Mastering Medical Device

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: https://www.linkedin.com/in/stuart-f-simpson/https://thinksurgical.com/Support the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://twitter.com/patrickkothe Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support Thanks for listening!

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: https://www.linkedin.com/in/daverosa/https://nmtc1.com/Support the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://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: https://www.linkedin.com/in/ken-riordan/https://www.telospartnersllc.com/Support the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://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: https://www.linkedin.com/in/sjwolf/https://aerinmedical.com/Support the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://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: https://www.linkedin.com/in/rollie-carlson-ph-d-059074a/https://immunexpress.com/Support the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://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: https://www.linkedin.com/in/weronika-michaluk-mba-43811698https://htdhealth.comSupport the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://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: https://www.linkedin.com/in/keith-smith-725508bhttps://www.vonco.comSupport the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://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: https://www.linkedin.com/in/milton-yarberry-06a2311/https://www.ics.comSupport the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://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: https://www.linkedin.com/in/richardswalsh/https://www.corventmedical.comSupport the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://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: https://www.linkedin.com/in/jlandolina/https://cresilon.com/Support the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://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: https://www.linkedin.com/in/jordan-griffin-685b97209/https://www.bostonscientific.comSupport the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://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: https://www.linkedin.com/in/martygauvin/https://new.fertil.is/Support the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://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: https://www.linkedin.com/in/zach-champeau-50441264/https://www.salelytics.com/Support the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://twitter.com/patrickkothe Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support Thanks for listening!

Johannes Schaeferhoff is CEO of ROPCA, a company focused on an autonomous robotic solution to aid in the diagnosis and monitoring of Rheumatoid Arthritis. In this episode, Johannes shares some of the cultural differences in the countries he has lived in and what he learned, trends in medicine that led their team to develop their innovative solution, how efficiency in medicine can be as important as efficacy, and how the ROPCA system may help solve issues with patient access and the timely and accurate diagnosis and monitoring of patients with Rheumatoid Arthritis. Links from this episode: https://www.linkedin.com/in/johannes-schaeferhoff/https://ropca.com/Support the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://twitter.com/patrickkothe Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support Thanks for listening!

Zach Selch is CEO of Global Sales Mentor, and has decades of experience selling medical products in over 135 countries. He has authored books on international sales and has some great free resources that you can access from his website. In this episode he shares why you should consider international sales, whether direct or a distributor model is preferred, key buying influences in different countries, setting up a distributor for success, contract considerations, and managing a distributor sales process. Links from this episode: https://www.linkedin.com/in/international-sales-growth/https://www.globalsalesmentor.com/Support the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://twitter.com/patrickkothe Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support Thanks for listening!

Dr. Jay Shah is Chief Medical Officer at Aktii, where they are developing technology focused on identifying and monitoring hypertension. Dr. Shah is a practicing Cardiologist who pivoted his career from strictly patent care, to becoming the CMO of a start-up. In this episode he shares his thoughts on career pivots, how he researched options that were the right fit for him, what it is like to be a CMO in a start-up, what hypertension is and the difficulty of diagnosis, and how wearables can change the way hypertension is managed. Links from this episode: https://www.linkedin.com/in/jshahmd/https://aktiia.com/Support the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://twitter.com/patrickkothe Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support Thanks for listening!

Steve Gielda is President and Co-founder of Ignite Selling, a global sales training, simulation and consulting organization. He’s co-authored two books – Ignite Your Sales Strategy: A Field Guide to Accelerating Your Pipeline, and Premeditated Selling: Tools for Developing the Right Strategy for Every Opportunity. In this episode we discuss the changing medical device environment, why strategic planning is vital in today’s environment, what a sales simulation is and how it clarifies strategy and aligns your internal resources, tips for managers to make them more effective with their reps, and considerations in hiring your sales team. Links from this episode: https://www.linkedin.com/in/sgielda/https://igniteselling.com/Support the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://twitter.com/patrickkothe Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support Thanks for listening!

Lucas Piandegonda is Managing Director of Gradical, which provides specialized expertise to companies that need help with plastic evaluation, material compliance and testing, and training. In this episode he shares the challenge and opportunity of becoming a consultant, considerations in choosing a plastic, how additives and manufacturing processes changes plastics, the importance of supplier choice and management, and options for making our devices more sustainable. Links from this episode: https://www.linkedin.com/in/lucas-r-pianegonda-81142b110/https://gradical.ch/Support the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://twitter.com/patrickkothe Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support Thanks for listening!

Kevin Hardage is President and General Manager at Teleflex Interventional Urology. They’re treating a common problem males face as we age - Benign Prostatic Hyperplasia, or BPH. Their minimally invasive treatment provides relief for patients, and an effective way for physicians to better treat the disease. In this Episode Kevin shares the issues with BPH, educating physicians who use the product, direct to consumer marketing, metrics and objectives within DTC, how to involve referring physicians, and team development. Links from this episode: https://www.linkedin.com/in/kevin-hardage-8466a64/https://www.teleflex.comhttps://www.urolift.com/Support the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://twitter.com/patrickkothe Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support Thanks for listening!

Rich Wintersteller is VP Global Sales and Marketing Cardiopulmonary at LivaNova. In this episode Rich shares why market leaders need to change their approach to product design, how LivaNova moved to embrace customer-centric design, the benefits to this approach, why software and interoperability are keys in their new product, how to manage change, and how LivaNova’s new technology is helping perfusionists deliver better patient care. Links from this episode: https://www.linkedin.com/in/rich-wintersteller-7822616/https://www.livanova.comSupport the Show. Connect with Mastering Medical Device: https://www.masteringmedicaldevice.comhttps://www.linkedin.com/company/mastering-medical-devicehttps://www.linkedin.com/in/patrick-kothehttps://twitter.com/patrickkothe Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support Thanks for listening!