” Milton Yarberry“It clearly gives you a target population, a way they’re going to use it, a way they can misinterpret it, and all of those should become mitigations in your design.” Milton Yarberry“You can tell if you hit the right spot if the person wants to punch you.” Milton Yarberry“It’s hard to translate some of that science, that research, that clinical, that laboratory side of things into something that’s commercialized and into something that’s regulated.” Jon Speer“It’s a mindset of the manufacturer that I think is the main difference.” Milton YarberryLinks:Integrated Computer Solutions (ICS)ICS & Greenlight Guru PartnershipCenters for Disease Control and Prevention (CDC) - Waived TestsClinical Laboratory Improvement Amendments (CLIA)FDA - CLIA Waiver by Application510(k) Premarket Notification IEC Standard 6236621 CFR Part 820ISO 13485Laboratory Developed Tests (LDT)EU MDR and IVDREmergency Use Authorization (EUA)Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

For medical device professionals, there are the “knowers” and the “doers.” One group is knowledgeable about quality best practices and product realization needs, but may not know how, or have the desire, to act upon it. The other group puts that knowledge into action by doing the best practices that are needed to realize the product needs and [seize all] opportunities.In this episode of the Global Medical Device Podcast, Jon Speer talks to John Kapitan, CEO at Kapstone Medical, about the difference between knowing and doing as medical device professionals and how to do what’s right for the success of your medical device.Some highlights of this episode include:People view quality differently and need to overcome pessimistic and negative perceptions. Quality is a mindset and helps companies solve business problems.Quality is knowing the right thing to do versus doing it. Some people are ignorant because quality is not their role and do not necessarily know best practices. Other people are outwardly antagonistic who know the right thing to do, but choose not to do it for a variety of reasons.  Apathetic people have an idea of what to do or have been told what to do and want to do the right thing by the patients, regulatory bodies, and investors. Quality is common sense that focuses on best practices, documentation, and performance. Rather than caring about traditional technical quality related areas, a quality system is one of the last things some companies/investors consider.Pre-revenue and pre-commercialization companies don’t need to build a quality system that has all the bells and whistles. Start with the core and add-on as needs arise.There is a right and wrong way to implement quality in any organization. Take an efficient, effective, and pragmatic approach to understand compliance and the must-haves, not the nice-to-haves. Make sure to have someone on your team to discuss and champion quality, and implement a quality system that runs the company, not the company running it. Memorable quotes from John Kapitan:“I want to do the right thing. I know I can learn because I don’t know everything and there’s probably better ways to do this. More efficient ways, more effective ways to do this.”“If quality is not your role, you’re not necessarily going to be on top of what good practice is, what best practice is for quality, and what quality requirements are from FDA or overseas. You may be ignorant of just what to do and how to do it. ”“Quality is common sense. It’s not procedures, it’s common sense. It’s how would you do this if you were going to have this device put in your own body or your family members?”“There is a right way and a wrong way to implement quality in any organization.”“It’s always about prioritizing what we spend time thinking about, what we talk about, and what we invest in.”Links:John Kapitan on LinkedInKapstone MedicalFDA - Design ControlsISO 13485 - Medical Devices Premarket Notification 510(k)Premarket Approval (PMA)Investigational Device Exemption (IDE)Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, are you a customer who has benefited from using them?    In this episode of the Global Medical Device Podcast, Jon Speer talks to Alison Lee about her PPE startup Breathe99, which pivoted operations in developing its high-quality face mask product to meet respiratory needs and provide personal protection during the coronavirus pandemic.Some of highlights of this episode include:Breathe99’s mask filters 97 and 99 percent of airborne particles. It is not N95 certified, yet, but was designed based on those requirements.The prototype of the B1 mask offered protection with complete sealing around the mouth and nose, but allowed adequate breathing through a high-quality filter.The kickstarter for the B1 mask didn’t reach its goal, but then came an obviously serious and urgent need for high-quality respiratory protection. So, the kickstarter campaign for the B2 mask started. A total of more than $750,000 was raised.Positive Feedback—Doctors, teachers, volunteers, and other people feel safer wearing Breathe99’s B2 mask. It’s allowed them to continue doing their job.The FDA regulatory product approval process and NIOSH certification is not straightforward. Documenting users’ needs and testing requirements is a long-term path that requires proper and realistic planning.Alison discusses how Greenlight has been a resource for bringing the B2 mask to market. It offers peace of mind by going step by step at an appropriate pace to navigate the design and development process.The bureaucratic and complicated regulatory process takes much longer than expected. It presents common challenges, such as checks and balances of medical devices, change orders, and regulatory approval. Medical Device Journey: Learn while you’re learning it. Be deliberate and perform due diligence to be part of the solution. Understand your scope, users’ needs, and why it’s important to design appropriate, safe, and effective products. Memorable quotes from Alison Lee:“We’re a startup company based in Minneapolis that makes a high-quality face mask that filters 97 and 99 percent of airborne particles. Can’t say we’re N95-certified yet, but those are the requirements that we’ve designed our mask around.”“We love hearing about how people feel safer wearing our mask. It’s allowed them to continue doing their job.” “That stamp of approval from NIOSH and from the FDA is really, really important for people to trust our product.” “Be aware of your scope, and you can really only do that by talking to people as soon as possible before you, I guess, make an assumption. We definitely thought the regulatory process would be a lot faster.”

Do you fear needles and the associated pain? No one understands this fear more than physicians who see it firsthand with their patients day in and day out. And one physician in particular set out to do something about it.In this episode of the Global Medical Device Podcast, Jon Speer talks to Dr. Amy Baxter, CEO and founder at Pain Care Labs. Amy discusses the pros and cons of being a physician, entrepreneur, and inventor of reusable, physiologic medical products to eliminate unnecessary pain.Some highlights of this episode include:The medical world works on 2-D pharmaceutical schematics, but doctors’ minds work on three dimensions. Physician inventors see the whole body, person, and need to develop effective medical products.Physician inventors think they know everything, so it’s difficult for them to follow ISO 13485 and painstaking medical device development and not get frustrated. The time duration for Amy’s innovation and invention journey took years to get patents, meet regulatory requirements, and address the opioid crisis. Pain management is esoteric and subjective. Amy encourages physician inventors to fall in love with their problem, not their solution. Pain, chronic or not, is a real problem. Amy shares life lessons for physician colleagues with innovative ideas. Find a group like Greenlight Guru or GCMI to understand navigation early on. Branding matters, so choose wisely.Also, Amy advises physician investors to not get hung up on non-disclosure agreements (NDAs). Nobody steals an idea, they steal a medical product.Amy expects the future of pain management to include multiple specific energy devices in people’s medicine cabinets to use before and after surgery. Mechanical stimulation will be the primary one because it’s easy and safe to use.Buzzy® is a palm-sized device that combines cold and mechanical stimulation to block pain and improve muscle soreness, blood flow, and recovery. The VibraCool® Cryo-vibration product, VibraCool’s M-Stim, is 2-3.4 times superior to electrical stimulation (TENS) for physical therapy. It has demonstrated 35% fewer opioid tablets. Also, a lower back pain device is in clinical trials and expected to be released this year.Memorable quotes by Amy Baxter:“We see the whole body, we see the whole person, and we see the need.”“The downside of being a physician inventor is that we both feel like we know everything.” “Wanting to be able to do something is really the push that puts a lot of physicians into the entrepreneurial space.”“Fall in love with your problem, don’t fall in love with your solution.”“Try your idea out on someone who does not love you.”Links:Pain Care LabsISO 13485 - Medical DevicesISO 14971 - Application of Risk ManagementFDA - Part 11EU MDRNIH Small Business Innovation Research (SBIR))/Small Business Technology Transfer (STTR) Mayday FoundationGlobal Center for Medical Innovation (GCMI)Dr. Richard MelkerMedical Device Podcast, Ep 186: Building a Startup in the MedTech Industry Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Why does the FDA have three systems in place to address and handle risk related to medical devices? Each system serves a different purpose, but are all three actually necessary?In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about FDA’s three systems of risk for medical devices and the unique interdependencies and distinctions between them.Some highlights of this episode include:Three systems for medical device risk from FDA: product classification, significant vs. nonsignificant risk, software level of concern.The FDA’s classification system handles risk by classifying medical devices as Class I, II, or III. The higher the class, the higher the risk. The lower the class, the lower the risk. Yet, risk is a broad subject and there are a ton of exceptions.Also, classification numbers/levels used by the FDA in the United States do not translate in a linear way to those in the European Union (EU) and elsewhere. There are similar systems but different rules that are philosophically different. The significant vs. nonsignificant risk system focuses on clinical trials for medical devices. All clinical evaluations of investigational devices, unless exempt, must have an approved investigational device exemption (IDE).The software level of concern is important because it determines the level of documentation required for software development. The default classification for any new medical device is Class III. If it’s a new device, it’s not well-established and the benefits and risks are relatively unknown.When it comes to labeling, say anything as long as you can prove and support it. When technology stays the same but the labeling claim changes, risk changes.  The determination of significant or nonsignificant risk is not made by the FDA or Institutional Review Board (IRB), but the medical device company.The software level of concern consists of Class a, b, and c. Does the software have no possibility of causing injury or damage to health? Is non-serious injury possible? Or, is serious injury or death possible?Memorable quotes by Mike Drues:“Theoretically, the classification of your medical device depends on risk. In other words, the higher the class, the higher the risk. The lower the class, the lower the risk.”“The default classification for any new medical device is Class III, which basically means we set the bar at the highest possible level.”“Oftentimes in regulation, we do things not because they make sense, but because that’s the way we’ve done them in the past.”  “The determination of significant or nonsignificant risk is not up to the FDA. It’s not even up to your IRB, or Institutional Review Board, it’s up to the company.”Links:FDA - Classify Your Medical DeviceFDA - Significant Risk and Nonsignificant RiskFDA - Software Level of ConcernFDA - Product Code Classification DatabaseInvestigational Device Exemption (IDE)De Novo Classification ProcessCenter for Devices and Radiological Health (CDRH)Requests for Feedback and Meetings for Medical Device SubmissionsMike Drues on LinkedInGreenlight Guru Webinar - Advanced Strategies and Tactics for Using the De Novo PathwayGreenlight Guru Webinar - Understanding the Medical Device Classification SystemGreenlight Guru Podcast EP 37: Significant Risk vs. Nonsignificant Risk Devices - What's the Difference? Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD manufacturers approach quality management and other key elements based on these similarities and differences?In this episode of the Global Medical Device Podcast, Jon Speer talks to Joanne LeBrun from MDC Associates, which offers quality systems consulting, regulatory consulting, and implementation training.Joanne offers valuable insights on the topic of managing quality for in vitro diagnostic devices and the unique relationship these devices have to medical devices in terms of industry best practices and tools that manufacturers can use to produce high quality devices that are safe and effective for end users.Some highlights of this episode include:IVDs are different from medical devices and therefore treated differently. The difference between IVDs and medical devices is the way performance is proven.Read the FDA and EU regulations for medical devices and IVDs because changes are immense for the classification of devices. The amount of growth for IVD startups is driven by the up cropping of contract manufacturers. There’s a lot more bringing it to market with less resources.The pandemic has been good for the medical device industry and for bringing products from concept to fruition and through regulatory approvals quickly.Don’t reinvent the wheel. Focus on your technology and seek advice from quality professionals to achieve efficiency and effectiveness.Or, make space for the FDA to move in for months for an inspection and audit. Do the right thing and know what the right thing is. Keep your audit manageable.Perform quarterly quality fire drills with a robust internal quality audit program to prepare ahead of time. Review inventory, complaints, deviations, and more to be current on compliance. Big Mistakes and Common Challenges: Starting design control and risk management too late. It doesn’t take that much effort to document work. Memorable quotes by Joanne LeBrun:“The difference between IVDs and medical devices is the way that you can prove performance.”“The quality systems are similar, but if you’re a medical device person and you’re headed into an IVD situation, do keep in mind that it is quite different and the rules for IVDs are just a little bit more forgiving than in a medical device arena.”“There’s a lot more bringing it to market with less resources to be able to use some of those contractors.”“The pandemic, while it’s been very hard on a lot of people and I don’t certainly belittle that, it has been very, very good for our industry and has been very good for bringing products from concept to fruition and through regulatory approvals so fast, maybe too fast.” Links:Joanne LeBrun on LinkedInMDC AssociatesFDA - Medical DevicesEuropean Union Medical Device Regulation (EU MDR)EU IVDRISO 13485 Quality Management for Medical DevicesAbbott LaboratoriesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Does your medical device qualify for an investigational device exemption (IDE)? What does this process involve and what does FDA expect of these manufacturers? There is plenty to consider when it comes to the IDE timeline and process.In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill “Mr. Regulatory” who sheds valuable light on the topic of IDE, which allows an investigational device to be used in a clinical study to collect safety and effectiveness data, and how to navigate this process in an efficient and compliant manner.Some highlights of this episode include:FDA has a few programs to consider when it comes to safety and significant risk or not for products. High-risk devices could fall into a non-significant risk study.Exempt or not? Make sure to provide sufficient information to identify significant or not risks based on objective evidence. COVID-19 issues prompted FDA to post guidance on statistical considerations, confounding factors, and remote monitoring for IDE and clinical studies.When does FDA require an IDE? If it’s a new device category or significant departure from the existing technology, FDA will probably need clinical data.All PMA devices do not require an IDE. Also, a device that follows the 510(k) path does not require clinical data, but an IDE may be requested with a clinical study for marketing submissions and reimbursement. The contents of an IDE application must include 12 items, such as the name and address of the sponsor; a complete report of prior investigations of the device and an accurate summary of those sections of the investigational plan; and a description of the methods, facilities, and controls used for the manufacture, processing, packing, storage, and installation of the device.Within 30 days, the FDA is expected to give a decision on the submission. The study will be approved, approved with conditions, or disapproved.Memorable quotes by David Pudwill:“Everybody wants to be breakthrough, but not everybody is breakthrough.” “There are a lot of clinical studies that are just exempt from IDE regulations.”“Even high-risk devices could fall into a not significant risk kind of a study.”“There’s always a chance that the FDA is going to disagree with you, if you think it’s non-significant risk. FDA is going to lean, in general, towards a slightly more conservative judgement on gray area issues.” “Specifically, if it’s a new sort of category of device or a significant departure from the existing technology, you’re probably going to need clinical information.”Links:David Pudwill (Mr. Regulatory) on LinkedInMr. Regulatory WebsiteMr. Regulatory on YouTubeFDA - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission ProgramInvestigational Device Exemption (IDE)FDA - IDE  BasicsPodcast - An Introduction to FDA’s Regulation of Medical DevicesPremarket Approval (PMA)Premarket Notification 510(k)De Novo ClassificationHumanitarian Device Exemption (HDE)Breakthrough Devices Program (BDP)Early Feasibility Studies (EFS) ProgramEFS Breakthrough Device Designation Safer Technologies Program (STeP)Center for Devices and Radiological Health (CDRH) LearnInstitutional Review Boards (IRB)Significant Risk vs. Non-Significant Risk for Medical Devices21 CFR Part 812Greenlight Guru AcademyGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself? There’s a supplier management solution that will make your job a whole lot easier.In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-owner of ‎QUNIQUE, a quality and regulatory consultancy. Previously, Bassil worked with the notified body, TÜV SÜD.Bassil discusses QUNIQUE’s Quality Engine (QE) solution for supplier management, which helps manufacturers find compliant solutions to fulfill obligations and achieve continuity that puts medical devices on the market.Some highlights of this episode include:QE is a one-stop shop, like Amazon is for consumer products and Google is to ask questions about everything. However, QE specifically searches for healthcare, medical devices, pharma, and IVD products and service providers. QE is a platform invented but not influenced by QUINIQUE. Every notified body and registered consultants are listed. With QE, you can find, identify, select, and contact global suppliers.To join and register for QE, book a membership package, choose a service provider type, and search by selecting relevant criteria. QE includes testing labs, distributors, suppliers, and requests. Otherwise, if you’re searching for results, you have to connect with multiple places and people.Evaluating, monitoring, and selecting suppliers can be frustrating and time consuming. QE simplifies supplier management. Transparency is necessary to have fair competition and a clear supplier selection. Then, you no longer need to be dependent on a single supplier.Memorable quotes from Bassil Akra:“We are helping manufacturers and we are finding solutions toward getting them really compliant, but getting them also in a lean way fulfilling their obligation and being able to achieve the target of market continuity and getting their device on the market.” “Every one of us is nowadays struggling to find things.”“It is not the end list, this is the beginning. We’re going to extend this platform to get more transparency on the market.” “We have a large number of service providers who are unknown and they are available when we need them but we don’t know about them.” “Transparency is all what we need in life to have fair competition and a clear supplier selection.”Links:Watch this episode on YouTubeBassil Akra on LinkedIn‎Quality EngineQUNIQUE GroupEuropean CommissionEuropean Union Medical Device Regulation (EU MDR)European Union In-Vitro Diagnostics Regulation (EU IVDR) Notified BodiesTÜV SÜDMedTech EuropeAdvaMedGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that has historically been known to evoke a fearful, negative response by medical device professionals.In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, known in the industry as Mr. Regulatory, about the reasons why the PMA process is so dreaded by manufacturers bringing a Class III medical device to market in the United States.

Why is design, manufacturing, quality, and culture so important in the medical device industry? These key elements must exist and function in synchrony so that a medical device can save and improve patient lives.In this episode of the Global Medical Device Podcast, Jon Speer talks to Dan Purvis, CEO at Velentium—a design, development, and manufacturing firm that takes medical devices through an entire lifecycle.Dan gives listeners an update on Project V, an initiative involving the mass production of ventilators comprising five separate devices aimed at saving lives and meeting worldwide demand in response to COVID-19.Some highlights of this episode include:Velentium partnered with Ventec Life Systems, General Motors (GM), and the U.S. Government to build 30,000 ventilators and 141 manufacturing test stands in a 6-8 week period for Project V.Managing Manufacturing: The challenge with COVID is that so much is unknown. CDC provides guidelines for who can/cannot be in your facility, but not for who should/should not be allowed in your facility.Humans are hurting because of COVID. The gain or loss of productivity focuses on these key areas: Messiness of COVID, quality manufacturing, and culture of safety. How can a company maintain a culture of empathy, and at the same time, get a job done to pay the bills?Top Tips and Best Practices: Data Repositories: Move, store, and transition source code files, data, and other information as soon as possible to the Cloud.Design and Development: Foster a culture of understanding, efficiency, and flexibility.Four Variants of Design:Design for Manufacturability: Device passes design controls and receives approval, but it is extremely expensive and/or impossible to make.Design for Test: Testing throughout as you go, including product characterization testing and design verification testing.Design for Longevity: Manufacturable but think about design materials around longevity-oriented parts.  Design for Quality: Analyze for number of times used, shelf-life, patient safety, and cybersecurity.Memorable quotes from Dan Purvis:“That project was extremely successful. Thirty-thousand ventilators were built in Kokomo, Indiana, in an automotive factory that had not ever built a ventilator before.” “When you send these devices out into the marketplace, one hospital at a time, you can be assured that they’re going to do good just like they were intended to.” “Remind people that this is the real deal. Most of us, if not all Americans at this point, know someone who has passed away. Or, they know someone who knows someone who has passed away.” “The science is clear that when we are masked up and distanced, we have a much better chance of not spreading the disease.”

What do manufacturers need to know about the Safer Technologies Program (STeP) for Medical Devices from FDA? How is STeP different from similar programs, like the Breakthrough Devices Program? Which devices are eligible?In this episode of the Global Medical Device Podcast, host Jon Speer and his guest Mike Drues from Vascular Sciences offer answers to these questions and educate listeners on this new, voluntary program, helping manufacturers with eligible devices leverage STeP for easier, faster entrance into the US marketplace.

One of the main differentiators that makes Greenlight Guru so unique is its Guru Edge. The medical device gurus ⁠are a team of medical device professionals with decades of combined industry experience and subject matter expertise.In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru at Greenlight Guru. Sara shares how her professional journey began as a biomedical engineer in the post-manufacturing industry. Listen as Sara offers valuable advice to listeners about her work as a quality engineer leading Corrective and Preventive Action (CAPA) investigations and implementations, process improvements, and supplier and regulatory audits.

What does it take to build a successful MedTech startup? It’s a multi-million dollar question and the answer involves strong execution of a highly strategic plan.In this episode of the Global Medical Device Podcast, Jon Speer talks to Duane Mancini, president and founder of Project Medtech, and host of the Project Medtech Podcast. Listen as Jon and Duane talk about building a startup in the MedTech industry and why it’s so important for MedTech startups to be strategic in their approach to bringing a device to market, like taking advantage of reimbursement opportunities and leveraging a QMS to support all efforts along the way.

What makes Greenlight Guru unique? It’s Guru Edge⁠—a team of medical device professionals with a ton of industry experience.In this episode of the Global Medical Device Podcast, Jon Speer talks to Karen Schuyler, a Medical Device Guru at Greenlight Guru with nearly 15 years of experience working in the medical device industry.Listen as Karen offers value advice to medical device professionals on how to establish important system connections that coincide with regulations so that you can make your processes more efficient and supercharge the quality management engine for your medical device.

Imagine using medical illustrations, animations, and other types of artwork to tell the story of a medical device, its procedures, or its manufacturer.In this episode of the Global Medical Device Podcast, Jon Speer talks to Annie Campbell and Emily Holden from Now Medical Studios, where they create medical illustrations and animations for the healthcare industry. Listen to Annie and Emily explain how their unique artwork is transforming the way we see and understand medical devices.

Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are interested in entering the SaMD space, what do you need to know when it comes to FDA regulations and guidance?In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, “Mr. Regulatory”, who has nearly a decade of firsthand experience working for FDA.Listen to Mr. Regulatory and Jon discuss all things related to SaMD from the perspective of FDA and how the agency is regulating these emerging medical device technologies.

How can medical device companies be better prepared for remote and on-site inspections or audits? Practice, practice, practice so that you’re always audit-ready.In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry, lead consultant and senior advisor for Quality Systems and Compliance, respectively, within the FDA and Life Sciences division of their law firm, King & Spalding LLC.Listen to this episode where Steven and Eric share their keen insights and knowledge from working in the global regulatory sector of the medical device industry and offer best practices and tips that will help you prepare for FDA inspections and other audit events.

The new medical device regulation in the European Union (EU MDR) has introduced a host of new challenges for medical device companies. One challenge, in particular, has to do with the quality management system of a medical device.In this episode of the Global Medical Device Podcast, Jon Speer talks to Monir El Azzouzi, founder and CEO of Easy Medical Device. Also, Monir is a prolific podcaster, blogger, and YouTuber that helps medical device companies achieve compliance. Together, Monir and Jon discuss the ways in which EU MDR impacts a quality management system and best practices medical device companies can follow to maintain compliance with new requirements.Some highlights from this episode include:Medical device manufacturers have several QMS standards, regulations, and frameworks to follow, such as ISO 9001, ISO 13485, and FDA 21 CFR Part 820. Rumor has it that the FDA is harmonizing its Quality System Regulation (QSR) with ISO 13485:2016. Why? FDA’s QSR and ISO 13485:2016 offer significant similarities toward harmonization depending on where medical device companies, manufacturers, and products are located (in the United States or European Union). EU MDR implementation involves a complex transition process, it’s not about simply updating a technical file.What are the differences between ISO 13485:2016 and EU MDR? Refer to Article 10.9 for process requirements and Easy Medical Device courses. Research notified bodies to determine and verify authenticity, authorization, and accreditation. QMS changes related to EU MDR place greater emphasis on clinical and post-market surveillance as well as risk/benefit management. Be proactive!When everything goes well, nobody rechecks what you are doing. As soon as there is an issue on the market or there is a competitor that may want to raise some concerns, then the authorities can come and visit your site.EU MDR: Will it be delayed or postponed again due to COVID, remote audits, or because it’s too difficult to implement? MDR is a chance to level up and raise the bar in the medical device world. Memorable quotes from Monir El Azzouzi:“A quality management system is not just a bunch of documents.” “When you are, for example, manufacturing some medical devices, you have to respect some rules, some regulations.” “Don’t pay something twice (choose certification vs. notified bodies wisely).” “EU MDR is a regulation that is...raising the bar in terms of requirements and things that you need.” “When everything goes well, nobody will recheck what you are doing. But as soon as there is an issue on the market, as soon as there is a competitor that maybe wants to raise some concerns, then the authorities can come and visit your site.”

What do auditing and compliance protocols look like during a pandemic? Medical device companies continue to adjust to changing circumstances in an attempt to maintain business as close to normal as possible.In this episode of the Global Medical Device Podcast, Jon Speer talks to Colleen Hittle, founder of ProVeritas Partners, who brings years worth of knowledge and experience in the regulatory environment of healthcare and life sciences. Colleen provides listeners with guidance and support for engaging in virtual auditing and navigating the post-COVID digital world of compliance.

Keeping a constant pulse on current medical device industry standards for risk management, like ISO 14971:2019 and its companion documents, while also adhering to the recommended guidelines is one of the most important things a medical device company can do to be successful. In this episode of the Global Medical Device Podcast, Jon Speer talks to Ed Bills, risk management consultant and technical committee member of the working group for ISO 14971:2019 and ISO TR 24971:2020, who shares key insights from his work developing the latest version of the international risk standard and offers recommendations for companies that will help strengthen their product risk management practices.

Medical device reimbursement is a key consideration that must be well researched, understood, and managed by companies in order to ensure no money, to which you’re entitled to, is left on the table. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the importance of medical device reimbursement and offers tips listeners can use to build a competitive reimbursement strategy that puts dollars back in the company’s pocket once a device is on the market.

Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Health (NIH) aimed at accelerating the development, commercialization, and implementation of COVID-19 testing technologies that shorten viral detection cycles and increase access to reliable, accurate testing on a widespread scale. In this episode of the Global Medical Device Podcast, Jon Speer talks to Devon Campbell, founder of Prodct, who has been a major contributor in supporting the efforts being made by RADx teams. Listen as Jon and Devon share five actionable lessons learned from Devon’s involvement with RADx, each of which can be applied by medical device companies across the board.

What are the 2021 strategic priorities for FDA’s Center for Devices and Radiological Health (CDRH) and what impact will these initiatives have on the medical device industry? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about CDRH’s previous, current, and future strategic priorities, including those impacted by the COVID-19 pandemic.

What’s the relationship between product feedback, complaints, and adverse events? In this episode of the Global Medical Device Podcast, Jon Speer talks to guest Isabella Schmitt, Director of Regulatory Affairs at Proxima Clinical Research (CRO). Jon and Isabella discuss some important processes and methods medical device companies should consider for soliciting, receiving, and handling feedback.

What impact has artificial intelligence (AI) and machine learning (ML) had on the medical device industry thus far? Have the emergence of these new technologies created new, unanticipated regulatory and quality challenges for industry professionals? In this episode of the Global Medical Device Podcast, host Jon Speer and guest Mike Drues from Vascular Sciences revisit the topic of AI/ML to identify notable changes and technological advancements that have emerged as a result of these technologies and how industry professionals are responding.

Are you prepared for the aftermath of the pandemic’s impact on the medical device industry? It may be time for device professionals to start bracing for a new normal. In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry from King & Spalding LLC about post-pandemic readiness for the medical device industry and how companies can prepare for and embrace the new medical device landscape that’s expected to take shape from 2021 onward. Steven, a former FDA deputy associate commissioner and COO for the agency’s Office of Regulatory Affairs currently serves alongside Eric as the Quality Systems and Compliance lead consultants in the FDA and Life Sciences practice of their law firm. With more than 50 years of combined industry experience between Steven and Eric, the insights and knowledge of this episode’s guests, specifically as it relates to this topic is a MUST listen for any medical device professional. Some of the highlights of the show include: Steven and Eric discuss how COVID is pushing the FDA toward a voluntary pilot program for agency investigators to conduct virtual facility inspections. Steven describes the current state of FDA inspections as challenging to work remotely and conduct follow-ups when appropriate. The FDA has established a paradigm to continue on-site mission critical inspections. Eric expands on the logistical challenge for inspections by explaining that since the FDA has put a hiatus on its inspection scheme, many organizations are following the Medical Device Single Audit Program (MDSAP). The Medical Device Coordination Group’s (MDCG) 2020-4 Guidance lists four circumstances where organizations under MDSAP or EU notified bodies have remote audits—surveillance, re-certification, change notification, and termination. Impact of the Emergency Use Authorization (EUA) program and the influx of requests on FDA. Some EUA submissions require pre-approval inspections. Before EUAs are revoked, build a remediated QMS, prepare for inspection, and decide whether to continue manufacturing a product after the pandemic. King & Spalding’s FDA and Life Sciences team offers a full-service approach, including cardiologists to help with health assessment risks, premarket and postmarket mergers and acquisitions, and warning letters. Pre-submission is an initial but formal way to build communication, collaboration with the FDA. A pre-submission can be an effective means for understanding regulatory requirements.

The end of 2020 is near, which will close out a year that’s been fraught with challenges and difficulties. However, 2021 will bring its own set of new challenges for those implementing the European Union Medical Device Regulation/In-Vitro Diagnostics Regulation (EU MDR/IVDR). What do device companies still need to do to be prepared for the transition? In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-Owner of ‎QUNIQUE Group, a quality and regulatory consultancy. Bassil offers expert advice on how device companies need to prepare for these regulatory deadlines and transition to meeting the requirements of EU MDR/IVDR sooner rather than later. Some of the highlights of the show include: COVID-19 is an additional burden by impacting implementation, increasing requirements, and not being transparent about limited notified body capacity. EU MDR/IVDR Readiness: Under the new legislation, every device needs to receive re-certification by notified bodies to keep market access. EU MDR/IVDR Challenges: Additional guidance needed during transition to apply these regulations. Regulations put expectations that are not ready, such as EUDAMED. Increased requirements on clinical evidence via higher clinical and performance evaluation requirements. Continuous reporting increases expectations on resources for new and existing medical devices. EU MDR/IVDR Timeline: Number of notified bodies isn’t the most important part. How much capacity do those notified bodies have to address market needs? Tips for Medical Device and In-vitro Diagnostic Companies: Read the regulation(s). Understand implication(s) of regulation(s) on system(s). Identify/re-evaluate notified bodies that can address needs. Manage timeline/deadline for submission, implementation, certification.

Still seeking guidance to stay in the know when it comes to new and updated FDA requirements related to medical devices, especially during the ongoing pandemic? In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, senior director of regulatory affairs at ConvaTec and industry thought leader who has been coined the name “Mr. Regulatory.” Listen to this episode as Mr. Regulatory shares his predictions on potential policy changes or updates we may begin to see from FDA, as influenced by the Emergency Use Authorization (EUA) response to address the current health crisis caused by the COVID-19 pandemic.

Software as a Medical Device (SaMD) is one of the fastest growing segments of the medical device industry. How are regulators keeping pace with its growth? FDA has a set of specific requirements unique to SaMD that companies are expected to meet in order to market these devices in the United States. In this episode of the Global Medical Device Podcast, Jon Speer talks to Andrew Frink, regulatory affairs manager at Proxima Clinical Research (CRO) about the ways in which SaMD companies can improve final submission outcomes of these devices by leveraging Pre-submissions to FDA, which involves meeting the agency's applicable regulatory guidelines and pre-sub expectations.

There’s one niche market within the device industry that rarely gets the attention it deserves: products designed for military applications and use in other emergency settings. In this episode of the Global Medical Device Podcast Jon Speer and his cohost, colleague and medical device guru Wade Schroeder, talk to guests Monti Leija and Robert Futch from the Delta Development Team, manufacturers of ruggedized thermal systems who specialize in military applications. Listen to this episode to learn about the Delta Development Team’s journey designing their latest product the Autonomous Portable Refrigeration Unit (APRU) that provides a cooling and heating systems for extreme environments. Some of the highlights of the show include: APRU is medical refrigeration for medical professionals. It provides constant cooling of blood products, vaccines, virus samples, and temperature-controlled medications. APRU applications include military operations, disaster relief response, and emergency medical systems (EMS) because the device meets AABB guidelines and FDA regulations. The military provided end-user feedback on how it wants the APRU to function and perform. Therefore, the APRU is unique because it’s small and runs on a battery that can be charged. Power of Innovation: The biggest power consumers are refrigerators and air conditioners—both require refrigeration. Obstacles and Challenges: Every time somebody goes through the medical device journey it involves learning and becoming aware of regulatory guidelines. Recommendations: Find the right consultants, team members, and standards management tools. Wade Schroeder, Greenlight Medical Device Guru, has been a major asset to the Delta Development Team by providing regulatory guidance. Testing Methodologies: Motivation is to meet extreme environment requirements and standards. Some manufacturers choose to not meet some standards to make mobile medical devices that don’t work as well. APRU is the new standard. Root Cause and Right Configuration: Make minor adjustments to prototypes to reduce complexity, cost, and failure points via due diligence rather than rebuild.

Some sources claim that one-third of your product development project should be spent on defining good requirements. Why? Requirements are key determinants of success for any new product that’s being developed, especially a medical device. In this episode of the Global Medical Device Podcast, Jon Speer talks to Devin Mack, mechanical engineer and owner of Enqual, about the importance of spending enough time defining and managing requirements for medical devices. Some of the highlights of the show include: Story Behind Business Name: Enqual is a combination of Devin’s background in engineering plus quality to provide a balance between both. A picture (or graph and diagram) is worth a 1,000 words to describe product development and design controls for medical devices. A challenge that medical device companies tend to miss is the establishment of well-defined requirements during the product development process. Best Practices: Open communication between internal and external customers and the product development team as well as cross-functional involvement to define good requirements early in the process. Potential Pitfalls: What if stakeholders, engineers, and end users are not adequately considered in the development process? Everyone needs to voice their opinion to meet end user satisfaction and create a competitive edge to achieve goals. Stop Light, Agile, or Six Sigma Methodology? Track team’s progress versus focusing on customer specifications. Constantly evaluate where you are with respect to your requirements. Mantra: Invest time and money in useability/engineering models to get it right the first time to prove indications and meet proper requirements.

As the COVID-19 global pandemic continues, emergency use authorization (EUA) has become a highly utilized regulatory pathway to market in the United States. In this episode of the Global Medical Device Podcast, Jon Speer talks to Erica Loring, a medical device guru at Greenlight Guru. Jon and Erica discuss the positive and negative impacts of the EUA program on the medical device industry as well as the need for increased responsiveness to streamline distribution of in-demand products and services, such as tests, masks, and ventilators. Some of the highlights of the show include: EUA and PPE: Erica comes from a regulatory background and describes how the huge influx of EUA applications for ventilators and masks to in-vitro diagnostic device (IVD) and lab developed tests affect FDA tiers that reach consumers and companies. The FDA is government-funded and has a limited amount of resources. As a result, it’s scrambling to allocate people to review EUA submissions and 510(k)s for COVID-19 related tests to be legally marketed. Due Diligence: FDA’s review periods on other products have slowed down, but timelines still need to be met. Also, the quality of reviews has declined, not only with the EUAs but 510(k)s because of limited resources. FDA Statistics: A 510(k) review is supposed to take up to 90 days from the point of submission to an official response from the agency. However, EUA applications are being reviewed quickly to address a global public health crisis. Maybe too quick for regulatory quality and risks to be properly evaluated. Compare and Contrast: Erica describes the pros and cons of false-negative and false-positive results for COVID-19 and/or IVD tests. What risks do those results pose to the public? Research Use Only (RUO) to IVD: Companies that are not or have never been a medical device company need to have a quality management system (QMS), appropriate resources, and manufacturing transfers that can scale. This process takes time. FDA EUA Guidance: Proper development and design control provisions should not be viewed as optional. Companies should not cut corners but be expected to follow best practices and post-market challenges for quality events. EUA Impact Everywhere: Non-EUA products, procedures, and supplies were delayed, costs increased, and biocompatibility testing was affected due to the push for COVID-related products and services and eventual lift of those EUAs?