Send us a textChris Hermann is the CEO of Clean Hands – Safe Hands, a company dedicated to reducing healthcare associated infections through better hand hygiene.  In this episode Chris shares what his company is tackling, and the road they have taken from idea, to development, to clinical study to sales.  He discusses his take on the customer discovery process and what he refers to as Clinician Centered Innovation, and how what he learned led to changes in the product, along some of the mistakes they made along the way. Also, we discuss their regulatory pathway, and disclose wether their device is a medical device or not. Links from this episode:Chris Hermann, MD, PhDClean Hands - Safe HandsGeorgia Tech BioengineeringEmory University School of MedicineSupport the showConnect 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 a textDaniel Powell is the CEO of Spark Biomedical, a startup company that developed, and as in the process of launching, a neurostimulation device to provide patients relief during opioid withdrawal. Daniel and his team have developed a solution, based on a proven technology. Daniel discusses Spark and some of the challenges they faced including product and technology, reimbursement, business model, clinical, and regulatory. We also discuss the product development process, specifically customer discovery. Daniel shares how in the past 25 years, in two separate industries, he has been involved in customer discovery in large and small companies and how his philosophy was shaped based on different systems he was taught, but modified, based on his hard-earned experience.Links from this episode:Daniel PowellSpark BiomedicalKano ModelSupport the showConnect 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 a textIn this episode Pat Kothe recaps five critical customer motives that emerged from the first 10 episodes of the podcast and discusses why it is important for people within medical device companies to unravel them. He also discusses some of the issues we will begin to explore in future episodes, broadening out to include interviews with industry people, and why it is important to share the podcast with others you feel could benefit from the content, and how to best do so. Support the showConnect 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 a textDr. David Nelson is an anesthesiologist practicing in Austin, TX.  With over 30 years of experience in the field, he shares how his practice has changed with outpatient surgery and the emergence of ambulatory surgery centers, what medical devices he uses and why, what documentation really is and why it’s vital for reimbursement, and his message for people in the medical device industry. He has also founded a medical device company and is working on a very interesting technology to change the way unused drugs are discarded in the hospital setting.Links from this episode:David Nelson, MD LinkedInUnited States Anesthesia Partners (USAP)Support the showConnect 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 a textDr. Paul Davidson is an emergency medicine physician with over 30 years of experience, ranging from Level I trauma centers, to free-standing ER’s, to Urgent Care centers, to small town facilities with very little backup. He explains living through the challenges of the pandemic, what a typical day is like, who he works for and how that’s changed over the years, and products that have had massive impact on patient care. He is also an angel investor and he shares what he looks for when investing in a company, some of the companies he is currently involved with, and past investment successes and failures.Links from this episode:Paul Davidson, MD, FACP, FACEP - US Acute Care SolutionsPaul Davidson, MD LinkedInAmerican College of Emergency Physicians (ACEP)HeartHerodBMEDxSecurisyn MedicalSupport the showConnect 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 a textSarah Hermsdorf is a Surgical PA, specializing in neurosurgery, which encompasses surgical intervention in the brain and spine. Sarah discusses the details of her practice from the surgical suite, to hospital rounds, and in the clinic pre and post-surgery. She tells why she values good company representation in the OR, and what the best reps do to provide value to her, the physician and the patient. Additionally she shares why she loves her profession, the challenges, why patient education is so important, and what a typical surgery entails. Links from this episode:Sarah Hermsdorf, PA-CSSM HealthAmerican Academy of Physician Assistants (AAPA)PhysicianAssistantEDU.orgMayo Clinic Explore Health Care Careers - Physician AssistantUS News and World Report, Best Jobs - Physician AssistantSupport the showConnect 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 a textDr. Randy Kunik has a successful orthodontic practice built on high-quality results, stellar customer service, and sound business practices. But his loyalty to one medical device company has also been critical to getting him to the top of a competitive market - and keeping him there. In this episode, he explains business strategies for his practice, how he works with medical device companies and what is important in maintaining a long-term relationship, and a new technology he has implemented that makes orthodontic care more convenient for his patients, and better for his bottom line.  Links from this episode:Kunik OrthodonticsInvisalignaustin.comInvisalignDental MonitoringSupport the showConnect 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 a textDr. Chester Koh discusses how the challenges with pediatric device development are being overcome through the development and coordination of several ground-breaking programs. The smaller size of the pediatric market has often led to a lack of device development, but the patient needs persist. Dr. Koh explains how pediatric device development can be accelerated through a University engineering program Capstone Project, the FDA-sponsored Pediatric Device Consortium, NIH SBIR and STTR programs, and private funding.Links from this episode:Chester Koh, MD BioTexas Children's HospitalBaylor College of MedicineTexas Medical CenterTMCxTMC Venture FundFannin Innovation StudioPediatric Device Consortia Grants ProgramPhiladelphia Pediatric Medical Device ConsortiumNational Capital Consortium for Pediatric Device Innovation 2.0Southwest National Pediatric Device ConsortiumUCSF-Stanford Pediatric Device ConsortiumThe West Coast Consortium for Technology & Innovation in PediatricsPediatric Medical Device Development by Surgeons via Capstone Engineering ProgramsSupport the showConnect 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 a textNicholas Alana is a fourth-year medical student at the University of Texas Health Science Center in San Antonio. He describes what medical school is really like - the way lectures are consumed, what you do in anatomy labs, how clinical rotations work and what you learn, and details on all of the tests and applications. He also discusses his pathway to a medical career, and how his and his father's injuries and the care they received influenced him on the specialty he is pursuing.Links from this episode:University of Texas Health Science Center at San AntonioJoe R. & Teresa Lozano Long School of MedicineAmerican Association of Medical CollegesAmerican Medical Student AssociationMedical School HeadquartersPrinceton ReviewSupport the showConnect 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 a textDanny McIntyre is a fourth-year medical student and he describes his experience at the New York Institute of Technology College of Osteopathic Medicine's Arkansas State campus. He is also a recipient of a scholarship from the US Health Professions Scholarship Program of the US Military, and he describes the benefits and obligations of that program.  He tells how he became interested in medicine, how he prepared in high school and college, the medical school application process, and the challenges throughout.Links from this episode:American Association of Colleges of Osteopathic MedicineAmerican Osteopathic AssociationMedical News Today What is the Difference Between a DO and an MD?US Army  Health Professions Scholarship Program (HPSP)New York Institute of Technology College of Osteopathic MedicineSupport the showConnect 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!