Nolan’s Notes: The Eyes Have It
Global Sourcing Spotlight: Meeting the Challenges of Global Sourcing
Standard Of Excellence: The Products of the FutureTop 10 Factors to Consider When Selecting a Medical EMS Company
January 13, 2016 | Mo Ohady and David Estes, Digicom ElectronicsEstimated reading time: 2 minutes
What makes for a successful contract electronics manufacturing relationship and what does a medical device company need to keep in mind and consider during the selection process?
Once the decision has been made to use an electronics manufacturing services (EMS) company, selecting the right one involves several steps. Although most EMS companies perform the same basic services, every EMS company is different. You can tell when you walk into a place, examine the equipment and processes, and speak to the people.
Number 1: Prepare a List of Requirements
The initial basis for narrowing down your selection is to prepare a list of the basic requirements you expect an EMS provider to meet and detail specifically what you want the EMS to do—design, prototyping, material selection and purchasing, manufacturing, test, process validation, shipping and logistics, etc. Do you need manual or automated processes, small quantities or volume manufacturing? Is the EMS able to offer the range of services that meet your needs?
Number 2: Certifications
Does the EMS provider have the appropriate quality certifications to manufacture the product? There is no room for error with medical devices. A basic requirement for the medical market is ISO 13485:2003, the medical device manufacturing certification. This certification states the requirements for a comprehensive management system for the design and manufacture of medical devices, ensures that medical devices meet customer and regulatory requirements, and establishes a commitment to quality. The FDA’s Quality System Regulation 21 CFR (Code of Federal Regulations) 820 requires medical device manufacturers to perform a process validation when the process is not fully verified by a subsequent inspection or test. Process validation ensures that a process consistently produces a product that meets its specifications. It is an important component in the design, prototyping, and manufacturing process and one that, if done correctly, can save a considerable amount of time, money, and resources. By using an EMS provider that already has ISO 13485:2003 certification, regulatory bodies know that certain procedures and requirements will be met, so certification is less labor-intensive and approvals proceed more easily.
Number 3: Location
Check out where the EMS is located, where design and manufacturing are done, and make sure the size of the company is a good fit for your needs and products. Do you want the product manufactured close to where your company is located, close to where the product will need to be distributed, or are you manufacturing large volumes where cost is a major factor so a low-cost geography might be more beneficial? Considerations in choosing a location are the complexity of the device, process transfer, IP protection, shipping costs and time, and the degree of involvement you will need throughout the process.
Editor's Note: This article originally appeared in the January 2016 issue of SMT Magazine.
Share on:
Suggested Items
NOTE Grows in Medtech Through Strengthened Partnership with Global Company
08/29/2023 | NOTENOTE has strengthened its partnership with one of its long-standing customers, an industry leading company that is involved in the development of advanced medical devices.
The Doctor’s In: Beyond the Horizon—Exploring the Digital Future of Health
08/07/2023 | Henry Crandall -- Column: The Doctor's InIn today's fast-paced world, where technology has infiltrated almost every aspect of our lives, it is no surprise that the healthcare industry is undergoing a digital revolution. The convergence of health and technology has given rise to an era of digital health, reimagining how we approach patient care, monitoring, and even medical training. Despite a projected market value of $800 billion by 2030, and an impressive compound annual growth rate of 18%, you may feel that digital healthcare doesn’t seem to have reached your local clinic. Stay tuned. This article will walk you through how digital healthcare plans to reform every aspect of the medical landscape.
Resonetics, Resonant Link Announce Partnership
07/18/2023 | ResoneticsResonetics, a leader in implantable medical batteries, and Resonant Link, a leader in wireless charging, have announced a strategic partnership to provide integrated power solutions for the implantable medical device industry.
Congressman Emmer Visits Chaska-Based Circuit Board Manufacturer
07/07/2023 | Congressman Tom EmmerOn Wednesday, Congressman Tom Emmer (MN-06) toured Pro-Tech Interconnect Solutions. Pro-Tech’s Chaska facility has 83 employees and manufactures printed circuit boards for the military, aerospace, medical and commercial industries.
Kepler SignalTek Expands to New Batam, Indonesia Facility
05/18/2023 | VolexKepler SignalTek was founded in 2017 by Scott Hayden, a veteran of the medical device and interconnect industries with over 35 years of experience in leadership, design, and manufacturing.