Engineering and other technical advances continue to transform our daily lives in areas ranging from transportation to medicine. Medical device design in particular is undergoing a transformation with the evolution of robotics, sensing, and other technologies. In fact, the parallel development of many of these technologies is leading to several disruptive trends in the medical-device design space. Design News had the opportunity to chat with Bryce Rutter, founder and CEO of Metaphase Design Group Inc., ahead of the panel he moderated at MD&M East, part of the Advanced Manufacturing Expo, aptly titled, “Secrets of Disruptive Medical Device Design.”
Rutter’s company specializes in human-factor ergonomic design in the healthcare industry, which gives him a unique point of view. Their goal is to look at how products are used and identify where the pain points are. Interestingly, just interviewing or surveying people in these scenarios doesn’t provide adequate information. Medical device developers must take note of how individuals describe working with devices, but then observe them to see how they actually behave with them. The reason for this multi-faceted approach is that humans often have a knack for compensating for little annoyances—yet they do so unconsciously. Ideally, a medical device will be a more seamless extension of the user’s mind and body.
Yet such observations are not very easy to accomplish. According to Rutter, “With HIPAA constraints, going in to observe a surgery and do a time-motion study, in which you’re recording the procedure (this is where the a-ha moments lie—watching how people behave with the current systems) is considerably challenging. It has slowed down the design process because on average, it can take three to six months to go through all the approval processes with a hospital to gain access. By that I mean, the sign-offs from each person on the clinical team in most cases--the surgeon and assisting surgeon, circulating nurse, patient, risk management, hospital lawyers, etc. That has really slowed down the process and made it much more challenging.”
Rutter notes that the solution has been to go with more simulations by using cadaver labs, live animal labs, or test simulators and bringing users in and trying to mimic real behavior as close as possible. It’s kind of the 80/20 rule—you’ll get a lot, but you won’t get everything. But in many cases, the cost and the timeline are just out of the reach of many medical companies to try to persevere and get into the hospital.
|The Hydrodebrider from Metaphase Design Group, which is essentially a power washer that goes up your nose, is an example of how human factors engineering, hand function, and manufacturing intersect in a very positive way. (Image source: Metaphase Design Group)|
As medical design teams work to overcome these challenges, they also are reaping the benefits of technology developments. As technology boosts the development process, medical device developers should more easily be able to create products that are a more seamless extension of the end user’s mind and body. At the same time, the products should avoid causing stress, eroding dignity, and otherwise creating a negative experience for the user. Rutter points the following technologies or technology-enabled capabilities as the biggest current disruptors:
1. CAD and Rapid Prototyping
“Once you’re in the design phase, something that continues to counteract that increasing lag time to get in and get through that gauntlet of legal permissions is the speed of CAD and rapid prototyping,” states Rutter. “That’s a fantastic development for us; time to market across the product development cycle has been decreasing so we can be a lot more responsive by bringing products to a prototypical form for testing and validation and also getting them to market faster than we could have two or three years ago.”
Rutter considers rapid manufacturing technologies to basically be an outgrowth of rapid print models that are production grade. “We can rapid print metal components without having to have any expensive tooling,” he tells Design News. “With these smaller companies, as their volumes increase, we reach an inflection point where the volumes now can support a heavy capital tooling program. That’s been a big change in bringing things to market.”