Global Medical Device Podcast powered by Greenlight Guru

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.