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September 2017 - Issue 3
Welcome to Battelle’s Medical Devices newsletter. We offer this newsletter as a service to our clients to keep you informed of the latest news from our researchers and the industry.
Battelle’s Medical Devices team can help you accelerate your medical product development timeline – from ideation to evaluation to commercialization. Our newsletter will help keep you up-to-date on cutting-edge medical devices work, including device security, drug delivery, usability testing and neurotechnology.
By David J. Giles
Has the medical device industry lost its research mojo?
The industry spends billions on research and product development every year, and these investments are only increasing. The leading medical device companies reinvest 6%-12% of revenues into R&D, with the top 10 companies spending $10.5 billion on R&D in 20131. However, the vast majority of medical device research goes towards incremental improvements in product design or function rather than into truly revolutionary new products.
Revolutionary medical devices – those that upend market expectations or launch a whole new device category – are often built on new scientific discoveries or technological advances made in entirely different fields. To increase innovation in medical devices, we need to do a better job of translating academic research into commercial solutions. As technologies in one area advance, they will combine with other technologies to enable entirely new capabilities. The medical device industry will need to take a broader view of R&D to remain innovative.
There are a lot of different players in medical device research and development, but most of them will fall into one of three categories. Each of these organization types has its own set of priorities, strengths and weaknesses when it comes to R&D.
Academic institutions: Universities are strongly motivated to attract and retain talent who will enhance their reputation as both a teaching and research facility and help them attract students and research grants. In large research universities such as University of California Los Angeles or Ohio State University, faculty and grad students are given broad leeway in the research they want to pursue. Commercial applications of the resulting discoveries are not usually a high priority. This makes research universities excellent centers for basic and early-stage research. Because researchers are funded by grants and are not held accountable to achieving a return on investment for their efforts, they are free to pursue avenues of inquiry that may seem highly removed from any immediate useful application. In fact, they may not have the capacity to commercialize their findings even when a discovery does have commercial potential.
Commercial companies: Within the medical device market, the commercial sector includes both Fortune 500 behemoths like Abbott and Stryker and tiny biotech startups. However, whether they are publicly traded or privately held, all of these companies share a common goal: to make a profit. While many companies can and do reinvest profits into independent, internally-funded research, they need this research to generate results that can be commercialized within a relatively predictable timeframe. Unlike universities, they cannot afford to pursue interesting research questions that have a low probability of resulting in a financial return. Commercial companies are most likely to engage in late-stage development rather than pure research. Their R&D activities are generally focused on development of a new product or improvement of an existing product to meet a specific market need. Responding to shareholder and Wall Street pressures, public companies need to find ways to “move the needle.” In fact, some R&D executives have said that their organizations would rather acquire a company for $150M than spend $10M on a new product development program. This suggests that they are constantly balancing the risks of research with more quantifiable and certain transactions.
Contract research organizations: CROs fill an important role in the medical device development space. They give commercial companies access to scientific and technical expertise and specialized equipment and facilities that would be cost prohibitive for most commercial companies to host in-house. By engaging with a CRO, commercial companies can vastly expand their R&D capacity and shorten development timelines. Many CROs strictly act as “labs for hire,” performing specific, limited activities needed for product development or registration. Some large independent research institutions, like Battelle, do both contract research for commercial companies and independent or grant-funded basic and early-stage research. This allows them to act as much needed “connectors” between basic scientific discovery and commercial application.
All three types of research – academic, commercial and contract – are sorely needed in the industry. Too often there is a disconnect between discoveries made on the academic side and application of those discoveries to solve real-world problems.
Basic research forms the foundation of the R&D pyramid; discoveries made here can lead to unexpected applications or even entirely new industries. For example, foundational, publicly funded research in genomics, including the Human Genome Project, led to the emergence of innovative companies like 23&Me as well as numerous commercial applications for diagnostics, personalized medicine and forensics. The global genomics market is anticipated to be worth almost $20 billion by 20202. These markets, which include medical devices such as genomic diagnostic assays, would not exist without the foundational research that preceded them.
There are many areas of basic research that could have implications for medical devices, from materials science to molecular biology. New discoveries in optics could lead to better imaging devices. Research in insect biomechanics may suggest a different design for a prosthetic. Advances in functional materials could lead to implantable devices with lower risk of infection or rejection. But academic researchers may not be close enough to the market to see the potential applications of their research, and commercial companies may not be aware that the research exists. Building better connections between basic and applied research could accelerate the translation of discovery into product development.
To speed up translation, we need to build stronger connections between basic and applied research and across scientific disciplines. Independent research institutions like Battelle are well positioned to help bridge this gap.
Battelle occupies a unique space within the research ecosystem. As a nonprofit, the organization is mission-focused rather than profit-driven; all profits from contract research are either used philanthropically or reinvested back into research to “translate scientific discovery and technology advances into societal benefits.” This allows Battelle to operate in a middle space between purely academic and purely commercial R&D activities. Without the pressures of immediate commercialization, Battelle researchers can engage in research that builds off of basic research conducted at universities to advance our understanding and explore potential applications. They can also work on translational projects that look for new applications for existing technologies.
For example, Battelle researchers were working on a chemical resistant coating for the U.S. military to protect soldiers and equipment from chemical weapons. Researchers later realized that tweaking the formulation for the coating could result in an antimicrobial coating that could have applications in the medical device field. There are many opportunities like this to translate discoveries in one field or industry into applications in another. However, to make this happen, we need organizations with the capacity and incentives to find them.
There is no shortage of research happening in the medical device field today. Healthy investment continues in both academic institutions and commercial organizations. Where we need more focus is the middle ground that connects the two. It is this middle space where there is the most immediate and fruitful opportunities for groundbreaking medical device development.
About the Author
Dave Giles is Sr. Director of Commercialization for Battelle’s Medical Device and Consumer Products business unit.
1 Saxena, V. & Lawrence, S. (2017) “Top 10 med tech R&D Budgets” Fierce Biotech. Questex, LLC. http://www.fiercebiotech.com/special-report/top-10-med-tech-r-d-budgets
2 Markets and Markets (2016) “Genomics Market by Product (Instruments, Consumables), Technology (Sequencing, PCR, Microarray), Application (Diagnostics, Personalized Medicine), Process (Library Preparation, Sequencing & Imaging), End User - Trends & Global Forecasts to 2020.” Available from http://www.marketsandmarkets.com/Market-Reports/genomics-market-613.html
By Amy Schwartz
Who (or what) is your medical device designed for — the human who will use it, or just the disease you are addressing?
To get regulatory approval, it is understood that medical devices must perform their intended task (e.g., delivering a medication or taking a health measurement) accurately and without compromising the safety of the patient or caregiver. A device designed to monitor the blood sugar level of a patient with diabetes, for example, must provide reliable and accurate blood glucose readings. It must also meet basic human factors criteria to ensure that the intended user can use it safely and effectively.
But these basic requirements are only the beginning. Medical devices are used by human beings with complex emotional and social needs. Designing medical devices that better fit into people’s lives can improve not only user satisfaction, but also adherence with treatment protocols. Ultimately, humanizing medical devices is a path towards better adherence and patient health.
Anyone who has taken Psychology 101 should be familiar with Maslow’s Hierarchy of Needs. Maslow’s Hierarchy is commonly illustrated as a pyramid with basic physiological needs (food, shelter) at the bottom and higher needs (safety, love/belonging, esteem, self-actualization) ranked above. Maslow’s insight was that all levels of the pyramid are important for humans, but more basic needs must be met before people have the capacity to seek fulfillment of higher needs.
Medical device developers can use a similar pyramid to evaluate how well a device is meeting the needs of users. At the lower levels of the pyramid, the device must meet basic ergonomic and cognitive requirements. These levels encompass the human factors testing that medical device manufacturers already must complete for regulatory approval. At the higher levels, the device must also meet the user’s emotional and social or cultural needs. These levels are often overlooked in medical device development.
Each level requires understanding the needs of the users, as well as the context and environment in which they will use the device. Different types of users (children, seniors, patients with impairments related to their condition) may have different needs at each level. Contextual research with the intended user population can help developers better understand these needs.
Questions to consider at each level include:
Physical/Ergonomic — Is the device light enough to be easily held or carried? Does it fit comfortably into the hands? Are buttons or dials easy to reach and manipulate? Is visual information easy to see? How much hand strength is needed to manipulate the device? If it is worn on the body, does it interfere with other activities of daily living?
Cognitive/Perceptual — Does the device provide physical or visual clues that show me how it is to be held and used (e.g., a depression where the thumb should be placed)? Are visual information or instructions easy to interpret and follow? Does the device provide feedback to let me know when a step is successfully completed, or when another action must be taken? How many steps must I follow, and are they in an intuitive sequence? Do sensory alerts follow established cultural norms (e.g., flashing red lights when something is wrong, a steady green light when the device is ready to use)?
Emotional — How does the device make me feel when I use it? Does it make me feel sick or vulnerable? Does it make me feel stupid? Does it look intimidating or scary?
Social/Cultural — If other people see the device, or see me using it, how will it make me feel? Does it make me look weird or different? Am I embarrassed to be seen with this device? How does this device impact the way other people perceive me? Does using the device require breaking any cultural taboos?
Imagine you are a small child getting a CT scan. You are taken to a small white room with bright lights and asked to lie down on a platform. The platform slides into a bare white tunnel, where you can’t see your parents or the nurses. You feel vibrations and hear loud noises that you don’t understand. Someone you can’t see periodically gives you orders without explanations: hold your head still. Don’t breathe for five seconds. Ok, now breathe.
This is a frightening scenario for children, even if they understand the medical necessity of what they are doing. It is notoriously hard to get small children to follow instructions, even more so when they are frightened. For this reason, many children must be anesthetized before entering a CT scanner. But, an engineer at GE figured out a better solution: turning the CT scan into a storybook adventure.
GE designed CT machines with child-friendly “skins” that made them look like pirate ships. Instead of just telling children what to do, the medical staff turn the experience into a story: “OK, time to lie still—the pirates are coming!” In other words, they humanized the experience. Children were less frightened and more willing to follow instructions, and fewer children needed anesthesia before entering the machine, saving time and increasing scanner throughput for the hospital.
When device manufacturers don’t humanize the experience, users may do so themselves. While observing an elderly man with diabetes, I noticed that all of his supplies were in a Hello Kitty pencil box instead of the case designed to hold them. When I asked him about it, he explained that his granddaughter had given him the case to hold his supplies. When he pulled it out each day, he was reminded of why it was important to him to follow his diabetes protocol. The original case would have been more organized and functional, but it did not meet his social and emotional needs as well as the Hello Kitty case.
In both of the examples above, humanizing the experience of using the medical device did more than make people feel better. It made the devices more effective. Children could get accurate CT scans without anesthesia. The man with diabetes was more likely to follow through with blood sugar testing when he was reminded of the reasons he wanted to stay healthy.
When the medical device fits into the user’s life, he or she is more likely to use it as intended. Patients are much more than the disease being treated. They are human beings with full lives, and they don’t always want to be reminded that they are “sick.” They also don’t want to be looked at differently by peers.
For medical device developers, that means thinking not only about a device’s functionality, but also its “softer” dimensions, like aesthetics. Consider assistive devices and prosthetics. Do they need to look so, well, medical? 3D printing has made it easy and affordable to design prosthetics that are customized to the user’s personal taste and personality, as well as to their physical needs. Children can have an “Iron Man”-inspired artificial limb that is the envy of the playground instead of a device that inspires pity or bullying. And how much more likely is a young woman to wear the hearing aids she needs when they look like cool jewelry that anyone might wear, rather than medical devices she needs because of a disability?
Aesthetics are important in non-wearable devices as well, such as nebulizers or home infusion pumps. A bulky, overtly medical device doesn’t fit well with home décor, and it invites questions — or perhaps unwanted sympathy — from visiting guests. A sleek, attractive device that blends into the home is more likely to be left out where it is more accessible when needed and may even be used more regularly.
Aesthetic considerations may seem minor when considering the important medical functions performed by these devices, but these concerns are not small to users. People who need to use medical devices want to think of themselves first as people, not just as patients. Acknowledging users’ social and emotional needs, and designing devices to address them, isn’t just “fluff.” It is essential to promoting effective device use and adherence to medical protocols.
The best way to do this is to consider the entire medical device “hierarchy of needs” right from the start, prior to device conceptualization. Contextual research can help manufacturers better understand all of users’ needs, from the physical and cognitive to the emotional and social. An integrated approach to device development that includes attention to social and emotional needs will result in devices that are better accepted by users and promote better health outcomes.
About the Author
Dr. Amy Schwartz is a Human Centric Design Thought Leader at Battelle and an Adjunct Professor at Northwestern University Segal Design Institute. She brings more than 30 years of experience in Human Centric Design with an emphasis on medical devices and healthcare.
By Annie Diorio-Blum
The common approach to designing and developing an Instructions For Use (IFU) has been largely unchanged for years. Once a product is designed and made ready for manufacturing, an IFU is then written and tested. When errors are found, changes are made, and the cycle repeats until there is an acceptable IFU version that most users will be able to comprehend. Clearly, this approach is often time-consuming and costly.
Even with the more recent fundamental shift in how medical devices and products are designed – with most manufacturers moving towards a “user-centered design” approach – IFU, Quick Reference Guides (QRGs), training and labeling are typically left out of this process. Compounding the problem with patient comprehension of ancillary materials is the overuse of outdated standards found so frequently in IFUs, QRGs and labeling.
To address this ever-present issue, Battelle developed an innovative process in our research in which we asked end users to “create” their own IFU by giving them the opportunity to select the words and images that best communicated the intended use of a given medical device. These insights allowed for the development of simplified instructions that were not only easier to understand, but also more likely to be used (and used correctly) and more likely to improve patient adherence. Using this approach also proved to reduce the number of formative tests needed to reach acceptable comprehension and it streamlined the human factors testing.
From surveys to focus groups and in-depth interviews with target users, this process can be implemented in various ways. Using a mix of quantitative and qualitative survey methods, we conducted a small study looking at how different users understand and comprehend symbols commonly found in medical devices for home use. The purpose of this study was to demonstrate how symbols that are routinely found in medical device IFUs and labeling are not universally understood. Users were provided with an image of a symbol and asked to describe what it meant in their own words. They also were asked to rank the clarity of the symbol on a scale from 1-5 (after they were presented with the correct definition).
As the results in the graphic below indicate, many of the “abstract” symbols ranked low in clarity and were not identified correctly by the participants. Most commented that they would need the accompanying text to help correctly identify the symbol. In fact, some participants mentioned that certain symbol designs led them to believe they should do the exact opposite of what the symbol was trying to convey. For example, “Keep away from sunlight” was often interpreted as “place in sunlight” or “place in well-lit area,” which users pointed out is the exact opposite of the symbol intent and could have serious implications.
As medical device design continues to evolve, our hope is that more manufacturers will use this approach early and often when creating IFUs and labeling.
About the Author
Annie Diorio-Blum is a principal industrial designer at Battelle.
On Aug. 28, Battelle was awarded the Military Health System Research Symposium Outstanding Research Team Accomplishment Award.
The team, led by Dr. Erik Edwards and with funding from the Office of Naval Research, is developing a next generation medical device to treat severely injured limbs to maximize tissue preservation during the care continuum from field to trauma center.
A key accomplishment for the award was the development of an oxygen generating "pump" that requires no batteries and no external power to steadily provide three liters of oxygen to a wound site over a three-day period.
The oxygen pump will revolutionize the way battlefield traumatic injuries are treated and increase quality of life for service men and women. It also has potential to aid in the treatment of other chronic pervasive wounds that are worsened by poor circulation, such as foot ulcers, which affect millions of people living with diabetes.
Smart, connected medical devices have launched a transformation in healthcare. But as devices become more sophisticated and connected, they also become more vulnerable to cybersecurity risks.
When developing a cybersecurity plan, many manufacturers only think in terms of vulnerability testing. While testing is a critical part of the process, the most effective and efficient approach to mitigating cybersecurity risks starts with smart design. By building secure design principles into the device from the start, manufacturers can minimize their risks and avoid missteps that could lead to costly delays and expensive changes later in the development cycle.
Learn more in Battelle's new white paper - Medical Device Cybersecurity: Secure Design from Concept to Commercialization. Download it now.
Meeting cybersecurity requirements for sale of medical devices to federal agencies can be complicated. Battelle’s Kevin Stoffell is helping manufacturers navigate the process and make effective systems architecture decisions. Read More