Simulation is a game changer for the Medical Devices industry

Soma Tah

Rafiq Somani, Area Vice President- India and South Asia Pacific, Ansys explains how India can leverage simulation technology to reduce product development cost, improve reliability, performance, and speed up innovations in the Healthcare sector   

Medical innovations generally take a long time, but with the ongoing pandemic crisis, there has been mounting pressure on the entire healthcare ecosystem including the healthcare solution providers, the pharma companies, the medical device manufacturers to innovate more quickly than ever before. But as the development cycles are long and the costs are high, this sudden heightened push towards innovation can make the journey unsustainable altogether. 

When a patient’s life is at stake, product failure is not an option. Hence, engineers who work in the medical devices and healthcare sector face extreme design challenges sometimes, not to mention the human body is complex, and hence, the healthcare industry has some tough regulations, rightfully so, which makes it even more difficult for the engineers to develop effective products that meet the tough regulatory norms, standards.  

Physical testing of the medical devices consumes time and money also. The designers may not be able to identify optimal configurations since it is difficult to physically test every possible scenario. That’s where simulation and modeling come into play- Simulation modeling provides a safe way to test and explore different “what-if” scenarios without putting production at risk. 

Virtual experiments with simulation models are also less expensive and take less time than experiments with real assets. It is great for the healthcare solution providers, since they are the proven tools to address the high and unsustainable costs and time required for design and regulatory approval of increasingly complex healthcare solutions and they can also use the simulation insights to prevent risk to patients, when delivering new and advanced treatments. Here are some ways how healthcare ecosystem is leveraging simulation to bring innovations faster to market: 

Medical Devices

Applying engineering simulation throughout the device development cycle and the regulatory approval process is the only cost-effective way to bring new treatments to patients faster, while meeting safety standards and satisfying time-to-market deadlines. 

Clinical Applications

Clinicians are increasingly turning to extensively validated computer models of patient-specific surgical procedures to provide critically important insights during pre-surgical planning.  

Pharma and Biopharma

Physics based simulation optimizes drug production processes. Application of engineering simulation and mechanistic modeling helps to scale up production equipment from lab scale to mass production, identify the best delivery route, etc.  

“Medical uses for simulation are as diverse as medical specialties,” said Rafiq Somani, Area Vice President- India and South Asia Pacific, Ansys. “Companies can look at In Silico methods for everything from cardiovascular stents and pacemakers to custom 3D-printed orthopedic implants to smart wearables like insulin pumps. Medical system design benefits from simulation by not only looking at detailed behavior of a component using 3D physics-based modeling but also by efficiently evaluating the performance of the whole system and not just its parts. This is definitely an advantage over the physical testing of integrated systems and subsystems, which can be costly and doesn’t always identify all the potential issues and shortcomings,” said he.  

He also explains some of the use cases in detail:  

For testing medical devices 

Simulation solutions enable device manufacturers to carry out more tests and gain more insights than is possible with traditional physical testing. This allows more rapid prototyping, integrated designs that function from day one and the ability to fix operational problems before going into the physical testing phase. Let us look at some examples. 

Faster time to market: The new generation wearables and implantables can be brought to market faster using simulations that accurately model the body interactions with the Class II & III devices. This accelerates design and amplifies testing to meet the regulatory norms with digital evidence. 

Optimize performance: Simulation can also help maximize the performance and management of medical and hospital supplies by enabling engineers to predict and understand its behavior across diverse scenarios to ensure reliable performance at an affordable price. 

Validating performance: Simulation helps develop accurate physiological models that can better validate medical devices. Accurate modelling of the complexities of human or animal physiology can validate the performance of a medical device in its real working environment. 

Ensure reliability: Engineering simulation can also maximize reliability of hospital equipment without compromising on the safety of the patient. Simulation reduces the risk of incurring functional problems among critical hospital equipment with large capital expenditure way before they occur.

Thus, from ideation to post-market adjustments, simulation drives better development and higher performance for medical devices.   

For regulatory compliance 

In order to comply with regulatory norms and minimize clinical testing, companies can take the help of simulation. "In silico approaches that are powered by physics-based simulation make it possible to shorten the regulatory approval process, while ensuring maximum patient safety. What simulation does is to avoid the costly 'build and test' cycles, which is the industrial practice today. For a device, virtual Design of Experiments (DoE) over full parametric space can be conducted. For certain applications like drug delivery for oncology, patient specific models can be used to build confidence for a wide range of scenarios. Regulators in many countries are encouraging medical devices companies to use Computer Modeling & Simulations (CM&S) to speed up the approval process. This can certainly be explored in India," said Rafiq.  

Indian healthcare and medical devices cos stand to gain immensely

For any nation, the ability to provide medical products that are safe and trusted not only by the doctors, but also the patients is crucial and India is no exception. With technological advancements, medical device companies also need to innovate and come up with solutions that are better, safer and cost effective.  

There has been a significant growth in the healthcare and medical device sectors in India in the last decade or so but a huge gap still exists in the current demand and supply of medical devices, observed he.  "The Government of India has started many initiatives including Production-Linked Incentives (PLI) Scheme for Medical Devices 2020, introduction of Medical Parks etc. to strengthen the medical devices sector, with a special emphasis on R&D and even a 100 per cent  FDI for medical devices to boost the market. However, India still has a 75-80 per cent  import dependency on medical devices and in order to be self-sufficient, medical companies need innovation leading to reduced cost of development without compromising the safety and reliability," said he.   

Also, starting April 2020, Indian regulators have a new policy that all the medical devices available in the market need approval. A window of 36 months is given to all the companies to get their existing devices approved. Rafiq is hopeful that in these two aspects of efficient product development and regulatory approvals for medical devices, simulations can add significant value.