Global Medical Device Podcast powered by Greenlight Guru

Should your medical device company address biocompatibility? The short answer is, yes. Every single medical device should conduct some level of biocompatibility testing. What’s important is that you understand to what extent. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about biocompatibility of devices, the applicable FDA and ISO guidelines companies need to follow, and the possible ramifications if you don’t. Some of the highlights of the show include: Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin: FDA Draft Guidance is new, but doesn’t cover any new content. FDA’s intent is to clarify the types of biocompatibility information in submissions for certain devices made from common polymers and fabrics that come in contact with intact skin. What is biocompatibility testing? If you don’t know, that’s why regulation and guidance is necessary. Nobody knows everything, recognize what you don’t. ISO 10993 Evaluation and Testing: Review guidance, educate yourself, and engage experts because objective evidence is needed to corroborate the case for biocompatibility. FDA’s Recommendations for Biocompatibility: List device materials with direct/indirect skin contact and statement comparing/confirming safe use of those materials. Provide history and clinical study reports of adverse effects/events of skin contact materials, such as redness, swelling, irritation, allergic responses. Documenting sponsorship determining where biocompatibility risk and testing is not necessary, such as purchasing controls. Using labeling to mitigate risk of possible skin reactions. Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol: FDA Final Guidance raises special considerations for thermomechanical behavior and processing sensitivity of nitinol when compared to conventional metals.

What makes Greenlight Guru unique? It’s Guru edge⁠—a team of medical device professionals with decades of industry experience whose primary role within the company is to enable customer success. In this episode of the Global Medical Device Podcast, Jon Speer talks to Erica Loring, a medical device guru at Greenlight Guru. Erica shares her unique career journey working in the healthcare sector, which ultimately led her to enter the medical device and in-vitro diagnostic device space where she now provides world-class quality and regulatory support to device companies. Prior to joining Greenlight Guru, Erica worked in both the pharmaceutical and the biotech industry, serving as senior manager of quality and regulatory where she was responsible for implementing eQMS platforms for global enterprise companies. Some highlights of this episode include: As a medical device guru, Erica enjoys working with a wide range of companies, learns about various products, and helps those companies reach their goals by using a robust QMS. Erica’s superpowers, specialities, and strengths as a medical device guru revolve around all things regulatory and quality management to help companies function better and offer a sense of security. Conventional Wisdom: Are regulatory affairs and quality assurance the same or two different disciplines? Know it all and provide cross-functionality from product development to regulatory where quality doesn’t get in the way of productivity. Thought Process: Manufacturers, engineers, and others don’t have the mindset or systemic way to document inputs, outputs, and design development activities. Gentle hand or strict hindrance? Quality can enable or be an obstacle, but it’s the right thing to do. Check documentation, make changes, and meet demand. DiSC: If you have a hard time staying still, breathe and meditate for business development and personal growth. Strut industry knowledge to help companies. How can medical device companies be successful in today’s market? Time: Don’t rush or overlook anything. Plan for extra time and failures. People: Invest in the right and enough people, equipment, and space. Quality: Research and investigate suppliers. Make sure to have backups.

What is a multiple function device? From a high level, it’s a product with at least one portion that meets FDA’s Code of Regulations’ (CFR) definition of a medical device and at least one other portion that does not. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about multiple function devices to help listeners gain a clear understanding of this increasingly popular device type.

What could go wrong as more medical device products are used at home and in similar non-traditional environments outside of hospitals and healthcare facilities by non-medical professionals? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences. Jon and Mike discuss challenges related to safety, risk, and usability when medical devices intended for "at home" environments interface with untrained end-users.

What is FDA’s Safety and Performance Based Pathway and how does it relate to the Traditional, Special, and Abbreviated Premarket Notification 510(k) programs? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the Safety and Performance Based Pathway that's designated for certain types of medical devices only and what eligible companies should consider when using this pathway for submitting a 510(k) to receive FDA clearance.

Reminiscing about past and present lessons learned from listening to conversations with this show’s most frequent guest, one important principle emerged: Teach others how to think, not what to think. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues, president of the medical device consultancy firm, Vascular Sciences. Anyone who’s listened to the show knows that Jon and Mike are passionate about the world of medical devices, particularly design controls, regulatory affairs, and prudent engineering practices. Listen to this episode where they revisit how they met in December 2014 and what they have shared and learned through the years.

What sets Greenlight Guru apart from other quality management solutions? It’s Guru edge⁠—a team of medical device professionals with more than seventy years of combined industry experience. In this episode of the Global Medical Device Podcast, Jon Speer talks to Wade Schroeder, a medical device Guru at Greenlight Guru. As an electrical engineer and risk management enthusiast, Wade shares his unique approach to medical device product development and complying with regulations. He also shares a few of his favorite customer stories and offers his key recommendations to listeners on how to find success in the medical device industry.

Who looks forward to audits? Not most people except for maybe the actual auditor. Hold yourself accountable and stay audit-ready, so you can remove any pre existing concerns from the equation altogether. In this episode of the Global Medical Device Podcast, Jon Speer talks to Taylor Brown, a medical device guru at Greenlight Guru and certified Lead Auditor for ISO 13485. Taylor offers valuable tips on one of her favorite topics—audit etiquette. She explains her beliefs around how practicing a high level of conduct during audits alongside a right-sized quality system results in True Quality medical devices with high marks from your auditor.

What makes Greenlight Guru so unique, beyond its medical device QMS (MDQMS) software? Its Guru edge. In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rish, a senior medical device Guru at Greenlight Guru. Tom brings a breadth of knowledge to the Guru team with a biomedical engineering background and experience developing implant and instrument systems for one of the world’s leading orthopedic companies. Tom expresses his unbridled commitment to helping medical device companies, for customers by leveraging our MDQMS software to bring safe, true quality products to market faster, and for listeners by offering practical advice on industry regulations, standards, and frameworks. Some of the highlights of the show include: Tom’s favorite aspect of being a Guru is trying new medical devices in the tech industry and learning the business side of sales, clients, and personalities. Tom shares his beliefs on the best way to approach regulations, standards, and frameworks by taking a step back and looking at the big picture — they’re not overly complicated, but fairly simple efficiencies. One-man Teams: Tom admires surgeons, sales reps, and others that strike out on their own to start something important to them. They knew what it took to commercialize a product, but not enough about medical device regulations. Right-size your QMS: Look at the regulations. Focus on areas important to you. What makes sense now and worry about operations and other quality items later. Procedure Overload: People like to define the most efficient way to get things done. Write and test procedures while doing them. Keys to Customer Success: Keep it simple, focus on what you need to now, and stick to your business plan. Non-stop Paperwork: You need documentation for your submission, audit, design controls, and risk matrix. Don’t wait, do it as you go through the process to add value and communicate with others.

The current COVID-19 pandemic and its impact on clinical trials has created a sense of chaos amongst medical device companies worldwide. Are there creative ways to stay on track while ensuring the safety of those involved? In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Regulatory Affairs Consultant, and Stephanie Mull, Director of Clinical Project Management, from Proxima Clinical Research (CRO). Together, they discuss the challenges and concerns for medical device companies conducting clinical trials during the COVID-19 pandemic and offers new perspectives for listeners to consider in terms of potential efficiencies and cost savings to gain. Some of the highlights of the show include: - Challenges related to COVID-19 include sites suspending operations of clinical trials, and restricting CROs and subjects from traveling or coming to sites. - Some medical device spaces, products, and technologies have been impacted more than others. It’s more difficult than normal, but not impossible, to perform elective procedures, especially in hospitals. - Widespread, Worldwide: Clinical trials continue to be conducted in the United States, but in a different atmosphere with changes compared to other areas that have completely suspended trials temporarily, such as Europe and China. - Subject safety is the primary issue to be considered and evaluated related to risks, reasons, and causes to suspend clinical trials. - Staff Availability: Sites must have adequate and properly qualified and trained staff to conduct and provide oversight to continue clinical trials safely. - Electronic data capture (EDC) versus paper management of sites and studies for clinical trials is a more controllable way to document and collect data from patient monitoring and different types of visits. - Protocol deviations and amendments should be approved by the FDA before proceeding with a clinical trial. Subject safety, again, is always the first priority. - Human Factors: Changes should make medical device and clinical trial design more usable, such as patient monitoring from a safe distance due to COVID-19.

Are you considering patent protection for your software as a medical device? Should you keep your secret sauce via the trade secret route? Perform due diligence to stay ahead of the competition. In this episode of the Global Medical Device Podcast, Jon Speer talks to Kevin Buckley and Neil Thompson from Torrey Pines Law Group. Their biotech-focused legal firm specializes in artificial intelligence (AI) applied to medical devices. Together, they discuss intellectual property (IP) with software as a medical device (SaMD) and AI and machine learning (ML) powered technologies. Some highlights of this episode include: • Patent or not? From a patent perspective, it’s easier to understand protecting software from an IP perspective by considering the problem to be solved. • Perform a patent search using third-party vendors to determine if competitors have claimed inventions and infringement information. • Due diligence of competitive intelligence should address licensing, acquisition, investments, and freedom to operate that enhances research and development. • Interest in adapting AI, machine learning (ML), and SaMD is increasing as clients develop technologies from scratch (De Novo) for better ways to help people. • When deciding whether to seek patent protection on technology, consider international patent laws and follow the Alice: Two-step Rule for patent eligibility. • The pros and cons of choosing the patent protection over trade secret route include whether clients need limited or unlimited duration to enforce patent rights. • AI-enabled inventions, such as X-ray imaging, is software that utilizes and combines new/existing devices as systems using ML, algorithms, and datasets. • Regulatory pathways for medical devices include 510(k) and De Novo. Predicate devices may be required and potential improvements may be patentable.

What makes Greenlight Guru unique? It’s Guru edge, composed of a team of medical device experts with over seventy years of combined industry experience. In this episode of the Global Medical Device Podcast, Jon Speer talks to Jesseca Lyons, a senior medical device guru at Greenlight Guru, a self-proclaimed design control junkie with a mechanical engineer background. Listen as Jesseca shares her insights on the importance of design controls and how a deep understanding of the different pieces and parts can lead to improved outcomes for both the device and patients who use it. Some highlights of this episode include: • Customer Success Team: Jesseca is passionate about the medical device industry and connecting with customers to make a difference in their lives. • Jesseca’s favorite aspect of being a guru is the opportunity to work on different types of devices and ideas from beginning to end of the development process. • Customer Success Stories: Audits can be intimidating, but terrified customers are put at ease due to Jesseca’s extensive preparation tips and best practices. • Opportunities to help medical device companies worldwide improve quality of life is a rewarding experience for patients, providers, engineers, and everyone else. • The Greenlight Guru True Quality Virtual Summit and other content/conferences are opportunities to share knowledge and experience that makes an impact. • Jesseca is a Type A personality that enjoys being in control and telling people what to do based on the best options available and to get things done. • Design controls are necessary, exist, and may change. Most people either like or dislike design controls, but they have a much greater impact than realized. • Probable or Improbable? Jesseca once hated risk management until figuring out that nobody wants to cause harm. Now, risk management is important and fun.

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task that is often delayed until later stages of development. Don’t wait to implement a QMS; the consequences of waiting too long can lead to irreparable damage to your processes and, in some cases, product failures. In this episode of the Global Medical Device Podcast, Jon Speer talks to quality and regulatory expert Mike Drues, president of Vascular Sciences. Together they discuss why a QMS is so important to a company as it sets up its business and processes. Laying a proper foundation for a QMS to operate at its full capacity is just as critical, which involves a shared mindset and philosophy across the organization that reinforces a culture of True Quality. Some highlights of this episode include: • A QMS is not a system of compliance. It should describe how business is conducted through policies, procedures, processes, and philosophies. • If a QMS consists of devices not manufactured by the company, it’s an example of the copy-and-past approach to be compliant, but not customized. • A QMS is important to describe, document, and demonstrate roles, responsibilities, and rules to make decisions about products for patients. • A QMS focuses on four key areas: Accountability, traceability, consistency, and continuity. • Preamble/Introduction: One company’s QMS should not be a carbon copy of another company’s QMS. It should focus on its own mindset and philosophy. • Every QMS should include complaints, change management, and customer feedback to trigger notifications that affect safety, efficacy, and performance. • Product Lifecycle: During research and development, conduct post-market surveillance, beta test change management, and review risk management plan. • Document Management Control: All complaints and conflicts are not created equal. Get it right to make sure it’s effective and efficient.

What makes Greenlight Guru unique? The Guru Edge⁠—a team of medical device professionals with over eight decades of combined industry experience. Greenlight Guru’s mission is to improve quality of life, and those of customers, through True Quality products managed through its medical device quality management system (MDQMS) software. In this episode of the Global Medical Device Podcast, Jon Speer talks to Taylor Brown, a medical device guru for Greenlight Guru’s Customer Success team with 7+ years of industry experience. Taylor shares her valuable insights and learnings from auditing quality management systems as a certified Lead Auditor for ISO 13485. Some highlights of this episode include: • Taylor equates auditing to what needs to be done, just follow the rules, perform everything correctly, and understand how processes/people meet regulations. • Ins and Outs of ISO 13485: Understand the importance of following rules and regulations to be in compliance and not dread an audit. • Greenlight Guru: Taylor lives for meaningful lightbulb moments, such as when procedures, training, and guidelines make sense to bring devices to market. • Equalizer Experience: There’s no delay or stalker culture at Greenlight Guru to be efficient and get what you need completed. • Love/Hate Relationship: Audits with customers that implement Greenlight leads to losing fewer documents, a smoother process, and getting done sooner. • Celebrate successful customer stories, such as collaboration, continuous growth, and improvement. You don’t need to accomplish/implement everything on Day 1. • Every good idea starts with a plan. A phased approach sets clear expectations. If you don’t document something, you didn’t do it, according to the FDA. • Sometimes, it’s just not that deep. Due to the nature of the industry and pressure to comply quickly, people tend to over-complicate things and strive for perfection.

What is regulatory due diligence? Why does it matter, and how does it differ from other regulatory strategies and pathways? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about the importance of and reasons for regulatory due diligence that all medical device professionals should understand. Some of the highlights of the show include: • Regulatory due diligence involves looking at what’s been done so far when a company is developing a medical device similar to one on the market already. • Due diligence is important for business, regulatory, and engineering/product development perspectives to know before investing time, effort, and resources. • Differences and Similarities: Regulatory due diligence, regulatory strategy, and regulatory pathway to market are not synonymous and may depend on another. • Regulatory due diligence can be applicable to new or existing medical devices. Due diligence from an existing device provides essential background information. • Reminders/Requirements: Update regulatory due diligence in quality management system (QMS) and risk management plan through product lifecycle. • Past, Present, Future Challenges: Evolve and emphasize changes/corrections for prevention, design, risk, manufacturing, and regulatory perspectives. • Decouple and Rebuild: FDA is inherently concerned about entirely new and/or novel medical devices and technologies. • Take a cross-functional team approach to understand different perspectives, roles, and tasks to produce improved quality and regulatory due diligence.

Are you discouraged by all of the negative news and sad stories about COVID-19? Let's shift the focus to a story centered on positivity and innovation that will reignite hope for a better, safer road ahead. In this episode of the Global Medical Device Podcast, Jon Speer talks to Dan Purvis, CEO and co-founder of Velentium. Dan shares some much needed positivity through the uplifting stories and experiences of Project V, a collaborative venture backed by Velentium, Ventec Life Systems, and General Motors (GM). Project V is making a lasting difference by mass producing ventilators comprised of five separate devices to save lives and meet worldwide demand in response to COVID-19. Some of the highlights of the show include: • One-Stop Shop: Velentium is an end-to-end design, development, and manufacturing firm that transforms intellectual property into fully submitted and approved commercial medical devices. • The nine key areas of a medical device are human factors, cyber security, test systems, electrical, firmware, mobile, Cloud, mechanical, systems engineering. • Ask ‘why’ before ‘what’ when it comes to Velentium. Cash is necessary in a business, but it’s not the reason ‘why,’ which is to change lives for a better world. • Project V: Ventec could build more ventilators, if more resources and help were available. Velentium and GM answered the call for action. Right thing to do! • Pieces, Parts, and Production: Ventec’s 5-in-1 ventilator, oxygen concentrator, cough assist, suction, and nebulizer (VOCSN) device was scaled to a simple ventilator line called, V+Pro. • Politics, Businesses, and Pace: What’s more important and necessary? Dan describes obstacles and how Project V device developers overcame them. From a quality perspective, ventilators must help, not hurt people. • Human Moments: Ask for help and take business, physical, interpersonal, and emotional risks by reaching out during isolation. You won’t regret it.

There is a spectrum of feelings someone may experience in the midst of a career transition. For some, however, being laid off can turn out to be one of the best things to ever happen to them. In this episode of the Global Medical Device Podcast, Jon Speer talks to Aaron Moncur, owner of Pipeline Design & Engineering and host of the Being an Engineer podcast, as they both reflect on the twists and turns of their professional journeys to help others realize their full potential and seize new career opportunities. Some of the highlights of the show include: • Falling out of love with your role or no longer working in a previously held role? Do things differently and focus on ownership of the entire process, not just pieces. • Situational or necessity? Aaron’s sense of entrepreneurship and making his own money has existed since childhood. Being laid off pushed him into taking action. • Losing your job or starting a business: which is more terrifying? Being laid off made Aaron feel physically ill, compared to the thrill of being a freelancer. • Owners and employees have different perspectives and motivation regarding everyday work. The demand is for people who do specific work or do it all. • How well does your measurement system work? If measurement systems analysis (MSA) creates inconsistent data, it leads to less confidence in products. • Entrepreneurs’ Organization (EO) offers guidance on how to build a business, seek clarity, obtain feedback, find mentors/coaches, and narrow your niche. • Culture of Closing and Collaboration: Medical device industry is schedule driven and technically challenged to deliver on time to solve a problem.

Most of us have read about, observed, participated in, and spoke with healthcare providers and medical device professionals collaborating during the COVID-19 crisis. Creativity within reason can be an opportunity. Like many things in life, it’s not what happens to us that counts, it’s how we choose to respond. COVID-19 is not an excuse to cut corners. In this episode of the Global Medical Device Podcast Jon Speer invites guest Mike Drues of Vascular Sciences to join the show. Together, they share their own COVID-19 observations and insights into what has gone right and wrong, so far, for the medical device industry. Some of the highlights of the show include: • COVID-19’s unintended consequences on the medical device industry include new and agile product development, but funding challenges for some startups. • Emergency Use Authorization (EUA) is temporary, until the Secretary of Health and Human Services declares that the period of emergency is over. • Why is funding and regulatory pathways easier for COVID-19 medical devices? Devices already on the market can be modified or changed for a COVID indication. However, the ability to manage investors’ expectations is important. • Quick turnaround or years to go till getting back to business as usual? There’s always a need for short- and long-term opportunities to market medical devices. • Clinical Trials and Investigations: Healthcare providers and hospitals are shifting and reallocating resources to address perceived demand related to COVID crisis. • EUA equates to 510(k) due to underlying assumption of safety and efficacy, but EUA is not substantially equivalent to De Novo or PMA. • Altruistic vs. Opportunistic Attitudes: Filter motives, products, and people to accomplish post-market surveillance obligations, especially for COVID devices. • Lessons Learned: React accordingly, be proactive, address patient needs safely and effectively, and solicit feedback to improve quality of life.

What is a regulatory strategy? What are the components involved? In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues of Vascular Sciences to provide listeners with practical and pragmatic tips on how to construct a meaningful, not misunderstood, misapplied, and misused regulatory strategy. Some of the highlights of the show include: • Pro Tip: Regulatory strategy is not synonymous with Pathway to Market (element), or 510(k) and De Novo (tactics). • Regulatory Strategy Executive Summary: Living artifact that serves as a communication tool to articulate pros, cons, benefits, risks, and options. • Executive Summary components may include device description, labeling matrix, classification and risk, and potential pathways to market. • Investor Pitch Deck: Demonstrate medical device idea by knowing all options, and possessing knowledge and experience of fluid and dynamic environment. • Conventional Wisdom: Easiest, fastest, cheapest path to market to get through regulatory challenges doesn’t always make sense for products and technology. • Future Features List: What do you want added to a medical device in the future? Start with the ultimate end in mind and work backwards to build strategy and plan. • Product Development Process: Bring in regulatory sooner than later, earlier the better. Changes after a design freeze are difficult, time consuming, and costly. • Summary, Recommendations, and Takeaways: Who is your audience? Will they understand the purpose? Offer proof.

Does your software as a medical device (SaMD) function properly? Does it meet the needs of the end user? What are the expectations for post-market clinical surveillance and real world evidence for SaMD products in particular? In this episode of the Global Medical Device Podcast Jon Speer talks to Kevin Coker, co-founder and CEO of Proxima Clinical Research. Kevin shares tips and advice on what companies need to know about clinical evaluation and validation for their Software as a Medical Device (SaMD). Some of the highlights of the show include: - What IS SaMD? Software intended to be used for a medical purpose without being a part of the hardware of the medical device. - What ISN'T SaMD? Hardware that doesn’t need to be updated to function, such as a pacemaker or other embedded medical devices. - IMDRF documents capture, evaluate, and monitor SaMD categories of classification for critical or non-critical functions. - EU MDR delay means big changes to classification rules for categories, specifically SaMD status and amount of evidence that needs to be collected. - Three Key Components of Clinical Evaluation: - Scientific Validity: Does software have a valid clinical association between software and targeted clinical condition? - Analytical Validation: Does software correctly process data the same way, every time? - Clinical Validation: Does software accurately and reliably achieve the intended purpose for the target population? - Clinical Evaluation vs. Clinical Trial: Gather existing data for the same or similar intended use. A clinical trial is not always necessary to generate and justify evidence. - Importance of Independent Review(er): Objective outside party analyzes SaMD to make sure it’s safe and effective to use for critical decisions. - Real World Evidence: Collect a broad dataset to better understand adverse events, conditions, and comorbidities that impact a medical device on society.

What is artificial intelligence (AI) and machine learning (ML) and how do the two differ in the medical device industry? How can companies leverage AI and ML in their medical devices to improve the quality of life? In this episode of the Global Medical Device Podcast Jon Speer talks to Devon Campbell, founder of Prodct LLC, and Anthony Habayeb, co-founder and CEO of Monitaur.ai about how AI and ML can be utilized to produce better, safer, smarter, and faster medical devices. Some of the highlights of the show include: • What is AI? John McCarthy, Father of AI, defined it as: “The science and engineering of making intelligent machines.” Basically, it’s Independent robots thinking and acting like humans, completely autonomously. • ML is a technique within AI that focuses on algorithms and models in software to reach real-time conclusions and decisions based on a foundation of learning, training, and rules. • What’s the reality of AI adoption in major industries? It’s challenging to get large, regulated, medical device companies to implement ML due to safety risks. Yet, it can be transformational. • Machine Learning Assurance: Guidance on how to perform audits of ML models to create assurances that build trust and confidence in a quality management system (QMS) and development process. • Culture of Quality Control: Mistakes can and will be made. Is AI and ML behaving within certain bounds and rendering good results in the medical device industry? • FDA encourages collaboration for companies to demonstrate ML assurance, mitigate risks, prove quality control mindset, understand Algorithmic Change Protocol (ACT), and provide post-market surveillance. • Lean in and Lead: Focus on safety and effectiveness to meet the needs of patients and caregivers by using AI in some way with medical devices.

What does the 510(k) process involve? How should medical device companies know if this is the right regulatory pathway to market? When should a premarket notification be submitted to FDA and how should it be prepared? What’s the Refuse To Accept (RTA) checklist? In this episode of the Global Medical Device Podcast, Mike Drues of Vascular Sciences joins host Jon Speer to tackle these and other common questions, and offer tips on the Premarket Notification 510(k) process to help companies achieve FDA clearance to sell their medical device in the United States marketplace. Some of the highlights of the show include: • What is a Premarket Notification 510(k)? Regulatory pathway to bring Class II medical devices (or Class I) using substantially equivalent predicate devices to market in the United States. • Different regulatory pathway options include: • 510(k) types: Traditional, Special, and Abbreviated/Performance • De Novo • Premarket Approval (PMA) • When to submit 510(k)? When development, design freeze, verification/validation testing, and documentation are done. FDA may accept promissory notes. • When to prepare and compile 510(k)? Requirements and other prudent engineering for safety and efficacy are met, such as clinical evidence and data. • RTA Checklists for 510(k)s: Process involves administrative and scientific/substantive reviews.

Are you a medical provider or caregiver unable to find facemasks as PPE for COVID-19? Get one for free. In this episode of the Global Medical Device Podcast, Jon Speer talks to Sanjay Vakil and Devon Campbell from MasksOn.org to discuss the impactful efforts being made through the MasksOn initiative that’s providing personal protective equipment and relief at no cost during the coronavirus pandemic. MasksOn.org is a non-profit effort to mass-produce reusable, sanitizable emergency masks and distribute it to those clinicians who do not have access to FDA-approved equipment. Listen now to learn more about the project and how you can get involved to help protect clinicians and save countless lives. Some of the highlights of the show include: • Medical Device Product Development: Devon and Sanjay share lessons learned about moving quickly or spending too much time on regulatory details. • User-forward Process: Put physicians and users first and foremost throughout design and development to create a solution that solves a problem. • MasksOn’s level of investment included multiple design iterations, beta testing, tight timeline, user feedback, and quickly getting product developed and shipped. • If most masks make you feel claustrophobic, MasksOn’s retrofitted scuba masks and valve mechanisms are simple, safe, and comfortable. • Regulatory Challenges: FDA’s PPE guidance clearly describes labeling and emergency use authorization (EUA), such as for medical provider masks. • MasksOn’s Distribution Strategy: Word of mouth went viral as a side effect to COVID hotspot map. Lots of little things make a big difference in people’s lives. • Non-Profit Purpose: Raise in-kind and direct donations to keep clinicians safer. MasksOn is almost halfway there with about $2 million of its $5 million goal. • Lack of Ego Environment: Nothing gets in the way of progress because MasksOn is a non-profit organization, led by physicians, and run by volunteers.

NOTE: This episode was recorded prior to the EU Commission Proposal and now EU Parliament approval; pending EU Council (member states approval) and publication in the official journal (OJEU) for the official postponement of EU MDR. Once official, the DoA would be amended by one year, so when referring to the DoA as 26 May 2020 this would now be 26 May 2021. This live episode of the Global Medical Device Podcast was recorded at the Greenlight Guru True Quality Roadshow in Houston, with host Jon Speer his special guest Evangeline Loh, vice president of regulatory affairs at Emergo Group. Together they discuss key challenges medical device professionals are facing with EU MDR, how to best manage those challenges, and its impact on the medical device ecosystem. Some of the highlights of the show include: - EU MDR: The medical device regulation was scheduled to start on May 26, 2020, but will likely be postponed due to disruptions caused by the COVID-19 pandemic. - Second Corrigendum: Self-certified Class I medical devices under the current MDD 93/42/EEC will be up-classified under MDR and will not need to be certified to the new regulation until May 25, 2024. - Ecosystem Challenge: Delays have the medical device enterprise scrambling to find systems to register and market their medical devices to be compliant. - Number of Notified Bodies: MDR has 11 designated notified bodies, which is a significant increase. EU Commission plans to designate several more soon. - Beat the Clock: The advantage to receiving MDR certification before May 2024 by engaging a notified body to review/issue it is to become a legacy device. - Brexit (UK withdraws from EU): How will it impact and be impacted by EU MDR? From a regulatory regime perspective, it represents more work and duplication. - Despite delays, deadlines are approaching and will impact everyone. It’s important to monitor and understand what’s happening around the world.

Why is verification and validation (V&V) confusing and challenging for many medical device professionals? In today’s new episode of the Global Medical Device Podcast, Jon Speer and his guest Brad Graves, Principal Project Manager at The RND Group explore key aspects of the verification and validation topic and provide helpful clarification to medical device professionals about V&V cloud-based software. Some of the highlights of the show include: - Verification demonstrates that you designed the product correctly. Validation confirms you designed the correct product. - V&V are distinct, but interrelated activities. For example, a product can pass verification, but fail validation. Also, verification can be a product’s validation. - V&V Protocols, Approaches, and Tools: Involve product definition, requirements, risks, application and operating systems, and test cases. - Does all software require validation? Medical device software must be verified and validated, but software that supports medical devices may only require verification or validation. - Advantages and Disadvantages: Cloud software is easy to install, highly portable and scalable, but allocation of servers and additional IT staff are not necessary. - How can rules and regulations for computer and software validation be managed? Cloud changes are out of your control, but guidance is available on how to make or isolate changes via structures, architectures, and containers.

In response to the COVID-19 pandemic, medical device companies are improving and saving lives through innovative technologies and methods to combat the virus. In this episode of the Global Medical Device Podcast, Jon Speer talks to Jeff Veenhuis and Quinn Leach from Surfacide, a company actively working in the fight against COVID-19 with their proven UV-C technology that destroys pathogens, including the novel coronavirus. Listen to their powerful story about how Surfacide has embraced the opportunity and is scaling operations in order to protect frontline healthcare workers around the world. Some of the highlights of the show include: - ABCs of UV: All three ultraviolet heat types come from the sun, only UV-C is blocked by the ozone layer because high doses can damage genetic material and break protein bonds. - Multidrug-resistant organisms, such as COVID-19, MRSA, and SARS, affect 5-15 percent of hospital patients and create inefficiency, additional cost, and immortality. - Coronavirus Data and Evidence: Until a specific energy type is determined, early stages of Surfacide’s UV-C research airs on the side of caution and compliance. - Personal Protective Equipment (PPE): How can UV-C be used to disinfect masks and do a limited number of reprocessings? - Greenlight Guru’s Quality Management System (QMS) offers scalability for Surfacide’s solutions and sales to expand globally for a sustainable business. - Surfacide’s goal is to provide a safe environment for healthcare workers and patients by eliminating the bioburden potential. - Prevention Strategies and Infection Control Standards: Continue to wear masks, gloves, and other PPE at home, work, and everywhere else to make a difference and the world safer.

What qualifies and what does not for Emergency Use Authorization (EUA)? What is the impact of this rare regulatory pathway during the COVID-19 pandemic? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences in a highly relevant discussion on considerations for medical device professionals regarding EUA as a proper pathway to bring a medical device to market that can support the needs of healthcare providers and patients. Some of the highlights of the show include: - Why is it called Coronavirus? It has nothing to do with Corona beer. Rather, it comes from a family of viruses known for its crown or halo shape. - Similar to SARS Coronavirus that infected about 8,000 and killed about 800 people worldwide starting in 2002. Numbers for COVID-19 are much worse. - EUA has existed for many years and previously used primarily by drug and biotech companies for Anthrax, Ebola, H7N1, and other viruses/diseases. - EUA allows FDA to help strengthen the country’s protection against chemical, biological, radiological, and nuclear defense threats by facilitating availability and use of medical countermeasures needed during healthcare emergencies. - EUA requires new or modified existing products to diagnose, treat, or prevent Coronavirus. Due to COVID-19, FDA issued as many warning letters as EUAs. - EUA is not an approval, clearance, or alternative to 510(k) and PMA, but temporary authorization because all EUAs will expire. - Political Pandemic Pressure: What would be worse—not having enough ventilators, or having ventilators that don’t work? Do it quickly and correctly. - Ventilators are not simple and ubiquitous. Review FDA product codes; prioritize list; and strive for safety and efficacy, not shortcuts to lower regulatory burden.

Medical device usability is a critical, yet confusing component of medical device design, development, regulatory, marketability, and product success. Although three things are clear when it comes to your processes around usability for your medical device: do it early, do it right, and don’t try to cut corners. In this episode Isabella Schmitt, regulatory affairs consultant with Proxima Clinical Research, joins Jon Speer as his guest to discuss this topic, stressing the importance of usability and how you can integrate usability into your medical device. Some of the highlights of the show include: - Usability: Align and combine with other components to produce a successful medical device product and business. - Design Controls: Who are your users? What are their medical device needs? What appeals to them? What are they using now? - Risk Management: Start usability testing and human factors engineering early on and throughout the design process to mitigate errors and last-minute changes. - Perpetual Perfection: Why waste your time? Communicate with users to identify what problems need to be solved to intuitively and quickly use a medical device. - Founderitis and stagnated beliefs can prevent innovation and objective ideas that would otherwise be helpful to improve patients’ quality of life when designing, developing, and producing products. - Real World Usability Expectations: User testing, risk assessment, simulated environment with distractions, instructions/training, and documentation. - Usability Issues and Challenges: If you wait to wait to do usability and only do summative evaluation, unanticipated user errors arise and require changes.

In this modern digital world, did you know that most medical devices are not connected to the Internet? This episode of the Global Medical Device Podcast is a special live recording from The Greenlight Guru True Quality Roadshow in San Jose, California and is moderated by Tom Rish, Medical Device Guru at Greenlight Guru. Chris DuPont, CEO of Galen Data, joins Tom as his guest to discuss with live viewers and podcast listeners the design control and development process for software as a medical device (SaMD). Some of the highlights of the show include: - Galen Data’s Goal: Configurable, scalable, FDA-compliant software platform that easily and cost-effectively connects medical devices to an FDA-compliant Cloud. - Check Engine Equivalent: Galen Data’s facilitating staging platform for predictive analytics data and early integration into electronic medical record (EMR). - Input vs. Output: Design and risk controls for mechanical/hardware or software as a medical device are the same. - Design Control and Development Process: List requirements, build prototypes, and test design. Options include waterfall, agile, scrum, or sprint methods. - What’s the difference between verification and validation testing? - Verifying a spec is easy, validating it is difficult due to user requirements and actual use. - Regulatory Pathway: Documents and prototypes allow software design engineers to use tools that help produce objective evidence and make a better product. - Design History File (DHF) and Standard Operating Procedure (SOP): Document what you do, and do what you document. Follow your procedures. - SaMD Risk Analysis: Classification (I, II, and III) and categorization of objects and components as low, medium, and high software risks.

How can the IEC 62304 standard serve as a framework for your Software as a Medical Device (SaMD) development processes? Today’s guest is Cathy Wilburn, Director of Quality Assurance and Compliance for The RND Group, a medical device software development company that helps clients write software, submission readiness, and compliance. Cathy joins Jon Speer to clarify the confusing parts of IEC 62304 and helps listeners understand how they can leverage this standard to improve development processes. Some of the highlights of the show include: - IEC 62304 is a software framework that offers necessary documentation and software engineering practices for 510(k) and PMA submissions to the FDA. - Recognized Consensus Standard: FDA evaluated and recommends using IEC 62304 to satisfy regulatory requirements and software development needs. - Requirement vs. Recommendation: IEC 62304 is voluntary, not prescriptive. However, most in the SaMD industry use and follow it to meet requirements. - IEC 62304 covers the following high-level software processes: Development, maintenance, risk and configuration management, and problem resolution. - Lifecycle Processes: Examples and resources to blend waterfall, agile, scrum, and sprint methods for medical device software development and requirements. - Design controls and history file contents are detailed or defined in FDA 21 CFR 820.30 and ISO 13485, but not part of the IEC 62304 Standard. - ISO 14971: Risk management role in software development is defined in IEC 62304 via software safety classes for level of concern and risk requirements. - Myth or Truth? SaMD requiring waterfall method is a rumor. The purpose is to iterate, learn, and refine to produce safe and effective products.

The FDA announced another new pilot program to improve the consistency and efficiency of its 510(k) review process. It’s called, eSTAR, or electronic Submission Template And Resource. Today’s guest is Mike Drues of Vascular Sciences. Together, we discuss the details of the eSTAR Pilot Program to help you understand what you need to know and do as medical device professionals. Some of the highlights of the show include: - New Format, Same Information: Content and regulatory burden remain unchanged, but the template is in PDF format and eliminates RTA Checklist. - Two-Fold, Two-Step Process: eSTAR aims to increase efficiency of 510(k) administrative and scientific reviews to decrease rejected 510(k) submissions. - FDA is seeking nine companies that represent a broad medical device industry to volunteer at least one 510(k) submission and provide feedback on eSTAR. - Additional Technical Requirements: Medical device must include software and come in contact with body tissue, but not necessarily the body or be invasive. - Browser Restrictions: The 21-page eSTAR template is viewable via most Internet browsers, with at least one exception—Google Chrome. - Why participate in the eSTAR Pilot Program? Despite FDA’s lack of benefits and incentives for companies, it may make the 510(k) pathway more efficient. - Will eSTAR make things better? Time will tell, but it’s unlikely a solution that solves all problems or leads to safer and more effective medical devices.

Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k) options. However, there are several other major regulatory pathways along with several sub-pathways (traditional, abbreviated, special, and safety and performance) that are available through the FDA. Today’s guest is Mike Drues of Vascular Sciences. Together, we introduce all of FDA’s regulatory pathways to bring a medical device to the U.S. market to help you understand which option is best for you. Some of the highlights of the show include: - Pathways to Market: Why are they important? Without knowing all the options, it’s difficult to choose the best regulatory pathway for a medical device. - Which pathways are appropriate for a medical device? Depends on classification and risk, which are contingent on labeling, intended use, and technology. - Medical Device Pyramid: Which devices are regulated by FDA, and how are they classified? Class I, II, and III. Class 0 wellness devices are not FDA regulated. - De Novo: Alternative to 510(k) and appropriate for Class I/II Non-Exempt devices. However, De Novo is for new/novel devices without identified predicate. - Product Development Protocol (PDP): Uncommon pathway to market due to lack of guidance and regulation. Opportunity to not conform and forge your own way. - Humanitarian Device Exemption (HDE): PMA alternative and requirements include treating 8,000 or fewer patients per year. Most, not all, medical devices must be shown as safe and effective. HDE has no efficacy requirements. - Custom Device Exemption (CDE): Least common pathway with potential to be the most popular pathway to market due to personalized medicine (3-D printing). - Expedited Access Program (EAP) for Emergency/Compassionate Use: Ethical considerations because people are treated like guinea pigs, but an option to obtain early feasibility data and labeling.

Regulatory is a big deal for medical device companies. Whether it’s a startup or established business, a strong understanding of regulations and regulatory strategy is vital for product success in the marketplace. Today’s guest is Isabella Schmitt, regulatory affairs consultant at Proxima Clinical Research where she specializes in quality and regulatory business advice. Isabella shares how medical device companies can establish a solid foundation for fundraising and product success through a heightened regulatory focus. Some of the highlights of the show include: - Lack of Focus: When a medical device company starts with technology rather than solving a problem, it makes accelerators, investors, and others nervous. - Minimum Viable Product (MVP): What are you targeting and when to stop developing product? Break the habit of perpetually perfecting something. - Don’t forget your mission. Obtain feedback and be receptive to it. Different opinions, along with expertise and knowledge, help you make a judgement call. - Design Controls: Be clear on what needs to be done and justify changes made. - Regulatory Approval: Determine minor and major milestones that need to be achieved before reaching the finish line to increase company and product value. - 1/10/100 Rule: How much will an issue cost, if caught early on or later in the validation and verification process of designing a medical device? - What can you do to prevent and identify unexpected twists and turns, sooner than later? MVP, iteration, feedback, and tests. - Platform Technology and Pipeline of Tests: Marketability justifies classification of a medical device, appropriate regulatory pathway, and reimbursement strategy.

Are you looking to hire medical device professionals? Or, are you a professional seeking new job opportunities in the industry? Today’s guest is Mitch Robbins, founder and managing director of The Anthony Michael Group. He is a recruiter who specializes in quality and regulatory for the medical device industry. In this episode, Mitch breaks down the pros and cons of the four parts to the candidate interview process. Some of the highlights of the show include: - Candidate Prep and Priorities: Purpose is to help candidates decide whether to move forward in interview process by establishing value during initial interactions. - Do’s and Don’ts: Focus on previous outcomes, express interest in the company, and ask relevant questions, but avoid premature display of lack of interest. - Statistics: - 46% of all new hires fail within 18 months, and only 19% are successful. - 81% percent of people lie about themselves during job interviews. - Interview Process: - Part 1: Initial Assessment (core competencies vs. skills on resume) - Part 2: Competency Interview (hiring manager recaps core competencies for candidates to ask questions that indicate level of interest) - Part 3: DNA Interview (3-5 characteristics of top performers in company) - Part 4: Test Drive (put finalists in real-world scenario to perform) - Tips and Trends: On-demand interviews, videos, consistent theme to predict career trajectory, and contributing to work culture.

Everybody seeks advice and opinions from others from time to time, even those in the medical device industry. What are the pros and cons when it comes to hiring industry advisors? Today’s guest is Isabella Schmitt, regulatory affairs consultant at Proxima Clinical Research. Listen to this episode as Jon Speer and Isabella discuss good and bad practices when identifying and selecting advisors for your early stage or established medical device company. Some of the highlights of the show include: - Who are advisors? Consultants, board members, thought leaders, accelerators, and others that offer opinions on the course and direction of your company. - Who can you trust? Avoid advisors that are posturing, egotistical, always have to be right, and don’t listen to other opinions. A level of humility can gain your trust. - Startup vs. Established Company: Consider pass/fail criteria for advisors based on strategic approach, assessed risks, experience, cost, and connections. - Regulatory Affairs/Quality Assurance: If you ask three different advisors the same question and get three different answers, which do you choose? It depends. - Due Diligence: Review résumés of advisors with similar values from different perspectives. Determine if they can build a healthy, helpful, and appropriate relationship with you, your company, and products. - Be Careful: Choose advisors that guide and pivot you through challenges, obstacles, hurdles, and pitfalls—not create them for you and your company.

What top priorities can medical device professionals and patients expect in 2020 from the Center for Devices and Radiological Health (CDRH)? Today’s guest is Mike Drues from Vascular Sciences. We discuss the recent FDA report that outlines CDRH’s regulatory science priorities, all of which are important, some more than others. However, there are a couple big ones missing. Listen to this episode for actionable tips on how you can develop your own list of priorities for 2020. Some of the highlights of the show include: - A comparison of historical context from the same reports in 2016 and 2017 to 2020, identifies 8 out of 10 of the same top priorities: - Big Data, biocompatibility, real-world evidence, clinical performance, clinical trial design, computational modeling, patient input, and digital health/cybersecurity. - What two priorities are missing in 2020 report? - Reprocessing reusable medical devices: Not all devices are properly reprocessed to prevent deaths and cross-contamination between patients. - Human factors and usability: Companies still struggle with the concept of making medical devices easy to use and/or understand. - Why did these two priorities drop off 2020 list? A lack of high-profile reports from popular press about companies and medical devices causing problems. - What two top priorities from past reports reappear for 2020? Healthcare-associated infections, and precision medicine and biomarkers. - Medical device industry should develop its own list of top usable and actionable priorities. Effective communication with FDA may result in a consensus.

Change is constant… Especially in the medical device industry. Medical device change management can be a challenging concept and process for companies, especially during FDA inspections and other audits from regulatory agencies. Today’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to discuss the twists and turns of what to expect, what you may experience, and what to focus on when dealing with change management. Some of the highlights of the show include: - Do’s and Don’ts of Change Management: Depends on device class and complexity, as to how stringent communication and reporting is required. - Change Management Options: Notify FDA or do not notify FDA of change. The information is the same, but what a company does with it is different. - Letter to File: Documentation describing change, why it’s being made, testing conducted to determine no impact on safety, efficacy, and performance to device. - With a change, avoid marking up documents before performing a preliminary engineering and biological analysis and determining regulatory impact. - Examples of how to approach change management with catheters: Trivial or not, when FDA needs to be notified of changes following testing and analysis. - What is FDA-friendly material? Material with well-established history of use in various medical devices. - Companies should not be afraid to make changes to devices by inhibiting and preventing improvements to not deal with and notify the FDA. - Overall Objective: How can you improve internal change management practices to make them patient-focused and ensure highest efficacy and safety of devices?

FDA announced the launch of a new program for test lab accreditation that will evaluate medical devices for conformity to specific consensus standards recognized by the regulatory agency. The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program allows third party testing laboratories to become eligible for accreditation to FDA-recognized consensus standards upon their evaluation of device safety and efficacy. Today’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to discuss the nuances of this pilot program, as well as provide insights and opportunities that can help device makers. Some of the highlights of the show include: - Medical device companies have three options: Select accredited/certified testing lab, select non-accredited/non-certified testing lab, or conduct their own testing. - There are definite advantages to selecting accredited/certified testing labs through the ASCA Pilot Program. - How does the ASCA Pilot Program compare to Digital Health Software Pre-certification? Minor changes can be implemented without FDA approval. - The device manufacturer is ultimately responsible for inclusion of appropriate device testing information and standards are selected and used properly. - The ASCA Pilot Program is voluntary, but should it be mandatory to avoid major complications and conflict of interest? - FDA pilot programs often languish and guidances remain in draft form. The government is known for taking its time, but it makes sense to perform tests. - Why is ASCA Pilot Program important? What’s in it for medical device professionals? Depends on device competition and selected testing option.

Recruiting top, elite quality assurance and regulatory affairs (QA/RA) talent in the medical device industry is challenging, but vitally important. Today’s guest is Mitch Robbins, managing director of The Anthony Michael Group. As a recruiter, Mitch joins Jon Speer on the show to break down five myths about QA/RA recruiting and discuss the dos and don’ts medical device companies should consider when hiring these professionals. Some of the highlights of the show include: - Myth #1: Recruiting isn’t necessarily the hiring manager’s responsibility, but also involves Human Resources (HR) or Talent Acquisition to own hiring decisions. - Myth #2: No time to invest in recruitment process to hire elite talent because so much time is spent micromanaging average performers. - Myth #3: Trust your gut feeling. It’s never wrong. You know an elite person when you see them. - Myth #4: Elite talent/top performers can’t be hired because our business can’t compete with perks and benefits offered by billion-dollar companies. - Myth #5: Elite talent is expensive. We can’t afford to hire them because money is their top consideration. The best of the best won’t work for peanuts. - Job Posts: Only 32% of people in the employment market are actively looking for a job, but up to 80% are open to opportunities. - Resumes should summarize role and outcomes delivered. Update regularly to create document that conveys a compelling and relevant story of contributions. - All Talk or True Talent: Conduct a test drive scenario to demonstrate and validate candidate’s actual skills. The cost of a mis-hire is 13 times the leader’s salary.

Which medical technology, product, or device are you focused on bringing to market that will positively impact and improve the quality of life? What are the obstacles and challenges you can expect to experience? How will you overcome those? Today’s guest is Devon Campbell, founder of Prodct, LLC, who joins Jon Speer to discuss the value equation for MedTech companies to elevate and escalate quality and improve value. Some of the highlights of the show include: - Data Process: Sooner than later, think through the deployment and infrastructure for a company’s quality management system (QMS) to generate quality data. - Quality Strategy Mindset: Learn to appreciate, understand, and demonstrate the value and purpose of quality data. - Due Diligence: Multiple reasons exist for MedTech companies getting their product or process into the hands of users sooner and serve as revenue source. - Deliver not just data, but extensive confidence in that data and in a way that end users and stakeholders value and trust, as well as reduce risk. - Quality data is not a one-time occurance. Reproduce and repeat data consistently for process validation and scalability. - How does QMS strategy inform and offer value? Provides ability to articulate and appreciate quality by knowing where you are and want to be with your company. - Elements to consider for a value equation include technology, quality infrastructure, go-to-market regulatory strategies, and data integrity.

Effectively managing suppliers, vendors, consultants, and other third party entities that provide products and services can be challenging. How, what, and when do medical device companies manage relationships between those in the company and those outside of the company? Today’s guest is Mike Drues of Vascular Sciences, who joins Jon Speer to review and discuss the details of supplier quality management. Some of the highlights of the show include: - What is supplier quality management? Anybody outside the main company that provides products/services that directly/indirectly go into medical devices. - Why supplier quality management is important? Manufacturers must use good judgement when establishing and meeting quality system (QS) requirements. - Necessary evil or supplier quality management failure? Used for years, Ethylene Oxide (EtO) sterilization for medical devices is now a public health emergency. - EtO is flammable, carcinogenic, and key ingredient in thermobaric weapons. Companies should identify and consider other options for valid sterilization. - Defining critical vs. non-critical is not enough. Use risk-based approach when assessing criticality levels of suppliers for your products and processes.

Do you have a regulatory strategy to help your company prepare for the new European Medical Device Regulation (EU MDR)? With the May 2020 deadline right around the corner, a main area of focus for medical device companies will be transitioning to the new European regulation. Today’s guest is Isabella Schmitt, regulatory affairs consultant with Proxima Clinical Research. Isabella joins Jon Speer in this episode to share what listeners need to do to prepare for EU MDR, despite the recently announced two-year delay of EUDAMED. Some of the highlights of the show include: - Why EU MDR? Effort to address uproar over ruptured implant devices with unknown materials that made some patients sick. - What is EU MDR? The purpose is increased focus on safety and the entire lifecycle approach, not only pre-market approval (PMA). - Compliant Equivalency: Isabella describes biological and technological factors, as well as data and test requirements for clinical use and support. - Preparation - First Step: Assess general safety and performance requirements (GSPRs) via gap analysis of existing, needed, and publicly available data. - Startup vs. Established Products/Companies: Understand compliance of GSPRs, intended use, description of device, standard of care, and alternative options. - EUDAMED: Medical database with access to and reporting of clinical investigation information, post-market surveillance, universal device identifiers (UDIs).

Depending on the level of quality and compliance, medical devices can impact patients’ lives for better or for worse. Fortunately, FDA recently announced plans to open up and expand participation for its Case for Quality Initiative. Today’s guest is Mike Drues of Vascular Sciences. We discuss the benefits and incentives for compliant and noncompliant companies to participate in the Case for Quality program. Compliance doesn’t necessarily ensure quality. Some of the highlights of the show include: ● Pilot Program Premise: Partnership between FDA, MDIC, and CMMI Institute to promote compliance and focus on true quality products and processes. ● Case for Quality is newer program with somewhat skewed participation from larger companies due to incentives favoring PMA Class III products. ● Case for Quality: Advantages for participating include being excused from routine FDA inspections when state of compliance was demonstrated previously. ● Making changes to positively impact PMA products involves challenging process to submit a supplement. Are regulatory requirements for changes necessary? ● Micromanage Case for Quality: Root cause for such regulations is to prevent shortcuts and oversee those that don’t know what or how to be in compliance. ● Why are some companies not in compliance? They should participate in the Case for Quality Initiative to learn what they need to do.

If you're like many in the medical device industry, you've probably had some questions at one time or another around the FDA's Design Control Guidance. And if you're anything like the guests on today's podcast, you've probably gone through a lot of trial and error trying to implementing them. Wouldn't it be nice if some industry vets were willing to sharing with you their proven best practices and top recommendations for implementing design controls at your medical device company, so you can avoid problems later? You know, the kinds of problems that could cost you months of runway or even stop your device from being approved by the FDA altogether? If so, today's inaugural episode of the Global Medical Device Podcast powered by greenlight.guru, is for you. Jon Speer is a medical device expert with over 16 years industry experience who's played a part in getting 40+ devices approved by the FDA, and he is the Co-founder of greenlight.guru. Michael Drues, Ph.D., is a prolific speaker and consultant to the medical device industry as well as being the President of Vascular Sciences. Join in to hear Dr. Drues and Mr. Speer share some perspectives, opinions, and experiences about various interesting aspects of Design Controls for the medical device industry, including the classic discussion about "research" versus "development" and when should Design Controls begin? They'll also cover a range of topics including: - How do larger companies take on acquisitions when there is little to no Design Control documentation? - Examples of how to manage up-classification situations, i.e., class I à class II or III and addressing Design Controls - When should Design Controls begin? - When to make the transition from "R" to "D" Buckle in, these guys really know their stuff about medical device product development and the nuances Design Controls can present.

Medical device design reviews - are more or less better? What about independent reviews? Are they necessary? How do you get one done? These are a few of the topics we touched upon in episode 3 of the Global Medical Device Podcast, How To Improve Your Medical Device Design Reviews. And they seem to have struck a nerve. That’s why today, we’re excited to release our first bonus episode, 3.5, so that we could expand upon these topics for you. One area deals with getting those independent reviews of your product done and the other concerns comments about slowing down during the product development process. Jon Speer and Michael Drues Ph.D felt they owed it to you to explore these topics on a deeper level in this bonus episode of the Global Medical Device Podcast. As we said, Medical Device Design Reviews are critical steps within your design and development process. If you’re a startup strapped for cash it may be difficult to have an independent review done. Getting that review can be challenging, but it still needs to be part of the process. One way to do so may be to have somebody who is part of a medical device incubator/accelerator that shares the same physical space as you assist in doing the review. Although it’s easy to say, but sometimes hard to do, medical device design reviews need to be a part of your planning. The second thing we wanted to further explore is Jon’s comment about slowing down during the product development process. That can be difficult when you are dealing with expectations from senior management or investors. Jon clarifies that his intent is to say, be more deliberate. Don’t be in such a hurry to get to the next milestone. Start with a project mission and keep the end goal in mind. Follow the structured process so that you can find problems early and often and correct them. Eighty percent of medical device companies have fewer than eighty employees. Depending on the nature of your failure, if your product fails, then your company fails, so it’s better to find problems sooner with a deliberate approach. Now grab some pen and paper because you’re going to want to take some notes in this 18 minute bonus episode where Jon & Mike really dive deep on a topic they brought back by your popular demand.

Risk management for medical devices from a regulatory and product development perspective is the topic of today’s podcast. We take a look at a few tools to help in the process and liability as it relates to on-label vs off-label use (Some really interesting points on this topic). We suggest following the ISO 14971 standard which provides manufacturers with a framework to manage the risks associated with the use of medical devices. Another helpful guidance document is TR 24971 (Yea it’s not free, but probably worth the couple hundred dollar investments). If your product will be released in Europe, then it’s good to know the European version as well. FMEA is another popular risk management project tool and there are others available. We then discuss the on-label use versus the off-label use of a product, and admittedly the whole thing is a dilemma. From a product liability perspective, if legal counsel can show a manufacturer knew a risk associated with a product that they did not mitigate, then the manufacturer can be held to a higher level of liability. We dive deeper into the topic as we discuss: Setting a strategy regarding limiting discussion on use The difference between intentional and unintentional off-label use The meaning of unintentional misuse Staying focused on the intended use of the product When to push back with regulators Risk management can be overwhelming if you let it. Approach it from a process point of view and understand the documentation suggested. greenlight.guru is about to make following risk management so much easier, featuring a module that allows you to conduct risk management activities and integrate with design control activities all in one, cloud-based solution. Your hosts today for the Global Medical Device Podcast, Jon Speer and Michael Drues Ph.D thank you for listening as they continue to share how you can implement their proven strategies at your organization.

Superbugs. Reprocessing. The White House. And Design Controls. Probably not a combo of topics you see grouped together very often. But we have them all for you on today’s Global Medical Device Podcast. This is the 2nd edition in our series focused on Design Controls and related topics within the Medical Device Industry. During this episode, we’ll surface some interesting and potentially controversial views on the subject with our three industry thought leaders. If you’re like many, you may very well have already heard about the high profile superbug outbreak connected to reprocessing. You may also have already seen some of the industry’s reactions with lawsuits being filed, FDA alerts being issued...and even the White House getting involved. That’s where we kickoff today’s conversation with our amazing guests Mike Drues, Jon Speer and Jason McKibbin along with moderator Bill Loss. All three guests share some very insightful and through provoking responses to Bill’s questions like: 1. What’s the background behind this reprocessing tragedy anyway? 2. How do our experts see the responsibility panning out at the manufacture’s level as well as those ultimately handling the reprocessing? 3. Could better orchestrated design controls have potentially prevented this tragedy? 4. Do existing design controls apply to problems like this, and if they don’t, should they? 5. Was this problem a design control failure or possibly different steps that should have been handled during the design review process? 6. How do you feel the Design Verification and Design Validation process should fall into place? You’re going to want to listen closely because these guys really dive deep on some important and controversial topics.

With nearly half a century of combine experience performing medical device Design Reviews between them; Michael Drues Ph.D., Jason McKibbin, and Jon Speer have the battle scars they want to help you to avoid. They peel back the lens on what has worked for them over the years and how you can implement their proven strategies at your organization. Design Reviews are clearly a topic that this group has some strong, and at times, counter intuitive thoughts on. In this 24 minutes episode, our experts really get down to sharing actionable tips and advice that your team can start using today to help improve your Design Reviews. They reveal their candid opinions and advice on a range of Design Review related topics including: • Why Design Reviews are important? • How do Design Reviews fit within Design Controls? • Explain the concept of an “independent reviewer” and why this is necessary? • When should Design Reviews take place? And how often? • What should not be included within a Design Review? • How are Design Reviews the same (or different) from a Phase Review? • What actionable tips & advice do you have to improve Design Reviews?

What are the most common mistakes a startup medical device company usually make? Hear Ronny Bracken candidly disclose how to avoid some very expensive lessons when starting out in the medical device business. With his 26 years of Research and Development experience for medical product development at the executive level, he will show us how to avoid a $20 million haircut on your valuation because your design controls and quality system are not up to speed. Presently Ronny is the Principal at Paladin Biomedical Consultants, LLC, as well as chief operating officer for a tissue engineering startup and an antimicrobial medical device startup. His extensive experience has guided a lot of companies to have a solid business model that brings in revenue, ensuring sustainability of the projects in which he is involved. Ronny has a knack for creating intuitive, valuable, and innovative products that solve very specific problems in their markets. Episode Highlights · Common mistakes that small companies make and how to do the right thing, graciously pointing out the aspects of the business that small companies need to focus on. · His points of view regarding treating the regulations asa way of life, why embracing risk management practices is the key and how to have design controls that work. · Merger and acquisitions and how it affects the small companies. · How to create a team from research and development to the marketing aspect of the business. From manufacturing the product to bring it to the market. · How to balance your product research and commercialization. Valuable insights about your passion and funding. · When to figure out what the market needs and why it’s important to determine the product’s purpose early in the development. Ronny warns against falling in love with the invention, leaving no room for improvement or strategic marketing to generate revenue. For him, in order for a product to be profitable, it needs to listen to customer feedback. He relates an interesting point view about losing early, for him it’s important to know early on if you have the right product for the right customer. The patient may be the beneficiary but it’s the medical practitioners who are the purchasers of the medical equipment. So it's still important to design a product that they will need and at the same time stay compliant with industry standards.

In today’s episode of the Global Medical Device Podcast Jon Speer welcomes Sara Naab to the show. Sara is the co-founder and director of quality and marketing for Sandstone Diagnostics. Sara shares with us insights into what it’s been like going from idea, to raising funding, to being name one of the 40 most innovative life sciences companies in the Bay Area. Pretty impressive and interesting. It all started in the summer of 2012. The company makes consumer wellness products to help people better understand their health. They provide over the counter results of tests to patients and physicians. Sara begins the discussion with the company’s first product, Trak. Trak is an app that will help men monitor their sperm count and how to improve their fertility. Medical devices are expensive for a reason. Getting started is hard. Money will always be a challenge. That is her opening advice to startups. At the beginning of Sandstone, Sara was pregnant. Her first suggestion to her co-founder (her husband) was a pregnancy test. This suggestion lead to the idea to create a sperm counter. After researching the topic, they learned about a void in the market that was not being addressed. Not too surprisingly, sperm testing is a very delicate and private subject for most men. Turns out sperm count is a sign of good health and being able to monitor it is very empowering to the patient. A number of factors can affect sperm count such as diet, stress, and even weight gain. Sara says humor is actually very important when handling patients and being non-judgement is key to helping men talk and think about their health. Trak is a mini centrifuge that will take a sperm sample from a patient and spin it so the cells can be analyzed. Then the app is used to track the progress. The service is in the trial stage right now. Manufacturing, investors, and regulations are among the obstacles Sara lists as the biggest challenges. The design control, risk management and production seem to be the positives Sandstone has going for them. Sara thinks the importance of education has played into their success and the quality of their team. She advises other medtech startups to consider the customer and remember who you are helping. You can find Sara on Linkedin, Sandstonediagnostics.com, or dontcookyourballs.com.