Stuart Simpson is CEO of Think Surgical. During his stellar 24-year career at Stryker he led an orthopedic industry transformation that established surgical robotic joint replacement as a standard of care, beginning with the acquisition of Mako Surgical in 2013. In this episode he shares his roots in medical device and how orthopedics became his passion, how competition is deeply imbedded in him, the challenges surgeons and hospitals face with the proliferation of robotics in the OR, how Think Surgical is trying to solve clinical, logistical and monetary issues, and his thoughts on how you can become a stronger leader.

Links from this episode:

• Stuart Simpson LinkedIn https://www.linkedin.com/in/stuart-f-simpson/
• Think Surgical https://thinksurgical.com/

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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

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Dave Rosa is CEO of NeuroOne Medical Technologies, a company that has developed high-definition, minimally invasive diagnostic and treatment devices based on a unique thin film electrode technology, with an initial focus on epilepsy and the fast-growing neurostimulation market. In this episode he shares some times when tough feedback helped him grow as a leader, why taking the stretch assignment was the better choice, structuring a marketing group, key criteria when evaluating distribution options in a start-up company, and how NeuroOne is providing technology helpful to patients and clinicians.

Links from this episode:

• Dave Rosa LinkedIn https://www.linkedin.com/in/daverosa/
• NeuroOne Medical Technologies https://nmtc1.com/

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

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Ken Riordan, Regulatory Affairs Project Manager at Telos Partners, brings a unique but essential perspective to his clients having worked in both the public and private sector. He was a lead reviewer for the FDA where he conducted scientific and engineering reviews of pre-market applications for cardiovascular devices. Ken’s broad experience in the private sector with Bayer Pharmaceuticals, Philips Respironics and others enables him to apply creative and effective solutions to his clients. In this episode Ken shares what it was like to work at FDA, how reviewers are chosen, how collaboration within the agency works, what you should know about the three new Guidance’s on the 510(k) process that were recently released, and how Telos Partners helps medical device companies.

Links from this episode:

• Ken Riordan LinkedIn https://www.linkedin.com/in/ken-riordan/
• Telos Partners https://www.telospartnersllc.com/

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!