/resources/image/template/step.png Choosing an EMS Partner

Choosing an EMS Partner

There has been a significant increase in demand for electronics manufacturing services, EMS in the past ten years, particularly for high complexity, low volume medical electronic devices.

With medical OEMs facing increased pressure to reduce lead-time from initial concept to order fulfillment, they must also respond to dynamic, fast paced electronics market where competition is fierce and regulation is tight.

In addition, the current economic climate means organizations of all sizes face significant challenges and need to reduce costs, improve efficiency and ensure their internal resources are used effectively - in short, it’s a tough time to be a medical OEM.

Working with an EMS partner

Working with an EMS company can help a medical OEM to better respond to the evolving challenges of electronic device manufacture while improving return on investment on resources deployed in the manufacturing process.

Whereas in the past an OEM would call upon an EMS company to fulfill a set function at a critical stage of the manufacturing process, today an EMS company is a trusted integrated partner who can add value at ever stage of the product realization process.

So, what do you need to consider before choosing an EMS partner?

Maximize in-house capabilities and resources

Before consulting an EMS company, a medical OEM should first take a long hard look at their own internal strengths and capabilities. Conducting an internal audit enables the company to assess where their core capabilities lie and to identify any significant areas where an EMS partner can add the most value.

This will vary depending on the stage the medical OEM is at – a young start-up company will be naturally keen to maximize their value and may have strengths as a product, surgical or diagnostic company but may not have the skill in place to engineer or manufacture products themselves, making an EMS partner an ideal fit to test, manufacture and provide direct order fulfillment.

Find a partner who is the right fit and right size for you

EMS contractors have in recent years increased the scale and extent of what they can offer device manufacturers, now providing a wider array of services from system assembly to shipping devices to the end user, but not every medical OEM will want that level of integration with an EMS partner.

The question to ask is around the volume and complexity of the medical electronic device – there are companies who specialize at different levels of volume and product complexity and it’s essential to choose an EMS partner whose core specializations complement internal capabilities.

Generally speaking, most medical OEMs will have low-volume demands for electronic products and it is more practical to work with an EMS partner to fulfill this function, rather than use up internal resource.

Level of collaboration Some medical OEMs will want to work with an EMS partner who can help drive decisions and support with medical device design, whereas others simply need support at a given stage, such as quality testing, manufacture or customization.

A growing number of emerging medical OEMs want to work with an EMS company as a single, integrated partner who can add value at assembly stage and customization of finished devices, freeing them up to focus their attentions on marketing and product development.

Rules and regulations

An experienced EMS partner can also provide invaluable assistance meeting international regulations. Take for example the RoHS recast, an existing EU directive tightened in June 2011 to regulate large amounts of toxic electronic waste.

Medical devices must comply with RoHS recast regulations, and the transition to a RoHS recast compliant medical device can affect the overall performance of the product as extensive testing is required to ensure reliability, verification and validation.

This will be particularly difficult for medical OEMs who call on custom electrical and mechanical component suppliers, as not all will provide RoHS compliant processes and materials.

EMS partners can support medical OEMs with the transition to compliant products, ensuring a RoHS compliant supply chain to ensure an effective unit cost solution. This minimizes the potential for revenue loss but also enables the medical OEM to work with an EMS partner to develop new RoHS recast compliant prototypes with support through testing and verification processes, enabling the medical OEM to make secure business decisions for future product development.

Supply chain flexibility

Medical OEMs who were affected by component supply issues worldwide in 2008 and 2009, and to a lesser extent today, as vendors juggle allocations, will welcome the opportunity to work with an experienced EMS partner, allowing them to tap into a wealth of supplier design and procurement resources to provide a more competitive cost and greater flexibility – two important considerations for any OEM.

The future

While there is an on-going trend to outsource medical device development, every medical OEM will need to maintain a core engineering function or product team who can lead the development of the next generation of medical devices, while an EMS partner can complement and enhance this activity.

Over the next ten years medical OEMs will become more reliant on their EMS partners. The medical device market will become more global, more complex and specialized and lastly, even more heavily regulated, the OEM will in time become the hub around which other work is arranged, with an EMS partner adding value at every stage of the product realization process.

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