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It's an exciting time to be part of the global medical device industry; a large percentage of companies have found opportunities for growth, investment in medical device research has increased and there has been a surge in collaborations, which have led to significant technological advancements.
In recent years, the regulatory landscape for medical devices has become more and more risk-focused with the aim of ensuring patient safety by taking a process rather than product-based approach. When you look closely at manufacturing processes for critical parts, such as PCBs, the specific challenges encountered mean that companies often bring in a trusted medical electronics manufacturing partner to negate risk.
Electronics are at the heart of a medical device and are responsible (alongside the software and firmware) for correct, safe and continued operation. If a medical device fails in the field, patients can’t be treated or diagnosed and that is a serious problem. This leads to a high level of business risk for the legal manufacturer (the business that is outsourcing) as they will incur the costs of replacing or repairing the device and may have fines or compensation clauses in their supply contracts.
A challenge for medical EMS providers is the need for continual supply. Once a medical device has become part of clinical practice there is an expectation from users that it will always be available where needed. Electronics have a relatively short lifespan and so an EMS provider can provide added value by helping their customers to manage these risks by implementing obsolescence mitigation strategies.
Medical electronics manufacturers must also be able to manage change control and it is vital that changes made to the design of a medical device are properly documented. This is ultimately the responsibility of the legal manufacturer but an EMS company will have to ensure that the introduction of any change is properly controlled and documented on their side too.
Supplier management is also an important consideration. A medical PCB manufacturer is required to maintain a compliant supply base for components, bare boards and so on. This is likely to involve regular auditing and continued maintenance of an approved vendor list.
When planning for the manufacture of medical electronics, cost and budget is a significant challenge. Investing in facilities, machinery, extra staff and everything else needed is a substantial expense. With big outlays comes big risk—in a nutshell outsourcing minimizes that risk and frees up a lot of capital.
There are a lot of things to consider when choosing who to work with and it is worth taking time to make sure the partner fits your needs. In the past, many organizations would be tempted by the lowest quote or fastest turnaround, but it is worth thinking more strategically than that. It is important to look beyond the present and ask questions like: If your production increases, could your preferred supplier meet these new demands? What are the benefits of working with a supplier with a quality management system (QMS) in place? Safeguarding for the future is paramount.
To help you make comparisons between suppliers, ITL has listed a set of questions to ask your prospective medical PCB manufacturer. These will help ensure that the manufacturer you work with has the right experience and expertise for you.
Editor's Note: This article originally appeared in the July 2016 issue of SMT Magazine.