Description:In this episode recorded in front of a live audience in Boston, MA, we speak with Christy Sheehy-Bensinger, the CEO & Founder of C-Light Technologies, Inc. about their recently cleared eye movement monitor. Listen as we unpack her journey from academia to startup life, explore the complexities of medtech communication, and delve into the intricate dance of securing FDA clearance. This was a fun conversation, with good Q&A at the end where we discuss the highs and lows of pioneering digital health solutions, the significance of a quality-first mindset in MedTech, and the art of crafting a passionate team.Some of the highlights of this episode include:Transitioning from academia to startup, and the demands of adaptability; navigating the real-world validation while staying solution-driven.Navigating the regulatory landscape, and the marathon that it is and how being FDA-cleared is just one of the many milestones.Building a quality-centric culture from day one to set the tone for long-term success in the MedTech space.How building a startup is akin to fixing a plane mid-flight – it's challenging but passion and clarity make it feasible.Tailoring communication, and how suiting it to the listener's background can be the game-changer in understanding and collaboration.Quote:"Management, speaking their language is super important. If I can compare it to what I already know, then that's easier." - Christy Sheehy-BensingerReference Links:Christy Sheehy-BensingerC-Light TechnologiesGG Academy - use Promo Code podcast25 for a 25% discountGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

Description:In this episode, we explore the impact of software development methodologies in the medical device industry. With industry experts from HTD Health, we dissect the Agile approach to compliance, the intricacies of Quality Management Systems (such as Greenlight Guru), and go-to-market challenges for innovative medical devices.Zach, CEO of HTD Health, is a self-taught software engineer turned serial entrepreneur. His first venture, Fresh Corner Cafe, served fresh food in Detroit's food deserts for eight years. He then founded HTD Health to craft digital health solutions, pioneering the shift to virtual care. The company supports care providers, device makers, and life sciences. Zach also founded Exos, a governance SaaS, and sold it in 2022.Weronika Michaluk, a jack-of-all-trades in biomedical engineering, business, and public health, leads HTD's Software as a Medical Device unit. With degrees from Miami and Warsaw, plus a Doctorate in Public Health, she's worked on everything from wireless ECGs to digital health consulting. At HTD, her laser focus on quality and customer satisfaction drives organizational success.Some of the highlights of this episode include:An introduction to "Compliant Agile," a balanced methodology for MedTech development that prioritizes customer interaction while maintaining regulatory compliance.The importance of choosing the right Quality Management System (QMS), highlighting the flexibility and feature-rich experience of Greenlight Guru.The need for companies to focus on their core competencies while being adaptable and compliant.The importance of a positive mindset and a well-defined success metric for any MedTech project.Quote:"Our mission is to make the industry more accessible, more human centric and more productive" - Zach MarkinReference Links:HTD Health pageHTD SaMD InsightsHTD SaMD ChassisZach Markin LinkedInWeronika Michaluk LinkedIn GG AcademyGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

Description:Join Devon Campbell in MedTech funding. He unveils startup red flags, from data integrity to product maturity. His message? Know your weaknesses, fill the gaps.Considering cold-calling other Founders? It works. Understand your their investment landscape first. Recognize that VCs and Angels have different risk profiles. Devon says know your funding options and their strings. It’s about terms and expectations, not just money.Think a sleek exterior hides internal flaws? Devon focuses on product readiness and QMS. Be manufacturing-ready and optimize. No shortcuts in MedTech.In a red-tape world, paperwork matters. It's about confidence, not bureaucracy. Devon shifts focus to quality systems as confidence builders. His point? "Unquestionable, indelible data—that’s what I can trust." Get organized, and confidence becomes your MedTech currency.Some of the highlights of this episode include:Knowing your weaknesses. It's important to recognize your gaps and seek the right help.Maintain data integrity. Full disclosure of data builds trust - no sugar-coating..Evaluating product maturity - good looks aren't enough; be manufacturing-ready.The importance of a strong Quality Management Systems (QMS). Document, document, document. No excuses.Risk Management isn’t a checkbox: it's an ongoing pledge to safety.Quote:"Unquestionable, indelible data—that's what I can trust. That's confidence." ~Devon CampbellReference Links:Devon CampbellProdctGG AcademyGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

Description:In this episode, Etienne Nichols and Ellie Reynolds explore FDA's Breakthrough Device designation. They discuss pursuing breakthrough status, aligning marketing strategies with FDA review, and navigating the medical device industry. This episode provides a roadmap for this complex regulatory terrain.Learn about the benefits and scrutiny of the breakthrough designation, hear examples that emphasize the need for precise data and quality in the application process, and listen as we explain the planning and considerations for success, and how innovation can thrive within regulation.Some of the highlights of this episode include:The changes in CMS reimbursement, and how breakthrough devices no longer guarantee automatic CMS reimbursement.Planning for FDA Submission, and how to align with FDA timelines.Competitive Landscape - how achieving breakthrough is still possible, even if competitors have it.Whether or not it's worth pursuing Breakthrough Designation.The benefits of Breakthrough Designation Benefits (such as FDA priority review and potential marketing buzz).Quote:"Say you are a direct competitor with someone else, and they got breakthrough but they're not on the market yet... You can still get breakthrough for the same indication. FDA does not consider that as a cleared or approved alternative - even if they're miles ahead of you."Reference Links:Ellie Reynolds LinkedInProxima CROEtienne Nichols LinkedInetienne.nichols@greenlight.guruGG AcademyGreenlight Guru*Interested in sponsoring an episode? Use this form and let us know!

Description:In this episode of the Global Medical Device podcast, we discuss the intricate world of medical device regulations, design, and innovation. Hosted live in San Jose, the podcast features the esteemed Nada Hanafi, SVP - Regulatory Strategy at Veranex, who brings her rich experience of 12 years at the the FDA and Regulatory Strategy to discuss pressing issues and notable developments in the industry.Join us as we delve deep into crucial topics such as biases in medical device testing, the evolving approach of the FDA, and the importance of user-centric design. This episode offers a comprehensive look into the dynamic and ever-evolving realm of medical technology, emphasizing the balance of innovation and regulation.Highlights of the episode include:Skin Tone Bias in Medical Devices: Nada Hanafi spotlighted the biases in pulse oximeters, shedding light on how these devices often fail to perform efficiently across varied skin tones. A lack of diversity in validation tests, mostly relying on Caucasian young men, resulted in compromised health outcomes for others.Evolution and Transparency of the FDA: Nada traced the journey of the FDA, illustrating its transformation towards greater transparency and predictability. Emphasizing the human touch behind FDA's decisions, she dispelled the myth of the FDA being an impersonal "black box".Global Regulatory Movements: Highlighting a shift in the MedTech landscape, Nada pointed to the trend of global regulatory harmonization, particularly noticeable in the realm of software-based medical devices.Importance of User-Centered Design: Nada and the panel emphasized the significance of involving patients early in the design phase. Using tools like personas and human factor tables can lead to products that truly cater to users' needs, ensuring both usability and safety.Embracing Learning in MedTech: Nada's hope for companies to learn from past oversights and adapt to changing regulations stressed the crucial role of iteration and learning in medical device innovation.Navigating Modern MedTech Challenges: From addressing the significance of thorough documentation practices to discussing the challenges of regulating AI-driven medical devices, the discussion underscored the ever-evolving MedTech arena and the imperative need for regulators to stay updated.This episode paints a comprehensive picture of the medical device industry, addressing both its challenges and its advancements.Quote:"Medical devices shouldn't be designed with a one-size-fits-all approach. We've seen firsthand the impact of biases, like with pulse oximeters. It's crucial that we validate devices across diverse populations to ensure safety and efficacy for all."Reference Links:Nada HanafiMedTech ColorMedTech InnovatorVeranexEtienne NicholsTrue Quality RoadshowGreenlight Guru AcademyGreenlight Guru Software

Description:During the Houston leg of our True Quality Roadshow series, we had the opportunity to sit down with Dan Purvis, CEO of Velentium and author of "28 Days to Save The World." Dan tells the story of how his company weathered the early days of startup life, and how the pandemic - which took so many companies down - turned out to be the springboard that tested the culture that Dan and his co-founder had molded from the very beginning.If you're not familiar with our True Quality Roadshow - you should definitely check it out! It's a free half-day event at one of 6 cities across the world. Links below!Some of the highlights include:The role Velentium played in upscaling the production of ventilators during the pandemic - this was a significant achievement and showcases Velentiums leadership, collaboration, and company responsiveness during this worldwide crisis.Real-life challenges faced by companies, especially dramatic stories like the purchase of parts without a PO and the personal involvement of the leadership, and paint a vivid picture of commitment and dedication.The central theme of a company's mission ("We exist to change lives for a better world") and how it guides its decisions is foundational and deeply impactful.The pivotal role that company culture plays, even when compared to strategic planning.The long-term vision of a company, and we emphasize that while actions and technologies change, the core mission remains constant.The decisions Dan was faced with, such as how (or if!) to pay employees during a crisis, and we highlight the ethical considerations a company has to make, and how to stay aligned with a company's core values.The emphasis on finding clients to fund growth rather than relying on investors - this is not only pragmatic advice for startups but also provides a unique perspective on business growth.Quote:"Because as a leader, if you don't clearly know where you're headed, it's really hard to get a bunch of people to follow you. And I don't want people to follow me. I want them to race me up the mountain, which is the one that we've all decided to ascend together."Reference Links:Dan Purvis LinkedIn28 Days to Save The World bookEtienne Nichols LinkedInTrue Quality RoadshowVelentiumTexas Medical Center for Innovation

DescriptionIn today’s episode, Shawnnah Monterrey discusses the 3P510k - which is short for the 510k 3rd Party Review Program. This is a lesser known program, but there can be significant benefits from using it, which we talk about during the episode. Some of the issues we discussed include:How utilizing this program can accelerate the submission process, or at least remove some uncertainty around the timelineWho this program is for - not just for small startups, but rather how even experienced Regulatory Affairs specialists working at large corporations can benefit from this program.Lastly, we don’t usually get into the specifics of cost and expenses, but we even discuss some of the differences in how much you’ll pay using the 3P510k route vs. the traditional submission route.Shawnnah Monterrey is the founder of BeanStock Ventures after nearly a 20-year career as a technical leader. Shawnnah was responsible for developing strategies and leading complex global product development programs and functional management of software and software quality assurance departments for both startup and mature organization with emphasis on the development of medical instruments, life science, diagnostics, clinical applications.Reference Links:Shawnnah Monterrey on LinkedInBeanStock Ventures – 3P510kEtienne Nichols on LinkedInGreenlight Guru softwareFDAs 3P510k page

DescriptionMost people in the world of Medical Devices know that they need a Quality Management System, but what is the best way to go about building that QMS, when should you start, and how do you know when you've built it to the point it can stand on this own?In this episode, Rob MacCuspie, PhD, Manager of Regulatory and Quality Affairs at Proxima Clinical Research, Inc., discusses the best practices of companies he has worked with to help implement their Quality Management System in a manageable way.Takeaways:What is the difference in your QMS and a Document Management System?What is the most important aspect of a QMS?Who really needs a QMS, and when?What are the phases of a QMS?How to start building a QMS.Quote:""If my SOPs and training process can bring in somebody that has no experience and they can hit the ground running, I'm not worried if the auditor has any experience now in my space, right. Because I now have everything in place to show somebody how they can teach themselves and learn and get up to speed and walk through the process."Reference Links:Rob MacCuspie on LinkedInEtienne Nichols on LinkedInProxima Clinical ResearchGreenlight Guru software

DescriptionIn April of 2023, FDA released a draft guidance entitled, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning (AI/ML) - Enabled Device Software Functions." In today's episode, we speak with Mike Drues, PhD, President of Vascular Sciences, about artificial intelligence in medical devices, the history of this type of technology in the medical device field, and what this guidance means and doesn't mean. We hope you enjoy this episode of the Global Medical Device Podcast!Questions AskedWhat does artificial intelligence mean in software as a medical deviceWhy is this new draft guidance needed?What recommendation for medical device companies does the draft guidance provide?What are the challenges with validating the modifications for an ML-DSF? (Or are there other, greater challenges?)What are some of the specific items a PCCP should include?Does a PCCP negate a future need of a Letter to File or new 510k? What would necessitate an additional market submission?Quotes"I really try to stress what I call 'regulatory logic,' because if you understand the regulatory logic, really, all of this should be common sense." - Mike DruesReference LinksDraft FDA GuidanceEtienne NicholsGreenlight Guru

In this episode with Fran Cruz, Chief Customer Officer at Greenlight Guru, we explore the investment of a purpose-built electronic Quality Management System (eQMS). Some of the topics we explore are:3rd- party study by Hobson & CO that reveals significant reductions in setup time, full-time employee requirements, time spent on development and documentation, training time, and audit preparation time.The recent ROI Calculator developed by Greenlight Guru to help customers customize the study's findings to their specific inputs and demonstrate the value of the software for their business.The current economic climate, with budget cuts and limited investments, and the importance of efficiency and cost savings provided by a quality management system.Prioritizing success metrics, measuring outcomes, and holding ourselves accountable lead to better decision-making and improved effectiveness in the long run.Success criteria for customers implementing a quality management system include time to implement (time to value) and achieving specific outcomes.How Greenlight Guru aims to balance efficient setup and time to value for customers, focusing on milestones like entering documents and processing changes.The way different customer profiles require different approaches, such as providing guidance and templates for early-stage companies or assisting with migration for existing quality systems.The different functions Greenlight Guru offers, such as services like Guru Assist and GG Academy to support customers in their implementation and learning process."I think ultimately this whole study was really illuminating because it was able to give executive teams, buying teams the numbers that they needed to make a smart decision." ~Fran CruzReference Links:Etienne Nichols LinkedInIndependent Study on ROI of eQMSROI CalculatorGreenlight GurupKtQjeyoDImuAoc2OjH5