Katie Cooney, founder of Leap Compliance an expert in quality culture, training and compliance. With extensive experience in MedTech, including roles at Boston Scientific and leading training initiatives globally, Katie is on a mission to ensure that quality is woven into every aspect of organizational culture

In this episode, Katie discusses her journey into MedTech and how she transitioned to entrepreneurship with Leap Compliance. We delve into effective training strategies, the importance of leadership in fostering a quality-first mindset and real-world examples of what happens when quality is neglected. Katie also provides actionable advice on building and maintaining a robust quality culture that stands the test of time

Timestamps:

[00:00:27] The Role of Leadership in Quality Culture

[00:02:30] Creating a Mock Production Environment for Training

[00:05:22] Building Psychological Safety in Teams

[00:07:33] Reducing Over-Assignment in Training Curriculums

[00:12:09] Enhancing Training with Contextual E-Learning

[00:15:33] The Impact of Neglecting Quality: Case Studies

[00:18:10] From Retail to MedTech: Katie’s Journey

Get in touch with Katie Cooney - https://www.linkedin.com/in/katie-cooney-08ab7061/

https://www.leapcompliance.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Axel Strombergsson, Vice President, QuickVault at Veeva Systems a seasoned leader in medical device development and commercialization. With over 18 years of experience in R&D, operations and startup growth, Axel has a proven track record in navigating the complexities of regulatory pathways, venture capital, and global market strategies

In this episode, Axel shares his journey from mechanical engineering to becoming a driving force in medtech innovation. We discuss AI-powered diagnostic tools, the importance of proactive healthcare models, and the evolving role of startups in advancing medical technologies. Axel offers valuable advice on preparing for funding rounds, building impactful pitch decks, and addressing key investor concerns

Timestamps:

[00:00:24] MedTech Innovation Trends

[00:04:02] From Engineering to MedTech

[00:08:21] Proactive Healthcare Models

[00:10:30] Building Investor Confidence

[00:14:09] Navigating Global Markets

[00:21:49] The Role of Venture Capital

[00:25:33] Startup Growth Challenges

Get in touch with Axel Strombergsson - https://www.linkedin.com/in/axel-strombergsson/

https://www.veeva.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Kristen Mittal, Founder & CEO of Mittal Consulting a seasoned expert in regulatory affairs with over a decade of experience in the field. Kristen’s expertise spans across global regulatory challenges, innovative pathways and mentorship in quality and regulatory careers

In this episode, we dive into why regulatory affairs is a rewarding yet complex career path, explore innovative programs like the FDA’s Breakthrough Device Designation and Total Product Lifecycle Advisory Program, and discuss the importance of harmonizing global standards in medical device submissions. Kristen also shares insights into the evolving landscape of sectors like pediatric devices, FemTech and AI/ML in medical technology

Timestamps:

[00:00:20] Rewards of a Regulatory Career

[00:01:53] Key Qualifications for Regulatory Success

[00:08:21] EU vs. USA Regulatory Pathways

[00:10:30] Understanding Pre-Submission and 513G Processes

[00:14:09] Designing Clinical Studies for Global Approval

[00:21:49] Emerging Trends: Pediatric Devices and FemTech

[00:25:33] Breakthrough Devices and Total Product Lifecycle Advisory Program

Get in touch with Kristen Mittal - https://www.linkedin.com/in/kristenmittal/

https://www.mittalconsulting.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Dr. Morgan Taylor, Chief Nursing Officer of Archer Review has redefined nursing education with her innovative teaching methods and empathy-driven approach, fostering confidence and competence among the next generation of nurses.

In this episode, we explore the gaps in nursing education exposed during the pandemic and how Dr. Taylor is addressing these challenges through groundbreaking solutions like virtual reality and AI-enhanced training. We discuss her global health experiences in Guatemala, her passion for pediatric care and how she leverages technology to bridge educational gaps. She also shares her insights on telehealth, the adolescent mental health crises during the pandemic and the shift toward proactive value-based care models

Timestamps:

[00:00:27] Gaps in Nursing Education During the Pandemic

[00:02:30] Global Challenges in Practical Nursing Training

[00:05:35] AI as a Tool in Nursing: Opportunities and Risks

[00:06:36] Unique Challenges in Paediatric Care

[00:08:55] Telehealth’s Role in Enhancing Accessibility

[00:13:13] Moving Toward Proactive, Value-Based Healthcare

[00:15:38] Burnout and New Career Paths for Nurses

Get in touch with Morgan Taylor- https://www.linkedin.com/in/morgan-clark-taylor/ https://www.archerreview.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

Sam Libby President and Managing Director of TCB Capital Advisors is one of healthcare’s most impactful leaders, with a career devoted to revolutionising patient care through strategic investments, Sam has navigated over $20 billion in transactions across the life sciences and diagnostics sectors

In this episode, we delve into how healthcare companies raise capital alongside the traits he seeks in potential partners, how he went from investment banking to more of a focus on the medical sector, his introduction to the disparity within female health and his early career within martial arts

Timestamps:

[00:00:15] First exposure to colorectal cancer

[00:05:23] Importance of early detection and diagnosis

[00:09:47] Challenges in colorectal cancer treatment

[00:14:02] Working with EDP Biotech and its mission

[00:19:18] Innovations in cancer screening technology

[00:24:35] The role of data in advancing cancer diagnostics

[00:30:12] Future trends and goals in cancer research

Get in touch with Sam Libby - https://www.linkedin.com/in/shmuel-libby-b4530b48/

https://www.tcbcapitaladvisors.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

Dr Adam Power Co-Founder and CMO of Front Line Medical Technologies is a leader in innovative medical devices for trauma and emergency care who is committed to lowering the barriers to bleeding control and resuscitation, having previously worked as a vascular surgeon he quickly realised that there needed to be a better way for haemorrhage control so went on to co-found Front Line Medical Technologies in 2017.

In this episode, we delve into the fascinating world of trauma care and the groundbreaking innovations in haemorrhage control, Dr. Powers journey from general surgery to vascular surgery, the importance of preventive medicine alongside the role of new technologies in healthcare and the effect of the pandemic on global healthcare systems.

Timestamps:

[00:02:38] Quick haemorrhage control techniques.

[00:07:00] Gearing up for European CE Mark

[00:09:30] From Physician to entrepreneur in med tech.

[00:12:51] Shortage of physicians, focus on prevention.

[00:15:39] Impact of pandemic on healthcare

[00:18:49] Uses for telehealth

[00:22:21] Barriers in telehealth

Get in touch with Dr Adam Power - https://www.linkedin.com/in/adamhpower/ https://frontlinemedtech.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Alexandria DeVito Founder and CEO of Poplin is a functional nutritionist who specialises in fertility and preconception health, prior to founding Poplin, she worked as a management consultant in the finance industry before making the jump into healthcare

In this episode, we delve into the single most important thing someone can do to enhance fertility and increase their likelihood of having healthy children, the meaning of the term Preconception expert alongside what their roles are, the process of writing a book from start to finish and the common misconception of fertility rapidly declining in women after the age of 35.

Timestamps:

[00:03:15] Biological Markers for Pregnancy Success

[00:06:28] Optimizing health before conception for fertility

[00:13:10] Proactive approach in preconception

[00:15:39] Impacts of Chronic Stress on fertility and pregnancy

[00:20:34] Process of Book writing

[00:22:59] Writing a Book Vs Entrepreneurship

[00:25:47] Importance of Continuous Learning

Get in touch with Alexandria DeVito - https://www.linkedin.com/in/alexandria-devito-3381553/ https://getpoplin.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

Bob Roda President and CEO of Hemosonics, the creators of the Quantra Hemostasis Analyzer, a diagnostic platform that provides a comprehensive blood analysis detailing hemostasis in the operating room in less than 15 minutes. Bob joined HemoSonics in February 2020 as the company’s President and CEO, bringing more than 25 years of global experience developing and commercializing innovative diagnostic and medical device products and services

In this episode, we explore his transition from economics to medtech, highlighting the urgent global need for blood donations and the causes behind the current blood shortages. We also examine the significant effects of COVID-19 on blood supply, the biological process of bleeding and its implications for military trauma care.

Timestamps:

[00:02:34] Blood crisis due to COVID, global issue.

[00:05:23] Blood product technology helps save lives.

[00:08:22] Technology for acute bleeding management, military applications.

[00:14:38] Body's response to injury and bleeding.

[00:21:35] Vetinary Applications

[00:24:58] Responsibility of leadership: be present, humble.

[00:27:56] Passion for healthcare can change lives.

Get in touch with Bob Roda - https://www.linkedin.com/in/bob-roda-8175b24/ https://hemosonics.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Eva van Rikxoort Founder and CEO of Thirona started her career as a scientist but transitioned as she wanted to create a business model to make AI centered around how to help a patient. She believes that AI is necessary in healthcare, unlike pharma, where she views AI as an option.

In this episode, we delve into the traditional methods of medical imaging and the benefits of using AI for better detection, why AI is proving to be popular in the radiology space, lesser-known causes for lung disease and her journey into entrepreneurship

Timestamps:

[00:02:41] AI in Medicine

[00:10:41] Lung cancer causes and advancements in AI

[00:13:43] Regulating AI in Medical Devices

[00:16:30] Early Detection for Rare Diseases

[00:19:34] Gathering Data and Clinical Trials

[00:21:39] CT screening for lung cancer, emphysema detection.

[00:25:15] Bootstrapping a Start-Up

Get in touch with Eva van Rikxoort - https://www.linkedin.com/in/evavanrikxoort/ https://thirona.eu/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

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Christian Espinosa Founder and CEO of Blue Goat Cyber is a leading medical device cybersecurity expert, who started his career within the United States Air Force as a Computer Systems Officer and is now a serial entrepreneur, best-selling author, avid adventurer and Ironman triathlete.

In this episode, we delve into the vital necessity of safeguarding medical devices to avert potential harm or fatalities stemming from hacking. We cover the significance of initially designing devices with security in mind and advocating for ongoing monitoring throughout their lifespan. Furthermore, Christian offers valuable insights for companies on effectively integrating cybersecurity from the outset of development.

Timestamps:

[00:03:27] Securing wireless connections

[00:06:57] Threat modelling methods

[00:13:43] The need for continuous testing for medical device security

[00:19:47] How military discipline helped build a successful business.

[00:26:08] The importance of delegation

[00:28:47] Focusing on mono-tasking for productivity

Get in touch with Christian Espinosa - https://www.linkedin.com/in/christianespinosa/ https://bluegoatcyber.com/

Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal

Subscribe to the Podcast