The Med-Tech Talent Lab

In this episode of The Med-Tech Talent Lab, we dive into the complex world of Laboratory Developed Tests (LDTs) with Julie Ballard, a clinical laboratory expert with over 25 years of experience in operations, quality systems, and regulatory compliance. Julie shares her journey from working at Stanford Health Care to leading roles in startups like GRAIL, Genomic Health, and Guardant.We unpack the implications of the FDA's groundbreaking LDT ruling, discussing its potential impact on patient care, lab operations, and the broader industry. Julie explains the distinctions between LDTs and FDA-approved tests, the challenges labs face in adapting to the new regulations, and the critical steps they should take now to stay compliant.Julie also sheds light on how these changes create opportunities for talent in regulatory, quality, and consulting roles, offering insights into how labs can navigate this regulatory rollercoaster.Don’t miss this expert analysis on one of the hottest topics in clinical labs today!Connect with Julie: https://www.linkedin.com/in/julieballardcarrotclinical/Learn more about Carrot Clinical: https://www.carrotclinical.com/

In this episode, we talk with Talent Acquisition professional, Allie Patterson, about how job seekers can stand out in today’s ultra-competitive, employer-driven market. Allie shares her own journey, tips on building a strong personal brand, and the importance of networking and targeted outreach. Her advice is essential for those navigating an intense hiring landscape.Allie has a background in recruitment across multiple industries (Med-Tech, Renewables, etc.) She holds a bachelor’s degree in Human Resources Management and has honed her expertise through diverse industry roles. Allie also runs Elevate and Bloom Consulting, where she supports nonprofits with recruitment and marketing services.Key Takeaways:Are you leveraging LinkedIn to its fullest potential? You won’t believe the impact a tailored approach can have, especially when it comes to outreach and standing out in applications. Plus, we explore the power of personal branding and how storytelling can transform your connections with hiring managers. With resilience being key in a competitive market, are you ready to adapt? Tune in for actionable tips and insights to elevate your career.Allie Patterson on LinkedIn:https://www.linkedin.com/in/alliesheley/

In this jam-packed episode, Mitch Robbins sits down with Dr. Greg Critchfield, a titan in molecular diagnostics and biotech. This is a leader who’s done it all—from spearheading Myriad Genetics into global prominence to raising over $300 million for groundbreaking women’s health innovations. But that’s just scratching the surface!🔬 Why You Need to Tune In: Dr. Critchfield shares how his early passion for diagnostics was sparked by his father, a physician, who once said: “The hardest part is the diagnosis.” Since then, Greg has led pioneering efforts in genomics, transforming the landscape of molecular diagnostics and helping shape the future of personalized medicine.🌟 The Ultimate CEO Insights: What does it take to build powerhouse teams? How do you scale a company from a biotech hopeful to a market leader with 54% annual growth for 12 years? Dr. Critchfield shares priceless advice on surrounding yourself with relentless problem solvers and the importance of challenging the status quo. His Formula 1 analogy on biotech performance sums it all up.💡 Challenges and Triumphs: Taking a company public? Greg did it virtually during the pandemic and shares the inside scoop on how they pulled off a successful IPO without a single in-person meeting. Plus, hear about the toughest decisions he’s made as a CEO—when loyalty to long-serving employees meets the harsh realities of growth.🌊 Bonus: Passionate about the environment? Greg’s work with Bear Lake Watch will inspire you to think about conservation in a whole new way.This episode is a masterclass in leadership, biotech innovation, and building lasting impact—don’t miss it!🎙️ Hit play now to dive into a world where diagnosis meets data and biotech pushes the boundaries of what’s possible.

In this episode of The MedTech Talent Lab, host Mitch Robbins sits down with Mike Winterling, Chief Operating Officer at Junkosha USA. Mike shares his journey from spending nearly three decades at WL Gore & Associates to making the leap into a leadership role at a much smaller company, Junkosha.He discusses the challenges of transitioning from a well-established corporate environment to a more agile, fast-growing organization, and offers valuable insights for leaders navigating similar changes. Whether you’re scaling a team or managing cultural differences in a global company, Mike’s experience offers a blueprint for building a high-performing team in a lean environment.Tune in to hear about the importance of company culture, the impact of hiring right, and the adjustments needed when leading a small, dynamic team in today’s competitive marketplace.

How do you successfully recruit top-tier engineers in a location no one’s heard of?Summary: In this episode, Mitch Robbins dives deep with Julia Campbell, Talent Acquisition Manager at Terumo Medical Corporation, to explore the art of recruiting technical talent in the MedTech space. Julia shares her journey from falling into recruitment by chance to becoming an integral part of Terumo’s hiring strategy. They discuss the unique challenges of hiring for highly specialized roles, managing hiring manager expectations, and Julia's secrets for identifying top candidates. With over 14 years of experience, Julia offers invaluable insights into building teams that propel innovation and growth.🎧 Why You Should Listen: If you're involved with recruiting for technical roles, or you're a candidate in a technical role, this episode is packed with actionable advice. Julia’s strategic approach to building trust with hiring managers and candidates alike will leave you rethinking your own recruitment processes.

Joining us for episode #109 was Ms. Kathy Jeffery, the Chief People Officer at Element Science. Kathy comes to the show with over 20 years experience as a Senior leader overseeing People Operations, Talent Acquisition, Organizational Development. She’s had the opportunity to scale five start-ups across industries, including Pear Therapeutics in the Digital Health space. She holds her Bachelors in Human Resources from DePaul University in Chicago & her Masters in Managerial Communication from Northwestern University.For those unfamiliar with Element Science, the company is a Medical Device & Digital Health start-up that leverages data science & machine learning to develop lifesaving wearable solutions designed to deliver an outstanding experience.Some highlights:-What exactly is culture & how do you define it?-In a rapidly scaling organization, how do you balance culture while ensuring you retain core vision & values-How Kathy & Element Science are attracting sought-after Med-Tech Talent in one of the most competitive hot beds, the San Francisco Bay area-How to keep the focus on employee development as the organization continues to scale-How start-ups can support internal Diversity, Equity & Inclusion....and so much more!Kathy Jeffery on LinkedIn:https://www.linkedin.com/in/kathyjeffery/Element Science on the web:www.elementscience.com

Joining Mitch for episode #108 was Ms. Jana Melamut, the Senior Manager of Talent Acquisition at NeoGenomics Laboratories. Jana comes to the show with over 24 years of recruitment & staffing experience. She's worked in both the 3rd party agency world & of course on the corporate side of talent acquisition. Companies like Veeva Systems, Alcon, & The Medical Affairs Company have all been graced by her talents. She received her Bachelors Degree in Business Administration from The University of Florida. NeoGenomics Laboratories is a premier cancer diagnostics, pharma services & information services organization serving oncologists, pathologists, pharmaceutical companies & academic centers in their pursuit of providing better futures for people living with cancer.Some highlights from what we discussed:-The importance of, & how to, of building relationships with hiring managers-How to establish trust with them-The importance of strong intake meetings & Jana's process for conducting them-Setting up a search plan & interview expectations-Iterating on those expectations when results just aren't happening...and so much more!Jana Melamut on LinkedIn:https://www.linkedin.com/in/janamelamut/NeoGenomics Laboratories on the web:www.neogenomcs.com

Joining us for episode #107 was Mr. Jason Kroh, the Chief Technology Officer at Strados Labs.Jason comes to the show with over 25 years of experience in Med-Tech. At the front end of his career he held positions in both Product & Electrical Engineering and began to work his way into Executive leadership roles overseeing R&D, Engineering & eventually becoming a CTO. He’s worked for companies like Vero Biotech, CardioMEMS, & Cybersonics to name a few.Jason has simultaneously been a Panel Reviewer for the National Science Foundation reviewing both Phase I and II SBIR & STTR grant applications. Jason holds his Bachelors of Science in Biomedical Engineering & his Masters of Science in Electrical Engineering. Since 2018 Jason has been the CTO at Strados Labs. For those unfamiliar with the organization, Strados is home to the world’s only FDA-cleared device called the RESP Biosensor which is clinically validated to capture lung sounds including coughing, wheezing, rhonci & other adventitious breathing sounds over time without requiring episodic patient intervention. This leads to a stronger understanding of treatment response & earlier insight into exacerbations to prevent uncessary hospitalizations…especially for people suffering from chronic respiratory diseases such as COPD & Ashtma.Some highlights of what we discussed:-How Jason got into Med-Tech-The roles & responsibilities that were pivotal for propelling his career to the Executive level-Making the transition from contributor to leader-How Jason manages the stress of Executive responsibilities & balances with other aspects of life-The difference between average & top performance, especially in Engineering-The future of Cybersecurity in the Medical Device industry...and so much more!

Joining me for episode #106 was Mr. Naveen Agarwal, the Founder at Creative Analytics Solutions.If you’re in Med-Tech, & you browse LinkedIn, chances are you’ve seen some of Naveen’s content, especially centered around Risk.Naveen comes to the show with over 25 years industry experience. He’s worked for well known organizations like Kimberly-Clark as a Research Scientist and for J&J in Business Analytics & Quality Management.Over the last 7 years or so he has led Creative Analytics which is a consulting firm providing Quality Systems expertise to Medical Device organizations through it’s trademarked platform called Exceed Innovative Quality Solutions Platform across 4 broad areas (Customer Experience, Regulatory compliance, Risk Management & Quality Culture)Some of the highlights we discussed:-Biggest pitfalls when it comes to device manufacturers risk management programs-What are some low hanging fruit teams can go after when it comes to improving risk management safeguards?-Regarding the new QMSR , from a risk perspective, what will be the biggest challenges for companies when it comes to implementation ?...and so much more!Naveen Agarwal on LinkedIn:https://www.linkedin.com/in/naveenagarwal/Naveen's Substack:https://naveenagarwalphd.substack.com/aboutCreative Analytics Solutions:https://www.linkedin.com/company/exeedqm/

Mitch Robbins had the pleasure of hosting Mr. Jason Gorman, the Vice President of Regulatory, Quality & Compliance at Propeller Health for episode #105. Jason comes to us today with over 25 years of experience across the Med-Tech industry. He has a proven track record for developing & implementing Quality Management Systems, Risk Management strategies & Regulatory Compliance processes to meet the highest standards of excellence in customer satisfaction. Prior to working for Propeller Health, Jason spent over a decade working for Accuracy. For those unfamiliar with Propeller Health, now owned by Resmed, it's a precision digital health company on a mission to uplift every person living with chronic disease so they can take control of their health and live a better life. The Propeller Platform includes FDA-cleared & CE Marked medical devices, consumer apps support & coaching and secure access to clinical data for provider monitoring.Some highlights:-Jason's journey into Quality & Regulatory-The evolution of his interest & responsibilities related to privacy & security-Cybersecurity's disruption to Med-Tech in relation MDR & QMSR changes-Jason's prediction for the evolution of Reg Affairs & Quality roles with regards to Cybesecurity-The relationship between Quality Management Systems & Information Security Management Systems-Cybersecurity vs AI....what is the common thread?...and so much more!Jason Gorman on LinkedIn:https://www.linkedin.com/in/jason-c-gorman/Propeller Health on the web:www.propellerhealth.com

For this episode, I had the pleasure of hosting Ms. Jennifer Mascioli-Tudor, Founder & Principal of JMT Compliance Consulting. In this episode, we discussed:-Jennifer's transition from corporate to consulting-The challenges and rewards of consulting-The importance of community, and the need for vulnerability and connection in the industry....and so much more!TakeawaysTransitioning from corporate to consulting requires a willingness to embrace uncertainty and risk.Building a community and fostering connections is essential for success in consulting.Being vulnerable and taking risks in reaching out to others can lead to valuable connections and opportunities in the industry.About Jennifer Mascioli-Tudor:Jennifer comes to the show today with over 23 years experience in Med-Tech Regulatory & Quality. Having worked in a variety of different capacities for many organizations…. Companies like J&J, Medtronic, Boston Scientific, Outset Medical & GE Healthcare have all been graced by her talents.She’s currently an instructor at UC San Diego & simultaneously runs her consulting practice. Jennifer holds her bachelors of science degree in Physiology/Chemistry & French from Eastern Michigan University & her MBA from the University of Phoenixhttps://www.linkedin.com/in/jennifermascioli/About JMT Compliance Consulting:JMT Compliance Consulting helps organizations navigate the quality and regulatory landscape providing coaching, mentoring & foundational business support. Where appropriate the team also provides COO & CQRO leadership to support growing businesses.www.jmtcompliance.com

Mitch Robbins had the opportunity to host Mr. Garth Conrad, the VP of Quality for Flex Health Solutions. Garth shares his career journey and insights on leadership and building a strong company culture. He emphasizes the importance of relationships, curiosity, and drive in achieving success. Conrad also highlights the role of mentors and coaches in career development. He discusses the differences between individual contributor and managerial roles, as well as the qualities that separate top performers from the average. Conrad stresses the significance of aligning values, beliefs, and behaviors to create a positive company culture. He encourages professionals to gain experience in different functional areas and to actively solve problems. Near the end of the show Garth humanly shares the vision for the legacy he hopes to leave behind.TakeawaysBuild strong relationships and value the people you work withCultivate curiosity and a drive to understand the 'why' behind thingsDevelop leadership skills by managing yourself, then a small teamEstablish a network of mentors and coaches for guidance and supportFocus on making your people successful as a leaderCreate a positive company culture by aligning values, beliefs, and behaviorsGain experience in different functional areas to broaden your skillsBe proactive in solving problems and taking initiativeBuild leaders within the organization and help others succeed in their careersAbout Garth Conrad:Mr. Garth Conrad comes to The Med-Tech Talent Lab with almost 25 years of industry experience across Med-Tech. He's worked for a variety of the large strategics like Medtronic, J&J, BD, etc. Garth holds a bachelors of science degree in materials engineering, an MBA, and he is also a Lean Six Sigma Black Belt. Garth on LinkedIn:https://www.linkedin.com/in/garth-conrad-38b3835/About Flex & Flex Health Solutions:Flex Health Solutions is a division of Flex which is a $30 billion dollar organization with about 170,000 employees worldwide. The company is a global supply chain and manufacturing solutions provider.https://flex.com/resources/flex-health-solutions

In this episode, we talk with Mr. Mark Rhein, the Head of talent & Learning at Glaukos Corporation. Mark shares his experience in building a learning and development program at Glaukos, focusing on middle-level leadership development. He emphasizes the importance of prioritization and designing programs that provide the biggest value to employees. Mark also discusses the company's unique approach to performance management, which involves regular check-ins and feedback conversations. He shares insights on workforce planning and the need for flexibility in a rapidly growing organization. Overall, Mark highlights the importance of continuous learning and adapting to meet the needs of the business.TakeawaysPrioritize learning and development programs that provide the biggest value to employees.Design leadership development programs that focus on middle-level leaders, who have a direct impact on the majority of employees.Implement regular check-ins and feedback conversations as an alternative to traditional performance management.Streamline workforce planning and focus on critical roles and areas of expertise.Chapters00:00Introduction and Background01:12Building a Learning and Development Program at Glaukos Corporation05:01Focusing on Middle-Level Leadership Development07:23Designing and Implementing Leadership Development Programs09:16Expanding Learning Activities and Classes11:15Balancing Time Constraints with Learning and Development20:34Providing Feedback and Recognizing Achievements22:09Streamlining Workforce Planning32:27Lessons Learned and Advice for Building a Learning and Development Program35:27Exciting Innovations at Glaukos CorporationAbout Mark Rhein:https://www.linkedin.com/in/mark-rhein-7b3944/Mark has built a storied career over the last 25+ years building Learning & Development programs across industries. Deloitte, Sprint, Abbott, & now Glaukos are just some of the fine organizations Mark has contributed to. Mark’s expertise, which I know we are going to dig into today, lies in the areas of Organizational Development, Performance Management, Leadership Development across all levels & project Management. Mark Holds his Bachelors degree in Enviornmental Design from the University of Missouri-Columbia & his Masters Degree in Executive Leadership & Organizational Change from Northwestern University.About Glaukos:www.glaukos.comGlaukos Corporation is a ophthalmic medical technology & pharmaceutical company based out of Southern California that is focused on novel therapies for the treatment of glaucoma, corneal disorders & retinal disease.

SummaryIn this episode, Mitch Robbins interviews Alan Beckman, the Vice President of Market Access at Blue Wind Medical. They discuss Alan's background, his transition from sales to market access, and the challenges and rewards of working in market access. Alan shares his insights on interviewing and hiring, the qualities of a successful market access professional, and the changes in market dynamics post-pandemic. He also talks about managing stress and maintaining a routine, his desired legacy, and the exciting developments at Blue Wind Medical.TakeawaysMarket access is a complex and challenging field that requires a focus on patients and a willingness to navigate the intricacies of coding, coverage, and payment.Honesty and transparency are crucial in the interview process, both from the employer and the candidate.Building a strong network and seeking guidance from experienced professionals in market access can be invaluable for career growth.The gratification of helping patients and improving access to therapies is a rewarding aspect of working in market access.The post-pandemic healthcare landscape has presented new challenges for market access, including the need to partner with healthcare systems and address delayed procedures.Managing stress in market access involves maintaining a routine, focusing on family and patients, and finding ways to stay active and mindful.Success in market access requires tenacity, a patient-focused mindset, and the ability to navigate rejection and overcome obstacles.Blue Wind Medical is experiencing exciting growth and is poised to make a significant impact in the UUI space.About Alan:Alan received his Bachelors in Economics from Rutgers University & MBA from Fairleigh Dickinson University & comes to us today with almost 30 years of experience across Med-Tech & the greater LifeSciences having held positions in sales, progressive roles in sales leadership and for the last 14 years leadership roles overseeing Reimbursement, Market Access & Healthcare economics. Back in the day he worked for companies like Cephalon and Abbott Labs. More recently he was a Senior Director of Healthcare Economics & Reimbursement for LivaNova before joining BlueWind Medical in 2022 as the VP.https://www.linkedin.com/in/alan-beckman-mba-abb5986/About BlueWind Medical:Bluewind Medical, is introducing a transformative new treatment for urgent bladder leaks. The company’s product, Revi, is a miniature device implanted near the ankle that sends signals up through the nerves to the bladder to help manage symptoms. With up to 95% patient satisfaction, Revi is a long-term solution designed to help calm and control your bladder symptoms. https://bluewindmedical.com/

Joining us for this episode was Mr. Ken Mariash, the CEO at Sinaptica Therapeutics. For over 20 years Ken has been leading & growing new business ventures on both the 'Buy Side' and the 'Build Side.' He started his career in management consulting at Charles River Associates then jumped to industry at CLS, then Baxter BioScience (acquired by Takeda) and then Boston Scientific with leadership roles in marketing, strategy & corporate development. Ken holds degrees in both Biochemistry & Business Economics from Brown University.Today, Ken is leading the team at Sinaptica to advance their personalized closed-loop neuromodulation therapy for Alzheimers which has generated unprecedented Phase 2 sham-controlled clinical data that was recently published in the Oxford journal, 'Brain.' Sinaptica has FDA Breakthrough status for its novel proprietary approach which combines rTMS, EEG, and Neuronavigation with a sophisticated ML-derived personalization engine based on a novel brain target--the precuneus, the central hub of the Default Mode Network, a brain network involved in episodic memory. The company has completed all clinicals to date with non-dilutive funding and is now in-process of obtaining financing to complete the clinical product (SinaptiStim-AD) ** and prepare to initiate a pivotal study in one year's time.Some of the major highlights we discussed:-How Ken's upbringing shaped his early & future career days-Pivotal roles that were instrumental in Ken's career development to becoming a CEO-How Ken manages stress, especially during difficult times-Ken's perspective on the toughest part of being a CEO-Career advice for others coming up behind him...and so much moreKey Takeaways:Early interests and experiences can provide clues to future career paths.Pivotal roles and responsibilities can shape a career and provide valuable skills and experiences.Opportunities and the belief of others can play a significant role in career progression.Being a MedTech CEO requires managing time and maintaining focus amidst numerous demands. Maintaining focus is crucial for productivity. Techniques like taking short walks, facing the sun, and prioritizing tasks can help regenerate focus.Managing stress involves letting go of outcomes, maintaining an optimistic outlook, and imagining a future where goals are achieved.Establishing a daily routine that includes meditation, setting intentions, exercise, and prioritizing sleep can contribute to mental and physical well-being.Building a high-performance team requires individuals with an all-in mentality, personal responsibility, and a focus on winning together.Culture is a system of unspoken values that determine the behaviors that get rewarded. Leaders must actively shape and reinforce the desired culture.Leadership involves pushing others to achieve their best, providing honest feedback, and being open to personal growth.Career and life advice includes becoming excellent in your area of focus, being curious and hungry to learn about other areas, and seeking new opportunities.The future of Synaptic and their work in Alzheimer's therapy is exciting, with promising data showing the potential for significant impact.Find Ken Mariash on LinkedIn:https://www.linkedin.com/in/kenmariash/Sinaptica Therapeutics on the web:https://sinapticatx.com/Note: (SinaptiStim is a trade mark of Sinaptica Therapeutics)

In this episode, we were joined by Mr. Anthony Incontro, the Talent Acquisition Manager for Vertos Medical. We discussed the importance of creating a best-in-class candidate experience and how to streamline the application process. We also explored the challenges of collaborating with hiring managers and delivering tough feedback to candidates. Anthony shares insights into the growth and culture at Vertos Medical, a company focused on developing innovative treatments for lumbar spinal stenosis.TakeawaysTreating candidates with respect and transparency is key to creating a best-in-class candidate experience.Streamlining the application process by eliminating unnecessary steps can improve the candidate experience.Engaging candidates throughout the process and providing regular updates can help alleviate their anxiety and maintain their interest.Hiring managers should understand that hiring is a two-way street and that candidates have choices. Treating candidates with respect and valuing their time is crucial.Delivering tough feedback to candidates requires empathy and clear communication. It is important to provide constructive feedback that can help candidates improve.Company growth and culture play a significant role in attracting and retaining top talent.Chapters00:00Introduction and Background01:16Importance of Candidate Experience05:49Streamlining the Application Process06:36Engaging Candidates Throughout the Process09:32Managing the Hiring Manager's Role12:14Delivering Tough Feedback to CandidatesAnthony Incontro on LinkedIn:https://www.linkedin.com/in/aincontro/Vertos Medical on the web:vertosmed.comAbout Anthony Incontro:Anthony received his bachelor’s degree from Rutgers University in Labor Relations & Human Resources Management, and since 2005, he has been building his career in Talent Acquisition. Anthony’s had the opportunity to work across the LifeSciences ecosystem in both Pharma & Medical Device having worked for various organizations like Johnson & Johnson, Novo Nordisk, Alcon, Integra LifeSciences & Acadia Pharmaceuticals to name a few. Today, as I mentioned, he leads Talent Acquisition for Vertos Medical.

Joining us for this episode was Mr. Michael Tutera, the Vice President of Market Access at Nalu Medical. Michael came to the show today with almost 25 years of experience across the Medical Device, Biopharma & Pharma sectors. Michael got his start in the industry by way of Sales and over the years has continued to take on progressive amounts of responsibility in Sales leadership and then of course both Reimbursement & Market Access leadership. He’s worked for companies like Forest Laboratories which many of you now know it as Allergan, Mallinckrodt Pharmaceuticals, Intersect ENT which is now part of Medtronic, and of course now now, Nalu Medical.For those unfamiliar with Nalu, it has been repeatedly recognized for its revolutionary technology & innovation including being named as one of the top 100 new products in the world by R&D Magazine. The company was also the gold winner of the 2021 Medical Design Excellence Award and winner of MedTech Visionaries Award for Best MedTech Company & Best Medical Device in the field of neurology. The Nalu Neurostimulation System gives patients more options for managing intractable, chronic pain. Some of the highlights we covered:-How Mike's upbringing shaped the early beginnings of his career-Mike's take on high performance, especially in Market Access -Why some make it to the top of their pyramid & others don't-Toughest challenges in 2024 for Med-Device organizations to achieve market access -How Mike handles stress as a leader with many varying personal & professional responsiblities...and so much more!

Joining us for this episode was Mr. Anthony Watson, the Vice President of Regulatory & Quality at Windgap Medical. Tony comes to the show today with almost 30 years of experience in the greater LifeSciences industry. Prior to working on the industry side, he spent almost 20 years working for the FDA where prior to resigning, he was the Director for the Division of Anesthesiology, General Hospital, Infection Control & Dental Services. If you can’t tell already, Tony has a tremendous breadth of experience working for companies like  Sanofi, Biogen, Pear Therapeutics and of course now Windgap Medical. He has been at the forefront of the development of FDA emerging technology global regulatory schemes affecting the evolution of regulated combination products, SaMD products & human factors and he is an expert when it comes to building new Regulatory teams, defining problems & finding optimal solutions. He holds his BS in Engineering from the United States Naval Academy & both his Masters in Management Information Systems & MBA from the University of Maryland.Some of the highlights we discussed:-How his formative years shaped his career trajectory-His transition from FDA to the industry side of the business-His take on leadership & lessons learned from his Military experience-What separates top performers from the average in RA and/or QA-Advice for those aspiring to lead the entire RA and/or QA functions..and so much more!Find Tony on LinkedIn:https://www.linkedin.com/in/anthony-w-77abaa3/Learn more about Windgap Medical:https://windgapmedical.com/

Joining us for this episode was Mr. Philip MacDonald, a Market Access Executive who has helped 100s of thousands gained access to proper care. He's worked for strategics like Medtronic, Abbott & Siemens. He's also worked for start-ups like Vertos Medical. He holds a Doctorate in Health Economics & a Masters in Healthcare Administration.Some of the highlights we discussed:-What separates top performers from the average in market access-Primary challenges manufacturers & sponsors face in 2024 to gaining market access for medical devices-A look back on what he would do differently if he could go back in time-Advice for those aspiring to lead the Market Access function..and so much more!Philip on LinkedIn:https://www.linkedin.com/in/philipmacdonald/

SummaryIn this episode, Mitch Robbins interviews Melanie Leibovitz, a regulatory and quality executive with over 25 years of experience in the medical device and digital health sectors. Melanie shares her journey from growing up in New Jersey to falling into the regulatory and quality field. She emphasizes the importance of soft skills for executive roles and offers advice on developing these skills. Melanie also discusses the role of AI in regulatory and quality and encourages professionals in the field to adapt and learn new skills. She concludes by sharing her hope of leaving a legacy in the industry.TakeawaysSoft skills, such as communication and problem-solving, are crucial for regulatory and quality professionals to excel in executive roles.Building a strong network and finding mentors who can provide guidance and support is essential for career growth.AI has the potential to enhance regulatory intelligence and make the work of regulatory professionals more efficient.Regulatory and quality professionals should embrace challenges and persevere in order to make a difference in the industry.Tune in for this and so much more!