Mastering Medical Device artwork

Mastering Medical Device

107 episodes - English - Latest episode: 3 months ago - ★★★★★ - 20 ratings

We help medical device professionals deepen their knowledge of customers, the industry, and their role. Our main objective is to help you become expert in your current position, and through a better understanding of others within your company and the best practices in others in the industry, enable you to fast-track your career.

Careers Business Health & Fitness Medicine medical device medical devices medical sales medical innovation medical device regulatory innovation medical device jobs medical device career
Homepage Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed

Episodes

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

January 16, 2024 10:00 - 1 hour - 41.4 MB

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 o...

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

December 19, 2023 10:00 - 1 hour - 41.4 MB

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.  ...

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

December 12, 2023 10:00 - 53 minutes - 36.5 MB

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 inv...

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

December 05, 2023 10:00 - 1 hour - 48.2 MB

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...

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

November 28, 2023 10:00 - 48 minutes - 33.6 MB

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...

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

November 21, 2023 10:00 - 54 minutes - 37.2 MB

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 ...

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

November 14, 2023 10:00 - 49 minutes - 33.9 MB

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 ...

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

November 07, 2023 10:00 - 56 minutes - 38.6 MB

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 ma...

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

October 24, 2023 09:00 - 58 minutes - 40.4 MB

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. Li...

Solidly Starting Your Medical Device Career with Jordan Griffin

October 10, 2023 09:00 - 48 minutes - 33.1 MB

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...

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

October 03, 2023 09:00 - 54 minutes - 37.2 MB

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...

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

September 26, 2023 09:00 - 59 minutes - 41 MB

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...

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

September 19, 2023 09:00 - 54 minutes - 37.6 MB

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 an...

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

September 05, 2023 09:00 - 50 minutes - 35 MB

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 ...

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

August 22, 2023 09:00 - 59 minutes - 40.6 MB

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 ...

Winning the Complex Medical Device Sale - How to Train Your Team to Act Strategically with Steve Gielda

August 08, 2023 09:00 - 1 hour - 50.1 MB

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 strate...

All Plastics Are Not Equal - Choosing the Right One For Your Device with Lucas Pianegonda

July 25, 2023 09:00 - 56 minutes - 38.6 MB

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 episod...

How to Expand a Market Using a Direct to Consumer Strategy with Kevin Hardage

July 11, 2023 09:00 - 53 minutes - 36.9 MB

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 physi...

Changing to Customer-Centric Design While Develping a Major New Product with Rich Wintersteller

June 27, 2023 09:00 - 58 minutes - 39.9 MB

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: Rich Wintersteller LinkedIn h...

How an Enabling Technology Can Unlock Product Performance with Tim Sullivan

June 13, 2023 09:00 - 55 minutes - 38.3 MB

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 administration.   Links from this episode: Tim Sullivan LinkedIn https://www.linkedin.com/in/timothy-sullivan-67089a/ Z...

Moving a Technology Out of a University and Into a Company with Chris Idelson

May 30, 2023 09:00 - 53 minutes - 36.8 MB

Chris Idelson is Co-Founder and Chief Technology Officer at ClearCam, a company dedicated to developing technology to improve surgeons visual field during minimally invasive procedures. In this episode we discuss what a Mechanical Engineering Ph.D. program is like, the importance of hands-on education, how the NSF I-Corps program has informed his view on product development, IP development and ownership in a University, how ClearCam is helping to solve a common problem with laparoscopes, and...

How a Clear Vision Clarifies Product Portfolio Strategy and Team Development with Brady Shirley

May 16, 2023 09:00 - 1 hour - 42.6 MB

Brady Shirley is President and Chief Operating Officer of Enovis, an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. The Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. In this episode Brady shares the history of the company, how they are leveraging market leadership in one segm...

How to Promote Your Product and Company When You're Challenging the Big Dogs with John Gumas

May 02, 2023 09:00 - 1 hour - 44 MB

John Gumas is the Founder and CEO of Gumas Advertising, a full service advertising agency based in San Francisco. John is recognized as one of the country’s foremost authorities on Challenger Brand Marketing®. He is the author of the popular books “Marketing Smart” and “Challenger Brand Marketing”. In this episode John shares how the medical device market is the same and different than other markets, selling without selling, positioning to be a go-to, trusted resource, the importance of mess...

Accelerate Your Success by Engaging with the Right Consultant with Dean Gray

April 18, 2023 09:00 - 1 hour - 46 MB

Dean Gray is a Partner at PA Consulting, a company with over 4,000 employees that operates globally, and helps companies in several industries become more effective. Dean also has has significant experience within industry at Pfizer, BD, Boston Scientific, Sanofi Genzyme, and Heidelberg Engineering. In this episode he shares how consulting is utilized, what a good or bad engagement looks like, best practices for consultants and what you should expect, how to begin a project correctly, the im...

Prioritizing Complex Markets, Products, Regulations and Reimbursement with Karen Zaderej

April 04, 2023 09:00 - 1 hour - 45.5 MB

Karen Zaderej is CEO of Axogen, where they provide technology solutions to help restore feeling and functionality to damaged peripheral nerves. After a 17-year career at the Ethicon Division of Johnson and Johnson, Karen took on the challenge of a start-up, and has built a successful company that is delivering much-needed solutions to clinicians and patients. In this episode she shares what nerve repair is, why it is important to bodily function and the quality of life of patients, why regul...

Applying a Consumer Market Mindset to Medical Device with Scott Nelson

March 21, 2023 16:00 - 59 minutes - 41.2 MB

Scott Nelson is Co-Founder and CEO of FastWave Medical.  He is also the host of the Medsider Podcast, as well as the Founding Partner and Managing Director of Big Sky Biomedical, a leading medtech accelerator. Scott is a medical device veteran, and has held leadership roles at Medtronic, Covidien, Boston Scientific, C.R. Bard and ConMed. He also co-founded Joovv, a popular health and wellness brand. His unique background moving from traditional medical device to the consumer market and back ...

Training with Virtual Reality – Accelerating Confidence, Competence and Experience with Richard Vincent

March 07, 2023 10:00 - 59 minutes - 40.8 MB

Richard Vincent is CEO and Co-founder of FundamentalVR, a company that is focused on improving patient outcomes by revolutionizing medical training through virtual learning platforms. Richard is experienced in building international businesses and has a keen interest in seeking out opportunities to disrupt markets through development and adoption of new technology. In this episode Richard shares insights into past medical training methods, where they excel and the limitations of the differen...

Building a High Impact Customer Education Program with Lori Harada

February 21, 2023 10:00 - 53 minutes - 36.9 MB

Lori Harada is Senior Manager of Commercial Technical Excellence at Terumo Blood and Cell Technologies. Starting out as a nurse, Lori found that education was her passion and she’s been involved in it ever since.  In this episode she shares the importance of education, what types of people are drawn to it and how to prepare them for success, considerations for designing an education program, and how Terumo Blood and Cell Technologies is changing the lives of patients. Links from this episod...

Working With Health Plans to Deliver Value with David Smith

January 31, 2023 10:00 - 55 minutes - 38.4 MB

David Smith is President and Chief Revenue Officer of Ilumivu, a company that is taking data from common smartwatches and using AI and machine learning to gain insights into the early detection of certain medical conditions. In this episode he shares how health plans are evolving, how physician perceptions of the plans are changing, how well care and early disease detection is good for their bottom line, and how Ilumivu can help individual patients and large populations. Links from this epi...

Confronting Physician Burnout - Help is on the Way with Dr. Laura Cazier

December 13, 2022 10:00 - 48 minutes - 33.4 MB

Dr. Laura Cazier is a Board Certified emergency medicine physician who is also helping other doctors deal with burnout and other challenges through life skills coaching. She co-founded The Whole Physician with two other board-certified ED doctors, providing mindset and wellness coaching for physicians, by physicians. In this episode Dr. Cazier shares the reasons why physicians feel burnout, what specialties are most impacted, the issues and reasons why burnout is different between men and wo...

Applying AI in Ultrasound - Helping Clinicians Become More Effective with Ohad Arazi

December 06, 2022 10:00 - 48 minutes - 33.3 MB

Ohad Arazi is President & CEO of Clarius, a company that provides a high-definition wireless ultrasound system that includes AI to help reduce the complexity of ultrasound. In this episode he shares about his time in the Israeli military and the surprising environment that encourages entrepreneurship, what you can learn while working in large and small companies, where AI is and where it’s going, how point-of-care ultrasound can benefit clinicians and patients, and how Clarius and their high...

Personal ECG - Creating a New Product Category with Dr. David Albert

November 29, 2022 10:00 - 1 hour - 42.9 MB

David Albert is a physician, inventor, and serial entrepreneur. He is the Founder and Chief Medical Officer of Alivecor, the leading company in personal ECG technology. He has founded 5 companies, and sold two – one to Arrhythmia Research Technology and one to GE which he joined as Chief Scientist of GE Cardiology. David has 32 issued US patents and has authored or co-authored over 50 scientific abstracts and publications. In this episode David shares what makes ECG such useful tool, how the...

Managing Your Career - Are You Doing It or Just Letting Things Happen? with Patrick Jamnik

October 25, 2022 21:00 - 59 minutes - 41 MB

Patrick Jamnik is President of Episurf Medical, an orthopedic company who provides individualized technology for the treatment of painful joint injuries. In this episode Patrick shares why a company personal development plan may not be the best for your career, why you need to be a lifelong learner, how to seek out mentors and where to find them, what a mastermind group is and how it can benefit you, some of the things to do when importing a technology to the US, and what Episurf is doing to...

Medical Affairs and How To Deliver Long Term Results with Dr. Agim Beshiri

October 18, 2022 09:00 - 1 hour - 45.3 MB

Dr. Agim Beshiri is the Chief Medical Officer at Nutromics, where they have developed technology for continuous diagnostic monitoring through a ‘lab-on-a-patch’ approach. Dr. Beshiri is a leading industry expert in developing medical affairs organizations and driving medical research and education. Prior to joining Nutromics, he contributed at Abbott Laboratories for over 16 years, serving as Senior Medical Director. In this episode he shares about earning a medical degree and applying it in...

How a Regulatory Change Created a Product Opportunity with Ethan Drower

October 04, 2022 09:00 - 55 minutes - 37.9 MB

Ethan Drower is the Founder and  Operating Partner at CiteMed Solutions, who provide full Clinical Evaluation Report services for EU MDR. Ethan is a software engineer and entrepreneur, trained to identify problems and implement solutions. In this episode Ethan shares how to listen for new ideas, R&D differences and similarities in industries, building early prototypes and capturing customer feedback, scoping a project, pricing for value, and how CiteMed has positioned itself. Links from thi...

Tackling an R&D Project When the "R" is as Large as the "D" with Andrew Buckler

September 27, 2022 09:00 - 1 hour - 41.9 MB

Andrew Buckler is the Founder, President and CTO of Elucid, a company that is focused on characterizing placque, with the goal of providing clinicians better information on placque stability, vessel structure, treatment options, and risk factors for cardiac events. In this episode, Andrew shares how to  found a company when you have a significant amount of research ahead of you, the importance of understanding biology when designing devices, the evolution of coronary angioplasty, translating...

Why You Need to Embrace the New Go-To-Market Strategy with Scott Alexander

August 30, 2022 09:00 - 1 hour - 46.2 MB

Scott Alexander is the CEO of iVelocity Marketing, and has been on the leading edge of identifying market shifts and building strategies and programs to embrace a new and improved go-to-market strategy. In this episode he shares  what providers don’t understand about medical device companies, what we don’t understand about providers, the reasons why the old go-to-market strategy no longer works in medical device, the benefits of using a digital strategy, and why sales will love – and prosper...

Choosing the Right Problems to Solve and Aligning Your Core Technologies with Stephen Mariano

August 23, 2022 09:00 - 55 minutes - 38.5 MB

Stephen Mariano is Vice President of Global Endosurgical R&D at FUJIFILM Healthcare Americas Corporation. Stephen has a long history of success in research and development for the medical device industry and has helped bring numerous innovative technologies to market. In this episode Stephen shares how a company chooses the types of problems to solve, how to choose a specific problem, leveraging capabilities and core technologies, strategic direction and planning, what to do when a technolog...

Studying vs. Experiencing Entrepreneurship - Shortening Your Learning Curve with Amit Vohra

August 09, 2022 17:00 - 1 hour - 43.2 MB

Amit Vohra is the Founder and CEO of Promaxo, a medical technology company that is commercializing an office-based MRI system. In this episode he shares  why entrepreneurs need a support system around them, how culture is really built in a company, identifying good start-up team members, why everyone needs to be a salesperson, working with advisors, the balance between being flexible and holding true to what you believe, and what Promaxo does and why the technology is a game changer.  Links...

Objectively Measuring Motion - A New Frontier with Frank Fornari

July 19, 2022 09:00 - 1 hour - 43.9 MB

Frank Fornari is the Founder and Chairman of BioMech, a leading company in motion analytics. In this episode Frank shares information on how our movement can indicate health, injury, decline, disease or neglect; why assessing motion can help to understand if we are getting better or worse over time, or after an intervention or surgery; the BioMech system; options for commercializing a platform technology; and the future of motion analytics. Links from this episode: Frank Fornari Bio BioMe...

Patient Preferences and Their Impact on Healthcare Facilities with Amber Schiada

July 12, 2022 09:00 - 1 hour - 44.1 MB

Amber Schiada is the Head of Americas Work Dynamic Research at JLL, one of the largest real estate services firms in the world. In this episode she shares the results of their 2022 Patient Consumer Survey and other topics, including the most important consideration in choosing a health care facility, generational differences in healthcare choices, attitudes toward tele-health, differences by geographical region and if you reside in an urban, suburban or rural location, life science hot spots...

Leveraging Data to Target Customers and Optimize Sales Territories with Skylar Talley

July 05, 2022 09:00 - 54 minutes - 37.6 MB

Skylar Talley is CEO of MedScout, a company that provides life science companies data and insights to help sales reps and sales managers be more targeted and effective. In this episode Skyler discusses upstream and downstream marketing, bootstrapping a company, why inside sales is becoming more popular, leveraging distributor organizations, why digital marketing should be moving higher on your radar, using data to design territories and target customers, surprising things medical device comp...

Leveraging Data to Target Customers and Optimize Sales Territories with Skylar Talley

July 05, 2022 09:00 - 54 minutes - 37.6 MB

Skylar Talley is CEO of MedScout, a company that provides life science companies data and insights to help sales reps and sales managers be more targeted and effective. In this episode Skyler discusses upstream and downstream marketing, bootstrapping a company, why inside sales is becoming more popular, leveraging distributor organizations, why digital marketing should be moving higher on your radar, using data to design territories and target customers, surprising things medical device comp...

Proven Processes to Simplify and Assure Sales Success - Part 2 with Jim Surek

June 28, 2022 09:00 - 46 minutes - 32 MB

Jim Surek is a recognized sales leader whose teams have performed wherever he has been, based on proven sales principles. Jim is currently VP of Sales at Explorer Surgical and is also host of the podcast, Medical Sales Nation.  In this episode Jim shares the sales process, including translating engineering language into customer language, aligning the company behind customer messaging, building a learning culture, question-based selling, setting sales targets for a new product, and identifyi...

Proven Processes to Simplify and Assure Sales Success - Part 1 with Jim Surek

June 21, 2022 09:00 - 40 minutes - 27.9 MB

Jim Surek is a recognized sales leader whose teams have performed wherever he has been, based on proven sales principles. Jim is currently VP of Sales at Explorer Surgical and is also host of the podcast, Medical Sales Nation.  In this episode Jim shares how medical sales has changed, why reps have evolved into enterprise salespeople, his mindset of helping to heal our healthcare system,  developing a value proposition for a multi-headed customer, commercialization as an initiative, the impo...

Understanding Software as a Medical Device with Vivek Thakkar

June 07, 2022 09:00 - 50 minutes - 34.5 MB

Vivek Thakkar  has over a dozen years of experience in regulatory affairs for Class II and III medical devices, while at Roche, JUUL, Cardinal Health, and Abbott Vascular. He is also a frequent speaker on software, artificial intelligence, and machine learning. Vivek is now focused on start-ups and consults with medical device companies to identify and refine their regulatory strategies in the software as a medical device space. In this episodeVivek shares the definition of software as a me...

How New Technology Can Make Wearable Medical Devices and Smart Watches Smarter with Andrew Rickman

May 31, 2022 09:00 - 57 minutes - 39.7 MB

Wearable devices have become common for a number of applications – from fitness tracking to tracking medical parameters for people with conditions like diabetes or heart arrhythmias. The overlap between consumer and regulated medical device wearables is becoming very fuzzy, but has a bright future. In this episode,  Andrew Rickman, the CEO of Rockley Photonics, discusses why wearables have taken off, the differences in consumer and medical wearables, how multi-parameter data can lead to bett...

What a Pulmonologist Wants You to Know About Your Lungs with Dr. Meilan Han

April 12, 2022 23:00 - 1 hour - 41.8 MB

Meilan Han, MD is a Professor of Medicine and Chief of the Division of Pulmonary and Critical Care at the University of Michigan, and a spokesperson for the American Lung Association. She is the author of a recently released book, “Breathing Lessons, A Doctor’s Guide to Lung Health.” In this episode Dr. Han describes how the lungs function, what can go wrong with them, lung development and why we need to pay attention to how we treat our lungs during their development phases, what medical de...

Project Management - Best Practices and How to Choose Between Internal or External Development Teams with Bryon Bhagwandin

March 22, 2022 22:00 - 1 hour - 45.1 MB

Bryon Bhagwandin is CEO of Recalibrate Solutions, a Denver Startup that is developing a system to monitor a child’s response to stress. Brian also has decades of experience managing development projects. In this episode Bryon shares the challenges of managing a medical device project, different models of project management, when to go to an outside development firm, what to look for when choosing one, and his advice for new project managers. He also shares a very interesting test his company...

Preparing to Compete in a New Digital Marketplace with Scott Carson

March 01, 2022 10:00 - 1 hour - 44.8 MB

Scott Carson is the Founder and CEO of MRP, a new kind of marketplace for medical products. Scott has been involved in several ventures that have innovated and developed new distribution models. He was part of the team that built the eBay Healthcare Marketplace strategy and structure, and was the Founder of US Medical, the first internet distributor of new and pre-owned capital medical equipment to the healthcare industry. In this episode Scott shares why early attempts to apply the internet...

Twitter Mentions

@patrickkothe 28 Episodes