TMD: What are some challenges faced by medical device manufacturers today?
MK: One of the main challenges is developing more personalized solutions. This can include tailoring devices based on specific patient and disease characteristics or developing decision-making systems to aid in optimal device selection and placement, going hand-in-hand with challenges to reduce device development timelines and lower treatment costs.
TMD: How do digital design tools work to meet the U.S. Food and Drug Administrations’ (FDA) challenge to speed product development?
MK: Continuing advances in digital design tools, in combination with machine learning methods, have made it possible to more efficiently assess and improve the effectiveness of various device designs. Enhancements and automation of image-to-simulation workflows, assisted with virtual reality-based visualization of simulation results, are starting to provide valuable information that can assist in the design of clinical trials with greater confidence in positive outcomes.
TMD: What is the FDA doing to support this while still regulating the industry?
MK: The FDA has invested in internal research and development (R&D) and external collaborations to develop guidelines, such as the validation and verification (V&V), and to encourage the systematic adoption of modeling and simulation technologies in various contexts of use. In addition, public support from various FDA leaders is starting to have a visible impact on more widespread interest in, and adoption of, computational models.
TMD: What direction do you see medical device development taking because of modeling & simulation?
MK: In addition to improving the effectiveness and reliability of medical devices, in silico modeling and simulation is a key enabler of what is often referred to as precision medicine. This includes the selection of treatments that are more personalized and optimized to provide acute relief and are effective for longer periods of time. This could play a significant role in controlling rapidly increasing healthcare costs.
TMD: Can you cite some examples of successful projects achieved because of these digital tools?
MK: Digital modeling and analysis are widely being used to develop implants and prosthetics to match an individual’s physical characteristics and lifestyle choices, such as athleticism. Simulation-based surgical planning in various medical domains, ranging from orthopedics to ophthalmology, is another area where startups and established companies are increasingly offering attractive solutions.
TMD: How is Thornton Tomasetti Applied Science particularly qualified to contribute in this arena, and what expertise does it bring to device development?
MK: We have been using digital modeling and simulation longer and more systematically than most companies. We have also been active participants on several American Society of Mechanical Engineers (ASME) V&V committees for computational modeling and continually develop new digital methods and workflows that are valuable to device developers. For example, the application of machine learning and uncertainty quantification principles to virtual human modeling often provides valuable information that can increase confidence in the use of simulations to make informed decisions.
Thornton Tomasetti Applied Science