Mastering Medical Device

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Mastering Medical Device

Patrick Kothe

104 episodes

6 months ago

Send us a textIn this episode, Chris McAuliffe, CEO of Theragen, shares his extensive journey in the medical device industry with a focus on non-invasive spine fusion. He recounts his personal experience as a patient undergoing spinal fusion surgery and how it has influenced his work and product design. The discussion covers the challenges of spinal fusion, the role of non-invasive electrical stimulation in patient recovery, and the importance of VIP customer service in healthcare. Chris's in...

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Health & Fitness,

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Send us a textIn this episode, Chris McAuliffe, CEO of Theragen, shares his extensive journey in the medical device industry with a focus on non-invasive spine fusion. He recounts his personal experience as a patient undergoing spinal fusion surgery and how it has influenced his work and product design. The discussion covers the challenges of spinal fusion, the role of non-invasive electrical stimulation in patient recovery, and the importance of VIP customer service in healthcare. Chris's in...

Show more...

Health & Fitness,

Episodes (20/104)

Mastering Medical Device

Thinking Like a Patient (or Being One!) Can Make Your Company's Device Better featuring Chris McAuliffe

Send us a textIn this episode, Chris McAuliffe, CEO of Theragen, shares his extensive journey in the medical device industry with a focus on non-invasive spine fusion. He recounts his personal experience as a patient undergoing spinal fusion surgery and how it has influenced his work and product design. The discussion covers the challenges of spinal fusion, the role of non-invasive electrical stimulation in patient recovery, and the importance of VIP customer service in healthcare. Chris's in...

9 months ago

1 hour 3 minutes

Mastering Medical Device

Defining and Managing Your Brand in a Complex Marketplace featuring Howie Chan

Send us a textIn this episode, we dive into the essentials of branding with expert Howie Chan, founder of Healthy Brand Consulting. The discussion covers the critical role of understanding and managing one's brand, both for companies and individuals. Howie shares insights from his journey from biomedical engineering to branding, offers practical advice for building and differentiating a brand, and highlights the importance of company values and leadership in navigating external events. Whethe...

12 months ago

59 minutes

Mastering Medical Device

How to Build and Manage a Powerful Advisory Board featuring Paul Hickey

Send us a textIn this episode, the discussion centers around the crucial role of advisory boards in guiding company strategies, product development, and business initiatives within the medical device sector. Featuring insights from Paul Hickey, CEO of ReShape Life Sciences, the conversation delves into best practices for forming and managing advisory boards, emphasizing the importance of team involvement and maintaining high-quality standards. Paul shares his extensive career journey across d...

1 year ago

52 minutes

Mastering Medical Device

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

Send us a textJoe 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 peopl...

1 year ago

1 hour

Mastering Medical Device

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

Send us a textStuart 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...

1 year ago

1 hour 4 minutes

Mastering Medical Device

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

Send us a textDave 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 d...

1 year ago

1 hour

Mastering Medical Device

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

Send us a textKen 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 h...

1 year ago

1 hour

Mastering Medical Device

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

Send us a textScott 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 t...

1 year ago

53 minutes

Mastering Medical Device

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

Send us a textRollie 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 own...

1 year ago

1 hour 10 minutes

Mastering Medical Device

Don’t Go Chasin’ Waterfalls – Why the Agile Method is Preferred for Software Development with Weronika Michaluk

Send us a textWeronika 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 ...

1 year ago

48 minutes

Mastering Medical Device

When to Use Contract Manufacturing, and How Life Prioritization and Self-Care Affects All Areas of Your Life with Keith Smith

Send us a textKeith 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 d...

1 year ago

54 minutes

Mastering Medical Device

What You Need to Know About the New Cybersecurity Regulations for Medical Device with Milton Yarberry

Send us a textMilton 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 regulat...

1 year ago

49 minutes

Mastering Medical Device

Transitions - From Sales Leader to CEO, From COVID Ventilator to Full-Featured Product with Rich Walsh

Send us a textRich 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 fe...

1 year ago

56 minutes

Mastering Medical Device

Persevering and Pivoting - The Entrepreneur's Companions with Joe Landolina

Send us a textJoe 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 in...

1 year ago

58 minutes

Mastering Medical Device

Solidly Starting Your Medical Device Career with Jordan Griffin

Send us a textJordan 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 interv...

1 year ago

48 minutes

Mastering Medical Device

How a Non-Medical Serial Entrepreneur is Shaking Up In Vitro Fertilization with Marty Gauvin

Send us a textMarty 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 paren...

1 year ago

54 minutes

Mastering Medical Device

Why You Should Implement a Direct to Consumer Strategy and How You Can Help Patients with Zach Champeau

Send us a textZach 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.linked...

1 year ago

59 minutes

Mastering Medical Device

How a New Autonomous Robot May Help Solve a Patient Access Problem with Johannes Schaeferhoff

Send us a textJohannes 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 ...

1 year ago

54 minutes

Mastering Medical Device

How to Expand and Effectively Sell in International Markets with Zach Selch

Send us a textZach 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...

1 year ago

50 minutes

Mastering Medical Device

Career Pivot - From Clinical Cardiology to CMO of a Startup Focused on Hypertension with Jay Shah, MD

Send us a textDr. 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 ...

1 year ago

59 minutes