Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice? The waterfall methodology used to be the industry norm for medical device product development until an alternative approach known as the agile methodology emerged, leading to competing opinions over which product development approach is best. In this special 200th episode of the Global Medical Device Podcast, host Jon Speer and his guest Devon Campbell, founder and CEO at Prodct, discuss the waterfall an...
Apr 28, 2021•39 min•Ep. 200
Who loves internal auditing? Probably 99.99 percent of medical device professionals answered “not me!” While it may not be everyone’s favorite pastime, internal audits are very important...especially if you have or want a true quality culture and mindset of continuous improvement. In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru at Greenlight Guru. Sara loves to talk about internal audits. She shares her valuable wisdom of internal audits...
Apr 26, 2021•34 min•Ep. 199
What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a medical device? In this episode of the Global Medical Device Podcast, Jon Speer talks to Milton Yarberry, Director of Medical Programs at Integrated Computer Solutions (ICS). Jon and Milton discuss practical pointers for determining and describing the similarities and differences between the two types of devices. Milton also offers some helpful recommendations for IVD manufacturers to consider whe...
Apr 21, 2021•34 min•Ep. 198
For medical device professionals, there are the “knowers” and the “doers.” One group is knowledgeable about quality best practices and product realization needs, but may not know how, or have the desire, to act upon it. The other group puts that knowledge into action by doing the best practices that are needed to realize the product needs and [seize all] opportunities. In this episode of the Global Medical Device Podcast, Jon Speer talks to John Kapitan, CEO at Kapstone Medical, about the differ...
Apr 19, 2021•32 min•Ep. 197
Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, are you a customer who has benefited from using them? In this episode of the Global Medical Device Podcast, Jon Speer talks to Alison Lee about her PPE startup Breathe99, which pivoted operations in developing its high-quality face mask product to meet respiratory needs and provide personal protection during the coronavirus pandemic. Some of highlights of this episode include: Breathe99’s mask filte...
Apr 14, 2021•28 min•Ep. 196
Do you fear needles and the associated pain? No one understands this fear more than physicians who see it firsthand with their patients day in and day out. And one physician in particular set out to do something about it. In this episode of the Global Medical Device Podcast, Jon Speer talks to Dr. Amy Baxter, CEO and founder at Pain Care Labs. Amy discusses the pros and cons of being a physician, entrepreneur, and inventor of reusable, physiologic medical products to eliminate unnecessary pain. ...
Apr 13, 2021•49 min•Ep. 195
Why does the FDA have three systems in place to address and handle risk related to medical devices? Each system serves a different purpose, but are all three actually necessary? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about FDA’s three systems of risk for medical devices and the unique interdependencies and distinctions between them. Some highlights of this episode include: Three systems for medical device risk from FDA: product ...
Apr 07, 2021•40 min•Ep. 194
How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD manufacturers approach quality management and other key elements based on these similarities and differences? In this episode of the Global Medical Device Podcast, Jon Speer talks to Joanne LeBrun from MDC Associates, which offers quality systems consulting, regulatory consulting, and implementation training. Joanne offers valuable insights on the topic of managing quality for in vitro diagnostic...
Apr 05, 2021•42 min•Ep. 193
Does your medical device qualify for an investigational device exemption (IDE)? What does this process involve and what does FDA expect of these manufacturers? There is plenty to consider when it comes to the IDE timeline and process. In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill “Mr. Regulatory” who sheds valuable light on the topic of IDE, which allows an investigational device to be used in a clinical study to collect safety and effectiveness data, and...
Mar 31, 2021•57 min•Ep. 192
Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself? There’s a supplier management solution that will make your job a whole lot easier. In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-owner of QUNIQUE, a quality and regulatory consultancy. Previously, Bassil worked with the notified body, TÜV SÜD. Bassil discusses QUNIQUE’s Quality Engine (QE) solution for supplier management, which helps manufactur...
Mar 30, 2021•22 min•Ep. 191
Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that has historically been known to evoke a fearful, negative response by medical device professionals. In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, known in the industry as Mr. Regulatory, about the reasons why the PMA process is so dreaded by manufacturers bringing a Class III medical device to market in the United States.
Mar 25, 2021•46 min•Ep. 187
Why is design, manufacturing, quality, and culture so important in the medical device industry? These key elements must exist and function in synchrony so that a medical device can save and improve patient lives. In this episode of the Global Medical Device Podcast, Jon Speer talks to Dan Purvis, CEO at Velentium—a design, development, and manufacturing firm that takes medical devices through an entire lifecycle. Dan gives listeners an update on Project V, an initiative involving the mass produc...
Mar 24, 2021•37 min•Ep. 190
What do manufacturers need to know about the Safer Technologies Program (STeP) for Medical Devices from FDA? How is STeP different from similar programs, like the Breakthrough Devices Program? Which devices are eligible? In this episode of the Global Medical Device Podcast, host Jon Speer and his guest Mike Drues from Vascular Sciences offer answers to these questions and educate listeners on this new, voluntary program, helping manufacturers with eligible devices leverage STeP for easier, faste...
Mar 21, 2021•33 min•Ep. 189
One of the main differentiators that makes Greenlight Guru so unique is its Guru Edge. The medical device gurus are a team of medical device professionals with decades of combined industry experience and subject matter expertise. In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru at Greenlight Guru. Sara shares how her professional journey began as a biomedical engineer in the post-manufacturing industry. Listen as Sara offers valuable adv...
Mar 17, 2021•20 min•Ep. 188
What does it take to build a successful MedTech startup? It’s a multi-million dollar question and the answer involves strong execution of a highly strategic plan. In this episode of the Global Medical Device Podcast, Jon Speer talks to Duane Mancini, president and founder of Project Medtech, and host of the Project Medtech Podcast. Listen as Jon and Duane talk about building a startup in the MedTech industry and why it’s so important for MedTech startups to be strategic in their approach to brin...
Mar 10, 2021•30 min•Ep. 186
What makes Greenlight Guru unique? It’s Guru Edge —a team of medical device professionals with a ton of industry experience. In this episode of the Global Medical Device Podcast, Jon Speer talks to Karen Schuyler, a Medical Device Guru at Greenlight Guru with nearly 15 years of experience working in the medical device industry. Listen as Karen offers value advice to medical device professionals on how to establish important system connections that coincide with regulations so that you can make ...
Mar 08, 2021•26 min•Ep. 185
Imagine using medical illustrations, animations, and other types of artwork to tell the story of a medical device, its procedures, or its manufacturer. In this episode of the Global Medical Device Podcast, Jon Speer talks to Annie Campbell and Emily Holden from Now Medical Studios, where they create medical illustrations and animations for the healthcare industry. Listen to Annie and Emily explain how their unique artwork is transforming the way we see and understand medical devices....
Mar 04, 2021•43 min•Ep. 184
Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are interested in entering the SaMD space, what do you need to know when it comes to FDA regulations and guidance? In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, “Mr. Regulatory”, who has nearly a decade of firsthand experience working for FDA. Listen to Mr. Regulatory and Jon discuss all things related to SaMD from the perspective of FDA and how the agency is r...
Mar 01, 2021•46 min•Ep. 183
How can medical device companies be better prepared for remote and on-site inspections or audits? Practice, practice, practice so that you’re always audit-ready. In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry, lead consultant and senior advisor for Quality Systems and Compliance, respectively, within the FDA and Life Sciences division of their law firm, King & Spalding LLC. Listen to this episode where Steven and Eric share their keen...
Feb 24, 2021•51 min•Ep. 182
The new medical device regulation in the European Union (EU MDR) has introduced a host of new challenges for medical device companies. One challenge, in particular, has to do with the quality management system of a medical device. In this episode of the Global Medical Device Podcast, Jon Speer talks to Monir El Azzouzi, founder and CEO of Easy Medical Device. Also, Monir is a prolific podcaster, blogger, and YouTuber that helps medical device companies achieve compliance. Together, Monir and Jon...
Feb 22, 2021•36 min•Ep. 181
What do auditing and compliance protocols look like during a pandemic? Medical device companies continue to adjust to changing circumstances in an attempt to maintain business as close to normal as possible. In this episode of the Global Medical Device Podcast, Jon Speer talks to Colleen Hittle, founder of ProVeritas Partners, who brings years worth of knowledge and experience in the regulatory environment of healthcare and life sciences. Colleen provides listeners with guidance and support for ...
Feb 18, 2021•31 min•Ep. 180
Keeping a constant pulse on current medical device industry standards for risk management, like ISO 14971:2019 and its companion documents, while also adhering to the recommended guidelines is one of the most important things a medical device company can do to be successful. In this episode of the Global Medical Device Podcast, Jon Speer talks to Ed Bills, risk management consultant and technical committee member of the working group for ISO 14971:2019 and ISO TR 24971:2020, who shares key insig...
Feb 10, 2021•40 min•Ep. 179
Medical device reimbursement is a key consideration that must be well researched, understood, and managed by companies in order to ensure no money, to which you’re entitled to, is left on the table. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the importance of medical device reimbursement and offers tips listeners can use to build a competitive reimbursement strategy that puts dollars back in the company’s pocket once a device ...
Feb 04, 2021•41 min•Ep. 178
Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Health (NIH) aimed at accelerating the development, commercialization, and implementation of COVID-19 testing technologies that shorten viral detection cycles and increase access to reliable, accurate testing on a widespread scale. In this episode of the Global Medical Device Podcast, Jon Speer talks to Devon Campbell, founder of Prodct, who has been a major contributor in supporting the efforts bein...
Jan 27, 2021•48 min•Ep. 177
What are the 2021 strategic priorities for FDA’s Center for Devices and Radiological Health (CDRH) and what impact will these initiatives have on the medical device industry? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about CDRH’s previous, current, and future strategic priorities, including those impacted by the COVID-19 pandemic.
Jan 20, 2021•47 min•Ep. 176
What’s the relationship between product feedback, complaints, and adverse events? In this episode of the Global Medical Device Podcast, Jon Speer talks to guest Isabella Schmitt, Director of Regulatory Affairs at Proxima Clinical Research (CRO). Jon and Isabella discuss some important processes and methods medical device companies should consider for soliciting, receiving, and handling feedback.
Jan 14, 2021•34 min•Ep. 175
What impact has artificial intelligence (AI) and machine learning (ML) had on the medical device industry thus far? Have the emergence of these new technologies created new, unanticipated regulatory and quality challenges for industry professionals? In this episode of the Global Medical Device Podcast, host Jon Speer and guest Mike Drues from Vascular Sciences revisit the topic of AI/ML to identify notable changes and technological advancements that have emerged as a result of these technologies...
Jan 07, 2021•44 min•Ep. 174
Are you prepared for the aftermath of the pandemic’s impact on the medical device industry? It may be time for device professionals to start bracing for a new normal. In this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry from King & Spalding LLC about post-pandemic readiness for the medical device industry and how companies can prepare for and embrace the new medical device landscape that’s expected to take shape from 2021 onward. Steven, a ...
Dec 23, 2020•43 min•Ep. 173
The end of 2020 is near, which will close out a year that’s been fraught with challenges and difficulties. However, 2021 will bring its own set of new challenges for those implementing the European Union Medical Device Regulation/In-Vitro Diagnostics Regulation (EU MDR/IVDR). What do device companies still need to do to be prepared for the transition? In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-Owner of QUNIQUE Group, a quality and regulatory...
Dec 17, 2020•31 min•Ep. 172
Still seeking guidance to stay in the know when it comes to new and updated FDA requirements related to medical devices, especially during the ongoing pandemic? In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, senior director of regulatory affairs at ConvaTec and industry thought leader who has been coined the name “Mr. Regulatory.” Listen to this episode as Mr. Regulatory shares his predictions on potential policy changes or updates we may begin to see fro...
Dec 09, 2020•39 min•Ep. 171
