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, ...
Dec 05, 2019•33 min•Ep 127•Transcript available on Metacast 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 o...
Nov 27, 2019•39 min•Ep 126•Transcript available on Metacast 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 announc...
Nov 26, 2019•31 min•Ep 124•Transcript available on Metacast 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...
Nov 26, 2019•37 min•Ep 125•Transcript available on Metacast 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 avo...
Nov 07, 2019•27 min•Ep 1•Transcript available on Metacast 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...
Nov 07, 2019•18 min•Transcript available on Metacast 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,...
Nov 07, 2019•23 min•Ep 4•Transcript available on Metacast 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 ...
Nov 07, 2019•25 min•Ep 2•Transcript available on Metacast 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...
Nov 07, 2019•24 min•Ep 3•Transcript available on Metacast 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 Pala...
Nov 07, 2019•23 min•Ep 6•Transcript available on Metacast 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 bette...
Nov 07, 2019•21 min•Ep 5•Transcript available on Metacast 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 regula...
Nov 07, 2019•30 min•Ep 7•Transcript available on Metacast 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 passio...
Nov 07, 2019•26 min•Ep 9•Transcript available on Metacast 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 cont...
Nov 07, 2019•26 min•Ep 8•Transcript available on Metacast 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...
Nov 07, 2019•26 min•Ep 11•Transcript available on Metacast 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 im...
Nov 07, 2019•25 min•Ep 10•Transcript available on Metacast 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...
Nov 07, 2019•29 min•Ep 12•Transcript available on Metacast 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 y...
Nov 07, 2019•28 min•Ep 13•Transcript available on Metacast 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 y...
Nov 07, 2019•23 min•Ep 14•Transcript available on Metacast 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,...
Nov 07, 2019•27 min•Ep 15•Transcript available on Metacast 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, ...
Nov 07, 2019•21 min•Ep 16•Transcript available on Metacast 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 ...
Nov 07, 2019•27 min•Ep 17•Transcript available on Metacast 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 develo...
Nov 07, 2019•30 min•Ep 18•Transcript available on Metacast 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. Tod...
Nov 07, 2019•31 min•Ep 19•Transcript available on Metacast 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...
Nov 07, 2019•30 min•Ep 20•Transcript available on Metacast 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...
Nov 07, 2019•28 min•Ep 21•Transcript available on Metacast 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 Sa...
Nov 07, 2019•23 min•Ep 22•Transcript available on Metacast In order to get your medical device to market, you will need to know about pre-submission and the pre-submission process. The FDA is trying to get the safest medical devices out there. The most common reasons that the FDA makes rejections is within the submission itself. The indications for use statement is not the same as within the submission itself. “There is no bigger fan of communication with the FDA. But, there is a caveat to that. That is, tell don’t ask, lead don’t follow.” - Mike Drues ...
Nov 07, 2019•31 min•Ep 25•Transcript available on Metacast One important piece of documentation that medical device companies rely on to get them through the regulatory process is the premarket notification 510(k). Since the FDA will refuse to accept submissions that are missing the appropriate documentation, it’s vital to understand what this is and when it is needed. Today’s guest, Allison Komiyama, PhD, RAC, is a former FDA reviewer who is an expert in regulatory submissions, quality systems, and biocompatibility evaluation. She started her consultin...
Nov 07, 2019•30 min•Ep 24•Transcript available on Metacast 3D printing can impact new product development and manufacturing. It’s a technology that is hot in many different industries, including medical device development. It’s been around for several decades, and now more than 85 devices are on the market that have been 3D printed, including a 3D-printed medication. While it’s not a new technology, there are new guidance considerations from the FDA on this subject. Mike Drues, President of Vascular Sciences, works with overseeing organizations includin...
Nov 07, 2019•32 min•Ep 23•Transcript available on Metacast 
