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Red Tape and 5 Market Disruptors: What’s Next for Medical Device Design

Red Tape and 5 Market Disruptors: What’s Next for Medical Device Design
With engineering developments enabling customized, remote, and otherwise futuristic healthcare options, Metaphase Design Group’s Bryce Rutter shares his thoughts on how medical device design is being optimized and what hinders it.

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.

Red Tape

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.”

2. Robotics

“The whole area of robotics is transforming surgery,” notes Rutter. “It’s transforming it because the robotics can shrink down to a size and be controlled through some type of surgeon interface that allow minimally invasive surgeries, which were typically considered to be laparoscopic, to be shrunk down even further. The research is in that the less disruption you do to the body in any procedure, the faster the recovery time. Robotic surgery, when it allows you to get small and very precise and actually makes surgeons better surgeons, has a dramatic impact on the speed and efficacy of the surgery.” Expect this area to make strides quickly, as it’s public knowledge that two big companies--Stryker and Medtronic--are looking at that area and have put together groups to pursue business.

3. Remote Care

People everywhere have begun doing more for themselves at home than at a clinic or hospital, and this trend is only expected to increase. According to Rutter, “The increase in self-administered drug regimes through auto-injectors or wearables—for example, a wearable that you would slap on your belly that slips a cannula subcutaneously, which would be automated and deliver a certain amount of a drug at specific intervals—that’s an area that would be quite disruptive in terms of the pharmacology side and how we actually deliver drugs. Rather than having to go into the doctor’s office to get a shot or go to the hospital or clinic to get an IV drip, we’re all going to be taking care of that ourselves.”

4. Personalized Care

This impressive trend is going to personalize pharmacology and be extremely disruptive while having a very positive output for patients. As Rutter describes it, “By taking our blood and spinning it down and testing it against a variety of potential drugs that could help us and also ‘type training’ each of those drugs, the future will be that the doctors say, ‘Alright, for Bryce, we want you to take this drug and because of your body mass, metabolism, and disease state, this is the perfect concentration for you.’” Three of us could have the same disease, he notes. But because it’s personalized, the amount of drug and the frequency at which we would take it would be customized to our own bodies.

5. “Smart” Instruments

Another area that’s going to be disruptive, generally speaking, is having manual instruments be “smart,” Rutter tells Design News. Here, embedded in manual instrumentation is some technology that will facilitate their use by providing certain types of feedback to the user.

As companies evolve their design and manufacturing processes to incorporate and even create these technologies, they also need to balance the need for input from end users. “With the  FDA’s requirement for formative and summative testing, you have to go out and talk to the people who use your design,” Rutter notes. “Until that was a mandate, about 75 percent of all healthcare manufacturers would engineer products with incredible technology, but forget that there were users involved—actual humans that had to pick it up, figure out how to use it, and much of that fantastic technology couldn’t be accessed because it was so difficult to use or so non-intuitive.”

According to Rutter, the impact of this mandate—to run usability testing regimes on products through the early development phases and then, as you zero in on a final design, testing that design with actual users—and also being forced by the FDA to test with all different types of users because they all have different experiences and capacities, both physical and cognitive—has really had a very positive effect. It means that the products that get to market now have really taken into account users of all types. Between such user insight and the evolution of technology, the design of medical devices will continue to improve—making healthcare easier, more comfortable, and more effective.

Nancy Friedrich recently joined Design News as Editor-in-Chief and Content Director. With a 20-year background in covering the electronic and mechanical engineering segments, Nancy has expertise across many areas. At Design News, she plans to focus on wireless and related areas.

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