Latest Contract manufacturing Podcast Episodes
David Liebl of Intricon on Wearable Sensors
Better Product Solutions Podcast - April 08, 2024 14:00 - 21 minutesIn this episode, we chat with David Liebl, Chief Commercial and Technology Officer at Intricon, about the latest in wearable healthcare sensors. We discuss current trends, industry priorities, and how these innovative wearables are brought to market. Join us for a glimpse into the future of heal...
Analyzing ECRI’s 2024 Top 10 Health Technology Hazards
Medtech Matters - March 19, 2024 12:00 - 51 minutes ★★★★★ - 5 ratingsIn 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 ...
Examining Institutional Review Boards
Medtech Matters - March 06, 2024 16:00 - 51 minutes ★★★★★ - 5 ratingsIn 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 fol...
Reimbursing Breakthrough Designation Products
Medtech Matters - January 02, 2024 13:00 - 51 minutes ★★★★★ - 5 ratingsIn 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 propose...
21- Steve Brabbs from DuPont on Tyvek
Better Product Solutions Podcast - December 19, 2023 14:00 - 24 minutesThe Better Product Solutions Podcast is hosted by Steve Davis, President at Tapecon, Inc. He's joined by experts in the manufacturing space to discuss a variety of topics ranging from flexible materials and chemistries to application technology and manufacturing processes. All conversations follo...
Strengthening the 510k Program
Medtech Matters - December 19, 2023 13:00 - 38 minutes ★★★★★ - 5 ratingsIn 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 clin...
20 - Jon Burgoon of Mativ on Advanced Wound Care Materials
Better Product Solutions Podcast - October 12, 2023 18:00 - 23 minutesIn this episode, we spoke with John Burgoon, medical sales manager for Mativ. Mativ manufactures advanced medical materials, composites, and skin-friendly adhesives. We discussed wound therapy construction, customization, and how Tapecon helps bring prototypes to scalable production. John also d...
Medical Device Manufacturing Recalls
Medtech Matters - October 03, 2023 12:00 - 46 minutes ★★★★★ - 5 ratingsIn 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 n...
AI Predetermined Change Control Plan
Medtech Matters - September 19, 2023 12:00 - 52 minutes ★★★★★ - 5 ratingsIn 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. T...
19 - Brad Hull of Tapecon on Printed Sensor Technology
Better Product Solutions Podcast - July 06, 2023 20:00 - 23 minutesIn Episode 19, we had a great conversation about printed sensors with Brad Hull, Printed Electronic Solutions Business Unit Director here at Tapecon. In this episode, we discuss the evolution and future of sensors, printed electronics, flexible hybrid electronics, portable healthcare wearables, ...
Can You Use a Recalled Device as a Predicate?
Medtech Matters - June 20, 2023 16:00 - 53 minutes ★★★★★ - 5 ratingsIn 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 follo...
18 - John Crosby from GR Label on Sustainability & Journey to Zero Landfill - The Better Product Solutions Podcast
Better Product Solutions Podcast - May 24, 2023 18:00 - 21 minutesIn this episode of our podcast, we spoke with John Crosby, Vice President of Operations at Grand Rapids Label (GR Label). We discussed GR Label’s journey toward zero-landfill, including the impetus, measures of success, reactions of suppliers and potential employees, and mentorship from other co...
17 - Aditi Subramanian from FLEXcon on OMNI-Wave - The Better Product Solutions Podcast
Better Product Solutions Podcast - April 26, 2023 21:00 - 20 minutesIn this episode, we spoke with Aditi Subramanian, Strategic Business Unit Manager for the Healthcare side at FLEXcon. We discussed how OMNI-WAVE™, a revolutionary biosensing technology, eliminates the need for hydrogel in medical diagnostic and therapeutic wearable devices. Aditi also explained ...
Leading Issues from FDA Inspections (or History Repeating Itself)
Medtech Matters - April 04, 2023 12:00 - 46 minutes ★★★★★ - 5 ratingsIn 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 di...
To Regulate or Not to Regulate…LDTs, Part 2
Medtech Matters - February 07, 2023 13:00 - 49 minutes ★★★★★ - 5 ratingsIn 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 ...
To Regulate or Not to Regulate…Lab Developed Tests, Part 1
Medtech Matters - January 31, 2023 13:00 - 42 minutes ★★★★★ - 5 ratingsIn 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...
16 - Arlene Short from Goodwill of WNY - The Better Product Solutions Podcast
Better Product Solutions Podcast - December 21, 2022 12:00 - 24 minutesIn this episode, we spoke with Arlene Short, Manager of Outreach and Recruitment for Goodwill of Western New York. Arlene discusses how the Goodwill Goodskills Career Builder program is training and connecting people in our community to meaningful work in the manufacturing and tech industries.
What Happens When the EUA Period Ends?
Medtech Matters - December 13, 2022 14:00 - 48 minutes ★★★★★ - 5 ratingsIn 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 alread...
What Does 510k Exempt Actually Mean?
Medtech Matters - November 29, 2022 14:00 - 50 minutes ★★★★★ - 5 ratingsIn 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 devic...
How Can Off-Label Use Be Promoted?
Medtech Matters - November 15, 2022 14:00 - 48 minutes ★★★★★ - 5 ratingsIn 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 ...
FDA's Intended Use Rule’s Relation to Labeling
Medtech Matters - November 01, 2022 12:00 - 51 minutes ★★★★★ - 5 ratingsIn 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...
Gaining an Advantage Through Class II Special Controls
Medtech Matters - October 25, 2022 12:00 - 47 minutes ★★★★★ - 5 ratingsIn 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. Additi...
FDA’s Refuse to Accept Policy for 510(k)s
Medtech Matters - October 18, 2022 12:00 - 50 minutes ★★★★★ - 5 ratingsIn 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...
Initiating a Voluntary Medical Device Recall
Medtech Matters - October 11, 2022 12:00 - 47 minutes ★★★★★ - 5 ratingsIn 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...
A Letter to File Deep Dive
Medtech Matters - October 04, 2022 12:00 - 45 minutes ★★★★★ - 5 ratingsIn 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? Al...
15 - Pjeter Berishaj from LA-CO Industries - The Better Product Solutions Podcast
Better Product Solutions Podcast - September 13, 2022 04:00 - 28 minutesThis episode is only our second podcast face-to-face in our post-Covid world, and we were excited to get to discuss some exciting safety technology with Pjeter Berishaj. Pjeter is the Global Sales Manager for LA-CO Industries and Tempil, Inc. and uses chemical engineering to work toward both me...
14 -Nick LaBelle from 3M on Pressure Sensitive Adhesives - The Better Product Solutions Podcast.mp4
Better Product Solutions Podcast - August 08, 2022 08:00 - 27 minutesIn this episode, we speak with Nick LaBelle, Advanced Specialist Application Engineer from 3M. As part of 3M, Nick has worked extensively with adhesive tapes and prefers to call them “Problem Solving Adhesives.” Nick’s role at 3M is to help bridge the gap between wanting a product to perform a...
13 - Mary Sennett of Tapecon - Our Compliance System - The Better Product Solutions Podcast
Better Product Solutions Podcast - June 15, 2022 15:00 - 24 minutesIn this episode, we speak with Mary Sennett, Tapecon’s Quality and Compliance Manager. Mary has 25 years of experience in the manufacturing industry. Mary discussed Tapecon’s compliance system, including documentation, inspections, and quality testing, and how we fulfill requirements for differe...
Harry Moser, Founder & President of the Reshoring Initiative
Better Product Solutions Podcast - March 11, 2022 20:00 - 28 minutesIn this episode, we speak with Harry Moser, president of the Reshoring Initiative. Harry has 55 years of experience in the manufacturing industry, including 22 years as president of GF Machining Solutions. He received his bachelor’s degree in Engineering from the Massachusetts Institute of Tec...
12 - Harry Moser, Founder & President of the Reshoring Initiative
Better Product Solutions Podcast - March 11, 2022 20:00 - 28 minutesIn this episode, we speak with Harry Moser, president of the Reshoring Initiative. Harry has 55 years of experience in the manufacturing industry, including 22 years as president of GF Machining Solutions. He received his bachelor’s degree in Engineering from the Massachusetts Institute of Tec...
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