Mastering Medical Device

Send us Fan Mail

Wearable devices have become common for a number of applications – from fitness tracking to tracking medical parameters for people with conditions like diabetes or heart arrhythmias. The overlap between consumer and regulated medical device wearables is becoming very fuzzy, but has a bright future. In this episode,  Andrew Rickman, the CEO of Rockley Photonics, discusses why wearables have taken off, the differences in consumer and medical wearables, how multi-parameter data can lead to better healthcare, the benefits of longitudinal data, the products Rockley is introducing, how medical device companies may benefit from this emerging technology, and the future of wearables.

Links from this episode:

• Andrew Rickman LinkedIn
• Rockley Photonics

Support the show

Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support

Thanks for listening!

Send us Fan Mail

Meilan Han, MD is a Professor of Medicine and Chief of the Division of Pulmonary and Critical Care at the University of Michigan, and a spokesperson for the American Lung Association. She is the author of a recently released book, “Breathing Lessons, A Doctor’s Guide to Lung Health.” In this episode Dr. Han describes how the lungs function, what can go wrong with them, lung development and why we need to pay attention to how we treat our lungs during their development phases, what medical devices she uses, her advice for companies developing technology, and why we should be testing and monitoring a fifth vital sign. 

Links from this episode:

• Meilan Han, MD LinkedIn
• University of Michigan Division or Pulmonary and Critical Care Medicine
• Breathing Lessons: A Doctor's Guide to Lung Health

Support the show

Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support

Thanks for listening!

Send us Fan Mail

Bryon Bhagwandin is CEO of Recalibrate Solutions, a Denver Startup that is developing a system to monitor a child’s response to stress. Brian also has decades of experience managing development projects. In this episode Bryon shares the challenges of managing a medical device project, different models of project management, when to go to an outside development firm, what to look for when choosing one, and his advice for new project managers. He also shares a very interesting test his company is working on to help children be more successful. 

Links from this episode:

• Bryon Bhagwandin LinkedIn
• Recalibrate Solutions

Support the show

Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support

Thanks for listening!

Send us Fan Mail

Scott Carson is the Founder and CEO of MRP, a new kind of marketplace for medical products. Scott has been involved in several ventures that have innovated and developed new distribution models. He was part of the team that built the eBay Healthcare Marketplace strategy and structure, and was the Founder of US Medical, the first internet distributor of new and pre-owned capital medical equipment to the healthcare industry. In this episode Scott shares why early attempts to apply the internet to healthcare failed, how to build a successful marketplace, why the solo practitioner is at a disadvantage when purchasing medical products, the evolving role of salespeople, why marketing is becoming more important, and what people within the industry need to do to prepare for potential disruption. 

Links from this episode:

• Scott Carson LinkedIn
• MRP

Support the show

Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support

Thanks for listening!

Send us Fan Mail

Nestor Hernandez, CRCST, CHL has 40 years of sterile processing experience in 5 hospital systems, and is the Director of Operation Sterile Processing (SPD) at Lee Health in Fort Myers Florida. Nestor is active in education within SPD community and also consults with medical device companies on issues related to sterile processing. In this episode Nestor shares who works in the SPD, what training, education and certifications are required, what devices should and shouldn’t be processed though SPD, what vendors should do to build a relationship, what the best reps do that others don’t, how to communicate with an upset surgeon who is in surgery, and the future of SPD. This is part 2 of a 2-part conversation.

Links from this episode:

• Nestor Hernandez LinkedIn
• Lee Health
• Hospital Sterile Processing Association

Support the show

Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support

Thanks for listening!

Send us Fan Mail

Nestor Hernandez, CRCST, CHL has 40 years of sterile processing experience in 5 hospital systems, and is the Director of Operation Sterile Processing (SPD) at Lee Health in Fort Myers Florida. Nestor is active in education within SPD community and also consults with medical device companies on issues related to sterile processing. In this episode Nestor shares how he entered SPD, a detailed description of what SPD does, teamwork within the hospital and educating hospital staff, and how to manage hospital acquired infection. This is part 1 of a 2-part conversation.

Links from this episode:

• Nestor Hernandez LinkedIn
• Lee Health
• Hospital Sterile Processing Association

Support the show

Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support

Thanks for listening!

Send us Fan Mail

Charlie Webb is the founder of Van der Stähl Scientific, a company that provides medical device packaging systems and services. In this episode Charlie shares information on the types of packaging systems available, materials used, considerations for choosing the correct system for your device, understanding user needs, what packaging sealers do and how they have evolved, why verification and validation are equally important, and packaging sustainability.  

Links from this episode:

• Charlie Webb LinkedIn
• Van der Stähl Scientific

Support the show

Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support

Thanks for listening!

Send us Fan Mail

Jon Bergsteinsson is the Founder and Chief Commercial Officer at Smart-Trial, a company dedicated to providing a simple, yet robust platform for electronic data capture. In this episode Jon shares the differences between pharma and device trials, pre-approval and post-approval studies and scoping them appropriately, why electronic data capture is preferable to paper based systems, his advice to start-up companies contemplating a clinical trial, how changes to the EU MDR have impacted companies and how they are managing the requirements, and the future direction of data collection.

Links from this episode:

• Jon Bergsteinsson LinkedIn
• Smart-Trial

Support the show

Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support

Thanks for listening!

Send us Fan Mail

The concept of creating your own personal brand has been around for years, but it is garbage advice. In this episode Pat Kothe shares how product and company branding differs from personal branding, the origins of branding, how a brand manager creates and manages a company or product brand, why fake-it-till-you-make-it is garbage advice, why focusing on reputation is the right strategy, and some tips for understanding and enhancing your reputation.

Support the show

Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support

Thanks for listening!

Send us Fan Mail

Patricia Zilliox has devoted her career to solving problems with the eyes. She had a very successful career at Alcon, then at the Foundation Fighting Blindness Clinical Research Institute, before joining Eyevensys as CEO.  Eyevensys is working on a technology that has the potential to solve a big problem. In this episode Patricia shares how a biologics company approaches device design and manufacture, combination product development, the regulatory pathway, funding challenges, how device differs but is similar to pharma and biologics, and how great companies retain great people. 

Links from this episode:

• Patricia Zilliox, PhD LinkedIn
• Eyevensys

Support the show

Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support

Thanks for listening!