On this episode, we’re joined by Michael Diethelm, Principal Territory Manager at BVI Medical. With over 26 years of experience in Ophthalmology device sales, Michael shares invaluable insights for medical sales reps everywhere.

We discuss:

- Why most eye surgeries are performed at surgical centers vs. hospitals.

- The different types of intraocular lenses on the market.

- Details around the development lifecycle of devices in the field of ophthalmology.

- The importance of bringing innovative devices to the market.

- The different motivations surgeons have for adopting or rejecting new medical devices.

- Why it’s typically easier to get your device into surgery centers vs. hospitals.

- Why the success of your product relies on its ability to stay on the shelf long term.

- Advice for getting into the field of medical sales.



Resources:

Michael Diethelm - https://www.linkedin.com/in/michael-diethelm-37a86391/

BVI Medical - https://www.linkedin.com/company/bvi-medical/

BVI Medical | Website - https://www.bvimedical.com/

Thanks for listening to the Medical Device Innovators podcast, powered by System Insight Engineering. If you enjoyed this episode, leave a review to help get the word out about the show. And be sure to subscribe so you never miss another insightful conversation.

#MedicalAI #MedicalDevices #MedicalInnovation

On this episode, we’re joined by Christopher Gates, Director of Product Security at Velentium. As a medical device realization consultancy, Velentium specializes in cybersecurity, device development, manufacturing and test systems.

We discuss:

- Christopher’s medical device cybersecurity book and other types of training programs he has built.

- The general lack of knowledge around cybersecurity in the medical device industry.

- A brief history of FDA cybersecurity guidance.

- How the Patch Act impacts cybersecurity for medical devices.

- The changing cybersecurity requirements for medical devices.

- What a software bill of materials (SBOM) is and what it's used for.

- Why it's never too early to think about cybersecurity in the device development process.

- How cybersecurity protects against counterfeit devices entering the market.

Christopher Gates - https://www.linkedin.com/in/christopher-gates-8912a81a/

Velentium - https://www.linkedin.com/company/velentium/

Thanks for listening to the Medical Device Innovators podcast, powered by System Insight Engineering. If you enjoyed this episode, leave a review to help get the word out about the show. And be sure to subscribe so you never miss another insightful conversation.

Resources:

- https://www.velentium.com/

- Medical Device Cybersecurity for Engineers and Manufacturers

#MedicalAI #MedicalDevices #MedicalInnovation

On this episode, we’re joined by Lane Hale, President and CEO at ECA Medical Instruments. Lane and his team at ECA Medical are industry-leading manufacturers and developers of single-use medical instruments.

We discuss:

- Lane’s background and how he got into the medical device industry.

- What ECA Medical focuses on and how they serve medical device companies.

- Considerations for single-use medical instruments.

- The benefits of single-use instruments. 

- How the trend of single-use instruments aligns with the growth of ambulatory surgery centers (ASCs).

- Regulatory details about single-use instruments.

- Differences between the environmental impact of single-use and reusable instruments.

- Optimizing packaging for single-use instruments.

- When companies should reach out to ECA Medical when transitioning to single-use instruments.

Lane Hale - https://www.linkedin.com/in/lane-hale-b472371/

ECA Medical Instruments - https://www.linkedin.com/company/eca-medical-instruments/about/

Thanks for listening to the Medical Device Innovators podcast, powered by System Insight Engineering. If you enjoyed this episode, leave a review to help get the word out about the show. And be sure to subscribe so you never miss another insightful conversation.

Resources: 

- https://www.ecamedical.com/

#MedicalAI #MedicalDevices #MedicalInnovation