The scrubs are a dead giveaway. Sort of.

Without them, Bon Ku, M.D., can easily be lost amid the sea of ordinary workfolk in downtown Philadelphia. His non-clinical ensemble of choice—a suit (either casual or formal), button-down shirt (tie optional), and matching (but stylish) dress shoes—seems more befitting of an engineer, teacher, or C-level business executive.

Ku assumes all three roles during a typical workweek, though his main job is an emergency room physician at Thomas Jefferson University Hospital. In addition to his ER duties, Ku works as an associate professor of emergency medicine at Jefferson’s Sidney Kimmel Medical College and is assistant dean for Health and Design. He also co-founded and currently directs the school’s Health Design Lab, a first-of-its-kind initiative that teaches medical students to solve healthcare challenges using design thinking methodology.

“What exactly is design thinking? My favorite definition comes from my colleague—author and designer Ellen Lupton. She says design thinking is a set of creative tools that generates ideas and solutions to meet human needs,” Ku said in a Quality Talks speech in late 2018. “The practice of design thinking uses physical prototypes, sketches, and storytelling to help teams build empathy, and actively engage with the situation. Ellen says design thinking is an open mindset that invites people to rewrite the rules of business as usual.”

Such a mindset comes naturally to Ku, whose professional career path has been anything but typical. The Midwestern native studied humanities and classics in college, and conducted research ranging from point-of-care ultrasound to improving care for Philadelphia’s homeless.

Working within the community, in fact, helped Ku realize his true calling: improving public health through a human-centered approach to care. Determined to effect change, Ku took a sabbatical from his ER job and studied public policy at Princeton University, where he encountered the concept of design thinking.

A self-admitted creative, Ku was immediately drawn to the philosophy of outside-the-box ideation. Design thinking allowed Ku to resurrect the creative muscles he had long stifled for the sake of data memorization and medical residency training’s “dehumanizing” culture. He soon began re-examining healthcare challenges and crafted solutions based on user needs.

“Design thinking helps us tolerate ambiguity. In medicine, we create solutions without bringing our patients into the conversation,” Ku noted in a 2017 Doximity op-ed Q&A. “It’s a very unilateral decision-making process. I think what design thinking really encourages us to do is to get the perspective of all the stakeholders in the room and really re-evaluate the problem. We often think we know what the problem is when we really don’t.”

“It also allows us to understand the human behind the patient—that a patient is more than their 15-minute office visit once or twice a year. At the core of design thinking is building empathy for patients and being able to understand their diseases in the [context of] their backgrounds. For me, design thinking has helped me feel less incapacitated when thinking about our broken healthcare system.”

Ku is hoping to eventually repair the system through Jefferson’s Health Design Lab, established in 2014. Its intent, he claims, is not to turn medical students into designers, but rather to help them become better doctors via creative problem solving. Students who enroll in the program learn to brainstorm their ideas, storyboard concepts, and challenge conventional assumptions to address unique healthcare challenges, such as reducing medical errors, reimagining hospital waiting areas and ERs, and devising products that improve comfort and efficiency.

Students enrolled in the Lab course are encouraged to collaborate with non-traditional partners on their solutions. One of the program’s first projects, actually, tasked medical and architecture students with improving emergency room workflow; through digital mapping, the pupils discovered that Jefferson’s doctors spent significantly more time on data entry than on patient care. To reverse that trend, Ku and his students discussed installing keyboard stations inside patient rooms, and/or making better use of scribes (employees who document care).

Not all the Lab’s solutions are so simple, though. The program—run from an old bank vault in Philly’s former Federal Reserve building—also has spawned more complex fixes like a redesigned urine cup that prevents bacterial contamination; a retrofittable bed-mounted system that determines the proper timing for turning infirm patients; a sensor-activated light that helps clinicians to provide nocturnal care to sleeping patients; and an ergonomically designed bandaging system that provides leak and odor protection for hidradenitis suppurative (skin lumps) sufferers.

“Healthcare suffers from a lack of creativity. There’s this misconception that if you’re a creative type, you’re never going to go into healthcare—you’re not going to become a doctor, you’re not going to become a nurse,” Ku told an audience last spring at Fortune’s 2019 Brainstorm Design conference in Singapore. “I believe that making people healthier is a creative pursuit. Patients and stakeholders should be active participants in the design process and not just objects that impact care. All human beings are stakeholders in the success of healthcare. I believe the future of medicine can incorporate designers on healthcare teams, and that good design can bridge the gap in healthcare.”

Good design also can bridge the innovation gap in medtech research and development (R&D), an area that has long been lacking in outside-the-box thinking. Innovation in the industry has rarely strayed from convention over the years; R&D investment dollars have mostly been spent on incremental improvements rather than breakthrough technologies—a strategy that is still largely dictated by financial viability rather than free will.

Simplicity is a motivating factor, too. Many large device firms approach R&D methodically (the “waterfall” method), wherein they isolate planning, design, importation, and product launch, and methodically complete each phase before moving on to the next. This approach, however, is not always effective at tackling innovation challenges or producing breakthrough technology. Contrarily, the “waterfall” approach can prolong the product development process and produce overly complicated devices.

“Large companies are much more likely to focus internal R&D on derivative products and incremental improvements in established markets. Large companies have worked hard to gain significant market share and to develop and installed base of loyal customers,” explained David Schechter, president of Meddux Development Corporation, a Boulder, Colo.-based engineering and development firm for interventional and minimally invasive surgical devices. “Game-changing innovation is not only risky, it can be costly to the established business and to the existing customer base. We tend to over-focus on technological solutions and features, and it is typical to fundamentally underestimate the problem we are trying to solve. Technologies and features are shiny objects that may, in fact, add only limited benefits to select users—but they also significantly increase complexity and costs. We could almost always spend more time and energy up front to better understand the problem we are trying to solve. This allows us to drive innovation efforts towards holistic solutions that can broadly serve user needs.”

Indeed, a better understanding of the problem(s) healthcare faces and the customers requiring services would enable medtech R&D to deliver the kind of groundbreaking innovation that patients crave. Such an understanding is a cornerstone of design thinking, which takes a human-centered approach to overcoming challenges.

Global professional services firm Accenture defines design thinking as way to “understand people, challenge assumptions and redefine problems...with an eye toward identifying fresh solutions that lie beyond current understanding.” In healthcare, the concept employs visualization and experimentation to conceptualize and develop products. Rigid methodologies are forsaken for the flexibility (and freedoms) afforded by interviews, observations, diagrams, storyboarding, prototypes, and role playing. Design teams focus not on technology but on real-world problems faced by doctors and patients.

Finding solutions to real-world problems, however, requires real-world research. Jefferson’s Design Lab students are encouraged to venture beyond the 908-bed hospital during their investigations; Ku often takes his pupils out in the community so they can engage in conversation with the general public. He believes that patient and clinician empathy is key to improving healthcare.

“My background in thinking like a designer and applying that to medicine has really helped me understand the importance of getting a broad perspective that’s not only my own,” Ku said last fall. “We emphasize in design the principle of empathy and that’s really understanding the emotional states of others. That’s key to medicine...”

And key to comprehending such complex emotions is hands-on R&D. Observing clinicians in their natural habitats—with all their imperfections—is really the best way to understand their emotional states, and by extension, their occupational needs.

“Years ago, I was in Ocala, Fla., to understand what the needs were surrounding a power device. I was down there watching surgeons perform procedures, and they would get ready to fire up one of the mechanical staplers,” recalled Dan Alesi, global vice president of engineering at NN Inc., a diversified industrial manufacturer of high-precision metal and plastic components and assemblies. “My team and I saw that the scrubbed-in nurse would have the gun [stapler] between her chest, upside down, pumping the handle because the doctor’s hand holding it was too sore. He couldn’t squeeze the handles—they were too hard. We saw the tip of the stapler going up and down, traumatizing the tissue, and we thought to ourselves, ‘My God.’ You have to be outside the four walls of your office to see that and understand the huge need. The stability, the precision associated with that device was gone. It hurt the doctors’ knuckles too much to fire the stapler five times in a [surgical] procedures, then go to the next procedure, and so on.”

“Doctors and their assistants will do all kinds of stuff just to get through the day and they don’t even know they are doing it. But if you stand back and watch it all—how everyone interacts—you can learn a lot,” Alesi continued. “You kind of become part of it and you understand better where the clinicians are coming from. If you’re open to being a part of it all, and you do it over and over, and you start talking with the clinicians, that’s where true innovation starts.”

Indeed, field observation is an important tool in medtech product development, but the investigative part of the R&D process can be challenging for various reasons, including unrealistic (or unattainable) clinical expectations, changing regulatory requirements, and shortcomings in digital health.

Overcoming these obstacles requires the help of both traditional and non-conventional partners. Collaborating with consumer technology or artificial intelligence firms, for example, can provide healthcare entities with the digital skills necessary for 21st century medical innovation.

Case in point: GE Healthcare teamed with NVIDIA Corporation two years ago to add AI technology to its 500,000 imaging devices worldwide, including the Revolution Frontier computed tomography system and ultrasound imaging products, such as the Vivid E95 and LOGIQ E10. The AI technology helped accelerate blood flow reconstruction and visualization flow on the machines, and improved 2D and 4D imaging for certain solutions. The technology also enabled deep learning algorithm applications for analytics, which was integrated into clinical and operational workflows and equipment.

Johnson & Johnson and Medtronic plc are reaping the benefits of outside assistance as well. Both OEMs partnered with AI firms in the second half of 2019 to improve orthopedic and stroke care. J&J tapped Zebra Medical Vision Ltd. to co-develop programs that create 3D models from cheaper 2D X-ray images, thereby eliminating the need for magnetic resonance imaging or CT scans during surgical planning.

Medtronic, meanwhile, has teamed with Viz.ai, whose AI-powered imaging software is designed to quickly diagnose and treat ischemic stroke. Viz.ai’s technology uses artificial intelligence to identify suspected large vessel occlusion (LVO) strokes and automatically notify specialists. The Viz.ai software connects to hospital computed tomography scanners and alerts stroke specialists within minutes that a suspected LVO stroke has been identified, sending the radiological images directly to their smart phones where they can be viewed. The company received U.S. Food and Drug Administration de novo clearance for its clinical decision support software for stroke in February 2018 and is currently pursuing regulatory approvals in other countries.

“I think the days of developing devices without thinking about the digital continuum are fading into engineering history for our industry,” noted Scott Larson, chief technology officer for TE Connectivity Ltd., a global industrial technology provider of connectivity and sensor solutions, for the transportation, industrial, medical technology, energy, data communications, and home industries. “TE Connectivity is all about creating a future where our innovations touch lives and connect the world. The opportunities to do this in healthcare are immense but there is a journey ahead. For example, how do we take a basic surgical or interventional device beyond simple mechanical function so that it is providing data about the patient? At TE, we are innovating to solve questions like these. For example, we recently brought a new innovation to market named VERSIO—a specialized connector for high-density signal and power transmission in a low-profile catheter. Over a one-inch diameter we can accommodate 272 contact positions for analog, digital, and fibre optic data. The potential of such innovations to gather data in-vivo is immense. We are also integrating sensors directly into our devices. Providing these integrated platforms to our customers allows for real-time feedback to physicians during a procedure.”

Clearly, feedback like the kind Larson describes is invaluable to clinicians. That feedback, however, is just as valuable to the R&D and engineering team that produced the technology. The proliferation of healthcare data not only is enabling companies to develop better products, it’s also allowing researchers to reinvent the innovation process.

Educators contend that digital health—AI and machine learning in particular—are providing medtech firms with new R&D tools that improve upon their ability to conduct research and make observations. Historically, these kinds of advancements in analytics (e.g., the telescope, microscope, spectrometer, DNA sequencer) have triggered scientific revolutions; such is the case now with big data and AI learning algorithms.

“The R&D process itself is often described as a phased, iterative approach,” explained Dorota Shortell, CEO of Simplexity Product Development, a San Diego-based product development engineering firm. “The high-level nature of how the process works will not change fundamentally. However, AI, big data, and digital health will mean that researchers and engineers are armed with a lot more information throughout the process. This means that they may be able to pull in data sets of user behaviors directly into their prototypes during the early phases of the process rather than waiting for a prototype to be complete before seeing how users would interact with it. With AI, prototypes will also be able to ‘learn’ as they start to be put in users’ hands, providing more quantitative data to the developers, rather than relying on observation of user behavior.”

Back to School
Jefferson’s Design Lab students usually collaborate with various folks during the innovation process: Other pupils (non-medical, of course), clinicians, hospital bigwigs, politicians, patients, and members of the general public (even children).

Everyone, apparently, except the obvious choice.

With its unconventional approach to product innovation, the Lab is an ideal wellspring for medtech R&D. An industry partnership would actually be mutually beneficial, as it would give device manufacturers access to new ideas, early-stage research, and scientific talent, and provide the university with much-needed funding and commercialization expertise. Collaborating with the Lab also would allows companies to “de-risk” R&D and provide research cost avoidance, saving them money even as they funnel dollars to the university.

“We live in a fast-paced world of ideas. Universities provide the earliest look at where the next big idea will come from,” Marc Sedam, associate vice provost for Innovation and New Ventures at the University of New Hampshire, noted in an article posted on the VentureWell website. The non-profit organization funds and trains faculty and student innovators to create successful, socially beneficial businesses. “Companies aligned with early-stage research see early signals of what’s going to be the next big opportunity, and they get a head start on competition.”

Such early signals are relatively easy to find, too. Many universities—especially those located in medical device manufacturing hubs (i.e., California, Massachusetts, Minnesota, the Carolinas, Utah)—offer opportunities for industry and academia to partner on medtech innovation.

The University of Utah’s Bench to Bedside program introduces medical, engineering, and business students to the world of medtech innovation. Since its inception in 2010, the program has beget 229 medical devices, 158 patents, and 64 companies. Past innovations include a knee brace/rehabilitation system, a contact-free respiratory monitor, a smaller, quieter smoke evacuator, and a no-contact wireless baby monitor. Last year’s winning device, the Mapping Otoscope, was designed to detect ear infections by identifying the fluid behind the ear’s tympanic membrane. The electronic device has a touchscreen user interface and is capable of measuring and displaying how its pre-described pressure stimulus deflects the tympanic membrane in 3D.

“The university/academic partnerships in developing cutting-edge medical devices are of paramount importance,” Raghu Vadlamudi, chief research and technology director at contract manufacturing firm Donatelle, told Medical Product Outsourcing. “The ‘for profit’ companies do not develop new medical devices unless there is a huge market for them. There is a need in the medical device industry to provide solutions for rare diseases and pediatric disorders. Universities with government grants and not-for-profit companies together can make a difference in these areas.”

Clemson University students (South Carolina) helped make a difference in Tanzanian healthcare as part of the school’s Developing World Biomedical Device Innovation Co-Op program. The initiative partners U.S.-based biomedical companies with Clemson biomedical engineering students to improve medical devices and develop new innovations that better meet the needs of patients and clinicians worldwide.

To improve medical care in Tanzania, Clemson students developed more affordable test strips and a glucometer that could be made from readily available parts. They also designed an infant warmer and grass-woven neck braces.

The diabetic equipment works the same way as conventional test trips and glucometers, but the key difference is cost. The Clemson-designed strips can be printed for about a penny each by rigging an inkjet printer to shoot enzymes rather than ink. Similarly, the glucometer is composed of widely available parts that can be found in any U.S. electronics store or bought in bulk and shipped. The students specifically designed the glucometer in this manner to ease the difficulty of finding replacement parts (in Tanzania) for broken equipment.

“Industry/academia partnerships will continue to grow into long-term relationships. Industry lacks access to direct federal funding and generally likes to focus on product development with limited focus on fundamental research,” noted Rahul Maharsia, global R&D director for Porex Corporation, a developer of advanced porous solutions and a member company of the Filtration Group. “Universities, on the other hand, have access to direct state and federal funding to work on cutting-edge concepts over longer periods of developmental times. They, however, lack the experience and capability (generally) to commercialize a new technology and would rather license these through their ‘Technology Licensing Offices’ to allow industry to commercialize their innovations. This mutually beneficial arrangement plays a pivotal role in developing cutting-edge products. Some of the other benefits of this partnership includes: Access to top scientific talent, the ability to answer fundamental scientific phenomena that industry would rather outsource, and admission to a wider array of technical resources and labs.”

Indeed, many benefits await medtech companies that partner with an academic institution. But the accelerating pace of technological advancements and increased focus on value-based healthcare is prompting many device manufacturers to look elsewhere for their R&D needs.

Outsourcing research and development has become more commonplace in the medtech industry as companies attempt to access expert knowledge and maximize their ROI. The reasons for outsourcing nowadays are as varied as the technology under development: Finances, talent, corporate growth, regulatory changes, and politics, among others.

“Some of the biggest drivers of outsourcing medtech R&D can be access to qualified people, knowledge experts, and new technology,” explained Steve Maylish, chief commercial officer at Fusion Biotec, an Orange, Calif.-based product development firm. “As the pace of technology increases, it becomes more difficult to keep R&D teams apprised of cutting-edge technology.”

More difficult and more costly.

“R&D expands and contracts with business needs. If you diversify your product portfolio, it can be a challenge to use the same team, and depending on growth, to keep that team engaged,” said Maciej Jakucki, medical device manager of Element Materials Technology, a global independent provider of materials and product qualification testing, inspection, and certification services. “It is also expensive to hire specialized talent, and that talent has to be able to grow and pivot with the company. A smaller company can’t necessarily afford to bring on all the necessary experts so they have to decide on what is least prohibitive. Increase the timeline? Risk adding the expertise? Hire temps or partner with someone who can provide the resources so the business can focus on its core strengths? It also depends on the technology your are pursuing and how long it will take to implement. In our testing business, we have seen some customers increase their R&D outsourcing over the last year. It is also becoming more common for services like quality and regulatory to be outsourced as well. With upcoming increased regulation, the political and tax environment, and the uncertainty of the future economy, outsourcing some or most of your R&D seems like an appropriate option.”