-
-
News
News Highlights
- Books
Featured Books
- smt007 Magazine
Latest Issues
Current IssueIntelligent Test and Inspection
Are you ready to explore the cutting-edge advancements shaping the electronics manufacturing industry? The May 2025 issue of SMT007 Magazine is packed with insights, innovations, and expert perspectives that you won’t want to miss.
Do You Have X-ray Vision?
Has X-ray’s time finally come in electronics manufacturing? Join us in this issue of SMT007 Magazine, where we answer this question and others to bring more efficiency to your bottom line.
IPC APEX EXPO 2025: A Preview
It’s that time again. If you’re going to Anaheim for IPC APEX EXPO 2025, we’ll see you there. In the meantime, consider this issue of SMT007 Magazine to be your golden ticket to planning the show.
- Articles
- Columns
Search Console
- Links
- Media kit
||| MENU - smt007 Magazine
Changing Role of the Medical Device Contract Manufacturer
February 29, 2016 | Jay Wimer, ValtronicEstimated reading time: 2 minutes

In the last ten years, OEMs were chasing lower costs in other countries for manufacturing. Most recently, we are finding OEMs willing to build/manufacture medical electronics in the United States due to lower total costs and this has had an impact of the medical market on the electronics manufacturing industry. This is great news for our U.S. contract manufacturing facility.
Changes have encompassed our business in the past few years from the rising costs of medical insurance to a generational workforce; the economic changes anticipate and conceptualize our future as a medical device contract manufacturer. The biggest impact that the medical market has had on the electronics manufacturing industry is quality systems due to the regulations of medical devices.
So what does that mean for contract manufacturers? The major challenge we face today is cost, from an internal standpoint, and from a customer standpoint, it depends on what they are willing to pay for. ObamaCare's presence in the market has led to medical companies being more cost-conscious than ever.
Technology is the leading decision maker in our market. Technology allows for lower costs for the OEMs including opportunities for designers of medical devices for example. However, the changing regulatory environment is the key lead. When I say technology, I am bearing in mind, my costs to update our technology due to regulatory compliance and to stay afloat of our competition. Our most recent investment in the U.S. Offices due to continuous improvement is, an X-ray Inspection machine. Currently, we are working on updating dispensing units for encapsulation and rework systems. These are just a few items we have invested in during the past year and moving forward. Technology is not just a focused on our end, it is extremely important to the OEM to conceive, engineer, prototype, trial, approve and put to market a medical device.
In addition to investments, supplier components we also take extreme measure in reliability due to the high issuance of counterfeit component parts in the market. By utilizing a DFMEA analysis, and our requirements, we are able to ensure reliability to our components in our supply chain. Our ERP system also provides serialization and upward/downward traceability.
Changes to the medical device industry are also taking rapid change in Europe according to a study done by the European Union. Stringent changes to the medical device regulations are ahead which will bring higher development costs and slower the time-to-market. These changes/challenges will affect the entire supply chain, especially those smaller start-ups.
As the time to market trend continues to increase, we are also overhauled with innovation. Innovation is an exciting part of the healthcare industry. The biggest driver in medical electronics innovation is cost constraints that:
- Drive the reduction of medical devices
- Continued increase of millennials who are more apt to using various technologies
- Increase of biomedical graduate students
- Need for medical electronics
What we need to expect for our future is that change is relevant and never ending. Our focus is to comply with regulatory bodies and find solutions for our customers' issues. In the medical device industry, and even other industries like security or aerospace, electronic devices will continue to become more complex, smaller, lighter and faster with greater functionality.
Jay Wimer is the executive vice president of the Valtronic Group, and president and CEO of Valtronic USA.
Suggested Items
Nortech Systems Reports Q1 Results; Net Sales of $26.9 Million
05/15/2025 | Globe NewswireNortech Systems Incorporated, a leading provider of engineering and manufacturing solutions for complex electromedical and electromechanical products serving the medical imaging, medical device, industrial and aerospace & defense markets, reported financial results for the first quarter ended March 31, 2025.
I-Connect007 Editor’s Choice: Five Must-Reads for the Week
05/02/2025 | Marcy LaRont, PCB007 MagazineIn our industry, this week’s must-read features include CEE’s Tom Yang and his perspective on having a global business amidst tariff talk and other challenges. Joe Fjelstadt talks to the “Flexperts,” Nick Koop of TTM and Mark Finstead of Flexible Circuit Technologies. Nolan Johnson interviews the McGucken Group about the importance of empathic leadership in BANI times. NCAB’s Ryan Miller writes about reliability and compliance for building PCBs for medical applications, and surprise, more news from Siemens.
Fresh PCB Concepts: Key Considerations for Reliability, Performance, and Compliance in PCBs
05/01/2025 | Team NCAB -- Column: Fresh PCB ConceptsAs a field application engineer with many years of experience, I’ve conducted thousands of designs for manufacturing (DFM) analyses on printed circuit boards (PCBs). From basic one-layer boards to complex high density interconnect (HDI) designs, I’ve provided technical advice across a wide spectrum of technologies.
Real Time with... IPC APEX EXPO 2025: Exploring LCP Materials with Matrix Electronics
04/15/2025 | Real Time with...IPC APEX EXPONolan Johnson introduces Robert Berg from Matrix Electronics, highlighting the company's focus on high-speed, low-loss flexible materials, especially LCP materials. LCP (liquid crystal polymer) is a thermal plastic with unique properties that make it ideal for advanced PCB applications. Despite processing challenges, its stability and FDA approval for medical use drive interest in aerospace and medical markets.
Flex Opens New Product Introduction (NPI) Center Serving Healthcare Customers in North America
03/25/2025 | FlexFlex announced the opening of its new product introduction (NPI) center near Boston, Mass., serving healthcare customers.