Global Medical Device Podcast powered by Greenlight Guru

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

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

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

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

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.

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.

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

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

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

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