Companies looking for a contract manufacturer for their latest product have a range of options that range from low-cost but low-quality through to high-end medical grade production. For some products, the choice is obvious – as in the case of a semi-disposable children’s toy versus a safety-critical device where lives are at stake if it fails.
However, there is a vast grey area in the middle where the choice if not so obvious. Many companies want to deliver a quality product but also want it at an affordable price.
Most contract electronics manufacturers in the middle ground have ISO 9001 quality systems in place now. However, at the top end of the market, a few manufacturers have been certified to the IS0 13485 quality standard for the manufacture of medical devices. ISO 13485 is a much more stringent standard, due to the demanding requirement of medical regulatory authorities around the world.
A question immediately arises around whether the higher grade of quality is right for you. What do you get with the higher level of quality? Do you really need it? Can you maintain quality if you try to shift manufacturing off-shore to save a few dollars?
The answer comes down to your tolerance of risk. If reliability is a high priority for your organisation, then the business case for a higher standard of quality is easy to make. Let’s expand on the rationale for choosing an electronics manufacturer certified to ISO 13485.
A few key drivers govern the choice of quality, as follows.
• Impact of device failure: For some companies, the impact of a product failing in the field is of critical importance. The consequences range from the cost of replacement and repair through to the reputational damage and the possibility of lawsuits for economic damages flowing from the failure. If you can’t afford to have frequent failures, then you need to invest in higher quality.
• Unit cost: In electronics design and manufacturing, higher quality directly translates into the unit cost of an assembled printed circuit board (PCB) and the amortisation of design costs over the life of the product. Where the business case for medical grade quality stacks up, is when the overall price of the assembled unit is far higher than the amortised unit cost of the PCB. Many other cost factors come into play including mechanical engineering of the device, integration into broader organisational systems, regulatory approval processes, and branding and market development. When the cost of the embedded electronics is a small fraction of the overall cost, reducing the cost of the PCB increases the risk to the total investment dramatically for little gain.
• Problem resolution: The defining feature of ISO 13485 is the robustness of traceability from concept to deployed product in the field. At the design stage, requirements are traced through to the final schematics. At the manufacturing stage, the source of components are recorded, and every single component is tracked through to the actual device deployed in the field. What this level of traceability delivers is the ability to analyse problems as they arise and quickly resolve them. In the worst case, it facilitates product recalls. When companies have product operating at the cutting edge, where designs are frequently changing and it's important to have a high level of control, then superior quality systems are required.
Circuitwise’s General Manager, Serena Ross, argues that every company should be applying ISO 13485 level quality to the development of every product.
“We have totally integrated ISO 13485 into our manufacturing processes. Unlike other manufacturers, we don’t turn on the ISO 13485 process as required – we do it for every product we manufacture. We have positioned ourselves as the most reliable electronics manufacturer in Australia.”
Circuitwise has invested heavily in software systems to automate the quality management process and integrate them right onto the shop floor. The result is a level of automated quality that is allowing the company to company to compete not just on quality but on price as well.
“We recently had a customer who got a second quote from a manufacturer in Asia. The customer told us our quote was within 10% of the offshore price. When you consider all the difficulties and risks associated with offshoring the manufacturing process, the choice to go with an Australian-based ISO 13485 certified manufacturer was obvious,” Serena said.
Other factors to think about include the choice of electronics designer. Usually, electronics manufacturers take delivery of a manufacturing package from an electronics design consultancy. The package will typically consist of PCB schematics, a bill of materials, assembly instructions, firmware files and testing procedures.
The relationship between the designer and the manufacturer is of critical importance in ensuring a highly reliable product. It's important to effectively and quickly resolve questions around manufacturability and component selection. The better the quality of the manufacturing package, the less likely it is that errors will creep into the design of the final product.
If the product also has mechanical components or is handled by humans, then an industrial designer may also be required to develop the device.
Circuitwise has relationships with electronics and industrial designers that also have ISO 13485 certification. Working together with these partners, Circuitwise can facilitate the entire product development process at the highest level of reliability possible.