From Surgery to Cybersecurity, New Approaches to Medical Product Development

Device engineers can apply a variety of methods—from studying the nuances of a surgical procedure to using design thinking to ‘hack’ healthcare challenges—to accelerate innovation and lessen the risks of developing new technologies.

By Mark Shortt

The decision to develop a medical device to solve a critical healthcare issue is fraught with substantial risk. From the beginning of the design through the product’s use in the field, there are pitfalls to avoid and opportunities to embrace. And if you’re a medical device engineer who wants to develop a better surgical instrument, it’s important to know if you’re on the right track with your new design.

If you’ve identified a real clinical need that your design will attempt to solve, you’re starting off in the right place, said Dr. Denise Gee, M.D., an advanced laparoscopic surgeon specializing in minimally invasive general and bariatric surgery at the Massachusetts General Hospital. But recognizing an unmet need is often more difficult than it sounds, as it requires consistent and studious interactions with surgeons over a sustained period of time.

“For a device engineer, it’s really a combination of talking to surgeons and learning more about the problem—what  the issues are and how to address them—and also seeing the operations,” Gee said. “And then continually talking to the surgeons as you’re developing the product.”

Gee spoke with D2P in May at the BIOMEDevice Conference in Boston, shortly after participating in the panel discussion, “Addressing Unmet Needs in Minimally Invasive Surgery.” She said that ideally, the engineer and surgeon are engaged in an iterative, back-and-forth process that includes frequent feedback on the prototypes being developed. Continuous, open-minded communication is the key.

“You can’t just run off and start developing something in a vacuum. You have to continually refine it,” Gee said. “All parties have to be actively involved throughout the process for it to be the most impactful, clinically, in the long run.”

To refine the design, the engineer may need to go back into the operating room and observe more surgeries to absorb the nuances of the operation. It’s a critical piece of the product development puzzle that’s often missing.

“Everyone has their own specialty field, whether it’s medicine or engineering, and so it takes a while to really immerse yourself and understand the nuances of that field,” Gee said. “It requires continual communication and interaction with surgeons, going into the operating room, researching the details of the operation, and then, after a product prototype gets developed, continuing that process in an iterative fashion.”

Gee uses a variety of laparoscopes and laparoscopic equipment in her work, including graspers, dissectors, staplers, and energy devices. She sees the ergonomics of these devices—particularly the handles of graspers and staplers—as areas where surgeons and engineers could work together to devise more innovative solutions.

“For ergonomics, they’re continually improving, but I think there’s always room for new features that could be developed and incorporated in the future,” Gee said. “Stapler handles and the ergonomics of how to fire a stapler have improved considerably over the years, so that they require less force and are easier to manipulate. Similarly, the handles for energy devices have gone through many iterations and are also more user friendly.”

Surgeons would also benefit from technologies that deliver better optics and a wireless environment, she said. The laparoscopic surgeries that Gee performs require a camera cord, a light cord, and suction tubing for the suction irrigator. There’s also gas tubing that pumps carbon dioxide in; potentially an energy cord, and usually an energy device that also has a cord.

“That’s a lot of cords that get thrown off and can potentially get tangled,” she said. “If the majority of those became wireless, it would clean up the operative field, and you could move around more easily while you’re performing laparoscopy, with fewer obstacles in the way.”

Starting with the Right Question

Al Mashal, principal engineer with Cambridge Consultants’ Medical Technology Division, also participated in the BioMEDevice panel discussion on addressing unmet needs in minimally invasive surgery. He said if medical device companies want to be more innovative in their designs, the key is to start with the right question.

“The best innovation is trying to solve a real unmet need, a real problem, and that’s where you want to start,” Mashal said. “You want to be talking to doctors, trying to uncover unmet needs—both current and latent needs that are not known yet. That only happens through interactions, observing surgeries, talking to doctors.”

Mashal said that device makers need to focus on how they can design devices that improve clinical outcomes. “What are we doing to help improve clinical outcomes?” is a question that they should be able to answer readily. Their designs should reflect that mindset and address the problems voiced by surgeons and clinicians, rather than trying to solve a problem that really isn’t there, he said.

“You have to do your homework and address all the key elements, starting with identifying the problem. Once you move past that, you have to de-risk the technology, too. You can’t just pass that off.”

Mashal, who has a Ph.D. in electrical engineering, said he has seen startups who may have identified a problem and had a potential solution, but then “kicked the can down the road” instead of rigorously de-risking the technology. “On top of everything else, that’s an additional [step] that has to happen early, so that you have a successful product,” he said.

One of the platforms that Mashal works on at Cambridge Consultants is the development of minimally invasive devices, an area in which he sees multiple trends. One trend he sees is a move toward designing the next generation of devices with sensing capabilities that can assist with intra-operative decision making. These include technologies for intraoperative detection of cancer, as well as tools that identify critical structures that surgeons are trying to avoid during surgery.

Another trend is visualization of the surgical site, a challenge that is multiplying as  increasing numbers of surgeries become more minimally invasive. The smaller workspace required in minimally invasive surgery makes it very challenging for surgeons to see, especially for new surgeons who are trying to gain experience, Mashal said.

“So, the question is how do we aid surgeons by designing devices that allow them to use traditional laparoscopes, and combine that with smart tools, as well as pre-operative planning, to help them navigate the surgical site and take that pre-op plan and execute on it, intraoperatively.”

Speed Can Mitigate Risk

Contract manufacturers play a key role in bringing innovative product designs to market. Ben Masnado, strategic accounts manager at Protolabs, said that although the requirements of medical OEM customers depend on the various stages of product development, speed is usually among their most pressing requirements.

“Speed is often number one, no matter what stage they’re at,” Masnado said in an interview. “Every one of these products has a competitor. They’re constantly pushing the market faster. I was at a customer a couple of weeks ago, who said, ‘It seems like every two to three weeks, our competitor has a new product to market.’ We’re trying to keep pace with that.”

Protolabs is a digital manufacturer in Maple Plain, Minnesota, that specializes in rapid prototyping and on-demand production.  The company offers manufacturing processes that include injection molding, CNC machining, 3D printing, and sheet metal fabrication. Masnado said that although Protolabs’ customers are often looking for the fastest way to get to market, they’re not willing to absorb “a ton of risk” that speed could, potentially, introduce. “They need to combine speed with the iterations required to reduce that risk,” he said.

The medical manufacturing industry today comprises thousands of OEMs that produce a wide array of devices, from handheld surgical devices to enclosures, housings, and ventilators. Each device has a unique design, and each component on each device carries a certain level of risk. But they all seem to have one thing in common: They are in a race to get to market first, Masnado said.

“Protolabs is really well-suited to help them in getting to market fast, with the unprecedented speed that we offer, not only in our quote turnaround time, but also in the lead times,” Masnado said. “These lead times also allow customers who are developing these devices to mitigate a lot of that risk as they’re designing them, because they can do it so quickly.

“They’re shaving tons of time out of the development cycles; they’re utilizing some of our tools that we have to digitally design and iterate much faster than they’ve ever been able to, so that when they’re ready to submit these products to the FDA, or to market, they’ve essentially perfected them and eliminated a lot of, if not all of, the risk.”

Masnado said that Parker Hannifin’s efforts to mitigate risk—all while shortening its design cycles by manufacturing parts faster—led the company to Protolabs for assistance with its Indego robotic exoskeleton project.

The Indego robotic exoskeleton was a very different project for Parker Hannifin, a large company that had produced thousands of legacy products and built its supply chain accordingly. Early in the project, Masnado said, the Indego team would wait weeks for quotes from their traditional manufacturing suppliers, all while being tasked with a very aggressive development schedule.

“Their deadlines would come and go before they even got a quote back,” he said. “And they knew they were entering a marketplace that was highly competitive, where every day of product development could make or break the success of what they were producing.”

The product that Parker was developing—a robotic exoskeleton that helps patients with lower limb paralysis walk again—carried a substantial level of risk, Masnado noted. To deliver on the promise of helping people walk again, every component needed to work in harmony.

The risks, however, could only be mitigated through a series of iterations that required prototyping, testing, and making any necessary revisions to the parts. That was the only way to ensure that any engineering and quality issues were resolved. But because the Indego team was operating within a very condensed timeline, the iterations needed to be done more quickly than Parker’s team had been used to working.

“It was a pace they weren’t used to because they had been developing industrial products that maybe didn’t have this type of demand,” Masnado said. In the end, Parker eliminated the risks and sliced months off its development time. “It’s a great example of how a medical device company can get a product on the market quickly, all while eliminating a ton of risk along the way with the Protolabs services,” he said.

“I work on a lot of medical device type projects, but this one was really fun and rewarding. I got to be on the front end of the development of a device that a bunch of smart people designed and developed, and that allowed people who thought they would never walk again, to do just that. It was incredibly rewarding to see all of the work go into this, and then see it hit the market and see people stand up on their own again.”

Design for Manufacturability Looms Large

Matt Maunu, chief operations officer for Rubber Industries, told D2P that medical OEMs are interested in finding partners who can “work with them from start to finish on existing and new projects.”

“I think one of the biggest challenges that we see in medical devices is really taking those new projects from concept and design to mass production and manufacturing,” Maunu said in an interview. “That’s where I think Rubber Industries can really help our medical device manufacturers and OEMs—in designing for manufacturability (DFM).”

Rubber Industries, a 50-year-old company based in Shakopee, Minnesota, produces custom rubber, silicone, and liquid silicone (LSR) parts for medical, automotive, and industrial applications, among others. The company has a legacy of long-term relationships with its  customers, and specifically, with many of its medical OEM customers, Maunu said.

“Our OEM customers, ultimately, are coming up with the end design, but we’re able to apply our industry knowledge and expertise to the design work that our customers have done,” Maunu said. “We apply our expertise for the manufacturing process, and this helps our customers with product development. They know their project can be successful, for prototyping and into the startup phase, and into mass production.”

Maunu emphasized that because of the strict requirements of the medical industry, it’s important for customers to have the design discussions and design for manufacturing assistance early.

“We can make sure that those pain points are eliminated on the production side if we can really do some design work, and especially the design for manufacturing work, on the front end of those projects.”

An example of Rubber Industries’ design for manufacturing assistance was the company’s work with AJB, LLC’s Dr. John Boone, M.D., the developer of an award-winning ear drug delivery device called the clEARdropper. Maunu said Rubber Industries worked under a compressed timeline to get Dr. Boone up and running with samples for testing, and then ready for production.

“Dr. Boone came up with that idea and had some design work done. We were able to do multiple iterations of the product design and provide feedback for the application and the manufacturing process, so that it could be produced efficiently with high precision and quality. We were able to collaborate with Dr. Boone to provide him with a new product that will, essentially, lead the industry in its application.”

While going through the iterations, Rubber Industries also did some color matching with the silicone material to “make sure we had an aesthetically pleasing part, as well,” Maunu added.

Boone’s clEARdropper device won a Silver Award in the Drug Delivery and Combination Products category of the 2019 Medical Design Excellence Awards (MDEA), which were presented at the Medical Design and Manufacturing (MD&M) East event in New York in June.

Boone said that he was aware of Rubber Industries’ work for the medical industry, particularly its expertise with silicone and rapid prototyping.

“My device has a silicone part and a plastic part,” Boone said in an interview. “With regard to the silicone, Rubber Industries was able to help me adjust my design, tweak it a little bit so that it would be manufacturable and a reproducible, high-quality product.”

Rubber Industries employs three main molding processes—rubber injection molding, transfer molding, and compression molding. “We’re experts in medical molding, which is about 50 percent of our business,” Maunu said. About a third of the company’s business is overmolding, or bonding various rubbers to metal or plastic materials. This could include overmolding rubber onto stainless steel or aluminum, or liquid silicone rubber onto a thermoplastic polycarbonate (PC) part.

“When we say rubber, we mean any of the thermoset base polymers: silicone, natural rubber, neoprene, nitrile, EPDM—all of the different base elastomers in the rubber industry,” Maunu said.

Rubber Industries offers customers the ability to do quick prototyping and then move quickly into high volume production. One of the company’s strengths is its speed in building tooling, which helps with product development and getting projects to market faster, Maunu said.

“We have in-house tooling, so we can provide custom tooling for prototype and production,” Maunu said. “We can do prototype tooling in a day, and we’ve done multiple production tools in a week or less. Compared to the industry standard of weeks or months, that really provides our customers with a strategic advantage.”

Connecting the Dots Across Disciplines to Solve Healthcare Challenges

What else can biomedical design engineers do to speed the process of developing innovative, problem-solving healthcare products?

A group of MIT students and community members, known as MIT Hacking Medicine, are applying the principles of design thinking to do just that. The group teams up with corporate, clinical, and academic partners to organize hackathons and workshops that teach and encourage healthcare entrepreneurship.

“Hacking Medicine came into being about eight years ago,” said Shriya Srinivasan, a biomedical engineer and former co-director of MIT Hacking Medicine, in a phone interview. “A number of students at MIT got together and said, ‘There’s lots of disparate aspects of healthcare. Is there a way to integrate them such that we get more fruitful innovation and a path to really break through some of the system-based challenges?’”

The students decided to put together an event like a hackathon. “It’s modeled after code-a-thons, which are now rather popular,” Srinivasan said. “But the focus here is actually not code-based or app building-based.”

So far, MIT Hacking Medicine has organized more than 175 events across the world, and the results have been impressive. The group’s efforts have led to the creation of more than 50 companies that have raised more than $240 million in venture funding, the group said on its website.

On a Wednesday afternoon in mid-May, Srinivasan explained to D2P how design thinking can be used to “hack” healthcare challenges and bring novel devices to market more quickly. The idea is to draw people from different disciplines together and get them to collaborate to solve a problem.

“We have a kind of culture at MIT around hacking, which encourages us to use our ingenuity and creativity to solve challenges from a new perspective,” Srinivasan said.

Earlier that day, Srinivasan and Khalil Ramadi, a postdoctoral fellow at MIT and regional director of MIT Hacking Medicine, had co-directed a product development workshop at the BioMEDevice conference in Boston. The interactive workshop, “Cracking Interdisciplinary Challenges with MIT Hacking Medicine, Design Thinking Methodology,” showed biomedical engineers and designers how they can apply MIT’s pioneering Hacking Medicine methodology to break through some of the most intractable system-based barriers to healthcare innovation.

Srinivasan, who is currently a doctoral candidate at Harvard-MIT’s Health, Sciences, and Technology program, told D2P that bringing people from diverse disciplines together creates a “cognitive diversity” that propels new ideas forward. People can learn how problems were solved in a different industry, and then find out if there’s a way to apply that solution to their own problem.

“By bringing all the stakeholders into one place, holistic design becomes significantly easier,” she said.

The MIT Hacking Medicine team has cultivated a design thinking methodology that enables them to systematically break down a complex problem into “easy-to-address chunks,” Srinivasan said. She described it as “improving the cognitive ergonomics” of the design process. It’s a skill that we often use when going about daily tasks to make it easier for our brains to process information.

“We chunk tasks together in our brain to help remember them better,” she said.

To illustrate an improvement in cognitive ergonomics, Srinivasan noted that clinicians used to receive patients’ lab values as a simple list of numbers. That was the norm until someone suggested organizing the numbers in a “fishbone structure” to provide context and highlight values that were outside the optimal range, for instance. That relatively minor modification made a big difference in helping clinicians process and interpret patients’ data.

“Simple design tools like that can make it infinitely easier for a person to look at a stack of numbers that’s organized in a specific way, and know ‘This is the sodium value,’ versus “This is the glucose value,’ et cetera,” she explained.

Similarly, if a person sees a list of 10 numbers, those numbers are often harder to memorize than they would be if they were broken up in the same format as a phone number.

“If I say ‘617-253-2255,’ it’s a lot easier for our brains to process than if I just read those to you in a linear fashion,” she explained. “Simple tasks like this are an example of how you can make a small tweak and reduce the cognitive burden, and that’s what I like to call ‘cognitive ergonomics.’”

Medical device designers, she said, can apply the same technique on a broader scale to a specific healthcare challenge. Sometimes, the challenge can be solved by tweaking small things to make the patient’s experience, or the clinician’s experience, better.

“By improving the cognitive ergonomics of the process, we make it very easy and almost obvious to innovate in some areas, just as a function of the methodology,” Srinivasan said.

MIT Hacking Medicine’s design thinking begins when participants come together for a weekend and discuss healthcare problems, or unmet needs, that they’ve identified. The process includes three major steps, or sections. The first is to identify the big problem and break it down into a group problem.

“We do a stakeholder analysis. We ask, ‘Who are the people that are involved?  What do they want, and what do they need?’ We ask them to consider the financial incentives, as well as practical considerations for each of these stakeholders,” Srinivasan said.

The second step is the “solutioning” phase, when participants conceptualize a solution to address their root problem. “We encourage them to hack the problem, to analyze the root problem and flip it on its head,” she said.

The third step is to make the solution better.

“This is the component where we stress the concept of iteration,” Srinivasan said. “It involves continual loops of feedback and modification to improve the solution and make it better than existing processes.”

Finally, participants practice pitching their business concept and their solution to some of the team members, who give feedback. Then, they pitch them to judges with the chance to win prizes.

“After the hackathon, we encourage a lot of these teams to continue their work by connecting them to funding sources, to clinicians who might be able to pilot the ideas, or to any other networks or resources from which they could benefit.”

The stakeholder analysis is a particularly important part of the design process, Srinivasan emphasized. In the medical device arena, relevant stakeholders typically include clinicians, patients, caregivers, and private and public payers. They can also include members of the patient’s family, rehabilitation and support staff within the clinical world, as well as engineers, suppliers, and distributors.

Often, bringing all the right people to the table at the start can solve many of the challenges.

“Often, these products, devices, and services are designed without one of those key stakeholders in the room,” Srinivasan said. “As a result, they either never make it to market, or they make it to market but have some sort of persistent pain point during implementation. You need to have all of these perspectives aligned for true innovation.”

A key takeaway from Srinivasan’s and Ramadi’s workshop was the proposal that teams sometimes need to shift their thought process, their workplace, and their product innovation process to a different approach—a different type of disciplinarity.

“You might be working in an interdisciplinary team. And sometimes, if you’re really stuck with a problem, you just need to make a shift to an intra- or a transdisciplinary approach, and that might help you break through some of those barriers,” Srinivasan said.

Srinivasan also drew upon her own research, which focuses on the interface between the human body, human physiology, and robotic prostheses. She said that currently, extremely advanced prostheses have a very low uptake rate because patients can’t get good sensory feedback from them and they’re hard to control. They’re also very expensive. She attributed many of the constraints to the fact that the amputation surgery itself “hasn’t changed in almost two centuries.”

“Over the course of my Ph.D., a big push was to unify the thought processes between surgeons, physical therapists, prosthetists, and engineers, and come up with an amputation surgery and rehabilitation paradigm that would be amenable to using these newer types of devices,” she said. “And so, I talk about changing the amputation surgery itself as a solution to fixing the interfacing challenges with advanced robotics. I show that in the process of doing and implementing this, almost 20 patients that have gotten this new surgery are finding incredible benefit and a greater ability to control advanced devices.”

Again, the takeaway is that people sometimes need to shift the way in which they integrate information. It’s not enough if an engineer and a surgeon sit in the same room. Instead, the engineer and surgeon need to train themselves to think like each other, she said. “By doing that, your thought processes can converge to better solutions, and you may be able to see obvious holes in a given solution.”

Designing for Cybersecurity

As microelectronics and software have grown more integral and essential to medical devices, the issue of cybersecurity has taken on greater relevance to device engineers. Today, designers and engineers need to be aware of potential security risks as they begin the process of designing their device.

Erika Winkels, senior external communications manager for Medtronic, acknowledged that medical devices are potential targets of cyberattacks, and anticipates those risks will increase and evolve over time. She said in an emailed response that Medtronic designs and manufactures its products to be “as safe and secure as possible, yet accessible to the patients and physicians who depend on them.”

Winkels said Medtronic takes measures to address security as its products are developed, once they leave the company’s manufacturing facilities, and as they’re used by patients and healthcare providers.

“During planning and design, our teams determine functionality and usability. We conduct a risk-based security analysis to determine appropriate controls. In the testing phase, teams conduct performance and security testing to find vulnerabilities. During the revisioning phase, we redesign the device as needed to address any vulnerabilities found and retest; we repeat as new risks are discovered.

“The regulatory review phase enables us to partner with regulatory bodies to review the device for safety, security, effectiveness, and quality. Once the product is in use by the patient, we track and evaluate security and safety risks and make updates as appropriate. Finally, when we retire a device, we consider security implications of decommissioning.”