Advertise on podcast: Mastering Medical Device

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 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!

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 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!

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 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!

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 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!

Weronika Michaluk is Digital Health Principal and SaMD Lead at HTD Health, a company dedicated to planning, designing and developing custom healthcare software. Weronika is an experienced professional with a diverse background in the fields of biomedical engineering, international business, and public health. In this episode she shares the differences between the waterfall and agile methodologies, what sprints and scrums are, controlling scope creep, working with a company that does not have agile experience, assuring regulatory compliance, and the tools and tech stack that are used in today’s software development environment.  Links from this episode: Weronika Michaluk LinkedIn https://www.linkedin.com/in/weronika-michaluk-mba-43811698HTD Health  https://htdhealth.comSupport 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!

Keith Smith is President of Vonco Products, a medical device contract manufacturer that works with some of the largest companies in the industry. In the first part of this episode Keith shares why companies decide to use contract manufacturers, what they look for when choosing one, the importance of transparency, and how Vonco transitioned from a job-shop serving many industries to focusing on high value industries, like medical device. The second half of the conversation goes deep into his personal story about the cost of going all-in on business, what he learned and how he has reprioritized his life, while maintaining a strong growth mindset in business. Links from this episode: Keith Smith LinkedIn https://www.linkedin.com/in/keith-smith-725508bVonco Products  https://www.vonco.comSupport 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!

Milton Yarberry is Director of Project Management at Integrated Computer Solutions. Milton has developed or managed software development for Motorola, Lucent, Cognex, Inktomi, and FEI, before moving into the medical software sector in 2006 with Foliage, Ivenix and now ICS. In this episode he shares about the Protecting and Transforming Cyber Health Care, or Patch Act, which FDA implemented in October 2023, including what software is impacted, the key take-aways from this regulation, if this effects legacy devices, and how medical device companies will be impacted. Links from this episode: Milton Yarberry LinkedIn https://www.linkedin.com/in/milton-yarberry-06a2311/Integrated Computer Solutions  https://www.ics.comSupport 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!

Rich Walsh is CEO of Corvent, a company that is focused on providing solutions in the ventilator market. Rich has a long history in sales and sales management, and has transitioned from sales to become a first-time CEO. At the same time, Rich and the team are transitioning from providing a ventilator for COVID, to a full-featured product. In this episode Rich shares about the foundation of his career and the importance of discipline, openness and leader engagement, how direct feedback can make or break a career, locating a company in a non-traditional city and state, building an internship program that benefits the company and interns, and leadership lessons learned from legends in our industry.   Links from this episode: Rich Walsh LinkedIn https://www.linkedin.com/in/richardswalsh/Corvent Medical  https://www.corventmedical.comSupport 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!

Joe Landolina is CEO of Cresilon, a company that has developed a technology and product intended to stop bleeding quickly and reliably. In this episode Joe shares how he began his journey at age 17, how a short project has turned into more than a decade of hard work, the impact pivots made on his team and investors, why open communication is best for the team and the well-being of the founder, and the importance of doing things the right way - even if it means delays and more investment. Links from this episode: Joe Landolina LinkedIn https://www.linkedin.com/in/jlandolina/Cresilon  https://cresilon.com/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!

Jordan Griffin is a Field Clinical Specialist at Boston Scientific. Jordan’s no stranger to the medical device field, as her dad owns a distributorship focused on spinal implants.  In this episode she shares what it was like to be a daughter of a busy, successful surgical distributor, product and sales education and how it differs in direct and distributor companies, managing a rural territory, how a clinical specialist differs from a sales rep, and what it’s like to interview and break into a large company.   Links from this episode: Jordan Griffin LinkedIn https://www.linkedin.com/in/jordan-griffin-685b97209/Boston Scientific  https://www.bostonscientific.comSupport 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!

Marty Gauvin is CEO of Fertilis, a company focused on helping prospective parents have a better experience with in-vitro fertilization. Marty is a serial entrepreneur and Fertilis is his first in medical device. In this episode Marty shares his views on entrepreneurship, where ideas come from, the differences and similarities between industries, what we can learn from outside medical device, and how the Fertilis products are aiming to increase the chance of people becoming parents.    Links from this episode: Marty Gauvin LinkedIn https://www.linkedin.com/in/martygauvin/Fertilis  https://new.fertil.is/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!

Zach Champeau is Sr. Director of Operations at Saleytics, an inside sales organization that has a program focused on DTC strategy. In this episode he shares the objectives companies have with DTC, where DTC activities have the most influence, types of programs that can help with lead generation, the main reasons why patients who need care drop out before receiving it, and how to measure the success of your program. Links from this episode: Zach Champeau LinkedIn https://www.linkedin.com/in/zach-champeau-50441264/Saleytics  https://www.salelytics.com/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!