Some medical OEMs will prefer to work with an EMS partner that can help drive solutions and support with medical device design, but there are others that simply need assistance at a specific stage, such as PCB assembly, higher level assembly or product configuration. There is a growing trend, however, within medical OEMs to work with an EMS company as a single, integrated partner which adds value throughout design and manufacturing process, freeing the OEM to focus its attention on core technology, intellectual property differentiators and marketing. This makes selection of an EMS partner critically important.
Rules and regulations
An experienced and trusted EMS partner will also be invaluable at providing assistance when meeting international regulations such as the RoHS recast, an existing EU directive tightened up in June 2011 to regulate large amounts of toxic electronic waste. Medical devices must comply with all RoHS recast regulations and the transition to a RoHS recast compliant medical device can affect the overall performance of the product.
This means that testing may be required to ensure reliability, verification and validation. Medical designs are renowned for long product life cycles and medical OEMs often have legacy designs that require sustaining support for the original design.
This can be a huge challenge for the customer, especially if that design features a significant number of end-of-life components. In order to meet the new RoHS compliance requirements, medical OEMs need to take the opportunity to update legacy designs. The replacements can range from simple direct replacement to complex redesign for example to replace design functionality with FPGAs.
An EMS partner will support, and in certain cases lead, medical OEMs with the redesign and transition of these products to ensure that they meet all current regulations. It will look to its supply chain to provide an effective unit cost solution. This refreshes a successful product to give it a greater lifecycle that is compliant to the RoHS recast and minimizes the potential for revenue loss. It also enables the medical OEM to develop new RoHS recast compliant prototypes with EMS support through testing and verification processes, enabling it to make secure business decisions for future product development.
With the on-going trend to outsource medical device development, defining individual core differentiators is key when looking at the development of the next generation of medical devices. In this way, it becomes evident to medical OEMs which areas are worth outsourcing to streamline their operations. Some will retain an in-house design and engineering team where others will outsource these activities and focus on the marketing of products. An experienced EMS partner will complement and enhance this activity.
Outsourcing to an EMS partner can seem a challenge but having a partner onside that can design early on in the process will optimize the process at every stage of the process from design through to manufacture.
Over the next ten years more and more medical OEMs will become reliant on EMS partners. The medical device market will become increasingly complex, more specialized and lastly, even more heavily regulated. Savvy OEMs will break through these obstacles, drive their business to the next level by adopting clever strategies and grow their operations through careful selection of an EMS partner capable of adding value at every stage of the product realization process.
Figure 1: Some EMS companies provide a wider array of services from conceptual design to system assembly and configuration / shipping devices to the end user.
About the author:
Willie MacKinnon is Vice President Customer Management EMEA with Plexus - www.plexus.com
Courtesy of EETimes Europe
If you found this article to be of interest, visit Medical Designline
where you will find the latest and greatest design, technology,
product, and news articles with regard to all aspects of clean
technologies. And, to register to our weekly newsletter, click here.