Designing devices that precisely match real-world clinical needs depends on establishing effective partnerships with end users. Too few companies are doing that, or doing it poorly.
Engineers are only human. And when it comes to developing products that end users actually want to use, they don’t always get things right. While engineers play an integral role in product development, the majority of medical devices on the market—from stents to ingestible sensors—were developed in close collaboration with physicians and other experts.
Clinicians have a key role to play in the development of medical technology, says Elizabeth Muir, project coordinator at Trustech (Manchester, UK; www.trustech.org.uk), an NHS organisation that seeks to foster the development of innovative medical products. “We encourage companies to get their input early in the design process,” she says, adding that her organisation regularly encounters inventors who have spent lengthy portions of their lives and sizable sums of money refining inventions with limited or no ultimate clinical need.
|Although physicians are routinely involved in the development of new medical technologies, there are many products on the market that are not widely adopted because they don't conform to their real-world needs and desires. Image from Flickr user opensourceway.|
Kathryn Stecco, MD, a medtech entrepreneur based in San Jose, CA, USA, who regularly oversees clinical trials in Europe, has similar thoughts. Although physicians are commonly involved in the development of medical devices, engineers generally would benefit from getting out in the field more often and developing closer ties with doctors, she says. “This is a huge problem in the industry. There are so many companies that seek limited physician input in product development,” she adds. “A lot of engineers in the medical device space are reluctant to seek outside help,” Stecco explains.
“In most companies, it is not common practice for engineers to go to a hospital [...] and hang out with clinicians.”
The very culture within some medical device companies can be an obstacle to building a long-term collaborative approach with clinicians. For that reason, it is difficult to develop a solid understanding the intricacies involved in clinical decision-making. “In most companies, it is not common practice for engineers to go to a hospital each Tuesday, for example, and hang out with clinicians,” says Fabien Schmitt, Senior Consultant, Technical Design, at London-based design bureau PDD. “Frequently, spending time with clinicians is something they have to fight for,” he adds. “It is understood that clinician input is important in the early phase of a new design project. But sometimes, especially in larger companies, the marketing department might handle many of the clinician interviews. An engineer doesn’t always get to go along, and that is frustrating for people who really want to understand the user need.”
Another consideration complicating matters is that physicians are notoriously busy and, in the United States, the Physician Payment Sunshine Act legislation may provide a further hurdle limiting physician/industry collaboration. “Still, getting physician input is critical. In this era of digital communications, I would advise engineers to at least have [remote or virtual] conversations with physicians to help them get a better feel for how things are out in the field,” says digital health consultant and former electrophysiologist David Lee Scher, MD. Scher also recommends that engineers having discussions with physicians online on non-public social media sites.
The nature of the industry/clinician relationship can vary depending on the firm’s size. “It is probably easier for big companies, because they have those relationships in place,” Schmitt says. “They already work with physicians who sit on their clinical advisory board on a regular basis. Startups will usually have to do a bit of legwork to establish those relationships.”
“In this era of digital communications, I would advise engineers to at least have [remote or virtual] conversations with physicians to help them get a better feel for how things are out in the field.”
Among startups, the collaborative process often depends on the company founder’s attitude. “Some founders understand that working closely with clinicians is critical to success, and they create a company culture to [foster] that,” Schmitt explains. “Others position themselves as the main conduit of clinical input into the company and this is obviously limiting,’” he adds.
“The doctors you talk to will, at some point, become your clinical advisory board, if they aren’t already. For that reason, it is important to try to work with a mix of physicians and get a variety of perspectives,” Schmitt says. “A lot of companies go for the most high-profile names because that helps their new product get a higher degree of public exposure. However, in terms of developing a product for the mass market, you want to make sure you talk to physicians with a wide range of skill and experience,” he says. Especially with usability becoming more important in terms of FDA guidelines, there is now more focus than ever on developing a device that minimises the potential for errors, says Schmitt. “Creating something that is intuitive to use and easy to pick up is important. And [gathering] input from people of various skill levels is an essential component in this process.”
Scher stresses the importance of seeking out physicians with a certain degree of altruism. “I’ve seen advisory boards where the physicians are just thinking about what they would like personally. They sometimes don’t put their corporate hat on and thinking of what is good for the company and the rest of the world.”
For whatever reason, there are many products on the market with features that clinicians either don’t use or don’t especially like. As example of the former, Scher points to implantable cardiac rhythm management devices that are often bundled with many features that “doctors don’t use because they don’t know they exist.” Electronic health record (EHR) systems are an example of the latter. “I can’t tell you how frustrated most doctors are with the EHR software used to order tests,” says John J. Pan, a radiologist at Harvard’s Brigham & Women’s Hospital and advisor to radiology startup Nephosity (San Francisco, CA, USA). Nephosity is profiled on the medtechinsider blog. “In the past, if a patient hurt his or her shoulder, a doctor only had to write ‘MRI of the shoulder’ on a piece of paper. But now, he or she has to log into the program and go through at least 50 mouse clicks and enter a bunch of information in multiple drop-down menus,” he adds. “And of course, every click is a chance for an error to occur.”
“So that is the challenge: to come up with something that is really, truly easy to use and makes doctors’ lives easier.”
“When I try out a new product, if I don’t like it after using it a couple of times, I am not going to use it again unless I have to,” Pan says. “Physicians have way too many things to think about,” he says. “So that is the challenge: to come up with something that is really, truly easy to use and makes doctors’ lives easier.”
On that note, Florian Altmann, Health Lead Europe, IDEO GmbH (Munich) advocates bringing a consumer design focus to medical technology. “One could think that designing for well-trained professionals, such as pilots or physicians, [would be] similar and completely different than [designing] for consumers.” In the end, though, the user experience for any product is based on emotional response and user preferences and options. “These emotional drivers can be strong enough to make or break all efforts. This means that we treat design in the area of healthcare as we would treat design for consumers.”
A good number of medical device ideas for future products come from influential physicians who, when evaluating a device, gives the manufacturer feedback on the technology. Another approach is based on the simple observation of clinical workflow. For instance, IDEO designers Arvind Gupta and Danny Stillion had observed in watching spinal surgery that a surgeon was unable to touch a 3-D navigation device because its surface was not sterile. Surgeons had developed a frustrating workaround where they would ask a nurse to touch certain parts of the touch screens on their behalf. To address the issue, the designers developed a sterile mouse for surgeons to put them in direct control of the device.
In 2006, design firm IDEO assisted Medtronic in the development of the StealthStation surgical navigation system for spine surgery. IDEO spent three months doing clinical observation work in a number of hospitals observing surgeries in a variety of hospitals to learn about the workflow in the operating room.
When doing field research, it is often helpful to bring along people who can observe clinical workflow with a fresh eye, Schmitt recommends. “Sometimes a surgeon will have spent 10 years working with a certain instrument. He or she will be performing a task in a certain way without realizing, for example, that the instrument is putting additional strain on the body because of bad ergonomics,” he adds. “Sometimes a product doesn’t change simply because there are insufficient incentives for the stakeholders to change the status quo. Specifically, if companies are making a product that hospitals are buying and the surgeons aren’t complaining, there is a high risk of innovation stasis,” he adds.
“Fresh eyes and experienced collaborators, various backgrounds and open communication ensure that the [well-trod] path is challenged.”
“This is also where an interdisciplinary approach helps to uncover innovation opportunities. Fresh eyes and experienced collaborators, various backgrounds and open communication ensure that the [well-trod] path is challenged,” says Altmann.
Often, the seeds for new products are planted when a medical device sales rep, or another company representative, visits a doctor and hears his or her frustration concerning particular products. “Or they will hear from us what we would really like,” says anaesthesiologist Lynn Webster of the Salt Lake Surgical Center (Salt Lake City, UT, USA), who has assisted companies such as Medtronic, Boston Scientific and Covidien with product development. The dialogue between physicians and industry can vary from a single casual conversation to off-and-on communication that spans a decade or longer, he adds.
While insight from physicians is critical in product development, simply asking a physician what problems he would like to see solved has its own pitfalls. “Physicians generally don’t have an engineering background. So they’ll define the problem in their vernacular,” says engineer and entrepreneur Mir Imran of InCube Labs (San Jose, CA, USA), who holds more than 200 patents and was instrumental in the development of the first implantable cardioverter-defibrillator. “Engineers’ vernacular typically doesn’t intersect very well with [clinical language]. An engineer’s understanding of a clinical problem might be incomplete even after hearing a physicians’ description of it. So unless the engineer is willing to incorporate knowledge of medicine in his or her brain, that person is not going to be a good innovator,” Imran explains.
“Unless the engineer is willing to incorporate knowledge of medicine in his or her brain, that person is not going to be a good innovator.”
Extensive clinician feedback is especially important in regards to disruptive innovations that address unmet clinical needs in a completely new fashion. “Disruptive innovations require a deeper understanding of diseases at a very fundamental level. Such innovation requires being able to go backwards and look at the problem in its very earliest form—the disease stage, for instance,” Imran says. This process requires vigorous investigation of both the clinical problem as well as the technology now used to treat it. “The assumptions underlying the problem or the definition of the problem have to be re-examined, and that requires by definition a deeper understanding of both medicine and engineering,” Imran says.
“During all this, the entire ecosystem should be kept in mind, including the ultimate recipient of the care. Ideally, designers and engineers observe the patients-physician-interaction in the disease area in question,” says Altmann in this context.
“Once you have a critical mass of information about an unmet need and you have validated it, the next step is to generate ideas on how to address it,” Schmitt says. “When generating ideas, you want to be as broad and creative as possible. Stop yourself and your team from jumping to a solution early on. Try to generate as many ideas as you can knowing they will later be filtered down using selection criteria based on your understanding of the unmet need.”
At this point, it is important to keep the focus solidly on the unmet clinical need rather than a particular technology. “In the very beginning, ideas for new medical devices should be all about helping the patient,” says Zeljko Roncevic, MD, PhD, a pediatric cardiologist based in Mostar in Bosnia and Herzegovina.
“In the very beginning, ideas for new medical devices should be all about helping the patient.” —Zeljko Roncevic, MD, PhD
Engineers are sometimes tempted to pull out a tool to address a clinical problem before completely understanding the need, says Mir Imran. “For instance, a mechanical engineer who has worked with catheters might be tempted to solve every medical problem with a catheter,” he explains. ”Or the engineer may jump to a solution for a clinical need based on a partial understanding of the problem.”
Using the information gained during the needs validation phase, the next step is to filter down the ideas to those that look the most promising. “This part is always very exciting,” says Schmitt, “because you are entering the iterative phase of the design process. As you start fleshing out ideas, building prototypes and testing them out, you will inevitably gain new insights that will lead to a better design.” In this context, usability ought to be seen as an opportunity. “Regulatory changes over recent years have really brought usability into the limelight,” continues Schmitt. “Here at PDD, we are keen to convey to our clients that formative usability studies in particular are a real opportunity to get an edge in the marketplace. By having engineers work alongside human factors experts and designers, the studies can do much more than ‘checking the regulatory box’; they can lead to a richer understanding of the user and thus safer and more user-friendly devices.”
“Sometimes, engineers don’t know what they don’t know. They may think they have a good idea but not know that it has regulatory or clinical problems.”
In conversations with clinicians, it is also important to get an understanding of how your product ideas would affect their workflow, and the degree to which your product will require the clinical community to be educated. A product idea may have significant potential to improve patient outcomes, but if it requires physicians or nurses to significantly alter their approach to patient care and, this is a hurdle that needs to be understood and managed. Or perhaps the reimbursement code given to a new product would result in clinicians being paid less for a procedure than if they used conventional technology. “In that case, they might prefer to use the old treatment because there is a hidden financial incentive to do so,” Schmitt says.
For all these reasons, the evaluation process for new product ideas should also involve collaborating with a cross section of experts—not just clinicians. Your team also should include experts on topics such as intellectual property, regulatory pathways, and reimbursement. “Sometimes, engineers don’t know what they don’t know,” Stecco says. “They may think they have a good idea but not know that it has regulatory or clinical problems.”
Brian Buntz is Editor at Large of EMDT sister publication MD+DI.