Global Medical Device Podcast powered by Greenlight Guru

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.