Global Medical Device Podcast powered by Greenlight Guru Greenlight Guru + Medical Device Entrepreneurs

Description:
In this riveting episode of the Global Medical Device Podcast, Etienne Nichols brings together the dynamic leaders from Greenlight Guru: David DeRam (internally known as DD) and Pall Johannesson. Together, they embark on a journey through the chronicles of Greenlight Guru and SMART-TRIAL, exploring its growth, trials, and moments that defined its course. The conversation is sprinkled with heartfelt personal anecdotes, emphasizing the brand's commitment to unwavering quality and the pivotal shifts during the COVID-19 pandemic.
The trio delves into the intricate dance of nurturing a thriving work culture in the MedTech arena, especially amidst the waves of the changing remote work landscape. They share profound insights into navigating the maze of regulations in the medical device sector, underscoring the critical importance of resilience—captured by the evocative term "alligator blood"—to thrive in such a challenging environment.
Drawing the curtain back on the transformative world of medical technology, this episode is a deep dive into the role of mindset coaching, poignant patient stories, and the horizon of MedTech. With glimpses into AI's impending role and technological leaps, interwoven with light-hearted tales of branded socks, Etienne, DD, and Pall craft a narrative that underscores the core values and vision that propel Greenlight Guru forward.
Some of the highlights of this episode include:
A deep dive into why thriving in MedTech hinges on a fervent love for the mission, an unwavering dedication to the community, and an undying drive to champion quality of life.The compelling origin story of Greenlight Guru, birthed from an unmistakable need to provide robust backing for medical device professionals.The courageous pivot of Smart Trial: How they chose to scrap months of effort and boldly embrace the future with cutting-edge technology.The resilience shown by Greenlight Guru during the COVID-19 storm: A seamless evolution from traditional office environments to adaptive global remote workspaces.How, even in a virtual setting, Greenlight Guru maintained a palpable culture that not only kept the team connected but resonated profoundly with customers.The blueprint for businesses in a post-COVID world: Understanding that adaptability and innovation aren’t just trends, but necessities for survival and growth.An exploration into the challenges and opportunities presented by regulatory shifts: For the forward-thinkers, these aren't mere hurdles, but potential goldmines.Why the term “Alligator blood” embodies the very resilience and fortitude required to chart the tumultuous waters of the MedTech industry.The secret sauce of MedTech success: A strategic focus on investing in individuals defined by their grit, fiery passion, and boundless ambition.A heartening reminder that MedTech’s real impact goes far beyond just technology—it's about making profound, tangible improvements in the quality of life.
Quotes:
"You have to fall in love with the space and the community and the patients, and the concept that improving the quality of life is everything if you're going to be successful here." - David DeRam
"We all have almost unlimited capacity. We can do pretty much anything that we want to do... It comes down to are we going to quit or are we not going to quit? We know what to do... Which is why we invest in Mindset coaching. We talk a lot about energy, we talk a lot about intention, and we built our team on that culture." - David DeRam
Reference Links:
David DeRam LinkedIna href="https://www.linkedin.com/in/palljohannesson/" rel="noopener noreferrer"...

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-Bensinger
Reference Links:
Christy Sheehy-BensingerC-Light TechnologiesGG Academy - use Promo Code podcast25 for a 25% discountGreenlight GuruEtienne Nichols LinkedIn
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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 Markin
Reference Links:
HTD Health pageHTD SaMD InsightsHTD SaMD ChassisZach Markin LinkedInWeronika Michaluk LinkedIn GG AcademyGreenlight GuruEtienne Nichols LinkedIn
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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 Campbell
Reference Links:
Devon CampbellProdctGG AcademyGreenlight GuruEtienne Nichols LinkedIn
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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
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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