What Can Happen When Clinicians and Medical Engineers Get Together?

As a clinician, how often do you use equipment that falls short of your expectations? When you are struggling with a specific task, do you just carry on or sometimes pause to think “there must be a better way?” Questioning the status quo by challenging the current methodology is what sets an innovator apart from the rest of us. 

Mark Webster, an interventional cardiologist from Auckland, New Zealand, had exactly that moment. The established way of preparing the patient’s arm for coronary angiography via the radial artery was primitive; the patient’s fingers were taped to an arm board with the wrist hyper-extended. Although this helped with vascular access, for the patient, maintaining an extended wrist position for the duration of the procedure was uncomfortable. 

After some sketching and consideration, Webster had formed an idea of what he wanted: an arm-positioning device that would allow for quick set up over the full range of patient sizes, and a system that would enable optimal radial access as well as adjustibility so that the patient’s wrist and forearm returned to a comfortable position for the duration of the procedure (Figure 1). 

Without a manufacturing partner to develop the concept and navigate the complicated regulatory hurdles, he was aware the idea would go nowhere. Webster knew that medical product development was a specialist skill and that he would have to find a company with the resources and expertise to do this kind of project. This is what he found in Adept Medical, a New Zealand-based product development and manufacturer of medical devices.

Webster said, “I was looking for an established company that had the capability to develop my idea through to market. Adept was recommended by a colleague as being straightforward and easy to work with, and having a proven track record of developing medical products.” 

The outcome of this collaborative project was the STARBoard, an arm positioning system for optimal radial access and patient comfort. It represents a successful joint project between a clinician and medical engineers (Figure 2). 

The clinical need was identified by a cardiologist with initial concepts captured by sketch. The engineers then spent time in the cardiac catheterization laboratory to see procedures from the perspective of both the laboratory staff and the patient. Mock cases allowed close assessment of procedure workflow. This depth of engagement from both sides was critical to the success of the product. 

Working together, simple, crude prototypes were trialled in situ (Figure 3). Problems were identified and solved before the design was finalized. Both parties were able to utilize their individual skillsets; the clinician and other catheterization laboratory staff offered their first-hand experience, while the medical engineers’ knowledge of design and materials contributed practical solutions that they knew could be manufactured efficiently and at reasonable cost. 

Since product launch, the design (Figure 4) has been continually improving as post-market feedback is captured and fed back into the development process. The process ensures continual device improvement over the life of a product, forcing manufacturers to monitor and react to ongoing market feedback to improve the product.

Following the launch of the STARBoard, additional, related products have been added and released to market, as part of the ongoing collaboration between Webster and Adept Medical. These include an additional arm support to facilitate left radial access, and STARTable, an adjustable ergonomic working surface to support catheters and other diagnostic and interventional equipment. The vertical portion of STARTable also has a lead core to reduce radiation scatter from the patient to the operator and their assistant. The products have received multiple New Zealand and international awards for design and innovation since launch.

Medical product development and manufacturing companies are always looking for novel, clinician-led product ideas. The ideas described above are all low-tech solutions that improve work flow and address real user needs. Engineers can have great ideas, but they must fulfil an unmet clinical need to be successful. They need to immerse themselves in the clinical environment and experience the issues first hand. Engineers and product designers are trained in the process of problem solving and identifying solutions utilizing differing technologies and manufacturing methods. 

It is important that both clinician and development engineer collaborate closely, as while the product need can be seeded by the clinician, the medical development engineer is trained in identifying the best way to develop it. Both have the same goal of better patient outcomes.

Murray Fenton, Managing Director of Adept Medical, comments,“Clinicians are in the best place to identify the problems that need solving but don’t always have the product realization know-how. 

We find it essential to research the real need for a new idea. A lot of time and effort here pays off by eliminating the false assumptions that most new ideas encompass about the desirability or commercial viability of the product. We’ve found that the person with the idea must be intimately involved with the industry they’re targeting.

Once we have confidence there’s a true market pull — which means there’s a need as well as a market with volume and value — then we combine the talents of the designers, toolmakers, and technicians to determine the concept and optimize it for suitability, quality and production.

This involves lots of meetings and discussions. Particularly with medical devices, the regulatory requirements can also impose enormous restrictions.”

Holding on to your idea too tightly will often inhibit its development. Input from others with product development and manufacturing skills can often lead it in a different direction to the idea that was initially envisaged, while still ultimately addressing the initial product need. Keep in mind that the intellectual property in the final product will likely be from both the clinician and engineers/product designers in the device development company. 

Tips for clinicians looking to engage with a medical device manufacturer:

• Before any idea disclosure or initial discussions, have a mutual (2-way) non-disclosure agreement (NDA) in place. If necessary, your solicitor can help you with this. An NDA is particularly important if you have not already filed a patent application protecting novel aspects of your idea. 
• Your idea may be worth protecting with a patent. Get some good advice from a solicitor with regard to the expensive and timely process of patent application. When chosing a patent attorney, try to find one with experience and expertise in similar medical devices.
• Pick a company with a proven track record of developing medical devices. If possible, speak with a clinician who has previously worked with them.
• Find a product development company with an ISO13485:2003 Medical Quality System. Smaller companies without this accreditation can assist with design and development, but not manufacturing and getting to market.
• Be open to alternative means of solving your problem. While the clinician is best placed to identify the need, they may not see the best solution to the problem. 
• Be clear about what you want out of the collaboration, and formalize this with a written agreement.
• Don’t have unrealistic expectations. Medical device development is a complex, expensive and uncertain process. As a rule of thumb, it will likely take twice as long and cost twice as much as initially planned. n