Best Medical Product Outsourcing Podcasts (2024)

1
Revisiting Real-World Evidence 54:03

2h ago54:03

54:03

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re revisiting real-world evidence (RWE), which is a topic that’s been getting some attention. So today, we’re going to look at what’s driving that attention and discuss the reasons behind it. We’ll also talk about how the FDA is seeking to…

1
The Most Dangerous Devices to Hit the Market 40:42

9d ago40:42

40:42

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re taking a look at several devices that unfortunately ended up being quite dangerous even though they made it to the market and were used by healthcare professionals. Some of these may have been brought up previously the Netflix documenta…

1
Headline-Generating Medical Device Safety Concerns 49:16

1M ago49:16

49:16

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re reviewing a few stories in the news that tie into the safety of medical devices. First, a story regarding plastic syringes made in China that were deemed not to be used by the FDA. The other story is about a report indicating third-part…

1
Analyzing ECRI’s 2024 Top 10 Health Technology Hazards 51:35

3M ago51:35

51:35

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at the latest annual list put out by ECRI, an independent authority on healthcare technology and safety, on their top 10 health technology hazards for 2024. The full list is available at the organization’s website, which is at w…

1
Examining Institutional Review Boards 51:11

3M ago51:11

51:11

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at IRBs, or institutional review boards. We’re taking a look at what these are, how they relate to medical device approvals, and why they are important. Specifically, the following questions are addressed: Could you please expla…

1
Reimbursing Breakthrough Designation Products 51:18

5M ago51:18

51:18

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the journey that’s occurred with regard to getting reimbursement tied to the FDA’s Breakthrough Designation Program (BDP). It’s been planned, called off by CMS, put into proposed legislation, but we still don’t have a definitive so…

1
Strengthening the 510k Program 38:06

6M ago38:06

38:06

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at guidances published by FDA regarding the 510k regulatory pathway. The subject matter of the three were: best practices for selecting a predicate device, the need for clinical data in a submission, and evidentiary expectation…

1
Medical Device Manufacturing Recalls 46:35

8M ago46:35

46:35

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at the recent rise in recalls that are being tied back to manufacturing issues. The discussion explores the recall mechanism itself and then move to the details behind the numbers. Finally, a strategy for mitigating risk is sha…

1
AI Predetermined Change Control Plan 52:17

9M ago52:17

52:17

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at a guidance from the FDA that explains how product sponsors can submit a predetermined change control plan for artificial intelligence and machine learning technologies. These are critical as these types of software evolve ov…

1
Can You Use a Recalled Device as a Predicate? 53:40

12M ago53:40

53:40

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA policy regarding the use of a recalled device as a predicate in a 510k submission. Is it a good idea? What considerations are there for doing so? Specifically, the following questions are addressed: First, would you please …

1
Leading Issues from FDA Inspections (or History Repeating Itself) 46:17

1y ago46:17

46:17

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the 483s and warning letters that resulted from FDA inspections in 2022. The list is alarmingly similar to previous years and the discussion explores why that’s the case. The discussion also centers around ways device manufacturers…

1
Strategic Medical Staffing, Business Grit & Personal Growth with Kiera Dent 51:25

1+ y ago51:25

51:25

If you own a medical practice, you will find so much value in today's episode. Host Rebecca Hannah welcomes Kiera Dent, Founder & CEO of The Dental A team. In this podcast, they explore strategies for improving the efficiency of dental practices, hiring the best people, and becoming a better leader. https://mymountainmover.com/resources/the-pinnacl…

1
To Regulate or Not to Regulate…LDTs, Part 2 49:18

1+ y ago49:18

49:18

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue to discuss lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. How would FDA oversight impact quality and timeliness of care? How do LDTs relate to what happened with Theranos? Specifi…

1
To Regulate or Not to Regulate…Lab Developed Tests, Part 1 42:03

1+ y ago42:03

42:03

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the debate over lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. What would this type of oversight do to the need for speed with these types of tests? Would FDA supervision make thin…

1
What Happens When the EUA Period Ends? 48:08

1+ y ago48:08

48:08

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at what happens to products on the market under the FDA’s emergency use authorization (EUA). Once the EUA period ends, what happens to these products? As President Biden has already declared the pandemic to be over, this timeframe wil…

1
What Does 510k Exempt Actually Mean? 50:33

1+ y ago50:33

50:33

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s use of the word “exempt” and what it means for medical device manufacturers. During this discussion, we look at the relationship between 510k exempt and Class of device. Specifically, the following questions are addressed…

1
How Can Off-Label Use Be Promoted? 48:46

1+ y ago48:46

48:46

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at how a company can promote the off-label use of a medical device. It would seem to go against FDA regulation to do so, but there are acceptable methods that can be utilized that essentially promote the off-label use. Specifically, t…

1
FDA's Intended Use Rule’s Relation to Labeling 51:05

1+ y ago51:05

51:05

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s Intended Use rule and how it impacts device labeling. It is also revealed how labeling can be used by medical device OEMs as a competitive advantage. Specifically, the following questions are addressed: Could you please e…

1
Gaining an Advantage Through Class II Special Controls 47:15

1+ y ago47:15

47:15

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the Special Controls that are part of the FDA’s regulatory requirements for Class II devices. During the conversation, the purpose of these Special Controls is presented. Additionally, ways to use these regulatory requirements to g…

1
FDA’s Refuse to Accept Policy for 510(k)s 50:36

1+ y ago50:36

50:36

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s policy known as Refuse to Accept (RTA) as it relates to 510k submissions. Sadly, some companies are rejected due to Refuse to Accept as many as three times, which is a completely avoidable problem. Specifically, the follo…

1
Initiating a Voluntary Medical Device Recall 47:21

1+ y ago47:21

47:21

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine medical device recalls. More specifically, the focus of the discussion is on voluntary recalls, why they occur, and why companies need to be ready to conduct a recall. The FDA’s involvement with a recall is also presented as well a…

1
A Letter to File Deep Dive 45:24

1+ y ago45:24

45:24

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a deep dive on the letter to file tool that companies can use for certain situations. But what are those situation and how do you know when it’s appropriate to use this pathway? Also, how do you ensure you are using a letter to file c…

1
Humacyte’s Bioengineered Tissue Platform Technology 27:37

2+ y ago27:37

27:37

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Juliana Blum, Co-founder and Executive Vice President of Corporate Development at Humacyte. She speaks to the technology behind their regenerative solution and how it can be leveraged as a technology pla…

1
Koya Medical Restores Mobility for Compression Therapy Patients 26:58

2+ y ago26:58

26:58

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Andy Doraiswamy, founder and CEO of Koya Medical. He highlights the benefits of his company’s compression therapy solution, which can be accomplished while the patient remains mobile and active. Specifically…

1
NeuroPace’s Aid in Tracking and Treating Epilepsy 20:00

2+ y ago20:00

20:00

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Mike Favet, CEO of NeuroPace. He offers insights into how his technology helps those suffering with epilepsy. In addition, he provides an explanation of the firm’s nSight Platform. Finally, he talks about th…

1
Aidoc Is Improving Patient Outcomes Through AI 21:25

2+ y ago21:25

21:25

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Elad Walach, Co-Founder and CEO of Aidoc. He explains how artificial intelligence is being leveraged to assist radiologists in diagnosing conditions that weren’t originally even being sought. The Aidoc softw…

1
Performing a Gap Analysis on FDA's Regulatory Protocols 43:38

2+ y ago43:38

43:38

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we highlight a number of areas in which the agency’s regulatory oversight could be considered lacking. If the agency incorporated the highlighted ideas from this podcast, might it smooth the pathway to market for some products? Might it enhan…

1
Stereotaxis’ Robotic Surgery System for Interventional Procedures 22:46

2+ y ago22:46

22:46

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with David Fischel, CEO of Stereotaxis. He explains how his robotic surgical system works and what makes it unique from other systems on the market. He also speaks about the additional benefits that could be real…

1
Fighting Tumors with Varian’s FLASH Technology 23:14

2+ y ago23:14

23:14

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Deepak Khuntia, chief medical officer and senior VP of Medical Affairs at Varian. He offers insights on the company’s FLASH technology* and the significant differences between it and other radiation trea…

1
RSIP Vision’s Diagnostic Imaging Advancements 20:05

2+ y ago20:05

20:05

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Moshe Safran, CEO of RSIP Vision U.S. He shares technology advancements and his thoughts about them as related to the imaging field. Of note is his comments on 3D reconstruction as well as the impact artific…

1
FDA’s Cybersecurity Playbook 42:25

2+ y ago42:25

42:25

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a recent offering put out by the FDA in conjunction with the Medical Device Innovation Consortium and MITRE. It is a playbook for device makers to involve threat modeling of medical devices in its approach to cybersecurity. Best pr…

1
Video Capture of Surgery with Theator 22:30

2+ y ago22:30

22:30

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Tamir Wolf, CEO and Co-Founder of Theator. He discusses his company and why capturing a video record of a surgery is beneficial to physicians. He speaks to the educational advantages that can be realized…

1
GE Healthcare’s Chief Digital Officer’s 2022 Predictions 29:30

2+ y ago29:30

29:30

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Amit Phadnis, chief digital officer at GE Healthcare. He makes several predictions for the new year about how technology will impact the delivery of healthcare. Topics of discussion include the reduction of …

1
DePuy Synthes Strives for Knee Restoration 28:22

2+ y ago28:22

28:22

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Andrew Ekdahl, worldwide president of joint reconstruction at DePuy Synthes. He offers insight on the company’s approach to knee replacement, blending a number of technologies to achieve a restoration. Ekdah…

1
Femasys Targets Fertility and Women’s Health 14:44

2+ y ago14:44

14:44

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Kathy Lee-Sepsick, founder and CEO of Femasys. She provides an overview of how the company’s technology is helping women who are dealing with infertility. She also speaks about a device that enables a non-su…

1
Front Line’s COBRA-OS Helps Prevent Bleed Out 23:29

2+ y ago23:29

23:29

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Asha Parekh, a biomedical engineer and CEO of Front Line Medical. She explains how the COBRA-OS can stop internal bleeding to prevent patients from dying due to loss of blood. She also explains how the t…

1
Pristine Surgical’s Single-Use Endoscopes 37:02

2+ y ago37:02

37:02

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Bryan Lord, CEO and co-Founder of Pristine Surgical. He provides a number of reasons why disposable endoscopes should be indicated for medical procedures. Lord also highlights some of the challenges with reu…

1
Discussing Spine with Medtronic's Carlton Weatherby 21:53

2+ y ago21:53

21:53

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Carlton Weatherby, vice president and general manager of Spine and Biologics at Medtronic. He provides insight on why the organization acquired Mazor and Titan Spine, the strategy for the division to address…

1
Aligning Regulatory and Commercial Strategies 41:25

2+ y ago41:25

41:25

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at ways in which medical device manufacturers can benefit from a commercial strategy standpoint through the leveraging of its regulatory strategy. Knowing how to make the regulatory process more challenging to help prevent “me too” pr…

1
Medtech Manufacturing at the U.S.-Mexico Border 41:12

2+ y ago41:12

41:12

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Jackie Butler, director of BIO El Paso – Juarez, and Philip Morton, product development lab manager at MCA. They offer insights on how strong the region has been in supporting medical device manufacturers an…

1
Surgical Instrumentation Update from Ethicon 26:22

2+ y ago26:22

26:22

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Tom O’Brien, worldwide president of Endomechanical at Ethicon. He shares insights on the company’s approach to the development of surgical instrumentation and reducing surgical complications. O’Brien also of…

1
De Novo Final Rule 33:59

2+ y ago33:59

33:59

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the final rule recently announced for the FDA’s de novo regulatory pathway. As part of the discussion, the de novo is explained, when it should be used, why it exists, and what points of interest were included in the final rule. Sp…

1
Options with an Overly Burdensome FDA 46:45

2+ y ago46:45

46:45

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the options available to a medical device firm who thinks the FDA is requiring them to take unfair measures or is being overly burdensome. We discuss the formal and informal options as well as the potential consequences. Specifical…

1
Molli Surgical's Breast Tumor Marker 16:47

3y ago16:47

16:47

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Fazila Seker, president and CEO of MOLLI Surgical. She explains the benefits of the MOLLI Surgical system as compared to the way breast tumors are traditionally located and marked for surgical removal. F…

1
Three Systems of Risk 44:03

3y ago44:03

44:03

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the three systems of risk as they relate to the U.S. regulatory system. While many are familiar with the device classification system, they may not be as familiar with the other two systems or their purpose. Whether or not all thre…

1
Glooko’s Remote Patient Monitoring for Diabetics 20:38

3y ago20:38

20:38

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Russ Johannesson, CEO of Glooko. He speaks about the advantages remote monitoring offers to both physicians of diabetics as well as the patients themselves. He also offers insights into how his solution is u…

1
Valencell’s Wearable Biomedical Sensors 18:47

3y ago18:47

18:47

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Dr. Steven LeBoeuf, founder of Valencell. He provides insights on his company’s biomedical sensors, which can be incorporated into many different types of technologies, from fitness clothing to bracelets to …

1
Regulating IVDs and LDTs 44:15

3y ago44:15

44:15

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at recently proposed legislation regarding in vitro diagnostics and lab developed tests. The previous version of the Verifying Accurate, Leading-edge IVCT Development Act or VALID, which was proposed just before the pandemic, split th…

1
LifeSource Discusses Organ Donation Technologies 18:01

3y ago18:01

18:01

In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Julie Kemink, COO at LifeSource. She speaks to the technologies being used within organ donation, primarily for transport and preservation. She also offers insights on upcoming technologies such as the use o…

1
Facility Falsified Sterilization Data 39:35

3y ago39:35

39:35

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we dig into a story about an Italian firm that reportedly falsified information related to sterilization certificates going back as far as 2016. On June 2, 2021, the FDA published a letter to industry regarding the firm Steril Milano. In the …

Podcasts Worth a Listen

Medical Product Outsourcing Podcasts

Podcasts Worth a Listen

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