SSI Executive Conversations

SSI with Shelly Gallup Part II

SSI with Shelly Gallup Part I

SSI with Michael Loiterman Part II

SSI with Michael Loiterman Part I

SSI with Augusto Grinspan Part II

SI with Augusto Grinspan Part I

Zack Lyon Podcast Part II

Zack Lyon Podcast Part I

Our next guest on the SSI Executive Conversation Podcast is Jennifer Fried, CEO and Co-founder of Flow Medical, a surgical software platform for treating pulmonary embolisms. Some topics that Darwin and Jennifer discuss are: - How Flow Medical started - Why the technology is so significant - Challenges start-ups face in getting funding - Software security relevant to FDA standards Jennifer Fried L...

Just released, Part 2 of Darwin and Rajiv's discussion on Cell and Gene Therapy. Some topics they discuss are: - Clinical holds - Gene Therapy developers and outsourcing - Evolving regulatory guidance for C>. Rajiv Gangurde LinkedIn: https://www.linkedin.com/in/rajiv-gangurde-ph-d-5b8ab5a/ #biotech #cellandgenetherapy #clinical #regulatory

Part 1 has landed! Join in on their conversation on the Cell and Gene Therapy industry. Some topics that Darwin and Rajiv discuss in this episode are: - The current status of cell and gene therapy approvals, - CMC challenges - AAV-based gene therapy Stay tuned to part 2 of their conversation. Remember to subscribe to the podcast to get the latest releases Rajiv Gangurde LinkedIn profile: https://w...

Part 3 is Here! Join Darwin and Aaron Snyder, VP of Quality at Allotex, as they wrap up with a powerful discussion on career growth, the critical role of career ladders, and how they drive higher retention, stability, and reduced risk in organizations. Aaron Snyder LinkedIn: https://www.linkedin.com/in/aaron-snyder-mscgmp/

Join us as we continue our discussion with Aaron Snyder, VP of Quality at Allotex. In this second installment, Darwin and Aaron define a stellar "Quality" candidate, highlight the significance of crossover skills, and the keys to assembling high-impact teams. Listen now for insights into leadership and team development. Also stay tuned next week for Part 3, where we'll explore even more facets of...

New Episode! Dive into Part 1 of our engaging three-part series on the SSI Executive Conversations podcast, featuring Aaron Snyder, VP of Quality at Allotex. In this episode, Aaron shares his inspiring career journey and gives us a behind-the-scenes look at what makes Allotex a standout company and why he joined. Stay tuned for Parts 2 and 3 in the coming weeks, where we'll explore different facet...

Now Live: Part 2 of our captivating series on SSI Executive Conversations, featuring Janet Johnson, VP of Global Regulatory at Terumo BCT! Janet offers her expert take on nurturing talent within an organization, emphasizing the critical role of a growth mindset in driving personal and professional development. The conversation also navigates the advantages and disadvantages of remote versus hybrid...

Launching Our Next Series: Join us for Part 1 of an enlightening two-part series on SSI Executive Conversations Podcast, where Darwin hosts Janet Johnson, VP of Global Regulatory at Terumo BCT. In this episode, Janet shares the lessons learned throughout her career, highlighting the importance of balancing risk with innovation and how to cultivate a team that thrives on this principle. And make su...

Darwin and Dr. Street delve into the crucial role of cultivating a strong business culture, laying the foundation for lasting success and innovation. Discover the strategies behind building an environment that not only attracts but also retains the right talent, aligned with the core values and vision of Inovus Surgical. Dr. Street shares his insights on identifying and hiring individuals who cont...

Dr Elliot Street is the co-founder and CEO of Inovus Medical, a multi-award-winning designer and manufacturer of surgical training technology. This episode is part 1 of 2. In this episode, they explore the fascinating origins of Inovus and the groundbreaking ways in which the company is revolutionizing Surgical Training technology. Elliot Street LinkedIn https://www.linkedin.com/in/elliot-street-7...

On this next SSI Executive Conversation episode, Darwin and Robert explore the nuances of regulatory pathways in the medical industry. They dissect critical insights, including the need to avoid a transactional approach in regulatory processes and the importance of strategic planning to mitigate risks. The podcast sheds light on the high rate of FDA rejections for 510K applications and emphasizes...

Robert has worked in Med Device Regulatory Affairs for over 30 years, including orthopedic implants and cardiovascular devices. He specializes in Regulatory strategy, writing successful regulatory submissions, and negotiating with the FDA and EU Notified Bodies. He works as a consultant for small to midcap companies and is the President at Cadence Regulatory, LLC. In this episode, Darwin and Rober...

Kevin Posey is a Subject Matter Expert in MedTech RA/QA with over 25 years of experience, working at companies ranging in size. In this episode, Darwin and Kevin talk about resource/responsibility management at small vs. big companies, The strategic importance of RA/QA, and the value of developing high emotional intelligence to communicate with governing bodies such as the FDA. To visit Kevin's Li...

This bonus episode is all about Creating SPG (Sustainable Profitable Growth) and highlighting Key Performance Indicators for Success and Failure. A forefront goal of SSI is to bring value to the market via Industry Insights. We work hard to conduct top-notch research on the current landscape and present it to our audience.

Dr. Margaret is the CEO/Founder at Rapid Nexus Nano-Tech Wound Technology, a cutting edge wound care MedTech organization. She has decades of experience in medical research, and has a passion for solving limb loss due to chronic and complex wounds. To learn more about Rapid Nexus and their Nanotechnology, click here .

Berk is the CEO of SentiAR, an electrophysiology technology company that is changing the game with its product. Berk's knowledge and insights come from his long-term experience as a leader in the MedTech and Life sciences spaces. In this episode, Berk and Darwin discuss executive strategies in delegation, workload, and company growth/development. To read more about SentiAR's product click here . T...

Berk is the CEO of SentiAR, an electrophysiology technology company that is changing the game with its product. Berk's knowledge and insights come from his long-term experience as a leader in the MedTech and Life sciences spaces. In this episode, Berk and Darwin discuss the direction of SentiAR in the upcoming years, voice of customer, and Berk's career journey. To read more about SentiAR's produc...