Personalizing Medical Devices
Innovative software focuses on a system-based, model-driven approach.
Since the dawn of the computer age, software has played a crucial role in both the product design and the quality management of medical devices, but never with as much integration as we’re seeing now.
For example, our November 2014 cover story, “Simulation Drives Medical Device Design,” showed how the number of prototypes needed to optimize medical device design has been drastically reduced via state-of-the-art simulation software. And at the 18th Software Design for Medical Devices conference in Boston in October 2014, industry experts led hyper-modern discussions on mobile medical applications, software validation, cloud management and risk analysis, and emphasized hot topics such as agile-based development and interoperality.
For reference, software engineer Kent Beck defined agile software development in his “Agile Manifesto” as a group of software development methods that evolve through collaboration between “self-organizing, cross-functional teams.” And according to the Institute of Electrical and Electronics Engineers (IEEE) Standard Computer Dictionary, “interoperality,” in the most general sense of the term, is “making systems and organizations work together” or “inter-operate.”
Clearly, the medical technology sphere is headed in the same direction as the mobile, automotive and smart home technology industries in one crucial regard: interconnectivity. The goal is to be able to text your washing machine or your coffeemaker from the smartphone that is hooked up to your car, and one day—although this process will probably be much more intricate and stringent from a risk protection perspective—the norm will be to text your medical device with specific demands, and also check an app that is hooked up to said device to make sure that everything is running smoothly.
But beyond the rapidity and relative ease that comes with interconnectivity, what else can be done to make medical devices more effective? Namely, how can these devices be made more affordable but also more comprehensive, consolidated and personalized to each user?
Product Lifecycle Management (PLM)
Hot on the personalization trend is Siemens PLM, a business unit within Siemens’ newly formed Digital Factory division that sells software-based solutions to medical device companies around the world, including Siemens Healthcare.
PLM stands for Product Lifecycle Management, which, according to Siemens, can be viewed as “information strategy,” building a coherent data structure by consolidating systems; “enterprise strategy,” allowing global organizations to work together in designing products; and “transformational business strategy,” providing an efficient and cost-effective way for companies to manage the entire lifecycle of their products, from ideation to manufacturing to disposal, in a state of “continuous innovation.”
The Medical Device and Pharmaceutical Solutions branch of PLM is centered on just that: Personalized Product Innovation. But what does “personalization” mean in the context of healthcare?
James B. Thompson, Ph.D, director of industries for Siemens PLM Software, describes personalization as “the ability to help customers engineer and deliver medical treatments, in collaboration with their physicians, on a patient-specific basis, using individual patient anatomy and therapies.” And this is also where a focus on “digitalization” of devices comes in.
“We see a lot of people in the medical device industry who are developing products using digital tools, but I wouldn‘t say that they are completely digital in the sense that they’re relying on models that they use to then predict the performance and behavior of devices,” Thompson explains.
He gives the analogy of using a mechanical CAD system just as a means to efficiently and productively create a drawing, when he could be using the CAD system to not only create a drawing, but also create finite element models to predict the behavior of a component or an assembly.
“We’re really trying to drive out this approach, which we like to call a digital enterprise, with a particular focus in the manufacturing space,” Thompson continues. “We have competitors who sometimes focus, I won’t say exclusively, but have an overemphasis on just product design; whereas I think at Siemens in particular, we’re trying to do a good job not only at product design but also manufacturing process engineering and design that is coupled with product design. That we believe makes an important difference, because when it comes time to manufacture the product, you’ve worked out as many quality issues and other kinds of problems in advance.”
Image to Implant
Siemens’ system involves a “highly automated image to implant process” for developing personalized medical devices and therapies.
“Image to implant process automation showcases various technologies that we have that actually make it feasible, and technically possible, to engineer personalized medical devices,” says Thompson. “In the past, I think people have always envisioned, if you will, this idea of patient-specific devices and implants that may have been technically feasible, but not economically feasible because of the costs involved in engineering and manufacturing on a very low volume, on a single part or a very small number of parts-basis.
“But we’re at a point, from a technological maturity standpoint, where we’re now able to offer automated solutions for nearly every step in the engineered order process,” he says. “And because of this automation, we believe we’re at a breakthrough point where it is feasible, both technically and economically, to design and manufacture on a personalized basis.”
Despite the swell of progress in recent years, Thompson recognizes that his industry still has a few key challenges to overcome. One is getting engineers and their management up to speed on this more mature style of development, which he says has been a historically common practice in other industries such as aerospace and automotive. Another is the change of view from quality being equal to compliance to quality being “the primary measurable objective in all aspects of the device lifecycle.”
In 2014, The U.S. Food and Drug Administration announced a public educational forum called “The Case for Quality,” which gathered input from medical device manufacturers and stakeholders on best practices to inspire better quality efforts.
Thompson views the FDA’s Case for Quality Initiative as a positive development though, saying that the statement of compliance being “not the end goal for device quality and safety,” but rather that quality “should be optimized throughout the product lifecycle, with compliance a natural by-product of a total quality orientation and QMS,” which provides a particularly fertile environment for innovation to flourish.
Looking into the future of the medical device industry, Thompson sees “steady growth and expanded use,” even surpassing the practices in other industries like aerospace and automotive. In what he calls his “crystal ball” statement, he speculates that as the worldwide population demographic grows older, “We’re all going to spend a lot more money on healthcare and medical devices compared to what we spend on cars, airplanes, rockets, etc.”
Of course, we have no way of knowing for sure. But with little doubt, there will always be money in healthcare, allowing for a steady stream of innovations to ensure that the quality of our devices—and by extension, the quality of our lives—is not only sustained, but continually improved.