I migliori DeGrazio podcast (2024)

1
Mastering Thoughtful Gifting and Business Growth with Annabelle DeGrazio of TAJA Collection 45:46

3d ago45:46

45:46

In this episode, we chat with Annabelle DeGrazio, the founder of TAJA Collection. Annabelle takes us through her wild journey from lawyer to launching her own customizable, non-toxic candle and home accessory biz. We talk all about the importance of finding happiness in what you do, thoughtful gifting, and why creating a positive company culture is…

1
153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio 21:56

17d ago21:56

21:56

On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran explores the transition from USP 381 to 382, focusing on stoppers and elastomeric closures. Fran explains the importance of evaluating packaging components as a system…

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155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach 25:25

3d ago25:25

25:25

On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC. In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing on combination product inspections and the 7356.000 Inspections of CDER-led or CDRH-led Combination Products compliance program. Laurie…

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Boost Your Brand Visibility: Public Relations Made Easy with Tools to Get Noticed 45:39

10d ago45:39

45:39

In this episode of the Her First Podcast, we’re diving headfirst into the wild world of public relations (PR) and why it’s a big deal for your brand and business. PR isn’t just a fancy buzzword—it’s all about managing how the world sees you (and no, we’re not talking about Instagram filters). We break down the basics of PR, showing you how to build…

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154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell 37:31

10d ago37:31

37:31

On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs, and the design, verification, and validation processes involved. Devin shares his extensive experience in both big pharma en…

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Scaling Your Agency: Joanna Newton’s Journey from Freelancer to Six-Figure Success 42:14

17d ago42:14

42:14

In this episode we're turning co-host Joanna Newton into our special guest as she spills the tea on how she grew Millennial Marketer from solo freelancing to a thriving multi-six-figure agency. She gets real about the power of client feedback, keeping a steady stream of clients, and why personal branding on platforms like Upwork and Kajabi is non-n…

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152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh 40:48

24d ago40:48

40:48

This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru(Episode #380). In this episode, Etienne and I discuss: 02:50 The Start of the Combinate Podcast 06:00 Efficiency and Tools in Podcast Production 08:40 Understanding Combination Products 09:43 Regulatory Frameworks and…

1
How to Build Trust and Scale Your Business Through Effective Communication 53:15

24d ago53:15

53:15

In this episode of Her First, we’re diving into the oh-so-crucial world of client communication. You’ll learn why talking to your clients the right way can be the difference between “I’m loving this!” and “I’m never coming back.” We’re sharing our best tips for setting expectations, nailing the onboarding process, and managing feedback like a pro. …

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151 - Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio 33:38

1M ago33:38

33:38

On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran discusses: 00:00 Introduction 02:29 Understanding the FDA's New Guidance: 05:05 Challenges in Supplier Management and the 08:22 Navigating Change Management 11:43 Insi…

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Reclaim Your Power: How to Overcome Business Plateaus and Stay Consistent 46:39

1M ago46:39

46:39

Let’s chat about reclaiming your personal power. Not sure what that means? Well, not having a strong sense of personal power shows up in your life with: inconsistency, nervousness to pitch yourself, not wanting to “bother” other people, taking unnecessary meetings, failing to “show up” in your content, lacking authenticity, feeling constantly distr…

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150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar 38:58

1M ago38:58

38:58

On this episode, I was joined by Maysaa Attar, Senior Vice President of R&D at Bausch + Lomb. On this episode, Maysaa discusses:00:00 Welcome to Episode 150!03:00 Challenges and Innovations in Ocular Drug Delivery09:30 Understanding Intravitreal Injections13:26 Regulatory Considerations for Ocular Products20:48 Innovations in Glaucoma Treatment29:1…

1
Start a Podcast with This Tech Stack & Essential Podcasting Tools 23:48

1M ago23:48

23:48

Want to start a podcast? Or improve your production quality? We share the tech stack and standard operating procedures (SOP) we use to produce this podcast efficiently and consistently. You need the right tools and processes in place to manage tasks effectively, particularly when collaborating remotely. We highlight tools for receiving guest inform…

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149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens 33:11

2M ago33:11

33:11

On this episode, I was joined by David Simeons, Founder of Life Science Professionals and an expert in Lyophilization/Freeze-Drying. On this episode David discusses:01:01 Recap of the Last Episode01:23 Understanding the Freeze Drying Environment01:46 Freeze Drying Equipment and Processes03:01 Cleaning and Validation in Freeze Drying03:58 Loading an…

1
Why a Woman Can’t Be President: Breaking Gender Barriers in Leadership 49:25

2M ago49:25

49:25

A little different than our typical episode - we’re chatting today about the challenges faced by women in leadership positions, particularly in politics, with a focus on Kamala Harris's presidential run. Societal and cultural biases, such as the differing standards for male and female candidates, impact women's opportunities and perceptions. We hop…

1
148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner 26:20

2M ago26:20

26:20

On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses the complexities involved in assessing the applicability of standards to medical devices and combination products. Leo delves into the importance of understanding product environment, intended use, and market specifics. …

1
Social Media Strategies with Ashlee Trelli: Creating Engaging Content 55:47

2M ago55:47

55:47

In this episode we explore the art of capturing high-quality content with special guest Ashley Trelli, managing partner at Capture the Concept. Ashley shares her journey from the corporate world to entrepreneurship and offers actionable tips for creating engaging video content with just a smartphone. Topics include the importance of personal brandi…

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How to Organize Your Day as a Business Owner: Practical Strategies for High Performance & Work/Life Balance 38:18

2M ago38:18

38:18

In this episode, we dive into the practical (and sometimes elusive) world of time management, sharing how effective planning and preparation can boost your business success and personal well-being. We chat about our scheduling tricks, prioritizing tasks, and setting healthy boundaries to balance work and life—because who doesn't want to be a produc…

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147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup 23:15

2M ago23:15

23:15

On this episode, I was joined by David Grosse-Wentrup, Research Director for Human Factors at Design Science Group. David walks through: David Grosse-Wentrup PhD is a Research Director at Design Science, a global human factors consultancy focused on advancing healthcare technology through user research and design evaluation. After his studies in bi…

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146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens 35:58

2M ago35:58

35:58

On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc. David walks through the freeze drying(lyo) process, primary drying via sublimation, secondary drying through desorption, and final steps such as backfilling and stoppering. David also explores the different considerations for lyophilization, the impact of var…

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Being a Woman in Business is Counter Cultural: The Financial Limitations Women Have Faced in Business Building 48:19

2M ago48:19

48:19

Being a woman in business is transforming the world. In today’s episode we chat about the historical and societal barriers women have faced concerning financial independence and business ownership, which is why we think that simply being a female entrepreneur is an act of rebellion. Women can have a unique impact on communities and the economy in a…

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145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi 40:28

2M ago40:28

40:28

On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses: 01:18 Understanding Regulatory Policy 03:18 Ryan's Career Journey 05:08 Challenges in Regulatory Harmonization 06:54 Legislative Frameworks and Regulatory Differences Globally 11:10 FDA's Role and Recent Legislation (User Fee reaut…

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Mid-Year Goal Assessment: Reflect, Reassess, and Reset for Success 37:22

2M ago37:22

37:22

How have your goals been coming along this year? In this episode Joann & Michelle reflect on milestones on their way to accomplish 2024 goals. In regards to goals, we think it’s about the journey over the destination, so that you create supportive systems, processes, and habits. There is power in reframing failures, recognizing barriers, and making…

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144 - Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo 35:36

3M ago35:36

35:36

On this episode, I was joined by David DeSalvo, Vice-President of Combination Product Development at Kindeva Drug Delivery. David and I discuss: 00:00 Introduction and Guest Overview00:04 David DeSalvo's Career Journey02:13 Understanding Injection Systems04:22 Early Career at BD10:51 Transition to SHL17:50 Starting a New Venture24:54 Experience at …

1
Mastering Networking with Maria Medina: Building Genuine Connections to Grow Your Business 45:18

3M ago45:18

45:18

We chatted with Maria Medina, founder and CEO of The Coaching Network, discussing the importance of networking in business. She shares her journey from moving to the United States, building her business from scratch through strategic connections, and eventually transitioning into coaching. Maria offers practical tips on becoming a 'super connector,…

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143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young 29:22

3M ago29:22

29:22

On this episode, I was joined by Alan Stevens and Rumi Young who walk through the contents of the FDA Draft Essential Drug Delivery Outputs for Devices Intended toDeliver Drugs and Biological Products Guidance for Industry. Industry Comments are DUE 9/29/2024.Alan Stevens is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie wit…

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The One Thing All Successful Launches Need 54:18

3M ago54:18

54:18

Discover the key elements to a successful business launch in this episode, where we break down case studies of real successful online businesses. Understand common myths surrounding the need for perfection, explore the strategic use of sales channels, and outline a simple yet effective funnel for lead generation. Through real-life examples and case…

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How to Create Consistency: The Invaluable Impact of Repetition in Health & Business with Manouk Vink 45:20

3M ago45:20

45:20

Tune in as we chat with Manouk Vink, a fitness and nutrition coach leveraging a 5-day challenge launch model to grow her list and online membership. We chat about the importance of clear messaging in marketing your online business and Manouk shares insights into her journey from personal training to online coaching, emphasizing sustainable fitness …

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142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin 30:26

3M ago30:26

30:26

On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: 01:53 Material Qualification Discussion Begins02:23 Material Qualification in Drugs vs. Devices04:00 Quality Standards in Different Industries08:54 Quality Tools and Their Applications11:22 Material Qualification and Supplier Mana…

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141 - Lessons from the Life and Legacy of Quality Guru H. James Harrington (1929-2024) 23:09

3M ago23:09

23:09

On this episode of the Combinate Podcast, I go over 6 lessons from the life and x of H. James Harrington. Dr. H James Harrington has a decorated career with 40 years at IBM, 10 years at Ernst & Young, and has held multiple executive roles at various companies since. He's written more than 55 books on performance improvement. He was the chairman and…

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Affiliate Marketing Scandal: Legendary Marketer & How to Avoid “Build a Business” Scams 52:44

3M ago52:44

52:44

Not all affiliate marketing is created equal. On this week’s episode join Michelle & Joanna as we talk about the recent scandal in digital business ownership surrounding Legendary Marketer. [Subscribe | Leave a Review | Share] Build a Successful Online Business Using Kajabi 33 Proven Ways to Drive Massive Traffic to Your Online Business Facebook Gr…

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140 - Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM's, Evaluating Skill and Mindset with Christian Espinosa 30:50

4M ago30:50

30:50

On this episode, I was joined by Christian Espinosa CEO of Blue Goat Cyber. On this episode, Chrsitian walks through:00:00 Introduction and Guest Overview00:20 Christian Espinosa's Journey: From Air Force to Cybersecurity03:41 Medical Device Cybersecurity: Challenges and Risks05:51 Freelance to Entrepreneurship: Founding Blue Goat Cyber07:05 Cybers…

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Best Marketing Strategy Ever of Nicole the Intern & Smashing Her Way to 500k Followers 1:00:52

4M ago1:00:52

1:00:52

Breaking down the viral marketing sensation, Nicole the Intern, and her journey to 520,000 Instagram followers. Discover the secret sauce behind her success, from creating relatable content and building a community to leveraging the bandwagon effect and engaging storytelling. Learn tactical tips for your own brand growth. @thebestmarketingstrategye…

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Overcoming Procrastination by Embracing Your “Done” Vision in Business (Moments with Michelle) 14:17

4M ago14:17

14:17

Let’s discuss why you might be playing small and how to shift your focus to your ultimate vision for your business. By doing this, you can take inspired action rather than procrastinating on important tasks. Instead of waiting for perfect conditions, struggling with self-sabotage, and battling anxiety, you can overcome your fears, simplify your app…

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139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh 27:43

4M ago27:43

27:43

This is a solo episode. On this episode, Subhi goes through: 01:51 Draft FDA Guidance - Platform TechnologyDesignation Program for Drug Development Guidance for Industry 13:03 EMA Guidance - Questions & Answers for applicants, marketing authorisation holders of medicinal products and notifiedbodies with respect to the implementation of theRegulatio…

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How Micro Habits Can Transform Your Mental Health with Dr. Diane Gehart 33:48

4M ago33:48

33:48

Welcome back guest Dr. Diane Gehart, founder of Therapy That Works, as she discusses her TED Talk on mental health and the failing mental health system. With over 250,000 clients and 12 books, Diane highlights the importance of understanding the connection between physical and mental health and shares her concept of micro habits for lifelong wellne…

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When You Go Viral on Social Media: What to Do to Keep the Momentum Going, Gain Followers & Handle the Trolls (Just Joanna) 18:34

4M ago18:34

18:34

Joanna discusses her journey of going viral on Instagram & TikTok. She reflects on the contrasting reactions from different platforms, hate comments, and the challenges of balancing viral content creation with running her business full time. She also shares strategic tips for maintaining social media engagement and managing mental health while deal…

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138 - Operations vs. Quality, KPI's, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture with Larry Mager 47:34

4M ago47:34

47:34

On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through: 00:31 Larry's Perspective on Quality 03:21 Importance of KPIs in Management Review 04:13 Management Review and Control 09:09 Operational Framework and Business Structure 18:46 Effective Business Processes 24:42 Understanding R…

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Decision Making with Human Design: Balancing Motherhood and Business with Megan 52:50

4M ago52:50

52:50

In this episode, we explore the intersection of entrepreneurship and motherhood with Megan Barrett, a seasoned business owner and life coach. Megan shares her journey from food blogger to mindset coach, emphasizing the role of human design in understanding energy flow for a more sustainable business approach. She discusses setting boundaries, choos…

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137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens 18:11

4M ago18:11

18:11

On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, Alan walks through: 00:38 Exploring Reliability in Combination Products 01:17 The Importance of Subscribing and Feedback 01:36 Alan Stevens Shares His Expertise 02:40 Understanding Reliability: Definitions and N…

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When You’re Doubting Whether You’re Cut Out for This Or Not (Moments with Michelle) 14:47

4M ago14:47

14:47

In this special segment of the Her First podcast, 'Moments with Michelle', Michelle shares a candid conversation about the challenges and realities of striving towards personal and professional goals. Reflecting on her experiences of investing time, energy, and resources without seeing the desired outcomes, she explores themes of expectation versus…

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haleyybaylee Met Gala Drama Let Them Eat Cake: 2024 Celebrity Blackout & How to Engage in Social Issues as a Creator 1:00:52

4M ago1:00:52

1:00:52

Proceeds Support the Palestine’s Children’s Relief Fund, so Buy the Book: https://www.48stories.com/products/48-stories-of-exile-from-palestine Trigger Warning: This episode of the Her First Podcast delves into the complexities of responding to social issues, controversies, and social justice movements as content creators, coaches, and business own…

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136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura 39:53

5M ago39:53

39:53

On this episode I was joined by Chuck Ventura, Founder of Ventura Solutions and CEO of HemoTek. On this episode Chuck walks through: 00:29 Design Changes When No DHF Exists 03:30 Challenges and Strategies in Document Management 04:49 Improving Design Inputs and Risk Management 21:37 Leveraging Tools for Better Traceability and Compliance Charles Ve…

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Mastering TikTok: Trends, Growth, and Authenticity with Expert Wave Wyld 59:33

5M ago59:33

59:33

In this episode, we're thrilled to chat with Wave Wyld, a real pro when it comes to TikTok marketing and trends. She's all about helping creators and business owners really make their mark and boost their profits, all while keeping their content authentic and community-focused. We dive into some hot topics like the potential TikTok ban, busting myt…

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Just Joanna: The Tortured Poets Department, A Reflection on Taylor Swift's Fame and Anti-Hustle Culture 15:30

5M ago15:30

15:30

In this episode of 'Just Joanna,' Joanna discusses Taylor Swift's latest album 'The Tortured Poets Department.' She explores how the album goes beyond romantic entanglements to deeply examine the price of fame, the intense scrutiny women in the public eye face, and the broader societal implications of hustle culture. Joanna connects the themes of t…

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135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson 41:16

5M ago41:16

41:16

On this episode, I was joined by Tony Watson, Vice President of Regulatory and Quality at Windgap Medical. On this episode, Anthony discusses: 03:11 The Formation and Impact of the Office of Combination Products 04:16 Challenges and Changes in the Regulatory Landscape for Combination Products 07:53 Understanding FDA Titles and Organizational Struct…

1
From Teacher to 7-Figure Entrepreneur: The Power of Mindset with Kathi Reuter 40:02

5M ago40:02

40:02

On today’s episode, enjoy the story of Kathi Reuter, Mindset Coach & Business Strategist, who shares her personal journey from being a teacher to successfully building a seven-figure health and fitness business. Kathi discusses the challenges of overcoming her major income plateau and the critical role mindset plays in achieving business success. W…

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134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch 41:49

5M ago41:49

41:49

On this episode, I was joined by Richard Koch, Founder of KochSaMD. Richard discusses: 00:29 Exploring Software's Role in Medical Devices 02:29 Deep Dive into Cloud-Based Medical Devices 06:29 The Intricacies of Software Development in Medical Devices 26:33 The Future of Medical Devices in the Cloud Era 32:56 The Potential Impact of Tech Giants on …

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Becoming a TEDx Talk Speaker with Dr. Diane Gehart 29:22

5M ago29:22

29:22

In this episode, we delve into Dr. Diane Gehart's captivating journey as a TED Talk speaker. Dr. Gehart, the founder of Therapy That Works, shares her remarkable experience of being approached for the opportunity through her YouTube content. Throughout the conversation, Dr. Gehart provides insights into the rigorous preparation process, which invol…

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133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell 22:26

5M ago22:26

22:26

On this episode, I was joined by Devon Campbell, Founder, Prodct LLC + CPO, myBiometry.Devon discusses: 02:20 The Journey to Consulting: A Year of Saying No 03:09 Advising Startups: The Role of a Consultant 05:08 The Shift to Consulting: Embracing Joy and Impact 09:21 Navigating the Startup Ecosystem: Challenges and Opportunities 13:31 Building a P…

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Beyond Regrets: Embracing Life's Lessons with Joanna and Michelle 52:21

5M ago52:21

52:21

If you could teach your younger self a lesson, would it be? In this episode of 'Her First,' hosts Michelle and Joanna delve into powerful life lessons they would impart to their younger selves, emphasizing that these lessons are derived from reflection, not regret. They share personal anecdotes — from bad breakups to business mistakes — and insight…

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