Global Medical Device Podcast powered by Greenlight Guru

Today, we are talking to Mike Fisher, who is the director of product development at the Global Center for Medical Innovation (GCMI). He deeply understands process and product development and has worked with some great companies both giant and small throughout his career. Mike is going to share some pearls of wisdom on process excellence and how it leads to product excellence. If you're involved in bringing new products to market, you won’t want to miss today’s show. Some of the highlights of the show include: -- What’s going on at GCMI: What they do, some recent developments, and what’s coming up. -- Why compliance is so important when it comes to product development and how it helps keep the process on the right track to the desired goal of an excellent product. -- Considerations to keep in mind when it comes to intellectual property rights, patents and getting regulatory clearance. -- Why a market assessment is vital to coming up with and selling a great product, as well as thoughts on choosing a niche. -- Insights Mike has gleaned from a disappointing experience. -- Why lining up resources and getting investments is difficult for many entrepreneurs and small medical device companies. -- Why many companies don’t understand value concepts: They don’t know why they’re doing what they’re doing and are more focused on box-checking. -- Mike’s best tips when it comes to making your process conducive to product excellence.

It can be confusing to know which submission type is the correct one for your particular development situation. Today we’re going to talk to Mike Drues, president of Vascular Sciences and regulatory guru, about what to keep in mind as you decide whether to use the 510(k), De Novo, 513(g), or Pre-Sub process. Some of the highlights of the show include: ● The difference between the 510(k) and the De Novo submissions and how to decide between them. ● An explanation of why the 510(k) submission process does not include proof of product safety or efficacy. ● Why the number of De Novo submissions is so small and what the process entails in terms of proving safety, as well as how it compares to the pre-market approval (PMA) process. ● How the relationship between a medical device company and the FDA resembles a poker game. ● Some statistics on the 510(k) and the PMA: How many are rejected the first time they’re submitted and why. ● When you should do a 513(g) vs. a pre-sub: how the two processes differ and when you should use each.

Have you ever considered the pros and cons of a PMA vs a 501(k)? Some of the considerations you must keep in mind are related to the path to market, but have you ever thought about competitive regulatory strategy? Going with the PMA approach might be a better business strategy than using the 510(k), despite the entrenched mentality that it’s a longer, more difficult road. Today we’re going to talk to regulatory guru, Mike Drues. Mike is the president of Vascular Sciences and he is well-versed on the entire process medical device companies go through to get their products on the market. He’s going to share his insight on competitive regulatory strategy and how it can help you make good business decisions. Some of the highlights of the show include: ● The pitfall of seeing the regulatory process only as a matter of jumping through hoops and the importance of seeing the bigger picture. ● What regulatory strategy is and how it differs from the path to market. ● How competitive regulatory strategy differs from regular regulatory strategy and how you can use it to your advantage. ● Some potential objections to using the PMA and how Mike responds. ● Thoughts on how to use guidance documents as a competitive weapon. ● Why one might consider a de novo classification as part of their regulatory strategy. ● Why you should always be looking for a different, better way to get through the regulatory process.

My guest today is Juan Carlos Serna, the co-founder of Right Submission. If you have been in the medical device business very long you know that 510k submissions for the FDA are a long, tedious, frustrating, and all round painfully experience. Juan Carlos and his team are medical device professionals who spent the late nights writing and formatting 510k submissions just like the rest of us. The hours lost creating submissions for the FDA inspired Juan Carlos to build a software that makes 510k submissions easier. The product is called Right Submission. Juan Carlos tells me about his “lightbulb moment” and why he believes the 510k process is old fashioned and in need of some upgrading. He also explains what exactly his product can do to make your next 510k submission painless. Here are this episode’s highlights: ● The 3 reasons why 510k submissions are stressful. ● The old fashion submission process that really hasn’t changed much. ● The 3 things Juan Carlos believes need to change in the 510k submission process. ● How Right Submission changes this process for the better. ● How Right Submission works.

Do you know the percentage of 510(k)s that are rejected by the FDA the first time? Shockingly, it’s 75%. The vast majority are rejected for poor substantial equivalence, which, as you know, defeats the purpose of the submission in the first place. Today we’re going to talk to Mike Drues, president of Vascular Sciences and regulatory guru, about some common mistakes that can sink your 510(k) submission. Some of the highlights of the show include: ● Jon’s motivation for writing an article about common mistakes that sink a 510(k) clearance. ● The importance of consistency with documentation and using the checklist off of the Refuse to Accept Policy. ● Why the Refuse to Accept guidance contains some minutiae. ● Recommendations on providing the required testing and following the best practices. ● Suggestions on how to handle showing a long shelf life. ● Thoughts on why the FDA is reluctant to accept promissory notes when a submission is not complete. ● Thoughts on risk management and why it’s an important part of a submission. ● The most important takeaways regarding the 510(k) rejection problem.

The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draft guidance was issued last summer and the final guidance was issued in August. So what does Real-world Evidence mean for you and from a regulatory perspective? Today we speak with Mike Drues, President of Vascular Sciences, about how real-world evidence can help you develop products that will improve and save lives. Some of the highlights of the show include: ● Why medical device companies should care about real-world evidence and why it’s as important and more realistic than the “gold standard” of randomized clinical trials. ● Reasons that a clinical trial can be less informative than real-world evidence and how the FDA is beginning to change its thoughts on accepting real-world evidence. ● Thoughts on why the quality of the real-world data is important when it comes to getting FDA to accept it. ● The mechanism of going down the path of using real-world evidence in regulatory matters. ● How real-world evidence might be used even after a device or product is already on the market, either in lieu of a clinical trial or as a reason to use a smaller clinical trial. ● Thoughts on the future of credible real-world evidence. ● Examples of how real-world evidence can be used.

Today we’re going to be taking the topic of risk management to the next level. We are talking to Jim Gianoutsos with Regality Consulting. We are going to explore some of the challenges with a company’s approach to manufacturing processes as they apply to risk management. Some of the highlights of the show include: ● Information about Jim’s background and about Regality Consulting. ● Thoughts on how risk is sometimes a box to check rather than an integral part of every discussion and every decision that’s made throughout the manufacturing process. ● Why the adoption of ISO 14971 has been so problematic for medical device companies. ● Why it’s important to consider risk management before planning design. ● Considerations to keep in mind when outsourcing or getting components and materials from other organizations. ● Thoughts on validating processes and sampling based on risk assessment and management. ● An example that Jim has seen regarding a lack of sufficient risk management: the takeaway is to address risk management now; don’t wait until you get a warning letter.

The topic of human factors can be confusing: How does it relate to design factors and risk? Why is it included in the regulations and how can this factor be handled? On today’s episode, we have Bryant Foster, the Vice President of Research & Design at Research Collective. Bryant applies the principles of cognitive psychology to the design of new technologies and is a great resource on the topic. Some of the highlights of the show include: ● What Bryant does as the VP of Research & Design at Research Collective and what his main focus is. ● The differences, overlaps, and intersections between human factors, design controls, project development, and research and development as these processes fit into the medical device industry. ● How companies should address the human factors standpoint. ● Common mistakes to avoid when considering the human factors. ● Human factors in usability and ergonomics as well as the difference between formative studies and validation. ● What a task analysis is and how that relates to the overall risk assessment. ● The importance of considering the various users of the product or device. ● What human factors has to do with post-market usability.

This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510(k). The question is, is this really anything new? Today, we’ll be talking to Mike Drues, president of Vascular Sciences, and he’s going to help us all understand what’s different about this fast track and how it might benefit you. Some of the highlights of the show include: ● What the new draft is about and how long this fast track has really been around. ● Some thoughts on the ramifications for the FDA and medical device companies since President Trump came into office. ● The FDA’s revised definition of “least burdensome.” ● Why, despite increased marketing and hype, the “new” path is not really new at all. ● What “abbreviated” means in this case and why it doesn’t necessarily mean faster or easier. ● Some questions to ask yourself if you want to know if you are working on something new or novel.

Do you have a firm grasp and understanding of what substantial equivalence means in regards to the 510(k)? Many don’t understand it; the evidence is the large percentage of submissions that are rejected due to a lack of demonstrating substantial equivalence. Today we’re talking with Mike Drues, President of Vascular Sciences about demonstrating substantial equivalence, so if you’re not rock-solid on the concept, you won’t want to miss this episode. Some of the highlights of the show include: ● Exactly what substantial equivalence means as it applies to the regulatory process and why it’s important. ● Why it’s challenging to demonstrate substantial equivalence. ● Mike’s approach to evaluating and demonstrating substantial equivalence. ● Some of the common errors that Mike sees in submissions that pertain to substantial equivalence. ● What happens if you get it wrong in the eyes of the FDA. ● An explanation of product codes and how they relate to substantial equivalence. ● Examples of how you might demonstrate substantial equivalence between common objects - stressing their similarities while de-emphasizing their differences.