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FDA has issued new draft guidance on cybersecurity for software as a medical device (SaMD). If the FDA releases that draft guidance ‘as is,’ it will massively and negatively impact the SaMD industry and it’s imperative that manufacturers understand how to prepare.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standards is alignment with software bill of materials (SBOM) tools.The most effort-intensive part of the new draft guidance is ongoing testing of anomalies to determine if they can be turned into vulnerabilities.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 Manufacturers Regulations (Submit comments to the FDA) Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions PATCH Act International Electrotechnical Commission (IEC) ISO (International Organization for Standardization) International Medical Device Regulators Forum (IMDRF) Chris Gates on LinkedIn Chris Gates Email Greenlight Guru YouTube Channel MedTech True Quality Stories Podcast Greenlight Guru Academy Greenlight Guru Community Greenlight 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 Talley Links:MedScout MedScout on LinkedIn The Rise of the Next Generation of Medtech “Milkmen” Omnichannel engagement in medtech: The time is now The rise of digital marketing in medtech European Union Medical Device Regulation (EU MDR) Salesforce Reptrax Greenlight Guru YouTube Channel MedTech True Quality Stories Podcast Greenlight Guru Academy Greenlight 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 Speer Links:FDA - 3D Printing of Medical Devices FDA - Technical Considerations for Additive Manufactured Medical Devices Guidance FDA’s Role in 3D Printing FDA - Process of 3D Printing Medical Devices FDA - 3D Printing Medical Devices at the Point of Care: Discussion Paper FDA - Classify Your Medical Device FDA - The 3Rs of 3D Printing: FDA's Role PART 820 - Quality System Regulation (QSR) Mike Drues on LinkedIn Greenlight Guru YouTube Channel MedTech True Quality Stories Podcast Greenlight Guru Academy Greenlight 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:ThreeBridges Cristiano Fontana on LinkedIn EU Medical Device Regulation (MDR) FDA - Pathway to Approval ISO 13485 Greenlight Guru YouTube Channel MedTech True Quality Stories Podcast Greenlight Guru Academy Greenlight Guru Global 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:Bioaccess Julio Martinez-Clark on LinkedIn OECD Pacific Alliance FDA - Early Feasibility Studies (EFS) Program ISO 13485 True Quality 2022 The Greenlight Guru True Quality Virtual Summit Greenlight Guru YouTube Channel MedTech True Quality Stories Podcast Greenlight Guru Academy Greenlight Guru Global Medical Device Podcast Email

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 with safety and efficacy in a regulated industry and may need to overcome software challenges.Most medical device software teams don’t build everything that is in a medical device. Scope appropriately because third-party components may involve risk.Safety is not the same as security, but both should be included early in the product life cycle. Cybersecurity standards include authorization, authentication, and encryption versus safety recalls, use cases, and vulnerabilities.SBOMs are not evergreen documents. They need to be maintained and updated regularly to act, react, and take action.Health care is the primary target for hackers over other verticals and the response time in health care has always been the slowest. Today, it takes about 160 days for a healthcare organization to discover a security breach. Memorable quotes from Ken Zalevsky:“A detailed list of those software components is really the essence of an SBOM.” “At the heart of it, the idea and the purpose of the SBOM is to give that transparency into software components that are utilized in medical devices.” “Most software companies, especially medical device software teams, don’t build everything that’s in the device. They take components from other third parties and there’s risk associated with those components.” “You can’t blame it all on the hospital because the hospital has no idea what’s running in those devices.” “Providing that transparency, understanding what you’re deploying on your network, just is common sense.” Links:Medical Device Security Made Easy - InSight Platform by Vigilant Ops SBOM - National Telecommunications and Information Administration (NTIA) NTIA - Minimum Elements For a Software Bill of Materials FDA - Guidance Documents (Medical Devices and Radiation-Emitting Products) FDA - Medical Device Overview AAMI TIR57: Principles for medical device security - Risk management The Greenlight Guru True Quality Virtual Summit Greenlight Guru YouTube Channel MedTech True Quality Stories Podcast Greenlight Guru Academy Greenlight Guru

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 - Guidances FDA - Cybersecurity HIPAA True Quality 2022 The Greenlight Guru True Quality Virtual Summit Greenlight Guru YouTube Channel MedTech True Quality Stories Podcast Greenlight Guru Academy Greenlight Guru Global 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 LinkedIn Senzo Health FDA - Emergency Use Authorization (EUA) Pathway FDA - 510(k) Pathway Teladoc Theranos Greenlight Guru Academy True Quality 2022 Greenlight Guru YouTube Channel MedTech True Quality Stories Podcast Greenlight 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:Velentium Dan Purvis on LinkedIn 28 Days to Save the World by Dan Purvis Quality Is Free by Philip B. Crosby ISO 13485 - Medical Devices FDA - Medical Device Overview Brian Tracy - Motivational Speaker Turning the Flywheel by Jim Collins Zen and the Art of Motorcycle Maintenance Paycheck Protection Program (PPP) FDA - Corrective and Preventive Actions (CAPA) True Quality 2022 Greenlight Guru YouTube Channel MedTech True Quality Stories Podcast Greenlight Guru Academy Greenlight Guru Global 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 LinkedIn Cortex Design FDA - Medical Device Overview Greenlight Guru Acquires CanvasGT: A Fire(less)side Chat True Quality 2022 Greenlight Guru YouTube Channel MedTech True Quality Stories Podcast Greenlight Guru

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 and cons of the De Novo pathway. Some people think it requires extra work and higher submission fees, but it’s an opportunity to work with the FDA to create and regulate a new product category that may be copied.The De Novo pathway takes longer to review than 510(k) submissions due to risk management activities. It’s worth it to be the first innovative leader in the field.Think, prepare, and plan for different scenarios and conflicting messages when choosing a pathway to avoid pitfalls, such as analysis paralysis.Don’t compromise core technology and features when making a product/device. Focus on quality without sacrificing compliance to improve quality of life.Work together and collaborate to understand the client’s needs and amount of key information to give to the FDA to provide meaningful and quality feedback. Memorable quotes from Rob MacCuspie:“So new, so innovative, so cool, there’s nothing else like that out there - that’s when the De Novo pathway might be the right choice for bringing this to market.” “The real opportunity with the De Novo pathway is that you are getting a chance to really create a new product category and you’re going to be helping the FDA figure out how to regulate this product category for people that want to try to copy you in the future.” “The desire that I have to want to just launch that perfect product with all the bells and whistles at the first stop, that can really slow down the time to market.” “Sometimes, it’s better to get something out there that helps and then get the full benefit out there a little bit later.” “Don’t be afraid of the De Novo process. It’s actually a really great tool.” Links:FDA - De Novo Classification Request FDA - Medical Device Overview FDA - Q-Submission Program Guidance FDA - 510(k) Submission FDA - Premarket Approval (PMA) FDA - Case for Quality Rob MacCuspie on LinkedIn Proxima CRO True Quality 2022 Greenlight Guru YouTube Channel MedTech True Quality Stories Podcast Greenlight Guru

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 certificates that expire in May 2024 and think they still have time to get certificates reissued.Several small companies, as well as large corporations, are choosing to not go to market or withdraw products in the EU because of the lack of value and revenue.The cost, clinical data, and limited number of notified bodies are some of the biggest challenges for those in the EU versus U.S. market.Companies should perform a market analysis to determine if their revenue model will support year-over-year costs and third-party fees to stay in the EU market.The impact to quality in the European healthcare system could turn the U.S. into a destination for medical tourism. It could happen if an analysis is not done by the government or competent authority.A quality management system (QMS) has to have an ISO 13485 certification in the EU. The U.S. doesn’t require a QMS until a product is put into commercialization and meets performances, standards, and expectations.According to Michelle, the five stages of regulatory grief are denial, anger, bargaining, depression, and acceptance.Memorable quotes from Michelle Lott:“If you don’t have a relationship with a notified body yet, you’re already almost too late. You just can’t make any commitments to or marketing plans for the EU right now, in terms of timing.” “The first thing is to do that market analysis, and then, if they decide that Europe is still  something that they want to do, second, you need to get in line with a notified body.” “There’s no such thing as grandfathering underneath the EU.” “There were 18,000 certificates issued under MDD, and only one percent of those have made it all the way through MDR.” “To properly prepare technical documentation, it is truly a cross-functional effort and it’s going to require a lot of very in-depth expertise.” Links:Michelle Lott on LinkedIn Regulatory + Quality Assurance (leanRAQA) leanRAQA - Free Guides RAQA Today Podcast FDA - Device Good Manufacturing Practice Advisory Committee (DGMPAC) European Union - Medical Device Regulation (EU MDR) ISO 13485 FDA - Quality Management System Regulation (QMSR) True Quality 2022 The Greenlight Guru True Quality Virtual Summit Greenlight Guru YouTube Channel MedTech True Quality Stories Podcast Greenlight Guru Academy Greenlight Guru Global Medical Device Podcast Email