18 May 2012
Guide to Choosing an EMS Partner
Willie MacKinnon, Vice President, Plexus, outlines the questions every medical OEM should ask before appointing an EMS Electronics Manufacturing Services 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 fulfilment, 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 organisations 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 fulfil 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 realisation process.
So, what do you need to consider before choosing an EMS partner?
Maximise 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 maximise 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 fulfilment.
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 specialise at different levels of volume and product complexity and it’s essential to choose an EMS partner whose core specialisations 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 fulfil 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 customisation.
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 customisation 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 minimises 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.
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 specialised 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 realisation process.
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About the author
Willie MacKinnon was appointed Vice President Customer Management in 2012, having worked as Senior Director at Plexus since 2005. In his role, he leads the EMEA Customer Management Team and works closely with Sector Customer Management Vice Presidents to co-ordinate client projects and drive EMEA regional growth strategies.
Plexus (www.plexus.com) delivers optimised Product Realization solutions through a unique Product Realization Value Stream service model. This customer-focused services model seamlessly integrates innovative product conceptualisation, design, commercialisation, manufacturing, fulfilment and sustaining services to deliver comprehensive end-to-end solutions for customers in the Americas, European and Asia-Pacific regions.
Plexus is the industry leader in servicing mid-to-low volume, higher complexity customer programmes characterised by unique flexibility, technology, quality and regulatory requirements. Award-winning customer service is provided to over 130 branded product companies in the Networking/Communications, Medical, Industrial/Commercial and Defence/Security/Aerospace market sectors.
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