Medical device manufacturers face unique challenges that other manufacturers simply do not have to face. Lou Washington reviews the impact of these market realities in terms of engineering changes over time.

By their very nature, medical devices face a much higher regulatory bar. Also, their useful life span is highly volatile due to technological advances, changing treatment protocols, market conditions, social convention or changes within the biology of a given disease. Almost all manufacturers will modify products over time to address changing needs or all sorts. Medical devices, meaning those devices that either diagnosis or mitigate illness, are no exception.

This article will review how engineering changes must be documented over time to assure that any device in use is properly equipped to address the application it is addressing. Specially, it will look at how technologies such as engineering change control systems and product lifecycle management (PLM) are used to make sure products in the field are kept current.

Products evolve. They change over time in response to the environments in which they’re being used and in the operational demands they are subject to. For simple, low-complexity products, this doesn’t present an issue. But for long-lived products, especially those with complex designs, large numbers of parts, configurations and other variability such as being subject to strict regulations, engineering changes can become tough to track.

Furthermore, the longer a product is in service the more important it becomes to understand the history of that product to differentiate it from other iterations deployed in the field. This has major implications for field maintenance and product support.

In the medical manufacturing industry in particular, auditability is a major requirement. Effective systems and technology to manage and document engineering change are crucial. Here are the top four reasons that medical manufacturers should have an engineering change control plan or system in their business:

  1. Engineering change control systems can be essential to avoiding unnecessary product recalls. Product defects that manifest themselves years after production may be limited to a small lot or percentage of the overall production run, or they may be universal to the entire product line. Well documented engineering change histories over the life of the product may determine the extent of the defect and hopefully limit the scope of the recall.
  2. New products frequently require change because of unforeseen usage complications encountered in the field. Older products’ requirements may change because of conditions in the field such as medical research developments, new diseases and procedures required or even unprecedented reactions and outcomes of use. Additionally, regulatory changes may affect products in the field as well as new production. Medical research is ongoing, never ending and always driving change in treatment protocols and device specifications. Engineering change control systems allow manufacturers to modify bills of material, change design, part or assembly specifications, and specify alternate or optional configurations to reflect changes driven by market, regulation or research.
  3. The regulatory environment. In Australia the Therapeutic Goods Administration (TGA) publishes a manual on regulations affecting medical devices built, sold and used in Australia. These regulations can affect the specification, configuration and other parameters related to design, composition and use of any product. These drive change at least as much as market forces or market driven improvements in design. In this case engineering change control allows medical manufacturers to reflect needed changes in design as specified by the changed regulatory requirement. Of equal importance, documentation related to the change is disseminated and tracked and stored to provide evidence of compliance on the part of the manufacturer as well as the deliverer of services.
  4. Staying competitive in a globalised market.

Engineering change control supports the whole notion of mass customisation in terms of maximising the utilisation of common parts and assemblies and minimising the need for one off designs that are either wholly useful or wholly obsolete. Economies of scale associated with volume discounts are not lost when a machine design changes. This means significant improvements or changes can be engineered into existing models without the need for a ground up re-design or build. Existing part inventory can be utilised and even existing assembly inventory can be modified and brought to current.

The change process covers: the initial requirement determination; problem analysis; a specific change request; a record of the specific changes suggested and documentation concerning the suitability of the change; costs involved; impact analysis of implementing the change; planning the change implementation; reporting and documenting the change; releasing the change; and finally reporting on its effect. When you consider all of those steps repeated many times throughout the life of a product, you can understand the challenge involved in doing this well.

Medical device manufacturing is doubtless one of the most demanding manufacturing sectors a company can participate in. Engineering change control facilitates economies for manufacturers and provides documented history of products in the field. The manufacturer that is able to exploit this level of dynamic requirement and still thrive will bring a clear advantage to market.

Lou Washington is a manufacturing expert at Cincom Systems. Cincom offers Configure Price Quote (CPQ) solutions to Australian manufacturing businesses looking to streamline sales and better link front- and back-end processes