TrainSmart: The Medical Device Educators’ Podcast

This week, Liz and Rachel discuss the interview with Marnie Hamp and the importance of staying relevant post-launch. In their conversation, they focus on the need for training, marketing, and sales to all have ears in the field and strong collaboration among departments so that the needs of the reps and the customers can be met. In addition, they discuss the need to cross-train clinical reps and sales reps while maintaining clear roles and responsibilities.In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Marnie Hamp InterviewSubscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

When is it time to move from a training consultant to a full time hire? In this episode, Liz sits down with Heather Ramsey, Director of Client Learning and Development for OneDigital, to discuss just that. In their conversation, they explore when to hire, who to hire, and how to align that hire with the business strategy. Along the way, they define what makes a good trainer and some of the common mistakes they see in hiring for an in-house role. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Heather Ramsey is the Director of Client Learning and Development for OneDigital Company. She oversees the OneDigital Leadership Coaching Services, Client Learning Development and Strategic Offsite Facilitators.She believes that empowered, engaged leaders and employees will help the organization reach its business objectives faster. She enjoys partnering with client leaders to build a learning and development culture with the client to support their business, increase retention and drive higher employee engagement. She and her team are seasoned professionals in the areas of training and development, leadership coaching, and facilitating leadership and company retreats.With over 20 years of learning and development experience, Heather uses innovative techniques to deepen each learning development program designed, or training class delivered. Virtually or in-person, she is a high-energy facilitator who captures her audiences immediately and keeps them engaged and on target throughout the training or facilitation.As a leadership and team building facilitator, she is an expert with working through difficult situations with ease and grace. As an Executive-level coach she connects with her clients and helps them to find new ways of working to help them be most successful. She infuses these same principles in her team as they work with clients.Heather is a subject matter expert and certified Predictive Index Partner. She is an avid learner and reader of business and leadership books, articles, and seminars. She holds a bachelor’s degree from U.C. Davis in Managerial Economics, and a master’s degree from Cornell University in Executive Human Resource Management.Here is a link to her website: https://launch.onedigital.com/learning-and-developmentSubscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn: ⁠⁠⁠⁠⁠⁠⁠⁠⁠Heather Ramsey⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠About Cumby Consulting:Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

Our guest this month is Marnie Hamp, a seasoned marketing executive who gets the importance of partnering closely with the training team, not only at launch, but in post-launch as well. She and Liz discuss best practices for continuing momentum, including knowing your targets, developing strong partnerships between clinical reps and sales reps, and listening in to what is actually happening in the field. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Marnie is an experienced Sonographer and dynamic leader with over two decades of experience in healthcare and medical device sales across three countries, specializing in ultrasound product development and market strategy. She has successfully led go-to-market teams delivering innovative solutions while training sales and clinical professionals to optimize product adoption and maximize impact. Her expertise bridges technology and patient care, ensuring medical advancements translate into meaningful outcomes. Beyond her professional expertise, Marnie is a passionate traveler who finds joy in exploring the world and sharing experiences with family and friends, whether at home or on the road. From immersing herself in different cultures to savoring local flavors, she embraces discovery with curiosity and adaptability, always seeking meaningful connections and enriching adventures.Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn: ⁠⁠⁠⁠⁠⁠⁠⁠⁠Marnie Hamp⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠About Cumby Consulting:Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

This week Liz and Rachel break down the interview with Tony Recupero as they discuss commercial training and the meeting of technical and selling skills. They reflect on the power of informal mentors, the need for good questions, and how to reinforce marketing messages within clinical training. They end their conversation reflecting on how they've changed their minds over the course of their careers.In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Tony Recupero InterviewSubscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

In this episode, Liz and Rachel dive into the interview with Sarah Keenan about commercial training. They discuss their thoughts on a competency model, how and why to certify (or not), and the benefits of developing a learning culture. The episode ends with a reflection how training starts with trust: without it, your training just won't be effective. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your commercial training? Contact us at training@cumbyconsulting.com.Related Resources:Sarah Keenan InterviewSubscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

This week Liz is joined by Sarah Keenan, VP of Commercial Excellence, to discuss the importance of building physician and rep competency for commercial success. In their conversation they dive into how to create a learning funnel, assess competency, and partner with hospitals to track training. Listen in for how to create a culture of learning at your organization. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Sarah Keenan is a senior commercial executive with over 18 years of experience driving growth, optimizing resources, and building high-performing teams within the medtech space. She specializes in scaling commercial organizations—from early-stage startups to mid-sized multinational companies—by aligning strategy, infrastructure, and talent for sustainable success.Sarah currently serves as Vice President of Commercial Excellence at Route 92, a company pioneering revolutionary procedural advancements to address unmet needs in neurovascular care. In this role, she leads initiatives that equip the commercial team with the tools, insights, and structure needed to thrive in a dynamic and evolving market.Prior to Route 92, Sarah was Vice President of Operations at Magnus Medical, where she established core operational functions to support the launch of the SAINT neuromodulation system for treating major depressive disorder—including manufacturing, installation, and HCP training.Before that, she was Vice President of Commercial Enablement at iRhythm Technologies, where she built the enablement function from the ground up. Her efforts were instrumental in equipping U.S. and international commercial teams with the knowledge and resources needed to scale the organization from a startup into a mid-sized leader in the cardiac monitoring space.Earlier in her career, Sarah held roles at CardioDx, where she launched Corus CAD and scaled sales training capabilities; as well as commercial and sales positions at ThermoFisher Scientific (Phadia AB), Merz Pharmaceuticals, Schering-Plough, and Altria Group.She holds a Bachelor of Science in Business Administration from the University of Illinois Gies College of Business.Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn: ⁠⁠⁠⁠⁠⁠⁠⁠⁠Sarah Keenan⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

In this episode, Liz and Rachel discuss Liz's interview with Sandy Waugh Ruggles on the importance of developing a go-to market strategy with specific physician targets. They share best practices for getting specific on who to target first, and how that information impacts the training process. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Sandy's interviewSubscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe!Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

Are you ready to launch? This week, Liz is joined by Sandy Waugh Ruggles to discuss go-to market strategy. In their conversation, they discuss the importance of identifying targets early and training commercial reps on those targets so that they can best sell the product. Sandy shares why she recommends utilizing psychographic descriptors for targeting and the importance of gaining alignment on these targets prior to launch.In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Sandra is the President of Summit Rock Strategy Consulting, where she specializes in leading medtech development teams through strategic decisions, assessing opportunities, defining product and portfolio plans, and preparing for commercial launch. She also serves as director for policy research in the Stanford Biodesign Policy Program. Sandra is both an inventor and an innovator. She holds over 20 patents in various domains, from consumer medical devices to therapeutic proteins, and has led multiple US product launches. Sandra co-founded Catalyst Biosciences and was named a Top Innovator Under 35 by MIT Technology Review. Sandra earned a PhD from the University of California, San Francisco in biophysics and was a Stanford Biodesign Innovation Fellow.Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe!Connect with us on LinkedIn: ⁠⁠⁠⁠⁠⁠⁠⁠⁠Sandy Waugh RugglesCumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting: Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

This week Liz and Rachel dive into the interview with Liana Mari-Gordon on building best practices during the clinical trial. They share what stood out to them and how they've seen Liana's comments play out at other organizations.In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Liana's interviewSubscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe!Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

In this episode, Liz Cumby is joined by Liana Mari-Gordon, an expert in mechanical engineering and surgical training, to discuss best practices throughout the clinical trial phase of medical devices. Liana shares her experiences of learning how what "looks good on paper" may need to be updated when the device is in the hands of a physician. They delve into the importance of standardizing training, capturing and sharing field data, and maintaining honest conversations about challenges and successes. The episode also highlights methods to implement continuous improvements and ensure best practices are disseminated across users.In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Liana Mari-Gordon is the owner of Liana Mari Gordon Consulting LLC, providing project management, training operations, and device development services to help set teams up for successful execution of training programs. She has spent her career in the medical device and pharmaceutical industries ranging from small startups to Fortune 500 companies. As a mechanical engineer designing spinal implants and surgical instruments at Globus Medical, her experience conducting hands-on training, supporting surgical cases, and evaluating product complaints from the field formed her passion for informed use of product and positive user experience. She joined Orbit Biomedical, an ophthalmic medical device startup, and became a surgical technical expert responsible for clinical trial device and procedure training. Liana’s responsibilities expanded to managing the logistics and execution of training programs and surgery support for a global team and multiple clinical trials as the startup merged with Gyroscope Therapeutics. As training operations lead, Liana led communication between cross functional teams to ensure readiness of and consistency across internal team members and trial sites. When acquired by Novartis, Liana was a key member in integrating existing practices within the larger organization and facilitating process improvements when needed. Liana earned a BS and MEng in mechanical engineering from Cornell University.Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe!Connect with us on LinkedIn: ⁠⁠⁠⁠⁠⁠⁠⁠⁠Liana Mari-Gordon⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting: Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

This week, Rachel and Liz discuss Liz's conversation with Nada Hanafi on the FDA approval pathway and how training can be used to mitigate risk. They share what they learned from Nada about the process and their insights for developing curriculum that has high standards to ensure patient safety. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Nada's interview Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe!Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

Liz is joined by Nada Hanafi to talk all things clinical trials. They start by defining the clinical trial pathways and all the acronyms used. Then, they discuss how training can be used as a mitigation measure for avoiding risk, exploring the benefits and drawbacks for this approach and how the strategy can be modified along the process. Learn more about the process and how the answer is often "it depends."In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Related Resources:Nada Hanafi is a thought leader within the Life Sciences and MedTech industry with over 22 years of experience across the public and private sectors. She is a Founder of MedTech Strategy Advisors, LLC where she advises life science companies on regulatory strategy, product development, and clinical research to accomplish regulatory, compliance, and business goals.Nada spent over 12.5 years working for the FDA, serving in increasing roles of responsibility and ultimately as a Senior Science Health Advisor in the Center for Devices and Radiological Health (CDRH), where she led cross - Center and Agency programs for the advancement of FDA's mission to promote and protect public health, including as Co-Founder of the Health of Women (HoW) program, the Network of Experts program and the Patient Preference Initiative. She served as CDRH Liaison and Subject Matter Expert to FDs’s Office of Women’s Health (OWH) and the Office of Minority Health and Health Equity (OMHHE). She collaborated with the Center for Tobacco (CTP) and the National Institutes of Health (NIH) where she served as Senior Management Advisor to the Director at the Office of Research on Women’s Health (ORWH), to improve regulatory efficiency and to strengthen data collection. Nada’s drive and passion to address health inequities with a focus on women and minorities led her to Co-Found MedTech Color, a non-profit focused on advancing the representation of people of color within MedTech. Nada also serves on the Steering Committee and as Co-Lead on the Regulatory and Science Policy subcommittee for the Innovation Equity Forum (IEF) led by the NIH’s ORWH and the Bill and Melinda Gates Foundation.Nada holds an MSc in Biomaterials and a BEng in Biomedical Materials Science & Engineering from Queen Mary College, University of London. She earned her MPH from Johns Hopkins Bloomberg School of Public Health. Nada is a Certified Quality Improvement Associate (CQIA) and a Certified Quality Auditor (CQA) from the American Society for Quality (ASQ).Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe!Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠Nada Hanafi⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

Liz and Rachel dive into Liz's interview this week as they discuss competency exams for clinical support reps. As they do so, they share their insights into how creating assessments first can drive curriculum development and contribute toward a successful trial.In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Listen to the interview with Varun here. Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe!Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

Liz is joined by Dr. Varun Malhotra on the podcast this month to discuss clinical competency exams for clinical support reps. As both a practicing physician and an industry leader, he shares invaluable perspective on both how a rep should act in the OR and how companies should prepare reps to do so. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Related Resources:Dr. Varun Malhotra is an ophthalmologist with specialized training in glaucoma who has successfully bridged the worlds of clinical practice and biotechnology innovation.Dr. Malhotra completed his undergraduate education at Dartmouth College before earning his medical degree from New York University School of Medicine. He continued at NYU for his ophthalmology residency, gaining comprehensive training in diagnosing and treating various eye conditions. His education was further enhanced with a specialized fellowship in glaucoma at the prestigious Illinois Eye and Ear Infirmary, where he developed expertise in managing this complex eye disease.With additional credentials including an MBA from the University of Chicago Booth School of Business, Dr. Malhotra cultivated a multifaceted career spanning both academic and private practice settings before making a strategic transition to the biotechnology sector with a role at Genentech, where he was the clinical lead for the Port Delivery System Diabetic Macular Edema program. He also served as the global surgical lead for the entire Port Delivery System, where he oversaw the expansion and surgical training for all internal and external stakeholders of ophthalmic clinical trials from the United States to encompass countries in Europe, South America, and Asia.Dr. Malhotra is currently the Vice President of Clinical Development for Ollin Bioscience, an ophthalmic biotech company. He still practices ophthalmology and trains resident physicians in clinical and surgical skills on a weekly basis. Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe!Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Varun MalhotraCumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality."

This week, Rachel and Liz discuss their key thoughts and learnings from Liz's interview with Shienal Patel. They dive into how learning about the procedure in the clinical trial phase can impact the trial itself and the product for years to come. They also discuss the need for a strong clinical trial training strategy, especially as the FDA is requiring different investigators for different phases of the trial, and turn their conversation toward the use of video recordings in clinical trials and the many ways your training strategy can incorporate them.In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us attraining@cumbyconsulting.com.Related Resources:Listen to the interview with Shienal here.Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care!Click here to subscribe!Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

Shienal Patel joins Liz in this episode to discuss how having strong investigator and clinical rep training strategies can impact the success of your product in the trial and into commercialization. In their discussion they explore why it's important to invest in training during the clinical trial, considerations for the level of training that needs to be offered, and the possible consequences for not providing great training. Shienal shares her own experiences and the key learnings she has had over her career. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Related Resources:Shienal Patel is a highly accomplished clinical affairs leader with over two decades of experience in the medical device and pharmaceutical industries, specializing in ophthalmology. Currently serving as Vice President and Head of Clinical Affairs at Myra Vision, she oversees the development of the Calibreye TGT System for glaucoma treatment. Previously, at Genentech, as Senior Clinical Scientist and Operations Program Leader, Shienal was instrumental in advancing the Port Delivery System (PDS) for Susvimo and other pipeline programs in ophthalmology. Her leadership spanned from clinical trial design and execution to regulatory strategy, including critical collaborations with cross-functional teams and regulatory bodies. Shienal has also contributed significantly to early-stage device development at NESOS, focusing on vagus nerve stimulation therapies, and led global clinical operations for pivotal ophthalmology and respiratory programs at Genentech. Her efforts have earned her multiple Roche Product Development Breakthrough Awards and industry recognition for innovation and excellence. Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! ⁠Click here to subscribe!Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠Shienal Patel⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

In this episode, Liz and Rachel discuss Liz's conversation with Kelly Carty about developing procedural consistency during the clinical trials. They'll share the best practices they've learned for training with the Instructions for Use (IFU) and procedure guide and share their own opinions about FDA-mandated training. Tune in and learn why this procedural consistency is the base of the mountain and an important stop on the journey. Related Resources: Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠ About Cumby Consulting:    Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality."

Liz kicks off this year's Medical Device Training Journey by interviewing Kelly Carty, who advises medical device companies on regulatory strategy throughout the product lifecycle. During their conversation, they dive deep into the clinical trials process, from how to develop the IFU to implementing best practices into a procedure, and how mandatory training can be a mitigation measure in the risk management process. Join Kelly and Liz as they discuss how a strong regulatary strategy can ensure companies have the best data, documents, and procedural steps to support their products. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle. Related Resources: Kelly Carty is a Co-founder of MedTech Strategy Advisors, LLC, a consulting company that advises medical device companies on regulatory strategy development and execution throughout the product lifecycle. Kelly spent 22 years working in the medical devices industry at companies ranging from small startups to large, well-established companies with a wide variety of devices and complex issues. She held positions of increasing responsibility, ultimately ending as the Head of Regulatory Strategy – Body Aesthetics for Allergan Aesthetics, an Abbvie Company. Following her time in industry, Kelly moved into consulting at Veranex, Inc. where she worked closely with her Co-Founder, Nada Hanafi. Together, Kelly and Nada routinely interface with FDA for their clients on novel product designs, pending submissions, and postmarket issues. Connect with us on LinkedIn:    ⁠⁠⁠⁠⁠⁠⁠⁠⁠Kelly Carty ⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠ About Cumby Consulting:    Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

In this episode, Liz and Rachel discuss how their predictions played out over the course of the year and share what they expect to see as trends in 2025. Get inspired for the year ahead as you think about what we could see in 2025! Related Resources: We'd love to partner with you! Email training@cumbyconsulting.com. Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠ About Cumby Consulting:    Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

In this episode, Liz interviews Holly Scott about organizational effectiveness. In their conversation they discuss how to get "the path of least resistance to get to certain goals." Holly shares the importance of ensuring there are both healthy companies and healthy careers and how the med tech industry can do just that. Related Resources: Holly is Vice President and a Senior Partner at The Mullings Group, and has been a part of the firm for 25+ years. She believes the most productive and fulfilling organizations are built on the complementary forces that make up a team. Her bidirectional approach to each search allows her to put the best interest of both the individual and the company at the center of her team’s work. She is passionate about the medical device industry, which works to elevate health and healthcare, the individual careers we help build, and the team at TMG. These individuals keep Holly committed to being better every day. Continuously giving back to the industry, Holly is a member, guest speaker, and advocate for MassMEDIC’s Women in Medtech organization. She also hosts two podcasts, The Power Curve, and Tech Talks with Holly Scott. Holly is a graduate of the University of Florida with a psychology major and a business minor. She has also been awarded Certified Senior Account Manager (CSAM) by MRINetwork, an international network of recruiting firms. Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠ Holly Scott ⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠⁠⁠⁠⁠ About Cumby Consulting:    Cumby Consulting’s team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.