The MedTech Podcast shares the journey behind the path of the people shaping the MedTech industry and its future. Join me as I connect with industry leaders, th...
#74 Navigating Regulatory Affairs with Kristen Mittal: Global Challenges, Breakthrough Devices and Career Insights
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
Subscribe to the Podcast
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30:30
#73 Nursing Innovation and Pandemic Lessons with Dr. Morgan Taylor: Burnout Solutions, AI in Training, and Adolescent Mental Health Challenges
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
Subscribe to the Podcast
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Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support
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29:50
#72 Colorectal Cancer and Raising Capital with Sam Libby: Delayed Treatments, The 60 Million Annually Undiagnosed and Healthcare Disparities for Aging Women
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
Subscribe to the Podcast
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Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support
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35:02
#71 Trauma Care and Vascular Surgery with Dr Adam Power: Preventive Medicine, Innovations in Haemorrhage Control and The Future of Emergency Medical Devices
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
Subscribe to the Podcast
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Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support
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30:07
#70 Preconception Wellness and Enhancing Fertility with Alexandria DeVito: Pregnancy Planning, Misconceptions around Fertility and Differences Between Physical and Biological Age
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
Subscribe to the Podcast
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Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support
The MedTech Podcast shares the journey behind the path of the people shaping the MedTech industry and its future. Join me as I connect with industry leaders, thought providers and innovators.
Hosted by Karandeep Singh Badwal, Karandeep is a Quality & Regulatory Consultant specialising in the MedTech Industry. If you have any ideas for future episodes or would like to be on the podcast then feel free to connect with me via the links below
Follow Karandeep on LinkedIn: https://www.linkedin.com/in/karandeepbadwal/
Follow Karandeep on YouTube: https://www.youtube.com/c/KarandeepBadwal/ Support this podcast: https://podcasters.spotify.com/pod/show/themedtechpodcast/support