Global Medical Device Podcast powered by Greenlight Guru

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.

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?

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.

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.

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.

We’ve got a good one for you today. In episode #8 of the Global Medical Device Podcast we welcome back Michael Drues, president of Vascular Sciences. As many of our listen may recall, Mike does consulting for medical device companies, the FDA, Health Canada and other regulatory bodies. Today Jon and Mike talk about 510(k)s and some of the major mistakes some companies make when they get 510(k) clearance. Specifically, they talk about companies that get 510(k) clearance but don’t have design controls, risk management and don’t have a quality system. And it’s chuck full of actionable advice and takeaways. “70-75% of 510(k) and PMA submissions are rejected the first time.” -Mike Drues The FDA’s mission is to make sure the products we bring to market are safe and effective. The 2 areas of 510(k) submissions that are getting the most scrutiny are the substantial equivalents argument and the risk mitigation strategy. If you don’t have a rock solid argument and a bulletproof strategy you will probably be rejected. Early and frequent communication with the FDA is the key to success. “Design controls are nothing more than a synonym for prudent engineering.” - Mike Drues Today Mike and Jon talk about: When a 510(k) isn’t necessary Reasons for rejection of a 510(k) “Lead don’t follow, tell don’t ask.” Design controls Multiple Predicate Strategy / Split Predicate Strategy Risk Mitigation Regulatory checks Corrective Action/Preventative Action Plan “Physicians can kill patients one at a time but an FDA reviewer can kill patients thousands at a time.” -Mike Drues What can a company do if they’ve been approved for market but aren’t prepared? Conduct a gap analysis, figure out what you have, figure out what’s missing, fill in what’s missing and be upfront about it. Ask for help if you need it. Go to the experts. There is so much more we can do to help before, rather than cleaning up problems later, but, “It’s never too late to do the right thing.” -Jon Speer

In episode 9 of the Global Medical Device Podcast we’re joined by Mike Cremeans. Mike is the Vice President in the Healthcare and Life Sciences practice at Willis (the third best insurance broker in the world). His main function is that of a risk strategist, for FDA regulated organizations worldwide. He also is the man behind Willis’ Life Sciences Twitter accoun,t which is actually how we met, so be sure to check out some of the great content he shares over there at @WillisLifeSci. Mike’s passion is helping leaders of highly regulated organizations to identify and navigate risks so they can focus on strategically growing their businesses. Mike has been doing medical device work for about 20 years. He has some great stories stacked up from all his years in the field, and he was more than happy to share a great deal of it with us, along with some key pieces of knowledge, as well. For instance, he tells us his top two pieces of advice for a company that’s pursuing bringing a product to market, but isn’t currently engaged in some kind of enterprise risk activity. Today’s topics include: An overview of Mike’s role at Willis and what they do for medical device companies -How he helps people identify, quantify and manage their risks -The horror story of a company that didn’t engage in risk management -ISOs you should be checking out and their predecessors -Striving to always put out an amazing product -The importance of a disaster plan -“Common risk language" “The principals involved with product risk management are similar or maybe even the same principles that you’re employing from an enterprise risk management.” – Jon Speer

On today's episode of the Global Medical Device Podcast, we’re discussing how startup entrepreneurs like you can remove the common regulatory obstacles your business faces and other tips and pointers you can use when developing new medical devices. Our guest today – Mitch Levinson – is the CEO of Cerebrotech Medical, and with over 30 years experience as a startup CEO and executive for companies that have IPO'd like ZELTIQ Aesthetics and Thermage, he knows all about the ins and outs of FDA regulation. His Number One Tip? Mitigating risks as early as possible. We discuss the ways you can reduce your risks and shorten your regulatory audits, and the best way to do that is to pick the right tech. Mitch also says to start early and meet with the FDA board as soon as possible so you know what parameters you need to meet ahead of time. And among these parameters, we also discuss more of Mitch’s insider tips, including… Holding early meetings with FDA to set your parameters right away Growing a quality system organically so you aren’t struggling through auditing later down the road Finding products that financeable so you can be backed by the investors you need Pursuing clearance in the US and the EU at the same time to speed up your approval process Building the right company culture so you have the most supportive employee team and board to keep your start-up running smooth Seeking FDA approval and mitigating risks go hand-in-hand in this industry. Tune in for Mitch Levinson’s insightful tips and tricks so you can start applying his advice to your startup today.

In episode 10 of the Global Medical Device podcast we welcome Matt Romey from the Azzur Group. Matt is a project manager for the Azzur Group and has been involved with many medical device projects. He was a founding employee and executive team member at GluMetrics, a venture-backed startup that raised over $67M. Matt has 20 years experience in the medical equipment design industry and has plenty of knowledge to share with new startups. During today’s conversation Matt and Jon will discuss the importance of Design Controls, which they both share a passion for. "Design controls are yes, required by law, but they also represent good business practices." - Matt Romey Matt believes so much in the importance of design controls that at one of his companies he had a line from the FDA Design Control guidance document taped to his wall that stated, “It is a well established fact that the cost to correct design errors are lower when errors are caught earlier in the design and development process.” "The 1 - 10 -100 rule. That's where if you catch it early in the process it may cost you a dollar to fix, then a little bit later in the process it will be maybe 10 dollars. Once you get into production... 100 dollars." - Jon Speer The most important thing to keep in mind while working on medical device design is user needs. These user needs will guide you to the right questions so that design inputs are effective and relevant. Today’s highlights include: ● Matt explains how good quality design control is just part of good business practices. ● You will hear why the classic “waterfall diagram” may not be the best guideline for a project. ● Why when you find design inputs, they need to be testable. "Design inputs should be a translation of your user needs to some sort engineering specification that can be measurable." - Matt Romey

If you are in the business of medical devices, then you must eat, breathe, and live quality management systems. In order to get to market and sell your products successfully, your quality system needs to be right-sized, and meeting all of the regulations can be one of the hardest hurdles to cross in this business. Our guest today is here to talk about how you can surpass these hurdles, and David’s insight and resources will help you manage your quality system in the best way possible. David Amor is a medtech consultant who’s behind the genius consultation firm at www.medgineering.com. And today he’s talking about exactly that: consultation for your quality management systems. Managing the quality of your products is something that needs to be taken care of when you’re starting your business. “The bigger your company gets, the more scrutiny you’re going to get from the FDA and the higher the expectation is from the FDA.” – David Amor That’s why finding the right-size system for you right now is extremely important. Tune in now to find out how you can build your business and your management systems at the same time. Today’s topics discussed: - What startups should do to succeed in the medical device realm - Understanding where your business fits within the field and the FDA’s regulations - Practical implementation of quality systems and its regulations - Finding the right size for your quality management system - How to manage your quality systems while still focusing on the development of your medical devices Resources mentioned: David built his consultation website – www.myquickconsult.com – exclusively for startups, giving you access to Med Tech execs who can answer your questions and give you reviews on your quality systems. Email David at [email protected] for a discount. And don’t forget to visit greenlight.guru for your quality management system needs.

Did you know ISO 13485 has been revised and approved in 2016? And is going to be published later this month. The quality management standard we’ve all grown to know is now being updated, and we’ll explain more on this episode of the Global Medical Device podcast. Today we’re joined by special guest, Mark Swanson. In addition to being a consultant for H&M Consulting Group, Mark has spent the last 4 years on the working group that wrote the new ISO 13485:2016. He knows all the insider details, and in addition to this podcast we’re doing a detailed webinar with Mark on the changes to ISO 13485:2016 and all the things you need to know it as the standard becomes live. Mark advises companies on quality management systems and business practices, and specifically he advises quality managers and other senior management in meeting industry standards and regulations for medical devices as well as general ISO management requirements. Be sure to check out Mark’s consulting group here. In this episode, Mark tells us the next steps to making the updated ISO 13485 an official published standard. It's important to have some solid info about the changes that are coming so people can get prepared and know the “why’s” about everything it brings. It’s been in the making for 4 years, so we’re obviously expecting this to be the best yet. Today you’ll be learning the single biggest change that people need to know about the new ISO 13485, and why it’s so important for global medical device companies to understand the topic of risk management as it applies to the updated standard. When it comes to ISO 9001:2015, there are no conflict or competing requirements between the two standards. Both ISO 9001:2015 and ISO 13485:2016 have the right hooks to hang additional requirements off of or whatever is necessary within the regulated environment to continue being consistent. They’ve truly been consistent with what the true requirements are. This new ISO 13485 is going to change the way medical device companies think and build products forever. We talk about controlling your processes, the things you need to know from a supplier control standpoint, its differences in structure, and what the timeline is for adoption. Essentially, we tell you all the things you need to know before making the switch. To get in touch with Mark, you can check out his website at hmcg.biz, feel free to shoot him an e-mail at [email protected], or give him a call at (763) 234-0727. In just a few short weeks we’re going to be hosting a webinar with Mark on Feb 9th, 2016 at 1:00pm EST, where we’ll go further in depth on all the topics we’re discussed today and the changes to ISO 13485 you need to be prepared for. You can sign up for the free webinar using this link: http://www.greenlight.guru/webinar/iso-13485-2016-changes

Standards are absolutely critical when you are developing a medical device. You need to understand why these standards are important when developing your product for your regulatory submission. You need to know what they are and understanding how to incorporate them as part of your design and development process at the beginning rather at the end. Today's guest Leo Eisner from Eisner Safety Consultants is a leading expert in medical device safety standards. He even has built a database to help you navigate the process. I encourage you to take a look. “The standards are rigorous and it’s for good reason.” - Leo Eisner Leo has over thirty years of experience in product safety and is a leading speaker and author when it comes to medical device safety. He knows quality systems, knows how to audit and test. He has recently released the “Standards Reconnaissance Database” so that medical companies can leverage his expertise. “Your indications for intended use [of your device] are directly impacted by the markets where you plan for your product to be used.” -Jon Speer Today Leo & Jon discuss: -How Leo’s career in standards began -Why standards are important -Why should I care about standards regarding my medical device -Standard IEC-60601 -Standards Reconnaissance Database -Benefits of standards -Updates to standards -Classifying your product, drafting a test plan, checking against standards "The most important reason you should care about standards is because of your regulatory submissions and your design process." - Leo Eisner Leo’s best recommendation when it comes to standards is to know your product well enough to know what standards apply early in the development process - from there you’ll know how much preparation and testing it will take. To get in touch with Leo please be sure to check out his website at Eisner Safety Consultants or feel free to shoot him an email at Leo at EisnerSafety dot com.

Another brilliant mind joins us today on the Global Medical Device Podcast. Peter Sebelius is the founder of Gantus.com and today we’ll talk medical device product development and project management. Peter is a certified PM and has vast experience in the industry and extensive knowledge of medical device standards. He is also a member of the joint working groups on ISO 13485 and Iso 14971. Today we’ll talk about lean management and agile as it applies to the development of medical devices. Can you be lean and compliant at the same time? “Medical device product development is far from a straight line.” - Jon Speer Knowing when to turn on the design controls is a delicate balance. Design controls should be a framework - they don’t necessarily need to stifle the creative process. It doesn’t have to be restrictive. “It was never intended in product management or design control to be changing technical solutions fundamentally while you’re in that process.” - Peter Sebelius Today we’ll talk about: - Can you be lean? - Finding the right balance with design controls - Using “TBDs” - Project Management and Design Controls as ‘best practices’ - “Guide for the Project Management Body of Knowledge” - “Shared responsibility is no responsibility” “You can’t write something down that you haven’t thought through well.” - Peter Sebelius Peter suggests that project managers should learn more about qualitative management and regulatory affairs. Make sure you know what’s good enough. Peter provides online training on risk management, project management and design control. You can find him and learn more at gantus.com.

It’s time to break down the how and why of intended use and indications of use statements for your new medical device. On this episode of the Global Medical Device podcast we’ll explain the differences between these two statements and how you can design your labels around them. Mike Drues, Ph.D. is our guest today giving some great examples of these use statements and successful label designs. He’s the President of Vascular Science, consulting for medical devices and regulatory bodies like FDA, and he travels the globe to set everyone straight on medical device regulations. Your intended use and indications of use statements are integral to getting your medical device to market. These statements help insure your device meets regulation when used properly. If you want to bypass any hiccups in your marketing plan, you need to understand the key differences between these two statements: First, intended use is EXACTLY what your product is used for. Don’t focus on what it COULD be used for. Rather, define exactly what it is in as few words as possible. Second, your indication of use statement are the precise situations and reasons where and why you would use this device. Again, being very clear and definitive here is extremely important. “They think they understand what intended use means, but they really don’t…Intended use is all about what we say this device is to be used for, and indications for use is under what circumstances or under what conditions you would use that particular product.” – Mike Drues Mike Drues goes into what he calls “high level labeling” with tips on how to get your label to market with as few words as possible. Little words do matter, and sometimes it may take you 6 different use statements before you find the right ones that work for your device. Breaking down examples, using clear-cut definitions, and using a trick Mike calls “label expansion” are all ways you can use your intended use and indication of use statements to your advantage. “The single most important thing that people should remember is to apply the same concepts and philosophies that we learned as engineers to product design [and] apply that same kind of thinking to label design…and indication of use statements.” – Mike Drues Mike also discusses the reimbursement pathway and how it is often overlooked in the beginning of our development processes. Changing up when you approach regulation can really make it easier to design and write the right kinds of use statements, and focusing on regulation this early on will often make it easier for marketing further down the road. Tune in now to hear how these tips can be applied to you, your team, and your medical device. To get in touch with Mike Drues, find him on LinkedIn.

Today on the Global Medical Device Podcast we have a very interesting and highly debated topic for you around research vs. development for medical device companies. We’ll challenge some conventional wisdom on the subject and dig into when ‘R’ should end and ‘D’ begin. Our guest on the show today is David Amor, a medtech/biotech consultant and mobile health entrepreneur. David is the founder of Medgineering, a consultancy specializing in implementing new quality systems, design control processes, and risk management for both startups and larger companies. Recently David also launched QuickConsult, an online consulting platform that pairs up medtech experts with startups or large companies. The online consulting model allows clients to work with the consultants of their choice who will help them understand their specific quality and regulatory needs. The subject of today’s episode is loosely based on a well written and thoughtful article David authored a few months back titled, “When does the ‘R’ end and the ‘D’ begin for medical device companies?” Jon and David touch upon a lot of the points in that post (which I encourage you to go read after listening to today’s episode) and really dig into why the conventional wisdom regarding ‘R’ and ‘D’ in medical device product development is often wrong. Specifically, today Jon and David get into: -Why should you start design controls early in development? -Are your thoughts about research wrong? -Will doing design controls early slow you down? -When do design controls ACTUALLY start? -How to view design controls as more than a paperwork heavy process. -The shift in traditional R&D roles. -What outcomes you should be focused on BEFORE research.

On today’s episode of the Global Medical Device podcast, we’re talking about the importance of incorporating business elements into your medical device product development process. When firms focus only on design controls, they may not experience the growth expected, which can lead to a surprisingly low bottom line. Today we are discussing this situation with Therese Graff, a partner with Strategy 2 Market, which is a boutique consulting firm located in Chicago specializing in new product development. “Design control is just good engineering practices... engineering common sense... The business case... allows me to define whether it makes economic sense to build the product.” - Therese Graff Therese has an impressive background in project management and project consulting. She earned her Bachelor of Science at the University of Illinois and her MBA at the University of Chicago. She’s a project management professional, certified with the Project Management Institute, and a new product development professional, certified by the Product Development Management Association. Her career history includes working with complex instrument project management, working as a project consultant for design teams, and, most recently, working with a Fortune 200 medical device firm to streamline design control processes. In our interview with Therese, you’ll learn about: - Factors to keep in mind as you begin the product development process. These include questions about your overall marketing strategy, reimbursement, and the regulations and standards of other countries (if you plan to eventually launch outside of the USA). - How to determine whether a particular product or design will make economic sense before you begin investing time and money into the project. - Free or inexpensive resources for small businesses, entrepreneurs or new product developers who might not have a team of experts or unlimited funds. - A sensible approach toward building a business case, including design control, documentation and prototyping.

Getting started in the medical product development process can be a huge undertaking. You might have an excellent idea, but maybe you’re unsure about where to start. Whether you’re just beginning to research, you’re starting to look for development partners, or you’re almost ready to start the manufacturing phase, having someone on your side who can advise you every step of the way is essential. Today we are talking to Meghan Alonso, the CEO of Imua Services, a company devoted to medical device product development firm, and host of the Inspired by Imua podcast. Meghan has a varied background in the medical field. She started out working with injured athletes during the time that she coached gymnastics. She began working at a general orthopedic rehabilitation clinic, and from there, she says she fell in love with medical devices and the impact that they were having on her patients. Since 2012, she’s been helping companies with their innovations. Meghan earned her B.S. from Texas A&M University and her M.Ed. from University of Houston, and she’s currently pursuing her MBA at Auburn University. On today’s podcast, Meghan will talk about: - Some of the “rough waves” that are common during the development process, including tight budgets and a lack of organization. - Tips on how companies can choose development partners. - Her podcast, Inspired by Imua, takes a three-pronged approach to helping those who are designing medical devices. She speaks to industry experts, companies who have already designed devices, and patients whose lives have been changed. - The types of services that Imua Services provides, which include one-on-one meetings with clients to guide them through the product development process. Imua can help a company formulate a slide deck, write up a regulatory plan, design the manufacturing processes, reduce their costs and identify the strategies and logistics that will go into sales. - And last, something special for the Global Medical Devices listening audience: a guide to the most common wipeouts in medical product development.

Here’s a question for our listeners: When it comes to making sure your medical devices are safe and effective, is it more important to find the right answers or to ask the right questions? In this episode of the Global Medical Device podcast, we are delving into everything related to design verification and validation, which is often called the V&V. We discuss why V&V is so important, the major differences between verification and validation, how they fit into your approval process and more. Today we’re talking to a familiar guest and medical device expert Mike Drues, president of Vascular Sciences. “We need to focus on asking the right questions. V&V is all about demonstrating what’s safe and effective.” – Mike Drues Mike works for and consults with medical device companies located all over the world. He also works with the US FDA, Canada Health, and other regulatory and government agencies in the US, Canada, Europe and elsewhere in the world. “When working with the FDA, tell, don’t ask. Lead, don’t follow.” – Mike Drues In our discussion about V&V, some of the points you’ll hear about include: - Validation and verification: What do these two words mean, what are the major differences between the two, and how do they both fit into your approval processes? - How to know when you need to go to the FDA with a 510k form and when you can simply use a letter-to-file. - The importance of knowing why you’re running the V&V tests to begin with. - How you can use the Five Whys tool in your V&V process. - Why it might not make sense to go through the V&V process, and how to approach the FDA to come up with a different procedure to satisfy the regulatory requirements. - Advice on which questions to ask the FDA during the pre-submission process with the FDA.

On today’s episode, we’re introducing the newest addition to the greenlight.guru team, Jessica Lyons. Jessica is a 2007 graduate of Rose-Hulman Institute of Technology and has worked in the medical device product development for nearly 10 years. She worked in custom integration at Beckman Coulter, then worked on getting medical devices transferred to manufacturing at CRI, a medical device contract manufacture. Jon and Jessica are discussing FDA inspections. “It doesn’t matter your size, shape or how long you’ve been around. You’ll go through an FDA inspection.” – Jon Speer No one looks forward to having the FDA come to inspect their facility, but you always need to be ready for it, as you might be subject to an inspection as frequently as every two years. We want to put your mind at ease by giving you information on how to best prepare for FDA inspections, which can take a minimum of five to seven days. “The FDA seems to find the one piece of information you wish they wouldn’t.” – Jessica Lyons Some of the topics you’ll hear about it in today’s podcast include: Jessica talks about her role at greenlight.guru, which is making sure the customers are successful, in whatever form that takes. - Why FDA inspections are high-stress. - How to prepare for an FDA inspection. - What to expect during your inspection? - Why the FDA nearly always finds potentially questionable items. - How to react if you receive a 483 warning letter. - What to do in order to resolve issues found during your inspection. - What FDA data is available to the public. Now if you liked today’s episode, then I know you’re going to find the free webinar we have coming up valuable. It’s titled, “How to Avoid and Respond to FDA 483’s and Warning Letters.” You can register for the webinar here: http://www.greenlight.guru/webinar/fda-483-warning-letter-response

As medical device developers, it is our responsibilities to make sure that our products are safe and effective. Unfortunately, the recent high profile cases of antibiotic-resistant superbugs spread by tainted endoscopes that have sicken many have called into questions whether there needs to be new regulations to prevent future infections. “If you have a device that is designed to be cleaned or reused, should not some of the design inputs include reprocessability requirements?” - Mike Drues Today we are speaking with a familiar guest Michael Drues, Ph.D. about the recently published guidance document released by FDA for reprocessable medical devices. Mike was one of several people who was invited to present at the panel meeting at FDA on this topic last year. “What good is the regulation if it’s not realistic?” - Mike Drues Mike is the president of Vascular Science, as well as a consultant for the FDA, Canada Health and other worldwide regulatory organizations and medical device companies. Due to his work with these organizations, Mike can see the issue from both sides: He understands the regulations and why they must exist, and he also knows that they need to be approached and implemented with real-world scenarios in mind. On today’s podcast, some of the topics we discuss include: - What happened in a landmark endoscope case from UCLA, and how it affects everyone in the medical device industry. - Who must be considered and included as the end users of a product. - The specifics of some of the new regulations, including new rules pertaining to UDI labels. - Thoughts on who should be handling the reprocessing validation. - Why over-complicated reprocessing manuals can do more harm than good. - Best practices for device development companies to keep in mind when following the new regulations.

If you are part of an organization developing or producing Class II medical devices, you should know that on September 24, 2016, your UDI submissions are due to the FDA. “I don’t mean to scare anyone, but we only have 78 working days left.” - Gary Saner UDI stands for “unique device identification,” and the new labeling regulations have been put into place to increase patient safety, reduce medical errors, and provide a foundation for secure global distribution of devices. Today’s guest, Gary Saner, is an expert on UDI submissions and other regulatory topics. As the Senior Manager of Information Solution at Reed Tech, Gary is speaking to us today about the UDI submission procedures and other relevant topics. “The UDI submission is not a one-time effort.” - Gary Saner With over 30 years’ experience in software management and data conversion, Gary is the go-to person if you have questions about UDI, and his company can help medical device companies of any size be sure that their submissions are in order. Some of the topics you’ll hear discussed on today’s podcast include: - What UDI is and what information needs to be included in each of its components. - The timeline of deadlines leading up to now and up to September 2016 as they pertain to different types of devices. - Some of the challenges that apply to larger and smaller companies when it comes to meeting the 9/24/16 deadline, as well as how the Reed Tech tool can help organizations of all sizes. - The importance of knowing and understanding the UDI submission process. - The two submission methods that the FDA has in place. - Tips and pointers to keep in mind as you go through the submission process.