Shows
Mastering Medical DeviceOpen or Closed Robotic Systems – Are We at a Crossroads? Featuring Stuart SimpsonSend 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 in the OR, how Think Surgical is trying to solve clinical, logistical and monetary issues, and his thoughts on how y...2024-04-301h 04
Mastering Medical DeviceHow Challenging Assignments and Brutally Honest Feedback Makes You Better with Dave RosaSend 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 distribution options in a start-up company, and how NeuroOne is providing technology helpful to patients and clinicians.Links from...2024-01-161h 00
Mastering Medical DeviceAn Inside View of FDA and Three New Guidance Documents on the 510(k) Process with Ken RiordanSend 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 his clients. In this episode Ken shares what it was like to work at FDA, how reviewers are chosen, how collaboration wit...2023-12-191h 00
Mastering Medical DeviceHow a Serial Entrepreneur Identifies and Evaluates Product Ideas and Brings Them to Market With Dr. Scott WolfSend 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 they meet with investors, the problems Aerin is addressing, and how they are serving the ENT co...2023-12-1253 min
Mastering Medical DeviceHow Cross-Training and Extreme Ownership Help You Advance Your Career with Rollie CarlsonSend 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 ownership, balancing company vision and mission, alignment of everyone in a company, why sepsis is such a big problem...2023-12-051h 10
Mastering Medical DeviceDon’t Go Chasin’ Waterfalls – Why the Agile Method is Preferred for Software Development with Weronika MichalukSend 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 does not have agile experience, assuring regulatory compliance, and the tools and tech stack that are used in today’s software development environment. 2023-11-2848 min
Mastering Medical DeviceWhen to Use Contract Manufacturing, and How Life Prioritization and Self-Care Affects All Areas of Your Life with Keith SmithSend 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 deep into his personal story about the cost of going all-in on business, what he learned and...2023-11-2154 min
Mastering Medical DeviceWhat You Need to Know About the New Cybersecurity Regulations for Medical Device with Milton YarberrySend 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 regulation, if this effects legacy devices, and how medical device companies will be impacted.Links from this episode:Milton Yarberry...2023-11-1449 min
Mastering Medical DeviceTransitions - From Sales Leader to CEO, From COVID Ventilator to Full-Featured Product with Rich WalshSend 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 feedback can make or break a career, locating a company in a non-traditional...2023-11-0756 min
Mastering Medical DevicePersevering and Pivoting - The Entrepreneur's Companions with Joe LandolinaSend 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 investment.Links from...2023-10-2458 min
Mastering Medical DeviceSolidly Starting Your Medical Device Career with Jordan GriffinSend 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 interview and break into a large company. Links from this episode:Jord...2023-10-1048 min
Mastering Medical DeviceHow a Non-Medical Serial Entrepreneur is Shaking Up In Vitro Fertilization with Marty GauvinSend 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 parents. Links from this episode:Marty Gauvin LinkedIn https://www.linkedin.com/in/martygauvin/Fertilis https://new...2023-10-0354 minMastering Medical DeviceWhy You Should Implement a Direct to Consumer Strategy and How You Can Help Patients with Zach ChampeauSend 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.linkedin.com/in/zach-champeau-50441264/Saleytics https://www.salelytics.com/Support t...2023-09-2659 minMastering Medical DeviceHow a New Autonomous Robot May Help Solve a Patient Access Problem with Johannes SchaeferhoffSend 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 the timely and accurate diagnosis and monitoring of patients with Rheumatoid Arthritis.2023-09-1954 minMastering Medical DeviceHow to Expand and Effectively Sell in International Markets with Zach SelchSend 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 distributor sales process.Links from this episode:Zach Selch LinkedIn https://www.linkedin.com/in...2023-09-0550 minMastering Medical DeviceCareer Pivot - From Clinical Cardiology to CMO of a Startup Focused on Hypertension with Jay Shah, MDSend 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 how wearables can change the way hypertension is managed. Link...2023-08-2259 minMastering Medical DeviceWinning the Complex Medical Device Sale - How to Train Your Team to Act Strategically with Steve GieldaSend us a textSteve 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 y...2023-08-081h 12Mastering Medical DeviceAll Plastics Are Not Equal - Choosing the Right One For Your Device with Lucas PianegondaSend us a textLucas 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:Lucas Pianegonda LinkedIn https://www.linkedin.com/in/lucas-r-pianegonda-81142b110/Gradical https://gradical.ch/Support the showConnect w...2023-07-2556 minMastering Medical DeviceHow to Expand a Market Using a Direct to Consumer Strategy with Kevin HardageSend us a textKevin 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:Kevin Hardage LinkedIn https://www.linkedin.com/in...2023-07-1153 minMastering Medical DeviceChanging to Customer-Centric Design While Develping a Major New Product with Rich WinterstellerSend us a textRich 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 https://www.linkedin.com/in/rich-wintersteller-7822616/LivaNova https://www.livanova.com Support the showConnec...2023-06-2758 minMastering Medical DeviceHow an Enabling Technology Can Unlock Product Performance with Tim SullivanSend us a textTim 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/Zateo Biomedical https://zeteobiomed.com/Support the showConnect with Mastering Medical Device: Website: https://w...2023-06-1355 minMastering Medical DeviceMoving a Technology Out of a University and Into a Company with Chris IdelsonSend us a textChris 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 what universities can do to better educate aspiring medical device developers. Links from this episode:C...2023-05-3053 minMastering Medical DeviceHow a Clear Vision Clarifies Product Portfolio Strategy and Team Development with Brady ShirleySend us a textBrady 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 segment into a broader vision, why they decided to rebrand, the importance of divesting and acquiring companies and technologies to align with vision, how outcomes are a...2023-05-161h 01Mastering Medical DeviceHow to Promote Your Product and Company When You're Challenging the Big Dogs with John GumasSend us a textJohn 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 messaging, interviewing your external and internal customers to develop your messaging, common promotional mistakes, and the Cha...2023-05-021h 04Mastering Medical DeviceAccelerate Your Success by Engaging with the Right Consultant with Dean GraySend us a textDean 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 importance of building relationships and how you can be a good partner.Links from this...2023-04-181h 06Mastering Medical DevicePrioritizing Complex Markets, Products, Regulations and Reimbursement with Karen ZaderejSend us a textKaren 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 regulatory excellence is one of their key strategies, building a successful career, and...2023-04-041h 06Mastering Medical DeviceApplying a Consumer Market Mindset to Medical Device with Scott NelsonSend us a textScott 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 again, opened his eyes to challenge some of his old mindsets. In this e...2023-03-2159 minMastering Medical DeviceTraining with Virtual Reality – Accelerating Confidence, Competence and Experience with Richard VincentSend us a textRichard 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 different methods, what virtual training is and its benefits, the data supporting VR learning, what haptics are and why they matter, and how...2023-03-0759 minMastering Medical DeviceBuilding a High Impact Customer Education Program with Lori HaradaSend us a textLori 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 episode:Lori Harada LinkedInTerumo Blood and Cell TechnologiesS...2023-02-2153 minMastering Medical DeviceWorking With Health Plans to Deliver Value with David SmithSend us a textDavid 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 episode:David Smith LinkedInIlumivuSupport the show...2023-01-3155 minMastering Medical DeviceConfronting Physician Burnout - Help is on the Way with Dr. Laura CazierSend us a textDr. 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 women, why physicians don’t seek help, the differences between mental health care and coaching, and what you should do...2022-12-1348 minMastering Medical DeviceApplying AI in Ultrasound - Helping Clinicians Become More Effective with Ohad AraziSend us a textOhad 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 definition, wireless ultrasound system is putting a powerful tool in the hands of all types of...2022-12-0648 minMastering Medical DevicePersonal ECG - Creating a New Product Category with Dr. David AlbertSend us a textDavid 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 idea for personalized ECG came about, ECG regulatory strategy, technology development, the importance of ro...2022-11-291h 02Mastering Medical DeviceManaging Your Career - Are You Doing It or Just Letting Things Happen? with Patrick JamnikSend us a textPatrick 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 help an underserved orthopedic patient...2022-10-2559 minMastering Medical DeviceMedical Affairs and How To Deliver Long Term Results with Dr. Agim BeshiriSend us a textDr. 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 inside industry, what doctors and companies need to recognize about each other, what Medical Affairs is and how it is structured, the long...2022-10-181h 05Mastering Medical DeviceHow a Regulatory Change Created a Product Opportunity with Ethan DrowerSend us a textEthan 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 this episode:Ethan Drower LinkedInCiteMedSupport the showConnect with Mastering Medical Device:2022-10-0455 minMastering Medical DeviceTackling an R&D Project When the "R" is as Large as the "D" with Andrew BucklerSend us a textAndrew 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 research into a product, the importance of staging a project, and the problems Elucid is targeting.Links f...2022-09-271h 01Mastering Medical DeviceWhy You Need to Embrace the New Go-To-Market Strategy with Scott AlexanderSend us a textScott 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 – from embracing this change.Links from this episode:Scott Alexander LinkedIni...2022-08-301h 07Mastering Medical DeviceChoosing the Right Problems to Solve and Aligning Your Core Technologies with Stephen MarianoSend us a textStephen 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 technology you own doesn’t fit in your portfolio, and an overview of FUJIFILM and how they’ve grow...2022-08-2355 minMastering Medical DeviceStudying vs. Experiencing Entrepreneurship - Shortening Your Learning Curve with Amit VohraSend us a textAmit 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 from this episode:Amit Vohra LinkedInPromaxoSupport the sh...2022-08-091h 02Mastering Medical DeviceObjectively Measuring Motion - A New Frontier with Frank FornariSend us a textFrank 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 BioBioMechSupport the showConnect with Mastering Medical Device: 2022-07-191h 03Mastering Medical DevicePatient Preferences and Their Impact on Healthcare Facilities with Amber SchiadaSend us a textAmber 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 in the US and globally, and trends in the short and mid-term.Links from this...2022-07-121h 04Mastering Medical DeviceLeveraging Data to Target Customers and Optimize Sales Territories with Skylar TalleySend us a textSkylar 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 companies don’t do that are common in other industries, aligning the sales team targets, and how sharing data to with pr...2022-07-0554 minMastering Medical DeviceProven Processes to Simplify and Assure Sales Success - Part 2 with Jim SurekSend us a textJim 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 identifying and segmenting buyer types.Links from this episode:Jim Surek LinkedInMedical Sales Nation Podcast - A...2022-06-2846 minMastering Medical DeviceProven Processes to Simplify and Assure Sales Success - Part 1 with Jim SurekSend us a textJim 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 importance of sales skills, sales training based on real customer knowledge, and how to begin a...2022-06-2140 minMastering Medical DeviceUnderstanding Software as a Medical Device with Vivek ThakkarSend us a textVivek 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 medical device, the regulatory requirements during product development, how hardware and software programs a...2022-06-0750 minMastering Medical DeviceHow New Technology Can Make Wearable Medical Devices and Smart Watches Smarter with Andrew RickmanSend us a textWearable 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 better healthcare, the benefits of longitudinal data, the products Rockley is introducing, how medical device companies may benefit from this eme...2022-05-3157 minMastering Medical DeviceWhat a Pulmonologist Wants You to Know About Your Lungs with Dr. Meilan HanSend us a textMeilan 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 devices she uses, her advice for companies develo...2022-04-131h 00Mastering Medical DeviceProject Management - Best Practices and How to Choose Between Internal or External Development Teams with Bryon BhagwandinSend us a textBryon 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 is working on to help children be more successful. Links fro...2022-03-221h 05Mastering Medical DevicePreparing to Compete in a New Digital Marketplace with Scott CarsonSend us a textScott 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 to healthcare failed, how to build a successful marketplace, why the solo...2022-03-011h 05Mastering Medical DeviceHospital Sterile Processing - What You Need to Know and How it May Effect Device Performance with Nestor Hernandez - Part 2Send us a textNestor Hernandez, CRCST, CHL has 40 years of sterile processing experience in 5 hospital systems, and is the Director of Operation Sterile Processing (SPD) at Lee Health in Fort Myers Florida. Nestor is active in education within SPD community and also consults with medical device companies on issues related to sterile processing. In this episode Nestor shares who works in the SPD, what training, education and certifications are required, what devices should and shouldn’t be processed though SPD, what vendors should do to build a relationship, what the best reps do that others don’t, h...2022-02-1536 minMastering Medical DeviceHospital Sterile Processing - What You Need to Know and How it May Effect Device Performance with Nestor Hernandez - Part 1Send us a textNestor Hernandez, CRCST, CHL has 40 years of sterile processing experience in 5 hospital systems, and is the Director of Operation Sterile Processing (SPD) at Lee Health in Fort Myers Florida. Nestor is active in education within SPD community and also consults with medical device companies on issues related to sterile processing. In this episode Nestor shares how he entered SPD, a detailed description of what SPD does, teamwork within the hospital and educating hospital staff, and how to manage hospital acquired infection. This is part 1 of a 2-part conversation.Links from this...2022-02-0844 minMastering Medical DeviceMedical Device Packaging - What's New and How to Stay Ahead of the Competition with Charlie WebbSend us a textCharlie Webb is the founder of Van der Stähl Scientific, a company that provides medical device packaging systems and services. In this episode Charlie shares information on the types of packaging systems available, materials used, considerations for choosing the correct system for your device, understanding user needs, what packaging sealers do and how they have evolved, why verification and validation are equally important, and packaging sustainability. Links from this episode:Charlie Webb LinkedInVan der Stähl ScientificSupport the showConnect with Mastering Medical Device: ...2022-02-0159 minMastering Medical DeviceClincal Study, Case Series, Registry, Survey - What They Should All Have in Common with Jon BergsteinssonSend us a textJon Bergsteinsson is the Founder and Chief Commercial Officer at Smart-Trial, a company dedicated to providing a simple, yet robust platform for electronic data capture. In this episode Jon shares the differences between pharma and device trials, pre-approval and post-approval studies and scoping them appropriately, why electronic data capture is preferable to paper based systems, his advice to start-up companies contemplating a clinical trial, how changes to the EU MDR have impacted companies and how they are managing the requirements, and the future direction of data collection.Links from this episode:2022-01-2558 minMastering Medical DeviceCreating Your Personal Brand is Garbage Advice - What You Should do Instead with Pat KotheSend us a textThe concept of creating your own personal brand has been around for years, but it is garbage advice. In this episode Pat Kothe shares how product and company branding differs from personal branding, the origins of branding, how a brand manager creates and manages a company or product brand, why fake-it-till-you-make-it is garbage advice, why focusing on reputation is the right strategy, and some tips for understanding and enhancing your reputation.Support the showConnect with Mastering Medical Device: Website: https://www.masteringmedicaldevice.com LinkedIn: https...2022-01-1832 minMastering Medical DeviceWhy a Device and Biologic Combination Product is a Challenge and an Opportunity with Patricia ZillioxSend us a textPatricia Zilliox has devoted her career to solving problems with the eyes. She had a very successful career at Alcon, then at the Foundation Fighting Blindness Clinical Research Institute, before joining Eyevensys as CEO. Eyevensys is working on a technology that has the potential to solve a big problem. In this episode Patricia shares how a biologics company approaches device design and manufacture, combination product development, the regulatory pathway, funding challenges, how device differs but is similar to pharma and biologics, and how great companies retain great people. Links from this ep...2022-01-0451 minMastering Medical DeviceA New Understanding: Concussion Definition, Diagnosis and Management with Scott AndersonSend us a textScott Anderson is a recognized concussion expert having spent 4 years at St. Mary’s University and 10 years at Stanford as the Director of Athletic Training. He is currently Chief Clinical Officer at SyncThink and is also a Medical Observer for the NFL. In this episode Scott describes what a concussion is, the symptoms, who should diagnose and treat the injury, medical devices used for concussion monitoring, why objective test data is vital, how the SyncThink technology is contributing to concussion management, and the future of eye tracking technology.Links from this ep...2021-12-0759 minMastering Medical DeviceHow to Critically Choose and Develop an Implantable Medical Device with Tammy GilonSend us a textTammy Gilon is the Founder and CEO of Laminate Medical Technologies, where they are developing solutions for improving vascular access for dialysis patients. In this episode she shares why she became interested in medical device, the systematic and thorough process she followed in choosing a project to pursue, finding a partner, what it is like to found a company and raise money as a young female, the start-up culture in Israel, and the long journey of designing an implantable medical device.Links from this episode:Tammy Gilon LinkedInLaminate Medical Technologies2021-12-011h 01Mastering Medical DeviceUnderstanding Telehealth and Remote Patient Monitoring with Kent DicksSend us a textKent Dicks has been involved in providing technology for remote patient monitoring or RPM since 2006. Kent is a thought leader in the space and is currently CEO of Life365, a leader in RPM. Prior to that he founded MedApps, which was sold to Alere in 2012. In this episode Kent shares some common terms used in connected health and their definitions, how the segment has evolved, how consumer choice is effecting where medicine is and will be delivered, the role of remote patient monitoring, how RPM works from patient enrollment and training to use...2021-11-231h 03Mastering Medical DevicePoint of Care Ultrasound is Changing the Practice of Medicine with Dr. Arun NagdevSend us a textDr. Arun Nagdev is one of the leading international authorities on Point of Care Ultrasound, or POCUS. He practices clinically and also is the Senior Director of Clinical Education at Exo, a company that is on a mission to modernize medical imaging through its high-performance handheld ultrasound platform and artificial intelligence. In this episode Dr. Nagdev discusses the evolution of ultrasound in the practice of medicine, how point-of care ultrasound impacts procedural success and patient care, the challenges with educating established physicians, changing the curriculum of residencies, POCUS reimbursement, the differences between clinical...2021-11-1757 minMastering Medical DeviceMy First Live Trade Show in Two Years - What It's Like with Pat KotheSend us a textTrades shows are slowly coming back on line. What can you expect? In this episode Pat Kothe describes his experience with making the decision to attend the largest trade show in his market segment, including decision criteria, costs, attendance of clinicians and exhibitors, COVID safety protocols, and attendee attitudes.Links from this episode:American College of Emergency Physicians (ACEP)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...2021-11-0931 minMastering Medical DeviceThe FSS Contract - Why You Need it and How You Get It with Hannah ZerpheySend us a textHannah Zerphy is a Managing Member of Orlaithe Consulting, a firm specializing in federal contracting. Hannah worked inside the VA as a Warranted Contracting Officer and a Training Coordinator for VA FSS, so she knows how the process works and how companies should present their products and opportunities. In this episode Hannah shares how to register on sam.gov, why a Federal Supply Schedule or FSS contract is usually your best option, choosing your product category, completing the FSS application, customer pricing disclosure, working with a contracting officer, and ongoing reporting.L...2021-10-0559 minMastering Medical DeviceWhat You Need to Know About Recruiters and Job Searches with Jordan ChaseSend us a textJordan Chase has seen hiring from inside a company, as well as from a recruiter’s perspective. Jordan spent over a decade at Medtronic, in human resources and talent acquisition. He’s spent the last decade as an outside search consultant with his group, Chase Medsearch. They focus primarily on customer facing positions in sales & marketing with a specialty in the neuromodulation space. In this episode Jordan shares what you need to know about recruiters, the difference between contingency and retained search, the challenges of an inside recruiter, how inside and outside recruiting diffe...2021-09-281h 04Mastering Medical DeviceSimple Ways You Can Become a Better Persuasive Communicator with Shelly O'DonovanSend us a textShelly O’Donovan is a recognized expert in persuasive communication who helps people in medical device and pharma communicate more effectively. Shelly is CEO of Authentic Influence Group and also a lecturer at Wharton. The first part of her career was in government, before she made the move to industry, spending 9 years at GSK. In this episode Shelly shares key communication factors, verbal and non-verbal communication, how to stand out in a meeting, how to build trust, the importance of being clear and concise while including proof sources, and why confidence is so im...2021-09-211h 03Mastering Medical DeviceBreaking Into Medical Device Sales with Jacob McLaughlinSend us a textWhen he was 25 years old, Jacob McLaughlin moved from being an athletic trainer to a surgical sales representative for one of the top medical device companies in the world. He used some traditional techniques for breaking in, but also some that were very non-traditional, including documenting his journey in his podcast, New to Medical Device Sales and his presence on YouTube, TikToK and Instagram. In this episode Jacob shares the similarities and differences between athletic training and medical device sales, advanced networking techniques, what the interview process is like from a candidate’s pe...2021-09-161h 04Mastering Medical DeviceInside the Value Analysis Process with Barbara Strain, Part 2Send us a textBarbara Strain is an expert in Value Analysis and Management. Barbara has forty-one years of provider experience, thirty-four of them in the University of Virginia Health System where she led teams in Value Management and Supply Chain Analytics. Barbara is one of the founders of the Association of Healthcare Value Analysis Professionals (AHVAP), and a past president. She earned the Brooke Berson Founders award from AHVAP in 2019, and in 2021 was honored to enter the Bellwether League Foundation Hall of Fame for Healthcare Supply Chain Leadership. In episode 2 of a 2-part series, Barbara discusses...2021-09-0753 minMastering Medical DeviceInside the Value Analysis Process with Barbara Strain, Part 1Send us a textBarbara Strain is an expert in Value Analysis and Management. Barbara has forty-one years of provider experience, thirty-four of them in the University of Virginia Health System where she led teams in Value Management and Supply Chain Analytics. Barbara is one of the founders of the Association of Healthcare Value Analysis Professionals (AHVAP), and a past president. She earned the Brooke Berson Founders award from AHVAP in 2019, and in 2021 was honored to enter the Bellwether League Foundation Hall of Fame for Healthcare Supply Chain Leadership. In episode 1 of a 2-part series, Barbara discusses...2021-08-3157 min