Robustness in Medical Device Development

By 20 September 2018 News No Comments
Alastair Clarke robustness in medical device development

What do we mean by it? Why is applying robustness as a philosophy so important in product development? Consultant Alastair Clarke discussed exactly why with us.

Where did robustness come from?

Robust product design is a concept pioneered from the teachings of Dr. Genichi Taguchi, which are still widely used in the product engineering process today. Deming, Taguchi and Clausing are arguably the route of wider appreciation of robustness in engineering design and manufacture, with PhDs having been written on the application of DFMA, QFD, 6δ and Robustness (or Technology Readiness), but they are most powerful when applied simply and with integrity.

Alastair first encountered the principles of robust design in discussions with Xerox engineers when they introduced him to Clausing and his use of a very interesting and profound principle that, when applied simply, solved previously insurmountable technology development problems. The power of Robustness is scalable from very simple mechanical products like Insulin Pens to complex supersystems like the International Space Station.

So, what do we really mean by Robust Design?

Robustness is a design philosophy and as such, can be applied across many different stages of the process. When applied, it means the right product is developed for the market, it has been designed and developed thoroughly, can be made routinely without any undue difficulty and can be supported in the marketplace without any unplanned intervention.

  • Marketing robustness – you know it will sell
  • Design and development robustness – you know it will work
  • Manufacturing robustness – you know it can be made
  • Supply chain robustness – you know it will get to the customer intact
  • Use robustness – you know it can be used correctly
  • Service robustness – you know it can be maintained in a cost-effective way

Not one to shy away from a challenge, Alastair really got thinking about how to achieve the above when a factory manager asked him to prove that every medical device his R&D team had designed could be made and would always work! It takes a lot of courage and thorough engineering to accept a challenge like that!!

When it comes to scaling robustness, we should first consider the product’s level of complexity (supersystem, system, subsystem, parts and features), at each of these levels, the principle can be applied. However, if you don’t know how a design’s features, parts and components truly interact then your product is unlikely to be properly robust! Functional analysis of the product, device or system provides the foundation to design and development robustness.

Applying the philosophy to your product development process has no end of benefits – but here are a few of the key ones:

  • Whilst it initially adds a short-term cost due to additional time and work in applying and dealing with any difficult to solve problems you may find, it is far better to consider this additional cost as essential so that you find issues before your customers do.
  • Limited resources don’t need to be a problem. If it stands alongside a good risk process then rational choices can be made in where to apply these resources. Having a project dashboard that records the risks and robustness status helps to manage activities.
  • The significant short term benefit is being able to run a shorter overall development timeline. Other longer term benefits will be lower overall project cost, lower production costs, lower maintenance and market support costs
  • The Primary benefit, particularly for highly regulated industries like Medical Devices, is the evidence produced by applying Robust Methodolgy.

Gaining Alastair’s insight into Design Robustness, and applying those principles have been incredibly helpful to Haughton Design, we have seen many benefits ourselves and for our clients. If you need help with improving your product and development process for increased Robustness please get in touch.