Medical device development has held a footing in Michigan since before Dr. Homer Stryker released his Circo-Lectric Bed in the 1950s, though few ideas have reached such adoption. The same journey from ideation to launch has since been extended by federal standards, but the basic outline remains the same: help people by making their lives easier, and call in whoever you need to make that happen.
For Dr. Stryker, that meant using the knowledge he had accrued over years working as an orthopedic surgeon to design a new hospital bed and, knowing he didn't have the resources to put them together himself, asking the Kalamazoo Toy and Sled Company for help.
Having seen their business dwindle as World War II had claimed most of the non-defense-related manufacturing sector's raw materials, the company obliged, and the first product of what would become a multi-billion dollar company was quite literally rolled out to regional hospitals systems, and beyond.
Development in process
Seventy years later and a few miles north of Kalamazoo, over 20% of Michigan's medical device professionals work in West Michigan, yet the region yet lacks any original equipment manufacturers (OEMs) focusing on the medical market. There are no companies that handle the full cycle of design, development, and manufacturing, putting their own names on their own FDA-approved widgets. However, according to The Right Place, Inc. Senior Business Development Manager Eric Icard, that has not slowed innovation in the field. Like Dr. Stryker, development and manufacturing companies often collaborate on getting products ready for market, sometimes even for a third party OEM that markets the device after launch.
Eric Icard, senior business development manager at The Right Place, Inc."Let's say, for example, a physician or nurse at Spectrum Health comes up with an idea for a product that will make lives easier or safer," Icard says. "They would, in many cases, take it to Spectrum Health Innovations, who would vet it. Then they are going to look for some prototyping and help with meeting FDA standards before they get them an actual working product."
Depending on what materials are needed and the manufacturing specifications, the next stage would involve a regional contract manufacturer, and eventually a distributor.
With names like Spectrum Health, Mercy Health, and the Van Andel Institute, West Michigan is well established as a regional leader in medical care. The same can be said of research and development, though it's the development side of that process that drives innovation in a far wider grouping than the other areas. Before a single medical product is launched, anything from a glucose monitor to an incubator for a newborn baby, there may be software and hardware teams involved, mechanical and industrial engineers, injection molders, machinists, designers of all stripes, quality assurance leads, doctors, and more, each contributing and collaborating at different stages, and each critical to the product's success.
Development in practice
Aaron Shaver, Ph.D., CISSP, Director of Healthcare and Life Sciences at OST, worked in support healthcare for most of his career before taking on his current role at the digital transformation and IT consultancy on Grand Rapids’ Westside. Though a drastic shift in some sense, he credits his experience in healthcare delivery organizations, service providers, and academic research with informing innovative solutions in product development.
"It has been a constant effort to use my skills to accelerate clinical care delivery through the use of digital tools and the associated organizational change required to adopt them," Shaver says.
That can involve considerations for highly technical systems, as well as legacy technologies that may be far less complex. According to Shaver, OST's digital transformation, "is much more than the digitization of existing processes; rather, it is the development of new business and clinical delivery models that include technologies like telehealth, virtual radiology, and clinical artificial intelligence."
Medical products are regulated by the US Food and Drug Administration and must meet the requirements of the Health Insurance Portability and Accountability Act (HIPAA), as well as ISO standards for quality management systems, information security management, and hardware and software architectural guidelines. Moreover, any computers involved in the development of these solutions must often be controlled under the National Institute of Standards and Technology (NIST) Computer Security recommendations.
There are volumes of federally-approved rulebooks between the nurse with a good idea and a product launch that saves lives and changes the world, especially where digitized patient data is involved, but there's also room for innovation.
"Any time we create new value for the users of the product, we are innovating,” Shaver says. “In a lot of cases, this involves new business and consumption models."
Innovation doesn’t require digitization, but medical products have been trending in that direction for several decades, prompting new regulations like IEC 60601, which outlines the safety and essential performance of medical electrical equipment. The standard was first published in 1979 but has required several revisions since, just as privacy laws regarding digital data have evolved.
"Medical solutions in Information Technology have mostly focused on the collection of structured patient data and the digitization of existing clinical processes," Shaver says. "As an industry, we are shifting towards the utilization of that data to deliver insights to clinicians, patients, and researchers. This phase of transformation creates much more impact to the cost and quality of healthcare."
Greg Nowak, chief IoT engineer at DornerWorks.DornerWorks chief IoT engineer Greg Nowak agrees, adding that networked digital products make it easier for developers to upstream critical updates or add new features.
"I think what we see now more than ever is the desire to connect medical products," he says. "You get a lot of benefit from a connected product as far as being able to update software after it's been fielded. You get the ability to make those corrections and push those firmware updates live, rather than having to recall the device for a major overhaul."
Practitioners aside, there is a lot more going on behind the scenes at a healthcare center today than there were just a few decades ago. And even those networks are evolving. The controller area network (CAN) systems that once linked devices together by physical cords is being replaced by updated low-power wireless systems. Smart watches, health trackers, and other discrete devices are making the same connections possible far outside the hospital, as well.
“A prosthetic arm, for example,” Nowak says. “Why would that have to be connected to the internet? Well, because you can configure it, you can push firmware updates, and it makes corrective actions a lot easier.”
The result is a product that enables freedom in more ways than one. The OEM or its support team does not have to recall the device to make updates and the prosthetist doesn't have to inconvenience the patient with a spaghetti mess of cord interfaces.
For health and safety reasons, many medical products are restricted to a single-use. For a device to be reusable, it needs to be made of materials that will not react to disinfectants or degrade too quickly, it needs to be sealed to keep out contaminants, and it needs to be cleanable. In a hospital setting, this might mean time spent in an autoclave, where extreme temperatures could damage the electronics inside. Despite their shorter lifespan, healthcare systems rely on data from these single-use products, too, to diagnose or apply treatments with greater accuracy.
If a single sensor placed on a patient’s body delivers biometric information that partly informs a physician’s diagnosis, connecting it to several other types of sensors over a wireless network helps to increase positive outcomes. And, just as more information makes life easier for practitioners and their patients, more development partners involved along the way can make for more capable products that further the same ends.
In West Michigan, those partners don’t have far to look to find each other. MIDevice, the medical manufacturing advocacy arm of The Right Place Inc., a regional non-profit economic development organization, provides a forum for companies involved in “high-tech solutions for every stage of the medical device product lifecycle.”
A prosthetic that serves as a test platform for different types of software. Now in its 12th year, MIDevice receives funding from the Michigan Economic Development Corporation’s Smart Zone designation, and in turn helps tech-minded development companies with networking, business planning, training, and in the case of medical product ideas, help with federal National Institutes of Health (NIH) and Small Business Innovation Research (SBIR) grants.
“The organization is focused on really growing the medical device industry in West Michigan, as well as promoting West Michigan as a place to make medical devices,” Icard says. “The ultimate goal of the organization is to build such a critical mass that we see an OEM take shape.”
As large technology and industrial development companies become more diversified, the formation of the region’s first medical OEM draws closer. Rather than wait for the business to come to West Michigan, MIDevice is hoping to accelerate that journey by bringing West Michigan to the business. The group is featuring seven West Michigan businesses at its table at
Medical Design and Manufacturing West, the largest medical device trade expo in North America.
The MEDC covers up to 50% of the costs associated with attending or exhibiting at trade shows with international attendance. That brings the potential of opening up entirely new markets for some companies while expanding their capability and reach within their wheelhouse.
“This helps us market West Michigan as a place to manufacture medical devices,” Icard says. “It's one thing for me as an economic developer to promote West Michigan with, ‘I want your business here, and we’re so great.’ But when I have companies that are successfully manufacturing devices in West Michigan, telling other companies about why they should be here, it carries a lot more weight. We love that model.”
Medical product development in West Michigan is a network unto itself. No single company is handling all the work on its own, neither is a single company responsible for disrupting the status quo with simpler or more helpful solutions. An old African proverb states, ‘If you want to go fast, go alone. If you want to go far, go together,” and the same story applies to companies working to make life easier for healthcare practitioners and their patients.
No matter who’s name is on the finished product, the best outcomes are more often than not a group effort.
Photography by Adam Bird of Bird + Bird Studio.
Urban Innovation Exchange highlights the people and projects transforming West Michigan through sustainable efforts. Matthew Russell is the editor for UIX Grand Rapids. Contact him at [email protected]ds.com.