The days of banking on a pill to deliver a “silver bullet” cure are ending – today’s medical treatments are far more complex. In an era where the fusion of technology and healthcare feels more like destiny than choice, cardiovascular, neurological and even orthopedic medicine have entered an extraordinary industry transformation. New players with waves of smart, AI-driven devices and cutting-edge delivery techniques are challenging the status quo, compelling medical design experts to embrace sophisticated engineering and manufacturing software tools once reserved for the world of automotive and aeronautics. Welcome to the next plateau of innovation, where the future of medical device design is being conceived.
Setting aside consumer-oriented “Healthtech” products coming from giants such as Apple, one need only look at the acceleration of novel device approvals from the FDA, a record number of 124 in 2023. This is a five-fold increase from the 25 granted 15 years earlier, whereas drug approvals have barely doubled and more than half of these require a device for delivery. Additionally, the agency has granted 921 “Breakthrough Device” designations, indicating the flood of completely new innovations emerging. More and more, the acceleration of these innovations is being driven through the use of virtual twins to test device performance before investing in expensive and time-consuming physical prototyping, thus avoiding sub-optimal designs. The result is not only new and innovative designs but also increased confidence in safety and efficacy before moving to physical prototypes for confirmation.
The impact of these new tools of medical device design, in comparison to large-scale manufacturing industries, is still in its infancy. But history has shown that those in the forefront will lead the way for a new age of high-value, accelerated, and more human-centric medical device technologies… with the commensurate ROI to show for it. Even the FDA has acknowledged its potential, as evidenced by its 10-year collaboration with the Living Heart Project and the publication of its most recent guidance document on the use of simulation.
Four pillars of virtual design
Digital twin-based engineering, also known as virtual twin engineering, is the use of a computer-based 3D functional replica of a physical asset, system, or process. With this methodology, as a new product concept moves from initial sketch to design and eventually commercial manufacturing, advanced modeling and simulation techniques are used throughout the process. Designers and engineers are able to collaborate on a common platform as they analyze and optimize the performance. Once the performance is achieved, the real-world counterpart is created and tested. The results are fed back to the virtual twin for refinement of the model and subsequent optimization of the design.
For Medical Devices, virtual twin engineering provides numerous benefits beyond improved design and operational efficiency, spreading to the full lifecycle of the product. It can be used for accelerated approvals, optimized treatment protocols, predictive maintenance, and faster response when problems do arise. By leveraging virtual twin technology, organizations make informed decisions, reduce costs, minimize risks, and accelerate innovation.
The Psychology of Everyday Things by Don Norman is required reading in most university engineering programs. His insights can be boiled down to four key factors, which also happen to be the cornerstones of virtual twin engineering:
- Make things visible: Full-time 3D modeling is accessible to all team members.
- Provide good mapping: The relationship between an action and the response can be tested.
- Create appropriate constraints: Common design parameters can guide designers throughout product development and testing.
- Design for error: If there is a way to use the device wrongly — or dangerously — a user will find it. Using virtual twin engineering, potential design or usage flaws can be identified and worked out before uncovering them in the market.
User-centered design
Taking this further, in this new era, it is not simply regulatory approval, but ultimately the end-user experience, whether it be the doctor or the patient that will govern success. An early research project on User Centric Design (UCD) by JD Gould and C. Lewis introduced three principles: 1) focus on users and tasks early and throughout the design process; 2) measure usability empirically; 3) design and test usability iteratively.
A UCD program using contemporary design tools and a virtual twin approach not only enables all three elements but also supports the collaboration critical to ensure the user experience is considered throughout the development process. Lacking these collaborative processes, teams often stay siloed and information-sharing is limited. “At best [the lack of collaboration creates] unnecessary delays in design and development due to interruptions and iterations that could have been avoided had end-user insights and feedback been researched and incorporated early,” notes Jeff Morang, lead human factors engineer at BlackHӓgen Design, a Florida-based mechanical device engineering firm.
Competitive pressure
From a patient perspective, competition usually results in better quality and more affordable devices. To the industry, it pushes companies into an intense race to get to the market first and keep ahead as competitors enter the market. A global marketplace, tighter regulatory controls, skyrocketing cost of clinical data, and the visibility of product recalls are fierce headwinds for innovation. Add to that increasing design complexities — with multiple subsystems using both electronic and digital connectivity, the industry now must adapt to be able to address costly design flaws early, while they are still cost-effective to fix.
In the high-risk world of medical device development, the pathways to success are being redrawn. The old paradigm of design-build-tests is yielding the benefits of virtual twin experience-driven strategies as the new frontier. Ones that weave together every phase of the lifecycle, allowing powerful simulations that scrutinize the performance, safety, and quality of medical devices before expenses climb. Virtual twin simulation allows devices to be designed at a fraction of the time and cost generally needed while allowing companies to explore and test all possible variables for improved patient safety, quality, and efficacy. It’s a game where we all win.
Editor’s Note: Steven M. Levine, PhD is the Sr. director of virtual human modeling at Dassault Systèmes. Dr. Levine has more than 30 years of experience in the development of computational tools that translate cutting-edge science into product innovations. He currently leads Virtual Human Modeling at Dassault Systèmes and is the Founder and Executive Director of the Living Heart Project.He is responsible for a Life Science incubator of startup healthcare companies within the 3D EXPERIENCE Labs, building a marketplace of digital healthcare services,and serves on several company boards. Dr. Levine was elected into the College of Fellows in the American Institute for Medical and Biological Engineering (AIMBE) and holds a PhD in Materials Science from Rutgers University. He began is career in health tech at the San Diego based startup Biosym that went public as Accelrys in 2004 and acquired by Dassault Systèmes in 2014.