Medical-device designers are continuously challenged to find ways that reduce time and cost in their design and manufacturing tasks. Offshore sourcing of product development and manufacturing is one way to lower the unit costs. However, the lowest unit cost is often not the lowest total cost, particularly when the hidden cost is increased time to market.

Cooperation between design and manufacturing teams is not a new idea, but it can be a challenge when teams must deal with language barriers, variation in market regulatory requirements, or variation in component characteristics. Developing a solid internal design and key-supplier relationship benefits the OEM by eliminating a learning curve that increases the number of design iterations or impacts product manufacturing.

Consider these questions when developing a relationship:

What internal processes does the supplier have to identify and resolve potential differences in either component selection or manufacturing practices?

Is the supplier familiar with constraints driven by medical-device regulatory requirements or does it view the project as similar to consumer products it supports?

Is there a good fit between teams in terms of competencies, language, and communications skills?

Are time differences between facilities a constraint or a time saver?

Is the supplier knowledgeable in regulatory practices required by targeted end markets?

Does the supplier have a track record with projects of similar complexity and scope?

Some teams assume that OEMs drive the offshore sourcing process. The fact is that a few offshore suppliers recognize that cutting time and cost from a development cycle (process expertise) is as important a skill as technical expertise. When design teams choose to tap that process expertise, they save time and effort.

Singapore's supply base offers good illustrations of the positive types of teaming relationships. For example, Rayco Technologies teamed with a medical-device manufacturer to develop material and components on a sleep-apnea product. The customer focused on clearly defining the end-market requirements, while Rayco focused on developing materials and processes which supported the customer's definitions for form, fit, and function. A key requirement was developing a soft elastomeric compound which had to meet requirements for both user comfort and a close fit, while meeting biocompatibility and quality standards.

Project challenges included developing tooling, demolding, process control, and assembly. Cosmetic and functional requirements demanded complex contours on the device which added to the challenge. Rayco managed needed testing to ISO 10993 standards at a third-party laboratory and produced the relevant Biocompatibility Certificate to the customer. The entire design-of-experiment from concept to prototype took three months and then was followed by a design-for-manufacturability analysis.

Another example points out how regional variations in specifications can create problems. John While Springs Pte Ltd worked with a medical-device company that needed a component consisting of a plastic part wrapped around a spring. The initial design used a part that wasn't readily available off-the-shelf in Asia. The customer wanted a substitute part that didn't infringe any patents and reduced cost.

JWS was able to design a component that met the requirements. They used a partner for the secondary assembly and managed the entire process for the end customer. An interesting aspect of this type of design-focused teaming is that it has driven demand for JWS to actually manage a higher percentage of product production. As a result, the company set up a specialized medical-industry support infrastructure including a supplier consortium and an internal business unit exclusively focused on new product development for the medical and aerospace industries.

In both examples, customers and suppliers managed distinct areas of expertise. In each case, the supplier was challenged to deliver an end result rather than simply a component. The benefits of tapping each supplier's expertise included faster development and approval cycles, and access to a wider supply chain whose capabilities aligned closely with the project requirements.

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IE Singapore is an agency under the Ministry of Trade and Industry spearheading development of Singapore's external economic wing.