A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.
…
continue reading
Join Sunrise Labs on the Making Bright Ideas Work podcast to discuss the ins and outs of bringing medical devices to life, and their impact on the industry and beyond.
…
continue reading
The go-to podcast for anyone looking to transform their business! Join host Amanda Desuacido, CEO of My Mountain Mover, as she interviews top industry leaders and business owners who are reaching new heights through premier virtual outsourcing. Expect creative productivity tips, business insights, and testimonials of how virtual assistants have revolutionized businesses around the world.
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Predetermined Change Control Plans, Part 2
57:41
57:41
Mais Tarde
Mais Tarde
Listas
Like
Curtido
57:41
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue speaking on the topic of predetermined change control plans. Potential scenarios for their use are discussed, examples are provided, and role of PCCPs for manufacturing processes are explored. If you haven’t yet listened to Part 1…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Predetermined Change Control Plans, Part 1
48:29
48:29
Mais Tarde
Mais Tarde
Listas
Like
Curtido
48:29
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA’s recent guidance documents regarding predetermined change control plans (PCCP). The first guidance addresses PCCPs for artificial intelligence (AI) and/or machine learning (ML) based devices (click here to hear an earlier …
…
continue reading
![Artwork](/static/images/128pixel.png)
1
What is a CAPA and How Do You Best Use It?
58:13
58:13
Mais Tarde
Mais Tarde
Listas
Like
Curtido
58:13
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re focusing in on a regulatory piece that’s been mentioned numerous times with regard to other topics we’ve discussed. This episode is focused on CAPA or corrective and preventive action. We’re digging into the CAPA, what it is, its purpos…
…
continue reading
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing what the process should be for a company once they receive a 483 or warning letter from the FDA. Best practices, first steps to take, who is responsible, and potential strategies for avoiding them are shared. Specifically, th…
…
continue reading
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
The Most Dangerous Devices to Hit the Market
40:42
40:42
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Headline-Generating Medical Device Safety Concerns
49:16
49:16
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Analyzing ECRI’s 2024 Top 10 Health Technology Hazards
51:35
51:35
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Reimbursing Breakthrough Designation Products
51:18
51:18
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
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…
…
continue reading
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…
…
continue reading
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Can You Use a Recalled Device as a Predicate?
53:40
53:40
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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 …
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Leading Issues from FDA Inspections (or History Repeating Itself)
46:17
46:17
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Strategic Medical Staffing, Business Grit & Personal Growth with Kiera Dent
51:25
51:25
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
To Regulate or Not to Regulate…LDTs, Part 2
49:18
49:18
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
To Regulate or Not to Regulate…Lab Developed Tests, Part 1
42:03
42:03
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
What Happens When the EUA Period Ends?
48:08
48:08
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
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…
…
continue reading
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
FDA's Intended Use Rule’s Relation to Labeling
51:05
51:05
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Gaining an Advantage Through Class II Special Controls
47:15
47:15
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
FDA’s Refuse to Accept Policy for 510(k)s
50:36
50:36
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Initiating a Voluntary Medical Device Recall
47:21
47:21
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Humacyte’s Bioengineered Tissue Platform Technology
27:37
27:37
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Koya Medical Restores Mobility for Compression Therapy Patients
26:58
26:58
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
NeuroPace’s Aid in Tracking and Treating Epilepsy
20:00
20:00
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Aidoc Is Improving Patient Outcomes Through AI
21:25
21:25
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Performing a Gap Analysis on FDA's Regulatory Protocols
43:38
43:38
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Stereotaxis’ Robotic Surgery System for Interventional Procedures
22:46
22:46
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Fighting Tumors with Varian’s FLASH Technology
23:14
23:14
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
RSIP Vision’s Diagnostic Imaging Advancements
20:05
20:05
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
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…
…
continue reading
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
GE Healthcare’s Chief Digital Officer’s 2022 Predictions
29:30
29:30
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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 …
…
continue reading
![Artwork](/static/images/128pixel.png)
1
DePuy Synthes Strives for Knee Restoration
28:22
28:22
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Femasys Targets Fertility and Women’s Health
14:44
14:44
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Front Line’s COBRA-OS Helps Prevent Bleed Out
23:29
23:29
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Pristine Surgical’s Single-Use Endoscopes
37:02
37:02
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Discussing Spine with Medtronic's Carlton Weatherby
21:53
21:53
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Aligning Regulatory and Commercial Strategies
41:25
41:25
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Medtech Manufacturing at the U.S.-Mexico Border
41:12
41:12
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Surgical Instrumentation Update from Ethicon
26:22
26:22
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading
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…
…
continue reading
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…
…
continue reading
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…
…
continue reading
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…
…
continue reading
![Artwork](/static/images/128pixel.png)
1
Glooko’s Remote Patient Monitoring for Diabetics
20:38
20:38
Mais Tarde
Mais Tarde
Listas
Like
Curtido
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…
…
continue reading