From The Editor's Desk

Are You Designing in the Dark?

By Maria Fontanazza
March 1, 2016


• Categories: 04-Product Design & Development, 05-Quality/Regulatory, From The Editor's Desk, RC - Device Design & Manufacturing

When developing a medical device, so many different moving parts are involved. As if silos within device companies themselves are not difficult enough to get past, the broader healthcare ecosystem of clinicians, physicians and patients needs to be pulled closer to both the product development and lifecycle management process.

It’s all about speaking the same language and coming to a common understanding of where and how the end product is being used. Of course this is much easier to preach than to actually put into practice. So where can companies start?

Consider your suppliers and vendors. How many people on their manufacturing floor understand what they’re making (the component), where it’s going to end up (the finished device), and how it is going to be used (the clinical/surgical procedure)? It’s no secret that there are device OEMs who don’t interact with their suppliers in terms of providing details about where the component that they’re making will ultimately land. They can be quite tight lipped for a variety of reasons, simply providing component specs and expecting the vendor to deliver. Giving suppliers an understanding of the impact that their product has on patients changes the perception of what they’re doing, said Jeffrey Tellmann, director of risk management at Medtronic’s minimally invasive therapy group, at the MedTech Intelligence Risk Management conference last week. Medtronic has been proactive in educating its manufacturing partners by having open conversations with them and hitting on the road to show suppliers exactly how their role in the final product is improving the quality of, or even saving, patient lives every day. “We need to get suppliers to understand what components they’re making [and] how it’s supposed to work,” said Tellman. “[For example], when it works well, this is what it looks like; when it doesn’t work, this is what it looks like.”

And then there’s getting into the mind of the clinician, whether it’s from the side of identifying user needs (product development) or finding out how they’re really using your product (lifecycle management). Bringing together the engineering and clinical perspectives is not an easy task. “One of the greatest challenges is releasing your medical device on the market and [clinicians] start using it in ways you didn’t imagine,” said Art Shedden, M.D., senior safety officer at Johnson & Johnson Vision Care. In order to successfully work with clinicians, companies first need to learn the language of whom they’re dealing with (For example, terminology used by a cardiac surgeon versus a general surgeon can be very different), advised José Justiniano, manager, WW design control & risk management at Johnson & Johnson Vision Care. Learning the terms that clinicians use will also help you relate risk management to their daily tasks.

Clinical engagement and understanding device context of use are important parts of managing risk in product development and throughout the lifecycle. “What we don’t often get exposure to is what’s really happening in the clinical environment,” said Tellmann. “It’s important to identify individuals within your company who are going to be consistently engaged with the clinical use of the product.” In addition, having a process in place that captures information about where the product travels, from when the device leaves the warehouse to every place it touches until it reaches the surgical suite, is crucial to getting a holistic perspective.

In the current and future healthcare environment, manufacturers cannot afford to design in the dark. Integrating the perspectives of engineering, clinical and suppliers, and effectively managing that knowledge, is vital.