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FDA has issued new draft guidance on cybersecurity for software as a medical device (SaMD). If the FDA releases that draft guidance ‘as is,’ it will massively and negatively impact the SaMD industry and it’s imperative that manufacturers understand how to prepare. In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Gates, director of product security at Velentium, about the shifting sands of medical device cybersecurity regulations for SaMD. Some of the highlights of this episode include:Chris views the FDA’s recent activity around cybersecurity requirements, regulations, and laws for SaMD as a necessity because manufacturers cannot seem to self-regulate. The Protecting and Transforming Cyber Health Care Act (PATCH) will give the FDA a direct mandate to manage the cybersecurity of medical devices.However, a clause in the PATCH Act allows for cybersecurity to extend to all existing legacy medical devices—not just new devices entering the market.As medical device manufacturers (MDMs) become aware of the clause, it’ll have a huge impact. MDMs will likely end support for device lines due to high costs. The biggest issue with the new guidance consensus vs. regulatory standards is alignment with software bill of materials (SBOM) tools.The most effort-intensive part of the new draft guidance is ongoing testing of anomalies to determine if they can be turned into vulnerabilities. The industry will be unable to keep up with additional testing because of resources and demand.All this added burden will be placed on MDMs at the cost of marginal improvements in cybersecurity. So, there’s no real benefit to the manufacturer.Structure a standard by not creating something brand new that is ill/undefined but align best practices to create secure medical devices.Memorable quotes from Chris Gates:“Legally-backed cybersecurity requirements by a regulatory agency are necessary to ensure secure devices are entering the marketplace and hopefully replacing the insecure legacy devices.”“This clause is going to have a huge impact on medical device manufacturers (MDMs) and I find it amazing how many MDMs are completely unaware of this.”“An SBOM is a software bill of materials. It’s an ingredients list for your application.”“This isn’t just one-and-done testing in your life cycle.”“You’re going to have a lot of extra work coming your way.”Links:Medical Device Cybersecurity for Engineers and ManufacturersRegulations (Submit comments to the FDA)Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket SubmissionsPATCH ActInternational Electrotechnical Commission (IEC)ISO (International Organization for Standardization)International Medical Device Regulators Forum (IMDRF)Chris Gates on LinkedInChris Gates EmailGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru CommunityGreenlight Guru

Do your field teams still rely on map, spreadsheet, and note apps? How medical device companies have historically generated sales is no longer adequate for selling medical devices in today's market...and there's a new revenue intelligence tool to help you bridge the gap.In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Skylar Talley and Mark Mescher from MedScout, a territory prioritization and sales enablement platform.Skylar and Mark discuss early stage territory planning to get more medical device sales, different aspects of go-to-market strategies, and building and demonstrating meaningful value by understanding pain points. Some of the highlights of this episode include:Tools have evolved and MedScout’s platform is a huge step forward. Basically, it brings an Excel spreadsheet to life, maximizes territory data, and is very intuitive and useful for sales reps to understand.Skylar has observed an evolution from frameworks/methodologies on the market based on geographic coverage to put numbers, early sales, and clinical proof-points out as fast as possible and leverage an early budgeted staff.Companies should start thinking about territory planning early on during the fundraising phase to benefit the commercialization and purchase processes.Skylar describes the 3-stage early commercialization roadmap strategy as getting the product into market, developing case studies and understanding where to take them, and knowing the distribution or rep model to execute.Relationships are vital early on with the development and commercialization of a medical device company. Physicians educate and innovate, just like engineers.Skylar and Mark agree that it’s worth being thoughtful when evaluating available solutions to make sure they are not adding time to your managers and reps.Marketers find and generate leads through interesting means, so there’s much better coexistence and co-creation between sales and marketing teams today.Memorable quotes from this episode:“Sales reps aren’t always the best at Excel spreadsheets. Most of them don’t have any idea what a pivot table is.” Mark Mescher“I don’t hear from a lot of reps out there in the field that they’re just over the moon with how they have to use Salesforce on a day-to-day basis and if they use it on a day-to-day basis.” Mark Mescher“No two health systems are created equal when it comes to product approval.” Mark Mescher“Marketing teams are really at the forefront of being very creative in finding and generating leads through really interesting means that weren’t necessarily accessible previously.” Mark Mescher“Anytime you’re in an early stage environment, or doing something entrepreneurial, go talk to 20 to 30 people that you’re going to be trying to create an impact for.” Skylar TalleyLinks:MedScoutMedScout on LinkedInThe Rise of the Next Generation of Medtech “Milkmen”Omnichannel engagement in medtech: The time is nowThe rise of digital marketing in medtechEuropean Union Medical Device Regulation (EU MDR)SalesforceReptraxGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru Community

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 is more subtractive than additive. What if the intended patient population is for one person, can a clinical trial be performed for validation? Additive manufacturing poses regulatory and quality challenges.FDA has sought input from the medical device industry, manufacturers, healthcare providers and facilities to explore appropriate regulatory approaches for Point-of-Care (PoC) 3D printing of medical devices.For example, Mike discusses that the regulation of today was not intended for 3D printing face masks and other protective gear. The lack of regulation should not hold back manufacturers from getting products on the market and through FDA.FDA, as well as Mike, recommends software certification for people using 3D printing in a controlled environment to make safe and effective products.Memorable quotes from this episode:“There’s been now about 100, a little more, medical devices that have come through the FDA onto the market that have been 3D printed.” Mike Drues“The phrase, ‘additive manufacturing,’ comes from the fact that many of these technologies, certainly not all, but many of them are based on layer-by-layer-by-layer technology.” Mike Drues“Additive manufacturing is 3D printing, but not all 3D printing is additive manufacturing.” Jon Speer“There’s two ways you can do a validation. One way is to validate the product. The way we do clinical trials today is we essentially validate the product, but the other way we can do a validation is to validate the process.” Mike Drues“The blending of tech and med device, it’s scary on one hand, but it can be exciting, as well. I’m looking forward to seeing how this impacts and hopefully improves our health care in the world.” Jon SpeerLinks:FDA - 3D Printing of Medical DevicesFDA - Technical Considerations for Additive Manufactured Medical Devices GuidanceFDA’s Role in 3D PrintingFDA - Process of 3D Printing Medical DevicesFDA - 3D Printing Medical Devices at the Point of Care: Discussion PaperFDA - Classify Your Medical DeviceFDA - The 3Rs of 3D Printing: FDA's RolePART 820 - Quality System Regulation (QSR)Mike Drues on LinkedInGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru

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 reliable and consistent business plan.Cristiano’s fundraising strategy is knowing how much money is needed for different stages and consistently targeting the ideal investor (tier 1 or 2).When approaching investors, expect a lot of ‘no’s’ from investors, but you only need one, ‘yes.’ It’s a learning process to identify QMS/regulatory inconsistencies related to fundraising and pre-money valuation.Medical device companies may face specific challenges, such as demand, expertise, and selecting investors. Also, know about regulatory approval, debt, and reimbursement and mitigate risk, generate cash flow, and grow with a QMS.There are several differences when it comes to fundraising in the United States compared to the European Union (EU), including the amount of equity/money in the market and investors’ expectations of how a company is managed.Cristiano offers advice on the dilution of funds and company ownership. Consider how the money will be used and the actual versus relative numbers of valuation.Memorable quotes from Cristiano Fontana:“Come up with a business plan that is reliable as far as a business plan can be reliable.”“You need a deep understanding of your business model, your market potential, your value position, so that you understand what really is the potential of the product.”“Many times, people are not succeeding in fundraising or are delaying the time for getting their money because they’re not targeting the right people.”“You need, also, to show that you know what a QMS is, you have that in place already, and it is really efficient and well managed. Having something that is well structured that is tailor made but is well recognized on the market that is working.”Links:ThreeBridgesCristiano Fontana on LinkedInEU Medical Device Regulation (MDR)FDA - Pathway to ApprovalISO 13485Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight GuruGlobal Medical Device Podcast Email

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 quality sites overseas.More companies are coming to Columbia because it is difficult, expensive, and time consuming to recruit patients in the United States and achieve regulatory approval at the FDA.Although the FDA implemented its Early Feasibility Studies (EFS) Program several years ago, it does not work well. Trials are still expensive, and it’s still difficult to recruit patients in the United States.Patients and physicians in the United States and those in Latin America tend to share a similar culture when it comes to their health and lifestyle.However, there are challenges for companies in Columbia, such as language barriers. Documents for regulatory approval need to be translated into Spanish.Columbia’s reputation has evolved into a knowledgeable country for companies to visit, feel safe/comfortable, and find patients to conduct trials for quality data.Memorable quotes from Julio Martinez-Clark:“U.S. companies struggle to find cost-effective, ethical, and quality sites overseas.”“The struggle that these companies go through is immense. They find it very difficult, very expensive, and time consuming to recruit patients in the United States, not to mention the regulatory approval at the FDA.”“The Early Feasibility Studies Program that they implemented about seven, 10 years ago, it hasn’t really worked because of the dynamics of the U.S. system. Trials are still expensive and it’s still difficult to recruit patients in the United States.”“It’s really a bargain to buy services from a hospital in a country like Columbia.”“These companies are, in essence, looking for fast regulatory approval, ease of patient recruitment, and cost savings.”Links:BioaccessJulio Martinez-Clark on LinkedInOECDPacific AllianceFDA - Early Feasibility Studies (EFS) ProgramISO 13485True Quality 2022The Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight GuruGlobal Medical Device Podcast Email

Certified CyberSecurity Leader Ken Zalevsky discusses Software Bill of Materials (SBOMs) and cybersecurity in the medical device industry. He highlights the importance of SBOMs, the distinction between safety and security, and the challenges faced by medical device manufacturers in ensuring cybersecurity. The episode delves into regulatory expectations, risk profiles, and the integration of SBOMs into manufacturing processes.

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 use SaMD, including hospital staff and patients - depending on their level of trust and understanding of technology.Potential Pitfalls: Classification and credential layers, such as permissions and passwords, can put the security burden on the users but leads to the need for risk assessment/management for possible harm. Biometrics: Cutting-edge technology, such as fingerprint, eye, and face scanning is not as secure, reliable, or consistent, but it’s getting better. Always have a backup plan.Key Takeaway: There’s a lot of push on cybersecurity, but don’t take away the convenience or the usability aspect. Find a way to balance both usability and cybersecurity.Memorable quotes from Abbas Dhilawala:“Ultimately, if you make the product in a way that’s hard to use, you can be secure. If nobody uses it, it doesn’t really matter.”“There’s lots of standards, just no harmonization.”“What can you do to minimize stress? Health care is already a stressful environment.”“The fundamental layer of security is to know who the user is.”“Having standards is a nice thing because then you can develop tooling around that.”Links:Galen Data (Schedule a Demo)FDA - GuidancesFDA - CybersecurityHIPAATrue Quality 2022The Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight GuruGlobal Medical Device Podcast Email

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 to offer a better test that resonates with end-users, government contractors, healthcare providers, and others.Main Barrier: Lateral flow tests are simple, but the technology and performance is limited. However, these tests could be good tools to use to monitor your own health, are relatively inexpensive, user-friendly, and fast.Data: With new technologies, Jeremy gains confidence and believes in Senzo Health’s products because of data generated and shared with investors, regulatory bodies, and other people in the industry.Healthcare reform: People are genuinely interested in having an active role in managing their health care and know the system is broken. It makes more sense to bundle tests, take in one place, get results fast, and develop a treatment plan. Mitigate Risk: Make decisions based on priorities, different technologies, and limitations. It takes the right technology, team, and vision - know when to pivot.Memorable quotes from Jeremy Stackawitz:“Our test is 10,000 times more sensitive than the dozen or so current offerings that you can buy.”“People have realized, ‘Wow, these could be really good tools for me to use to monitor my own health, they’re relatively inexpensive, they’re fast.’”“With new technologies, what gives you confidence is seeing data and then seeing data in other people’s hands.”“I think our problem will be not so much finding a home for the technology, it’s going to be prioritizing what the best match for what our technology can deliver and the unmet needs in various markets.”Links:Jeremy Stackawitz on LinkedInSenzo HealthFDA - Emergency Use Authorization (EUA) PathwayFDA - 510(k) PathwayTeladocTheranosGreenlight Guru AcademyTrue Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

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 industry. In the medical device space, quality aligns with risk and safety. A risk-based approach is needed to understand the harm that will ultimately happen to someone using your device.Compliance obviously matters, as much as safety. A medical device could be fully compliant and still unsafe, or it could be fully safe and not compliant.Team Effort: A high-performing organization needs a dedicated leader and excellent talent. If you’re teachable, there’s always hope. Also, even if you can’t hire perfectly, you can fire perfectly.The culture of quality management can be considered a partnership or the police. Create a process, not a problem for people to conduct reviews.Instill quality and get people to say ‘yes’ by creating and crafting a culture-forward company for people to be ready for anything at any time.Dan wrote the book, 28 Days to Save the World, which details how Velentium partnered with a small medical device company and large vehicle manufacturer to increase emergency ventilator production.Memorable quotes from Dan Purvis:“In our space, quality really, really aligns itself well with risk and safety.” “Quality - it really is driving your organization towards perfection. That doesn’t mean perfect people. That doesn’t exist. We’re all fallible. But how have I created the processes, the thinking, and ultimately, the culture that gives us the best shot at removing risk and creating devices that are not only ethical and helpful to people but safe for the long haul.”“You could be fully compliant, and still unsafe. You could be fully safe, and not compliant, and so compliance obviously matters. You can’t go to market with non-compliant devices because you’ll get shut down, and you should be shut down.”“The only rules in this company should be rules that are inspiring.”Links:VelentiumDan Purvis on LinkedIn28 Days to Save the World by Dan PurvisQuality Is Free by Philip B. CrosbyISO 13485 - Medical DevicesFDA - Medical Device OverviewBrian Tracy - Motivational SpeakerTurning the Flywheel by Jim CollinsZen and the Art of Motorcycle MaintenancePaycheck Protection Program (PPP)FDA - Corrective and Preventive Actions (CAPA)True Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight GuruGlobal Medical Device Podcast Email

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 completely foreign object. There should be familiarity with it already because it has features that exist in the person’s cultural landscape.When developing new medical products, engineers and scientists use different human-led design activities to get something to fit in someone’s home design.When designing a product, it’s important for engineers and scientists to understand that they may not be the audience. Ultimately, they’re designing the product for those that are going to use the product.Objects tell people how to interact with them. Unexpected behaviors and accordances signify improvements to bad design. Even small changes early on in the design process can have a big impact on user experience.Adding risk management methodologies to a product design/development approach and decision-making process is to use economic, regulatory, and market constraints to accurately assume, define, and validate user needs.The role beauty plays in medical products and devices is subjective, but there is beauty in well-functioning devices. The thing that is beautiful is when something considers how it appears and how it lives with the people that have it.Design only works within the constraints in which both manufacturability and aesthetic perception are successful. You can’t get away with one or the other.Memorable quotes from Dylan Horvath:“Design is a tool for understanding how people react to a technology and how people relate with technology, and specifically the design of those experiences so that we can empathize and create products that fit in with a person’s lifestyle and fit in with their experience.”“The challenge when developing medical products is the people and the skill sets and the activities that engineers and scientists typically go through to develop a new product can be very different from the types of activities that you go through to try and get something to fit in someone’s home.”“People design their environments, unknowingly, to sort of fit with the image that they want to project about themselves.”“When you’re designing a product, if you’re designing it for yourself, you can guarantee one sale.”“I really got interested in medical systems because of the opportunity for improving lives. That’s our philosophy to this day.”Links:Dylan Horvath on LinkedInCortex DesignFDA - Medical Device OverviewGreenlight Guru Acquires CanvasGT: A Fire(less)side ChatTrue Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru