Hemant Punekar, Senior Manager, ANSYS
Let’s read about how digital Twin is likely to reach key milestones in the foreseeable future.
A digital twin is a simulation model that represents the state of a physical asset in real time using the sensor data collected from the asset through an IoT platform.
As the digital twin technology is becoming a reality as we usher into the era of Industry 4.0, the healthcare industry is very much gearing up for this digital transformation.
The following on-going initiatives are paving the way for medical digital twins to achieve key milestones in the foreseeable future:
- Personalized Medicine to provide the necessary information to the digital twin.
- Complete Digital Prototypes to accelerate the emergence of this new technology.
- In silico Clinical Trials to obtain quicker approvals for innovations.
Personalized Medicine
Medicine is becoming personalized. Soon, all of us will be under permanent monitoring through wearables and other sensors. All our vital and non-vital parameters will be continuously monitored. But the bioelectronic market still needs five key innovations.
- Wearable monitoring and diagnosis equipment requires measurement of target parameters in a reliable and repetitive way.
- Energy efficiency to prevent the replacement or recharge of batteries.
- Signal interference, signal integrity and cyber security of wearables.
- Patient safety and compliance with strict regulations.
- Software and a simple interface that would be able to treat patient data and synthesize them in crisp recommendations for the patient.
Although this list may look intimidating, amazing progress is reported every day. Innovation should just be faster. Ansys Multiphysics simulations are used at various stages in the design of these devices, e.g. evaluation of the electromagnetic performance of antennas-sensors, interaction of the electromagnetic radiation with human body, low frequency inductive recharging, software code development compliant to standards, electrochemistry of the battery cells, mechanical durability, performance of the display etc. This virtual testing reduces the need for prototyping, thus saving time and money.
Complete Digital Prototype
Whether this is for designing the next wearable, new drug delivery processes or simply hospital beds, the product development process is often “under-digitized”. Computer Model and Simulation (CM&S) is used pervasively to cost effectively design products across all industries including leading medical devices companies that have reported dramatic acceleration and return on investment exceeding 1 to 30. There are a few reasons why small and medium enterprises have not yet fully embraced complete digital prototypes:
- Lack of skilled employees, trained in engineering
- Lack of confidence in capabilities of simulation which significantly reduce time and cost to market, possibly minimizing the risk for the patient, although widely reviewed in the
- Despite being convinced with the value of simulation and its RoI, companies keep delaying the necessary investment: the competitors and the patients can’t wait!
Fortunately, every year more and more companies adopt simulation. Ansys Multiphysics is again widely being used across industry to create this type of avatar of the relevant portions of respiratory, cardiac, recirculatory, neurological, orthopedic, ophthalmic, digestive systems.
In Silico Clinical Trials
The long and painful, but necessary, regulatory approval process is really what is preventing innovations from reaching the user faster. Conscious of this problem, but unwilling to compromise with patients’ safety, legislators and regulators are looking for alternative solutions such as complementing clinical trials with preliminary tests on computers, a.k.a. in silico clinical trials.
But we are still facing some difficulties:
- Building confidence in the medical community through extensive clinical validations
- Building large libraries of patient specific geometries, materials properties and pathologies
- Definition of the formal regulatory frame by legislation
Ansys’ simulations are used widely to assist regulatory approvals. Ansys fluids, mechanical and electromagnetic simulations provide digital evidence that reduces, and in certain cases eliminates, the need for other forms of evidence. For example, using Ansys simulations, a global medical devices giant released their new pacemaker 2 years in advance, saved $10M in regulatory approval and treated 10,000 patients. An Indian pharmaceutical company used Ansys’ simulations to get a complete clinical trial waiver from USFDA for a generic asthma inhaler.
Verification and Validation (V&V 40)
Getting enough confidence in engineering simulation for healthcare applications is the primary challenge in the way of developing a medical digital twin. I would like to acknowledge the phenomenal work of a group of medical and modeling experts under the supervision of the FDA which is defining the concrete steps necessary to properly verify that the models properly solve the equations and validate that these computer models accurately represent the reality.
The “Verification and Validation 40” document will be released within the next few months. It will facilitate large scale adoption of complete digital prototypes that will accelerate the pace of innovation and reduce the time for regulatory approval making personalized medicine a reality faster than through a traditional approach.
Ansys has played a key role in formulating this standard. A leading healthcare expert from Ansys has been a part of the committee which drafted this standard. Ansys experts also organize seminars/webinars to create awareness in the healthcare industry and regulators across the globe to speed up the adoption of these standards.