Beaumont Hospitals finds a niche in device design and consultation.
Is it a research institute? Is it a product test center? Neither. It’s Beaumont Services Company LLC’s newly launched Commercialization Center. Beaumont Services Company is a wholly owned subsidiary of Beaumont Hospitals, a three-hospital IDN with numerous medical centers, nursing homes and rehab facilities in the Detroit, Mich., area. In addition to complete, turnkey medical device commercialization services, the center provides device manufacturers with access to an environment where their products can be evaluated for how well they work, and how well clinicians and technicians can work them. Not only that, the Commercialization Center also draws on the expertise of its clinicians, physicians and technological staff to develop its own patented technology which, in turn, can be licensed to device manufacturers.
“We look to license products to both large and small companies, as well as in-license technologies that we believe we can improve,” says John Shallman, director, strategic business development, Beaumont Commercialization Center, Royal Oaks, Mich. For the most part, design ideas that originate within the IDN are specific to Beaumont specialties, such as cardiovascular, radiology-oncology and orthopedics, he says. “But, one of our OB/GYN physicians may have an idea for [improving on] the development of a device in that specialty as well. We rely on input from [any] of our doctors, clinicians and technological staff.” And, with a staff of 18,000, including 3,000 physicians, Beaumont Commercialization Center potentially has a substantial pool of ideas from which to draw.
When Beaumont Commercialization Center extends its consultation services to outside developers, it prides itself on being all-inclusive. “Any company can access us,” says Shallman. “A company may have a new product, or it may be looking to redesign [an existing] one. We work with Fortune 500 customers as well as small startups, although most of our customers are somewhere in the middle. Currently, Beaumont Services Company has 20 active customers, some of which are serial returning customers, and the number of proposals it has received has increased significantly over the last several months, he adds.
Whether ideas come from within the organization or from outside of it, however, the Commercialization Center is the IDN’s newest tool for supporting the device commercialization process from its origination to marketing to the regulatory stage to licensing. “Our service is comprehensive and unique, and there is a huge need out there,” says Shallman.
Human factors
“A large part of our efforts involve human factors engineering at some point in the project,” he continues. Human factors engineering is the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems and work environments, he explains. “Our human factors and clinical engineers play a critical role for the hospital in assessing and integrating medical devices and equipment, as well as troubleshooting problems. They take this experience and apply it in evaluating and analyzing medical device design for the industry. They may look at MRIs one day and infusion pumps the next, to assess how people interact with each device and how they can use the device safely.”
“Human factors engineering is an important component of how humans interact with devices and use them easily and safely to provide better quality of care,” Shallman says. “Our staff considers whether there are design characteristics that may interfere with ease of use, performance or patient safety. [We are helping] medical device developers design out the potential for error, and [enhance] efficiency, efficacy and usability. For instance, they know a CT scan operates a certain way, but the way the technician interacts with it is a critical design consideration that impacts its safety and efficiency.”
“Many medical errors [stem from] user interface with a device,” says Shallman. “If different connections on a device look similar, and the operator connects the wrong lines, [the patient is at risk].” This is where Beaumont Commercialization Center comes in: “We can perform critical design and performance analysis with and amongst all of the users in an actual hospital setting, while considering all of the situations and environments in which the product will be used.”
“Although human factors engineering and analysis is just one of the services we provide at Beaumont Commercialization Center, it is growing in importance within the industry,” he says. The Food and Drug Administration (FDA) considers it an important component of the product design process, he says. Still, the staff at Beaumont Commercialization Center looks at the big picture. “We look at products and how they work in the environment,” he says. “Some products come to us prior to FDA approval, and sometimes a company wants to improve on, or refine, a design. We evaluate pre- and post-FDA-approved products.”
Typically, engagements take two or three months, according to Shallman. “But, often, we complete a one-time engagement in a couple of hours to provide some [immediate] advice,” he says. “Other times, a company asks us to evaluate its product at the next level of design, which may require an additional month or two.” The cost of the service may vary from several thousand for a small project to seven figures for a large company that asks for more in-depth assessment, he adds. “We need to be accessible to [a wide range of customers] and offer an a la carte menu.”
Leveling the playing field
As more companies express an interest in Beaumont Hospitals’ Commercialization Center services, the Center is beefing up its staff to accommodate this. “We plan to add capabilities, from administration to engineering as needed,” says Shallman. “We intend for this to be a self-funding organization that is going to exceed its return on investment metrics within a few years.
“We provide extremely valuable access to the medical environment to device companies and developers of all sizes,” he continues. “No matter who a company is, it can benefit from this service. We level the playing field and enable the advancement of medical devices and technologies for the overall improvement of healthcare delivery.”
