Podcasts

This week, Darwin is joined by Dr. Elliot Street, CEO and Co-Founder of Inovus Surgical. Join Darwin as they explore Inovus’s fascinating origins and the groundbreaking ways in which the company is revolutionizing Surgical Training technology. To visit Dr. Street’s LinkedIn page click here.

On this episode of the SSI Executive Conversations podcast, Darwin hosts Dr. Margaret Kalmeta, the CEO/Founder of Rapid Nexus Nano-Tech Wound Technology, a cutting-edge wound care Medtech organization. On this insightful episode, Darwin and Dr. Margaret talk about a multitude of topics including wound care solutions, executive leadership, hiring for culture, where the industry is…

In this episode, we 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 the significance of emotional intelligence in regulatory professionals for successful submissions. Furthermore,…

Robert has a wealth of experience in authoring successful submissions and leading teams through oversight and strategy. We explore the vital role Regulatory should play in the C-Suite and how it can influence strategic decisions for efficient growth and risk mitigation. To visit Robert’s LinkedIn page click here.

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…

Francis Kim is a SME in Regulatory and Quality Affairs, with over 25 years of experience in the medical device and life sciences spaces. Francis also specializes in Operations Leadership, he has held positions at multiple large organizations, and focuses on professional development and building future leaders. To visit Francis’ LinkedIn page click here.

Hafeezah is the CEO and Founder of BackPack Healthcare, a children’s mental healthcare provider that is breaking ground in the industry. Hafeezah’s background and inspiring story drive the current and upcoming initiatives of BackPack Healthcare, including expansion in the US and a cutting edge mental health self care app for children. To learn more about…

Tim Ozier is a staffing and recruiting expert with over 30 years of industry experience. He now holds a role at MRI as the Contract Staffing Director. Click here to visit Tim’s LinkedIn Page. Click here to visit the website of MRI Network.

Justin is the Founder and President of Concise Engineering, an expert company on Program and Project Management, Risk Management, and Regulatory/Quality Affairs. Justin also runs a blog called MedTechMan, which gives substantial insights into the MedTech industry in regard to product development. Click here to visit Concise’s Services. Click here to visit MedTechMan.

Ray is a operations professional with over 30 years experience in management in the pharmaceutical and biotechnology industry. His background and knowledge are extensive. Visit Ray’s LinkedIn page here.