101 avsnitt

We help medical device professionals deepen their knowledge of customers, the industry, and their role. Our main objective is to help you become expert in your current position, and through a better understanding of others within your company and the best practices in others in the industry, enable you to fast-track your career.

Mastering Medical Device Patrick Kothe

    • Näringsliv

We help medical device professionals deepen their knowledge of customers, the industry, and their role. Our main objective is to help you become expert in your current position, and through a better understanding of others within your company and the best practices in others in the industry, enable you to fast-track your career.

    Commercializing a Disruptive Technology in a Hospital with Multiple Decision Makers and Influencers - Featuring Joe Steele

    Commercializing a Disruptive Technology in a Hospital with Multiple Decision Makers and Influencers - Featuring Joe Steele

    Joe Steele is Head of Commercialization at Hemosonics, where they are providing point-of-care solutions to help clinicians make more informed decisions on blood product usage.   In this episode Joe shares  why moving up the ladder too fast may not be the best way to go, why experiencing failure will help in the long-run, how to use wisdom from past experiences and apply it to new situations, the challenges of hiring, training and managing a group of hard-charging people, getting into the C suite, and how Hemosonics is helping doctors make blood product usage decisions quicker and better.

    Links from this episode:
    Joe Steele LinkedIn https://www.linkedin.com/in/janthonysteele/Hemosonics  https://hemosonics.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!

    • 1 tim.
    Open or Closed Robotic Systems – Are We at a Crossroads? Featuring Stuart Simpson

    Open or Closed Robotic Systems – Are We at a Crossroads? Featuring Stuart Simpson

    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/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!

    • 1 tim. 4 min
    How Challenging Assignments and Brutally Honest Feedback Makes You Better with Dave Rosa

    How Challenging Assignments and Brutally Honest Feedback Makes You Better with Dave Rosa

    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


    Thanks for listening!

    • 1 tim.
    An Inside View of FDA and Three New Guidance Documents on the 510(k) Process with Ken Riordan

    An Inside View of FDA and Three New Guidance Documents on the 510(k) Process with Ken Riordan

    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!

    • 1 tim.
    How a Serial Entrepreneur Identifies and Evaluates Product Ideas and Brings Them to Market With Dr. Scott Wolf

    How a Serial Entrepreneur Identifies and Evaluates Product Ideas and Brings Them to Market With Dr. Scott Wolf

    Scott Wolf, MD is the Founder & Chief Medical Officer of Aerin Medical, where they are providing products to bring relief from nasal airway obstruction and chronic rhinitis. Scott is a prolific medical device entrepreneur across a broad range of therapeutic areas, and has also been a venture capitalist. In this episode we discuss how he identifies ideas, what criteria he uses to select ideas to work on, how VC’s evaluate opportunities, what entrepreneurs should know before they meet with investors, the problems Aerin is addressing, and how they are serving the ENT community.

    Links from this episode:
    Scott Wolf, MD LinkedIn https://www.linkedin.com/in/sjwolf/Aerin Medical  https://aerinmedical.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!

    • 53 min
    How Cross-Training and Extreme Ownership Help You Advance Your Career with Rollie Carlson

    How Cross-Training and Extreme Ownership Help You Advance Your Career with Rollie Carlson

    Rollie Calrson is the CEO of Immunexpress, a company that is pioneering technology that can rapidly detect sepsis. Rollie contributed to the success of Abbott Laboratories for 20 years, starting off in R&D, then transitioning to leadership positions in global businesses and start-up ventures. His attraction to start-ups led him to become CEO of Asuragen and then WaferGen Biosystems. In this episode we discuss how he prepared for new opportunities, the benefits of extreme ownership, balancing company vision and mission, alignment of everyone in a company, why sepsis is such a big problem, and what Immunexpress is doing to help clinicians better manage sepsis patients.  

    Links from this episode:
    Rollie Carlson LinkedIn https://www.linkedin.com/in/rollie-carlson-ph-d-059074a/Immunexpress  https://immunexpress.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!

    • 1 tim. 10 min

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