Mastering Medical Device

Send us Fan Mail In 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 s...

Send us Fan Mail In 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 br...

Send us Fan Mail In 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 i...

Send us Fan Mail 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...

Send us Fan Mail 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...

Send us Fan Mail 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 str...

Send us Fan Mail 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 Pharma...

Send us Fan Mail 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...

Send us Fan Mail 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 Biosy...

Send us Fan Mail 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 agi...

Send us Fan Mail 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 t...

Send us Fan Mail 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 im...

Send us Fan Mail 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 foun...

Send us Fan Mail 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...

Send us Fan Mail 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 ru...

Send us Fan Mail 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 medi...

Send us Fan Mail 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 m...

Send us Fan Mail 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...

Send us Fan Mail 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 i...

Send us Fan Mail 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 i...

Send us Fan Mail 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 environmen...

Send us Fan Mail 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 importanc...

Send us Fan Mail 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...

Send us Fan Mail 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 technolog...

Send us Fan Mail Tim Sullivan is CEO of Zeteo Biomedical, a company dedicated to providing drug and biologic delivery systems. In this episode Tim shares how an enabling technology effects the efficacy of treatment, understanding each stakeholders needs, a systematic approach for gathering stakeholder input, working with pharma companies on combination products, and the future of vaccine administr...