Global Medical Device Podcast Powered By Greenlight.guru

What are the differences between 3D printing and additive manufacturing? What are the quality and regulatory considerations around 3D printing? What is FDA’s approach to whether or not this technology should be regulated?In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences about the pros and cons of 3D printing in the medical device industry and key considerations manufacturers should make with regard to this technology. Some of the highlights of this episode include:Although additive manufacturing and 3D printing are often used interchangeably, Mike explains that 3D printing is a very broad category with at least a dozen different technologies under that category, including additive manufacturing.FDA describes 3D printing as, “a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete.”Classic or traditional manufacturing

How does a quality management system (QMS) and regulatory factors impact fundraising, pre-money valuation, market access, and commercialization for medical device companies?In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Cristiano Fontana, founder and CEO of ThreeBridges.ThreeBridges is a consulting firm that provides business development advisory services for startups, distribution companies, and subject matter experts (SMEs) in the global medtech market. Also, Cristiano is a co-founder of CrossBay Medical, Inc., and partner of IStarter and ClubDealOnline. Some of the highlights of this episode include:When someone evaluates and/or values a company, QMS and regulatory impacts fundraising rounds and pre-money valuation by asking for backup evidence as well as understanding business models and financial motives.Cristiano describes the common paths that startups and entrepreneurs take when considering valuation. Start with a clear idea of the entire journey to create a reliab

Colombia represents an untapped destination for early feasibility, first-in-human clinical research for companies to first enter the Latin American market and sell medical devices.  In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Julio Martinez-Clark, CEO and co-founder of Bioaccess, about early feasibility studies in Latin America.Since 2010, Julio has supported more than 100 Medtech opportunities to design and operationalize successful clinical trial, regulatory, and market access strategies in Colombia and other countries in Latin America. Some of the highlights of this episode include:Julio is a big believer in the potential for medical device companies in Latin America. He explains how U.S. Medtech companies can succeed in Latin America with early feasibility clinical trials and market access entry initiatives.Latin America is a good location to conduct easy feasibility clinical trials because U.S. companies struggle to find cost-effective, ethical, and quali

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Ken Zalevsky, Certified CyberSecurity Leader and CEO of Vigilant Ops, about software bill of materials (SBOMs) and cybersecurity in the medical device industry.Ken has collaborated with the FDA, U.S. Department of Homeland Security (DHS), and National Telecommunications and Information Administration (NTIA) on cybersecurity initiatives, including cyber simulation exercises, industry guidance documents, and SBOMs. Ken’s written work advises medical device manufacturers on cybersecurity best practices and coaches hospitals on handling record numbers of breaches.Some of the highlights of this episode include:Ken defines an SBOM as a list of software components that compose any system, application, or device. In health care, medical devices are computer-based systems with software components.Engineers may know all about software and security, but not with medical devices and SBOMs. Medical device manufacturers are familiar

How do you balance security and usability of software as a medical device (SaMD)? It’s not easy and trade-offs may need to be made by device companies in order to give users what they want and need to safely use it as intended.In this episode of the Global Medical Device Podcast Etienne Nichols talks to Abbas Dhilawala, a cybersecurity and SaMD expert with Galen Data, about a new approach to cybersecurity and usability for SaMD companies to ensure products are both secure and user-friendly.Abbas has 18 years of experience developing enterprise-grade software for the medical device industry and is well-versed with technology, industry standards, and the privacy of data.Some of the highlights of this episode include:Usability and human factors testing standards exist. However, there’s no standard approach to follow for cybersecurity. Abbas’s approach is to obtain user feedback as soon as possible for SaMD to still be secure and user-friendly.Different kinds of users in the healthcare spectrum can be trained to

How many COVID tests have you taken at home, in hospitals, or at drive-thru clinics? Are you sick and tired of the long wait times to access the tests you need? Do you worry about whether you followed the instructions correctly or not? Does it take too long to process results - only to get false positives or negatives? In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Jeremy Stackawitz, CEO of Senzo Health about his company's focus on improving current testing product offerings through better performance. Jeremy has more than 20 years of experience in the healthcare industry and Senzo Health is an in vitro diagnostics and point-of-care company working on COVID-19 technology. Some of the highlights of this episode include:Positive vs. Negative Test Results: Jeremy discusses the pros and cons of COVID testing by using lateral flow products to increase the time to results and improve performance. Supply and Demand Constraints: Senzo Health’s reason for being is

How do you build a company that puts culture before function? Results before profit? Building a culture of quality to improve lives for a better world is more than just a slogan, it's a shared mission. In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Dan Purvis, CEO and co-founder of Velentium, about building quality-centric, life-changing products for the medical device space.Velentium is a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices. Its staff does meaningful work on clients’ behalf to bring products to market.Some of the highlights of this episode include:Dan describes quality through culture as a way to move beyond compliance to get true buy-in and engagement throughout your organization.Quality through culture is like a three-legged stool consisting of people, business, and quality. The three legs must work together and learn from mistakes.Dan’s definition of quality depends on indus

Are you passionate about human-centered design and how it relates to health care? Patients deserve a high quality experience when bringing medical devices into their home. They want a product that they can use and want to use, without sacrificing any elements that would otherwise exist in a clinical setting. In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Dylan Horvath, Founder, President, and Chief Product Officer at Cortex Design.Dylan has a degree in Systems Design Engineering and founded Cortex Design to be a firm that fosters human connection, improves health outcomes, and allows people to do things that they couldn’t do before.Some of the highlights of this episode include:Dylan describes design as a tool for understanding how people react and relate to technology. The design of those experiences should create empathy and fit in with a person’s lifestyle and their experience.When people bring home and use a new medical device or product, it should not be a comp

How do you navigate the De Novo process for your medical device? When do you decide to go that route rather than with other FDA submission pathways, such as Q-Sub, 510(k), premarket approval (PMA), and device designations?In this episode of the Global Medical Device Podcast Etienne Nichols talks to Rob MacCuspie, Manager of Regulatory Affairs at Proxima CRO, about the De Novo submission process. Rob oversees high-quality regulatory submissions to the FDA and other regulatory agencies and is passionate about bringing products to market in a safe, effective, and efficient manner. Some of the highlights of this episode include:In the medical device industry, De Novo refers to something new and innovative.  When you have an idea that has not been done before and is not substantially equivalent, then the De Novo pathway may be the right choice.The De Novo process is not as commonly used as the 510(k) pathway. The rate of innovation compared to incrementals tends to not be as often.Rob describes the pros

What are the regulatory pathways used in the United States versus the European Union (EU)? Dealing with regulators can be challenging and emotionally draining. Win in the U.S. and EU marketplace by delegating all things regulatory to a grief counselor. In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Michelle Lott, Founder and Principal of leanRAQA. Also, she served a four-year term on the FDA’s Device Good Manufacturing Practice Advisory Committee (DGMPAC).Michelle is on a mission to help smaller companies with regulatory strategy, planning, submissions, audit preparation and remediation, due diligence, quality systems, and compliance.Some of the highlights of this episode include:Why new clients work with Michelle: It’s easy to find a competent regulatory person, but how many are you going to enjoy working with and able to make you laugh when you really feel like crying?Even with the adoption of EU MDR, people are still in denial when it comes to those with ce

Have you ever played the game, Operation? The patient’s nose would light up and buzz if your tweezers touched the side. Neurophysiology is a lot like that game.In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Shawn Regan, CEO and Co-founder of Rhythmlink International, at the South Carolina Biosciences (SCBIO) Conference.From startup to industry leader, Rhythmlink is a company that designs, manufactures, and distributes medical devices that physically connect patients to machines to elicit or record neurophysiologic information.  Rhythmlink’s products are used during risky surgeries to help prevent or reduce paralysis, identify tumors, map the nervous system, and monitor brain waves. Its devices were the first of their kind to be cleared by the FDA to work specifically in MRIs.Some of the highlights of this episode include:Shawn describes neurophysiology as electrodes put on or under a patient’s skin to monitor their nervous system in real-time to identify dangerous sit

What will the future be for software as a medical device (SaMD) and cybersecurity? Manufacturers need to identify cybersecurity issues with their medical devices because incidents have become more frequent, severe, and impactful. In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Gates, Director of Product Security at Velentium and author of Medical Device Cybersecurity for Engineers and Manufacturers.Chris has more than 30 years of experience developing and securing medical devices for device manufacturers and collaborates with regulatory and standardization agencies to present, clarify, and systemize tools, techniques, and processes that enable the creation of secure medical devices.Some of the highlights of this episode include:Although the FDA understands the importance of updating cybersecurity guidance, it should tie the documents to real standards from ISO and EU MDR, rather than only referencing consensus standards for global harmonization.To make secure medical

In this episode of the Global Medical Device Podcast Etienne Nichols talks to Patrick Hayes, Associate Director of Program and Project Management at Commissioning Agents (CAI), about how to achieve operational readiness in a manufacturing setting.CAI is a professional service provider that helps medical device companies get their quality products to market through operational readiness. The company provides expertise to get products out the door and qualified in a safe, effective, and cost-efficient manner.Some of the highlights of this episode include:CAI utilizes integrative services to identify clients’ needs to achieve operational readiness. Then, operational excellence is the end goal. Most CAI agents are Project Management Professional (PMP) qualified through Project Management Institute (PMI). Patrick encourages and recommends people to attain PMP certification to enhance their degree of success.Patrick describes the steps of a solid project management process. It includes planning, integration, a

Selling a medical device in the EU? Understanding the importance of clinical data and what's required will be crucial to your success.In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Adam Steadman, Chief Commercial Officer for SMART-TRIAL, about best practices⁠—not shortcuts⁠—to bridge the gap between medical devices and clinical data.SMART-TRIAL is an Electronic Data Capture (EDC) company that provides software as a service (SaaS). The EDC software generates, collects, and manages data used in clinical studies.Some of the highlights of this episode include:EDC is a newer concept or discipline for the medical device industry. Compared to the pharmaceutical space, automation from the clinical trial perspective has been a bit slower because of smaller sample sizes.Post-market surveillance activities are driven by EU MDR. In Europe, medical device companies are now being forced to prove to the world that their device continues to be effective against its peers and new pr

Navigating the Medical Device Single Audit Program (MDSAP) may cover most of your regulatory requirements; however, it does not mean that your product will automatically be cleared or approved by FDA. Any medical device company considering MDSAP should be familiar with what the program is and is not.In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Danny Kroo, a medical device consultant and sub-contract lead auditor for several registrars that provides quality management system (QMS) and regulatory affairs services.Listen to Jon, Etienne, and Danny as they help to align expectations about the MDSAP journey so manufacturers can understand both how program works and how it should be leveraged from a regulatory strategy standpoint.Some of the highlights of this episode include:The reaction to requiring MDSAP certification to access and sell medical devices in Canada created price increases and smaller companies were unable to justify changing the notified body or auditin

Today’s innovative medical technology is more like a video game and makes a minimally invasive ablation so easy it could be done by a 12-year-old.In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mina Fahim, ​CEO and President of MediView, about bringing augmented reality (AR) medical technology to market.MediView gives clinicians X-ray vision and leverages AR and artificial intelligence (AI) to simplify, democratize, and inform healthcare delivery. Previously, Mina worked at Medtronic, Abbott, Beckman Coulter, and Excelen.Mina is a serial entrepreneur in the medtech and fintech spaces. He approaches his life with a foundation of trust, team, transparency, and track record to encourage collaboration and innovation focused on advancing people’s everyday lives. Some of the highlights of this episode include:MediView solved the problem of how to place a 3-D representation of a patient’s specific anatomy underneath the skin to millimeter accuracy.MediView’s solution

What are informational meetings with the FDA, why should you schedule them, and how should they be conducted to make them valuable and worthwhile? It’s never too early to engage, interact, and collaborate with the FDA, or is it? In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Isabella Schmitt, Director of Regulatory Affairs at Proxima and Principal at M1 MedTech.Isabella discusses the necessity of informational meetings and answers some commonly asked questions about them. Sometimes, it is too early to meet with the FDA if you don’t have the information needed to support questions. Some of the highlights of this episode include:Informational meetings are valuable and important for helping medical device professionals and manufacturers build a relationship with the FDA.Informational meetings tend to focus on the early stages of a specific product, technology, or suite of products.Being prepared for informational meetings is beneficial. Rehearse ahead of time

For many new medical device professionals a bill of materials (BOM) may feel like a big black box. Who owns it? How does it function within a QMS? How is it used differently in design versus in manufacturing?In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols learn the answers to these common questions, and more, about a medical device bill of materials from guest Mark Rutkiewicz, VP of Quality at Innovize, Founder of Consiliso LLC, and author of Medical Device Company In A Box.Mark has more than 30 years of experience in the medical device industry and takes organizations to the next level of quality system, product development, and operational excellence. His vision, experience, and hands-on leadership drive best practices in quality system processes and project management.Some of the highlights of this episode include:The FDA and ISO quality system requirements include design controls, which have a direct correlation to BOMs.The Design History File (DHF), Device Master Recor

FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems. How will, what's being referred to as Quality Management System Regulation (QMSR), affect the medical device industry and regulatory bodies?In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences and George Zack of Two Harbors Consulting about the changes unfolding and the pros and cons of harmonization between QSR and ISO 13485:2016—a standard not governed by FDA.Some of the highlights of this episode include:The FDA is not expected to adopt ISO 13485 or any other standards across the board. Instead, it will take a piecemeal approach. Any future revisions to the 2016 version of the standard would need to be evaluated before becoming part of U.S. regulations.How often are periodic changes and updates made to QSR, ISO standards, and FDA guidances? Do changes even need to be made

When developing a product in the medical device space, how does intellectual property (IP) protection work in the private sector versus at an academic institution, like a university? When is a patent needed and when is it not?In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Neil Thompson, Kevin Buckley, and Stephanie Willerth about intellectual property and why it's important to understand the difference between inventorship and ownership.Some of the highlights of this episode include:At a university, Stephanie describes the process that professors and students follow when they have an idea. Before they publish it, if they think they have something novel and meets the definition for a patent, they file a disclosure.In the private sector, Kevin describes the publishing, patent, and funding process as being very different. To patent a trade secret, it must be incredibly robust and support a very valuable program. Funding for commercial entities or for-profit companies d