Best Ikigai Essentials Podcasts (2024)

1
146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens 35:58

7h 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…

1
145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi 40:28

7d 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…

1
12. What is Kundalini Energy? The Power of Kundalini with Colleen Grady 43:46

3h ago43:46

43:46

On this episode, I invite my first guest onto the podcast - Kundalini Facilitator & Educator, Colleen Grady. We dive into world of energetics and talk about how kundalini energy works. Colleen's story is fascinating of how she got to exactly where she is today. If you've ever been curious about energy work, this is the episode to listen to! Colleen…

1
144 - Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo 35:36

3d 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
143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young 29:22

10d 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…

1
11. A Powerful Mindset Tool for a Major Perspective Shift to Become Unstoppable 23:44

13d ago23:44

23:44

What's the number one tool that's changed the trajectory of my life and brought me more happiness? Let's dig in! In this episode, I’m diving deep into my personal journey and sharing how understanding my own beliefs and leveraging confirmation bias has completely shifted how I feel about my life. I share real-life examples of how this powerful psyc…

1
142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin 30:26

22d 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…

1
Holistic Health Essentials: Father's Day and Postpartum Depression 24:33

23d ago24:33

24:33

As a new father, I was caught off guard by postpartum depression. I'm not alone... It's okay for men to experience postpartum depression too, in fact it is quite common. Join us this as we celebrate Father's Day and explore ways to overcome the negative health impacts of fatherhood.

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

24d 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…

1
140 - Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM's, Evaluating Skill and Mindset with Christian Espinosa 30:50

1M 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…

1
Holistic Health Essentials: Boredom and How to Fight It 32:19

1M ago32:19

32:19

Have you ever desired something intensely, obtained it, and then, after some time, felt like you wanted something else, even though what you achieved was objectively positive? Your brain was simply doing what it has evolved to do: habituate Habituation is a phenomenon where our responses diminish over time to constant or gradually changing stimuli.…

1
139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh 27:43

1M 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…

1
10. Finding Your IKIGAI to Make More Money Than Your Corporate Job 28:22

2M ago28:22

28:22

Have you ever dreamed of ditching your 9-5 grind for a life of financial freedom and adventure? You've felt trapped in a mold and you've thought to yourself "there's got to be more to life." Time to ditch societal expectations and live a life you truly want. In this episode of 'Radically Rewired,' I’m sharing my personal journey of how I left my co…

1
138 - Operations vs. Quality, KPI's, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture with Larry Mager 47:34

2M 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…

1
137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens 18:11

2M 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…

1
Holistic Health Essentials: Focusing on Financial Health in the AAPI Community 41:15

2M ago41:15

41:15

Have you ever been labeled as the 'Model Minority' when it comes to finances? This episode focuses on why the 'Model Minority' myth is harmful and the challenges faced by AAPI communities. Join us as we delve into our thoughts and ideas on how to raise awareness among the younger generation

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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

2M 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…

1
135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson 41:16

2M 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
Celebrating AAPI Heritage & Mental Health Awareness Month 55:30

3M ago55:30

55:30

In May, we honor both Asian American and Pacific Islander Heritage Month as well as Mental Health Awareness Month. In this podcast episode, we delve into the rich tapestry of our heritage and lineage, intertwining it with the complexities of our relationships with our children. Join us as we explore the intersections of culture, identity, and menta…

1
134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch 41:49

3M 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 …

1
133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell 22:26

3M 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…

1
132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner 31:11

3M ago31:11

31:11

On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses: 00:56 Evolution of Industry Standards 02:00 The Impact of Standards on Medical Device Development 02:10 Standards and Regulatory Challenges 02:42 Standards in Medical Devices and Emerging Technologies 13:19 The Auditing…

1
131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer 42:53

3M ago42:53

42:53

On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting. Jeanne and I discuss:- Assessing Drugs, Devices, and Combination Products for Sterility Methods- Regulatory Frameworks and EMA's Decision Tree (Link)- Novel Methods: liquid phase sterilization, ionization, physics based sterilization, high pressure s…

1
130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder 32:25

4M ago32:25

32:25

On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses: 00:58 Exploring the Impact of QMSR on Medical Device Companies 02:19 UDI Regulations 05:18 Understanding the FDA's Approach to QMSR and Compliance 18:02 The FDA's Inspection Techniques and the Future of QMSR 31:55 Where to Find Aaron and Closing Thoug…

1
Holistic Health Essentials: What's Your Self-Worth? 35:45

4M ago35:45

35:45

Ikigai Essentials is a movement to better overall health geared towards the Pan-Asian community but ultimately to all that can benefit. Join us as we explore and delve into the depths of self-worth and its profound significance in our lives. Additionally, let's emphasize the importance of exerting effort and bravely stepping beyond the confines of …

1
129 - Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens 32:59

4M ago32:59

32:59

On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, expect to learn from Alan about how reliability engineering concepts can be used for single use combination products. Why infusion pumps are susceptible to recalls. Why people call Allen captain Allen Stevens. A…

1
128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture 52:32

4M ago52:32

52:32

On this episode, I was joined by Former FDA Investigator and Managing Consultant of Practical Compliance Results, Vin Cafiso. Vin discusses: 01:35 Journey from Premed to FDA Investigator: VIN's Story 07:25 Understanding the Impact of QMSR on Industry 16:24 The FDA's Approach to Inspections and Compliance 27:45 The Shift Towards Quality Culture in F…

1
Rich Dad Poor Dad : Book by Robert Kiyosaki (Free Complete Audiobook) 4:43:35

4M ago4:43:35

4:43:35

Rich Dad Poor Dad: Book by Robert Kiyosaki https://patron.podbean.com/ntotomedia Hello friends, fans, and fellow dream-chasers! We are Ntoto Media, your go-to source for invigorating motivational speeches and enthralling audiobooks, designed to inspire, educate, and empower our amazing community of listeners. Steered by passion and a commitment to …

1
9. How to Shake Your Inner Critic & Give Yourself Grace 30:50

4M ago30:50

30:50

Let's talk about another one of my favorite topics, our inner voices – those sneaky narrators that shape our actions and mold our destinies. But fear not! In this episode, we're shaking off the shackles of negativity and embracing our true inner voice that guides us to our most aligned goals. Join me as we uncover the keys to silencing the nagging …

1
Essentialism: Greg McKeown 1:11

4M ago1:11

1:11

Essentialism: Greg McKeown https://patron.podbean.com/ntotomedia Hello friends, fans, and fellow dream-chasers! We are Ntoto Media, your go-to source for invigorating motivational speeches and enthralling audiobooks, designed to inspire, educate, and empower our amazing community of listeners. Steered by passion and a commitment to personal growth,…

1
The Obstacle Is The Way: Ryan Holiday 4:25:27

4M ago4:25:27

4:25:27

The Obstacle Is The Way: Ryan Holiday https://patron.podbean.com/ntotomedia Hello friends, fans, and fellow dream-chasers! We are Ntoto Media, your go-to source for invigorating motivational speeches and enthralling audiobooks, designed to inspire, educate, and empower our amazing community of listeners. Steered by passion and a commitment to perso…

1
The Automatic Millionaire: David Bach (Free Complete Audiobook) 5:16:28

4M ago5:16:28

5:16:28

The Automatic Millionaire: David Bach (Free Complete Audiobook) https://patron.podbean.com/ntotomedia Hello friends, fans, and fellow dream-chasers! We are Ntoto Media, your go-to source for invigorating motivational speeches and enthralling audiobooks, designed to inspire, educate, and empower our amazing community of listeners. Steered by passion…

1
127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal 48:25

4M ago48:25

48:25

On this episode I was joined by Naveen Aggarwal founder of Creative Analytic Solutions and host of "Let's talk risk". In this episode, Naveen walks through the big changes to risk management with the QMSR, and risk beyond safety. The episode covers the confusion surrounding the mandatory nature of risk management in particular and we spend the seco…

1
Eat That Frog: Brian Tracy 2:07:00

4M ago2:07:00

2:07:00

Eat That Frog: Brian Tracy https://patron.podbean.com/ntotomedia Hello friends, fans, and fellow dream-chasers! We are Ntoto Media, your go-to source for invigorating motivational speeches and enthralling audiobooks, designed to inspire, educate, and empower our amazing community of listeners. Steered by passion and a commitment to personal growth,…

1
8. Why Finding Your People is Essential in Your Healing Journey 28:56

5M ago28:56

28:56

So, you know that feeling when you're vibing with the right people and everything just clicks? Well, we're diving headfirst into that magic in this episode. I'm talking about the real deal stuff – how your inner circle can make or break your success journey. Annnnd we're getting real about friend breakups too. Yep, those sad, emotional situations w…

1
Holistic Health Essentials: Connection & Loneliness 38:14

5M ago38:14

38:14

Ikigai Essentials is a movement to better overall health geared towards the Pan-Asian community but ultimately to all that can benefit. Introducing the inaugural podcast and unveiling of the Holistic Health Essentials Series. Join us on a transformative journey through a curated collection of topics designed to elevate and enhance your overall well…

1
Super Human Mind (Free Complete Audiobook) 1:02:51

5M ago1:02:51

1:02:51

Super Human Mind (Free Complete Audiobook) https://patron.podbean.com/ntotomedia Hello friends, fans, and fellow dream-chasers! We are Ntoto Media, your go-to source for invigorating motivational speeches and enthralling audiobooks, designed to inspire, educate, and empower our amazing community of listeners. Steered by passion and a commitment to …

1
Don't Believe Everything You Think: Joseph Nguyen (Free Complete Audiobook) 2:16:51

4M ago2:16:51

2:16:51

Don't Believe Everything You Think: Joseph Nguyen (Free Complete Audiobook) https://patron.podbean.com/ntotomedia Hello friends, fans, and fellow dream-chasers! We are Ntoto Media, your go-to source for invigorating motivational speeches and enthralling audiobooks, designed to inspire, educate, and empower our amazing community of listeners. Steere…

1
The Body Keeps the Score: Bessel van der Kolk (Part 2 of 2 Complete Free Audiobook) 5:05:26

4M ago5:05:26

5:05:26

The Body Keeps the Score: Bessel van der Kolk (Part 2 of 2 Complete Free Audiobook) https://patron.podbean.com/ntotomedia Hello friends, fans, and fellow dream-chasers! We are Ntoto Media, your go-to source for invigorating motivational speeches and enthralling audiobooks, designed to inspire, educate, and empower our amazing community of listeners…

1
The Body Keeps the Score: Bessel van der Kolk (Part 1 of 2 Complete Free Audiobook) 5:45:54

4M ago5:45:54

5:45:54

The Body Keeps the Score: Bessel van der Kolk (Part 1 of 2 Complete Free Audiobook) https://patron.podbean.com/ntotomedia Hello friends, fans, and fellow dream-chasers! We are Ntoto Media, your go-to source for invigorating motivational speeches and enthralling audiobooks, designed to inspire, educate, and empower our amazing community of listeners…

1
126 - Combination Products Collaboration, Turnover on MedTech/Pharma Project Teams, and Lessons from working with Intel's CEO with Mat Stratton, Founder of Coalition Ltd 35:54

5M ago35:54

35:54

On this episode I was joined by Mat Straton, Founder of Coalition Ltd. In this episode, Mat discusses: 01:02 Venturing into Combination Products 02:46 Andy's Journey into Healthcare Space 04:48 Challenges in Deep Brain Stimulation 08:55 The Impact of working with Andy Grove 10:42 The Struggle with Parkinson's Disease 13:20 The Speed of Product Deve…

1
Ikigai: The Japanese Secret to a Long and Happy Life - Héctor García & Francesc Miralles 3:18:30

4M ago3:18:30

3:18:30

Ikigai: The Japanese Secret to a Long and Happy Life - Héctor García & Francesc Miralles https://patron.podbean.com/ntotomedia Hello friends, fans, and fellow dream-chasers! We are Ntoto Media, your go-to source for invigorating motivational speeches and enthralling audiobooks, designed to inspire, educate, and empower our amazing community of list…

1
Man's Search for Meaning: Viktor E. Frankl (Free Complete Audiobook) 4:32:46

4M ago4:32:46

4:32:46

Man's Search for Meaning: Viktor E. Frankl (Free Complete Audiobook) https://patron.podbean.com/ntotomedia Hello friends, fans, and fellow dream-chasers! We are Ntoto Media, your go-to source for invigorating motivational speeches and enthralling audiobooks, designed to inspire, educate, and empower our amazing community of listeners. Steered by pa…

1
Mastery: Robert Greene (Full Free Audiobook) 4:39:38

5M ago4:39:38

4:39:38

Mastery: Robert Greene (Full Free Audiobook) https://patron.podbean.com/ntotomedia Hello friends, fans, and fellow dream-chasers! We are Ntoto Media, your go-to source for invigorating motivational speeches and enthralling audiobooks, designed to inspire, educate, and empower our amazing community of listeners. Steered by passion and a commitment t…

1
The Alchemist: Paulo Coelho (Full Free Audiobook) 4:00:48

5M ago4:00:48

4:00:48

The Alchemist - Paulo Coelho (Full Free Audiobook) https://patron.podbean.com/ntotomedia Hello friends, fans, and fellow dream-chasers! We are Ntoto Media, your go-to source for invigorating motivational speeches and enthralling audiobooks, designed to inspire, educate, and empower our amazing community of listeners. Steered by passion and a commit…

1
Nipsey Hustle: How To Master Your Energy 10:51

5M ago10:51

10:51

Nipsey Hustle: How To Master Your EnergyBy Ntoto Media

1
The Way of The Superior Man: David Deida (Free Full Audiobook) 4:51:17

5M ago4:51:17

4:51:17

The Way of The Superior Man: David Deida (Free Full Audiobook)By Ntoto Media

1
125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh 42:04

5M ago42:04

42:04

On this episode, I do an active reading to begin to unpack the Quality Management System Regulations(QMSR) Final Rule that was issued by FDA in early February 2024. 0:00 Introduction 05:09 Initial Reactions to the idea of the QMSR 06:57 History of the Device cGMP's, QSR, and QMSR 11:52 What's changing in 21 CFR 820? 24:59 What's changing in 21 CFR …

1
Master Your Emotions: Thibaut Meurisse (Complete Free Audiobook) 4:05:14

5M ago4:05:14

4:05:14

Master Your Emotions by Thibaut Meurisse https://patron.podbean.com/ntotomedia Hello friends, fans, and fellow dream-chasers! We are Ntoto Media, your go-to source for invigorating motivational speeches and enthralling audiobooks, designed to inspire, educate, and empower our amazing community of listeners. Steered by passion and a commitment to pe…

1
15 Stoic Tips For Mastering Yourself (Seneca's Way) 13:50

5M ago13:50

13:50

15 Stoic Tips For Mastering YourselfBy Ntoto Media

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