The Engineering behind the Tools

Finite element simulations of the effects on the brain from the impact of an object on the head can help with improved protection against injuries.

Many of the tools and modeling capabilities that companies such as Thornton Tomasetti have been developing and honing since 1949 are at the cutting edge of some of the principles that are now being promoted by FDA and increasingly being adopted by the life sciences community. “I expect that our experience with stochastic and probabilistic assessments of various types of events will allow us to offer methods that are quite relevant to life sciences, considering the variations in population or disease characteristics,” says Scarangello.

“Yes, our development and use of vibration and piezoelectric methods has played a key role in improving ultrasonic imaging solutions and is already being used by leading medical imaging companies,” adds Kailasam. “Another example is the development and pioneering adoption of constitutive models for soils, which at first glance doesn’t appear relevant to life sciences until you realize that the same constitutive models are used to simulate the manufacturing of pharmaceutical tablets.”

Thornton Tomasetti has been active with various ASME committees for computational modeling, such as V&V 10 (Solid Mechanics), V&V 20 (Fluid Mechanics and Heat Transfer), V&V 50 (Advanced Manufacturing, covering additive manufacturing), and more recently have started engaging with V&V 40 (Medical Devices) as well.

Critical digital engineering capabilities that the medical industry needs include a wide variety of physics modeling solutions, covering everything from solids and fluids to thermal and electromagnetic simulations. Firms should have the capabilities to research and develop new material models, develop bespoke test fixtures and carry out physical tests to help with validation, and to develop and automate new or existing methodologies, such as for probabilistic assessments or optimization.

Thornton Tomasetti, for example, has expanded and is continuing to grow its team of engineers with specialized skills in bioengineering. “This allows us to provide virtual human modeling and simulation solutions covering a range of devices and organs, using both already available virtual models or, when needed, starting from imaging data to develop simulation-ready virtual human models, and then performing needed simulations,” says Kailasam.

After the simulations and assessments are completed, his team helps clients prepare thorough reports for submission to FDA or other regulatory bodies, including necessary evidence of the efficacy and validity of the simulations. If they are interested, clients can also access visualization solutions such as realistic rendering or VR approaches. “We’ve also established strong partnerships with companies like Dassault Systèmes and others to leverage the best available digital tools and bring to bear our expertise on addressing our client’s individual challenges,” says Kailasam.

Dassault Systèmes is one of the tool providers that have made an important commitment to the science and engineering communities by developing a commercial software platform capable of supporting the most sophisticated applications across all of domains important in life sciences.

“We provide a broad range of core computational methods and visualization environments, and an open system where our expert collaborators such as Thornton Tomasetti can develop custom methods and expert systems that accelerate the use by a medical device company,” says Levine. “And we have stepped up to advance the open development of accurate models of medical systems and participate in critical validation of these models for a given context of use.”

Future Directions for Digitization

Kailasam acknowledges that for the medical device or pharma company looking to take advantage of available digital tools “there are quite a few offerings from both software and solutions perspectives — with everybody solving a piece of the puzzle.” From a solutions perspective, he notes, one company may be able to create human models from imaging data, another might be good at assessing the structural behavior of a device, and yet another may be able to look at probabilistic assessments, and so on. “But few entities can pull and synthesize all the key elements together and do so in a rigorous manner,” he says. “At Applied Science, our goal is not only to help our clients solve specific pieces of a puzzle or workflow, but also to support them in building complete end-to-end solutions that can be automated and reused efficiently.”

This article was written by Lynn Manning, a science and technology writer based in Providence, RI. For more information, Click Here .