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 o...
Apr 08, 2020•45 min•Season 1Ep. 140
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 a...
Apr 01, 2020•31 min•Season 1Ep. 139
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 d...
Mar 26, 2020•41 min•Season 1Ep. 138
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...
Mar 18, 2020•37 min•Season 1Ep. 137
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 unchange...
Mar 12, 2020•38 min•Season 1Ep. 136
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...
Feb 26, 2020•39 min•Season 1Ep. 135
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 hei...
Feb 19, 2020•37 min•Season 1Ep. 134
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: Pur...
Feb 13, 2020•34 min•Season 1Ep. 133
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: -...
Feb 05, 2020•30 min•Season 1Ep. 132
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 highlight...
Jan 29, 2020•37 min•Season 1Ep. 131
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 Ch...
Dec 28, 2019•49 min•Season 1Ep. 130
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...
Dec 19, 2019•33 min•Season 1Ep. 129
Recruiting top, elite quality assurance and regulatory affairs (QA/RA) talent in the medical device industry is challenging, but vitally important. Today’s guest is Mitch Robbins, managing director of The Anthony Michael Group. As a recruiter, Mitch joins Jon Speer on the show to break down five myths about QA/RA recruiting and discuss the dos and don’ts medical device companies should consider when hiring these professionals. Some of the highlights of the show include: - Myth #1: Recruiting isn...
Dec 11, 2019•43 min•Season 1Ep. 128
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•Season 1Ep. 127
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•Season 1Ep. 126
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•Season 1Ep. 124
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•Season 1Ep. 125
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•Season 1Ep. 1
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
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•Season 1Ep. 4
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•Season 1Ep. 2
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•Season 1Ep. 3
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•Season 1Ep. 6
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•Season 1Ep. 5
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•Season 1Ep. 7
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•Season 1Ep. 9
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•Season 1Ep. 8
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•Season 1Ep. 11
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•Season 1Ep. 10
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,...
Nov 07, 2019•29 min•Season 1Ep. 12
