With the rising costs of drug development and increasing chronic diseases, simulation provides a cost-effective way for medical device developers to explore new treatments and medical products. Simulation enables healthcare professionals to test various designs and formulations and correct flaws before production. This approach saves time, reduces costs, and ensures patient safety.
It’s About Reducing Risk for Patients
Simulation technology has the potential to address the growing concern of medical errors. Recent studies of medical errors have estimated errors may account for as many as 251,000 deaths annually in the United States (U.S). These errors can range from misdiagnosis to surgical complications and can have devastating consequences for patients and their families. By utilizing simulation software, healthcare professionals can practice complex procedures, such as surgeries, without putting real patients at risk. This not only improves patient safety but also increases the confidence and competence of healthcare professionals.
In the past, healthcare professionals relied heavily on trial-and-error methods to test new treatments and procedures. This not only resulted in prolonged treatment periods but also increased the risk of complications and adverse effects. With the advent of simulation technology, healthcare professionals can now test new treatments and procedures in a virtual environment, allowing them to identify potential issues and optimize the treatment before it’s implemented in real life.
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What’s Possible in Medical Device Development?
We live in an age of medical advances, with new devices, drugs, and advanced therapies changing outcomes across a variety of illnesses. Yet these developments come with a cost. To bring these treatments and devices to market, FDA and other agencies can require extensive clinical trials and tests. Recent studies have estimated the average cost of drug development as high as $2.8 billion. Modern healthcare advances can also have a circular effect, providing a longer lifespan that often means more elderly patients with chronic diseases – creating higher costs that can stymie innovation in treating those diseases.
While there’s no silver bullet for reducing healthcare costs, there is a solution that’s delivering both clinical and business value: simulation.
Simulation can improve almost every angle of the Research & Development process, from helping healthcare developers minimize the cycle development time to improving patient safety to devising smarter strategies for bringing a device to market. Just as in other industries, it offers an exploratory environment in which engineers can create multiple designs for future drugs or devices and then test their results under a variety of conditions. In silico medicine, as it’s called, can cost-effectively and accurately predict the performance of these new therapies – from their impact on human physiology to commercial success.
Strategic Cost Savings
Because teams can correct flaws and discover improvements before production, simulation gives them the freedom to try different formulations and designs without the expense of physical testing. Consider Merck, credited with saving more than half a billion dollars over three years using simulation. Manufacturers can also identify mediocre products sooner and accurately select the promising devices and drugs that deserve more investment. Finally, it can help them beat a competitor to market, increasing the profitability of their new drug. These are just a few reasons 85% of the top 50 healthcare companies turn to simulation.
By providing an inexpensive way to invent, test, and explore new treatments, simulation allows them to achieve four important objectives:
- Predict the impact of a new medication or device on patients
- Tailor treatment to an individual patient’s needs
- Satisfy complex clinical trial requirements
- Speed time to launch – critical for oncology and other life-saving drugs
Real-World Examples
Here are a few real-world examples of how medical device manufacturers and pharmaceutical companies are using simulation to innovate intelligently.
- In silico clinical trials and Virtual Human Laboratories offer sophisticated computational modeling and simulation to test out treatments without involving real people. By using virtual patients based on real physiology, teams can test their products before (or alongside) a real clinical trial, course-correcting when necessary. This process also lets them sidestep any ethical concerns about testing on real humans. These uses skyrocketed during the pandemic when travel restrictions affected traditional clinical trials. While the results can’t replace regulatory requirements, they do signal when teams have a successful drug or device on their hands – and they can reduce the size of their required clinical trial, speeding up time to market.
- Combined with the right data, simulation is opening the door to tailored, personalized medicine and treatments, as well as population health strategies. Simulation can detect diseases before they emerge in a specific patient and help their providers formulate a customized treatment program On a larger scale, teams can test a prototype using large amounts of patient-specific data for a targeted population – developing a better understanding of drug-drug interactions (DDI) and dosing for that population and shaping clinical trial parameters.
- Simulation-based training is improving patient safety and lowering care costs by upskilling providers. By introducing simulation curricula for orthopaedic surgery residents, one children’s hospital was able to reduce cast saw injuries and the associated costs. Third-year residents were instructed in distal radius fracture reduction, cast application, and cast removal using an oscillating cast saw through simulation. The hospital saw the injury rate decrease to approximately 0.7 per 100 casts, while costs for cast saw injuries dropped from $65.83 per resident to “negligible” – resulting in a savings of $488,002.60 over a 2.5-year period.
- Virtually certified Body Area Networks (BAN) are another valuable tool, used to assess energy absorption from wearable and implantable devices. This kind of simulation measures the specific absorption rate (SAR) of the electromagnetic field on the body, so teams can better understand the risks of excessive energy absorption.
- Failure mitigation is another population use of simulation. One global medical device manufacturer couldn’t find the reason for repeated in-service failures of an electronic device, Simulation tools analyzed the operational thermal, shock, and vibration loading and found components that were exceeding their design limits under normal operating conditions. The team then adopted simulation in their product design process, helping them identify weaknesses and at-risk components before production – dramatically reducing costs.
Reaching the Peak of Performance: Ansys
One of the leaders in healthcare and medical device simulation, Ansys empowers innovations across industries, from aerospace to medicine to telecommunications. Healthcare is no exception, with eighty percent of the top 50 healthcare companies using Ansys software to design, test, and validate medications, biotech solutions, and medical devices. The sophistication and breadth of Ansys solutions can accommodate highly technical devices and advanced pharmaceuticals, offering complex virtual models of the human body for testing. The results: reduced research and development costs, an accelerated time to market, and an open playing field for innovation.
Forward-thinking healthcare companies continue to bank on simulation’s ability to help them assess drug safety, design efficient clinical trials, accelerate the pace of medical innovation, and protect patient safety. Yet it’s simulation’s ability to control skyrocketing R&D costs that may provide its greatest value to an industry hungry for cost-effective innovation. From creating and releasing life-changing drugs in a faster time frame to eliminating needless testing and trial inefficiencies, simulation offers a new era of profitability in healthcare.