Medically fit for the purpose
03 March 2008
PartnerTech’s Paul Gill and Eldon Lindsay talk to Tim Fryer about the company’s increasing focus on the medical and biotechnology sectors – and argue that while price is still important, proven sector experience, design & development capability, proximity to the customer, and meeting regulatory demands are the real critical success factors
Medical electronics OEMs are increasing their outsourcing at one of the fastest rates in the industry. According to the 2007 research report “Medical Electronics: At the Crossroads of Patient Care and Technology” from Technology Forecasters, Inc., outsourcing is expected to rise from a current penetration rate of 12 percent to 14 percent by 2010 with medical EMS revenues forecast to top US$9 billion in the next two years.
With the UK medical devices market ranked as the third largest in Europe behind Germany and France, it’s no surprise that this is a sector that is being actively targeted by contract manufacturers as a way to grow revenues and profits.
PartnerTech, one of Europe’s largest business-to-business contract manufacturing companies with 15 manufacturing centres and some 1,800 employees at sites in Sweden, Norway, Finland, Poland, the UK (Cambridge, King’s Lynn and Poole), the United States and China, is no exception and has been designing and manufacturing medical and biomedical devices for the past 15 years.
“The medical equipment market is one of our key business units and accounts for almost one fifth of total sales,” explained Paul Gill, plant manager at PartnerTech’s Poole facility, which is certified to the ISO13485:2003 standard.
“We have a wealth of experience in this sector and offer the full range of services, including electro mechanical capability, from product design, development and prototyping through to PCB manufacture and system assembly,” added Gill. “We can also offer offshore volume production if required and have a 2000 square foot class 10k clean room at King’s Lynn for manufacturing and assembling invasive medical products.”
PartnerTech works in partnership with a range of large and small companies in the medical and biomedical markets including, among others, Astron Clinica, Biotage, Pharmaceutical Profiles and Thermo Fisher Scientific.
It has worked on a vast array of different products such as blood analysis equipment, modules for dialysis and anesthesiology equipment, a mechanical heart compression system, allergy testing instruments, a male fertility tester, a digestible drug delivery system, food and DNA analysis instrumentation, a melanoma diagnostic tool, prostrate treatment equipment and a whole range of PCBAs for various other medical products.
So what’s driving the increasing level of outsourcing by medical and biotechnology product companies? According to Gill, there are a number of different factors. First, technology is developing very quickly and the latest medical products are highly sophisticated and contain an increasing amount of electronics, including wireless communications such as Bluetooth, ZigBee, and RFID devices.
Second, it’s a fast growing and dynamic sector where product innovation and speed to market is paramount so medical OEMs are keen to focus all their resources on their core competences of product development and marketing. However, says Gill, medical OEMs must balance innovation and speed to market with the need for consistent quality and conformance to product and regulatory requirements.
What do medical OEMs look for from their contract manufacturing partners? And what kind of services are most popular? Eldon Lindsay, business development manager, PartnerTech UK, explained: “While price is an important factor, it is rarely the prime consideration. Medical OEMs typically look for a financially sound partner as outsourcing relationships in this sector are often for the long term, due to extended product gestation periods, regulatory approvals and long lifecycles, so it’s important to select carefully.”
Choosing a partner with proven sector experience, perhaps one that has designed or manufactured a similar type of product in the past, is also an important consideration for medical OEMs, according to PartnerTech. “Most prospects expect to see certification to medical device standards such as ISO13485, and this reassures them that quality systems are in place to strictly control the manufacturing process and the traceability of components and materials used in the product,” added Eldon Lindsay.
PartnerTech stresses that more and more medical companies are looking for an outsourcing partner to assume total responsibility for the complete product lifecycle, and therefore they look for a supplier with a broad range of services, including product design/development, prototyping, NPI, test solutions, printed circuit board assembly (PCBA), full system build, logistics, distribution and after sales.
“The ability to provide clean sheet design, prototyping and NPI in close proximity to a customer’s own site is extremely valuable particularly during the early stages of development when there’s a lot of discussions,” added Gill. “Being local means that we can be responsive and pay close attention to our customer’s needs and, for the most part, the teams can meet face-to-face to discuss design changes. At the end of the day, we are an extension to the customer’s operation and want to encourage this kind of collaborative approach.”
According to Gill, it’s PartnerTech’s experience, engineering skills, project management and offshore manufacturing that attracts medical OEMs to its doors. “Our design for manufacture and test expertise coupled with our ability to ‘productionise’ a design is what customers find most valuable,” explained Gill.
“We have an excellent engineering team and their job is to look at an early design or early prototype and apply our in-house ‘Value Analysis/Value Engineering’ methodology to take out cost and improve performance and reliability, and ensure that it’s easy to manufacture in batch quantities and will scale to volume if needed.”
Medical OEMs are generally less concerned than their electronics counterparts with transferring production to low cost geographies. However, according to Paul Gill, most customers still see it as a desirable capability, and for some, particularly those in higher volume sectors, it’s seen as essential.
“At Poole and King’s Lynn, we have the capability to scale medical products from early design through to medium volume production – and, if required, we can seamlessly transfer production to plants in Poland or China,” added Paul Gill. “We have produced several products that began life in the UK and ended up in a low cost manufacturing region – having a unified global supply chain and purchasing team certainly makes for a smooth transition.”
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