Let’s make it personal!

The current “one size fits all” approach to healthcare fails to recognize the significant differences between the bodies and behaviors of different patients. This creates inefficiencies and cost overruns — but it also affects the quality of care provided. By personalizing the specific treatment to each patient, healthcare will become more affordable for patients and more profitable for providers due to increased efficiency. Implanted medical devices and wearables are becoming more commonplace, saving millions of lives each year. Yet personalized healthcare still requires a significant paradigm shift, as well as a new technology toolkit for collecting data via devices and wearables. Engineering simulation provides a cost-effective, rapid and straightforward solution for modeling patients’ bodies and designing devices that interact optimally with the body. This allows healthcare providers to devise truly personalized treatment plans, as well as to predict health problems before they occur, enabling early intervention. While this “medical digital twin” concept might seem like science fiction, advanced technology is poised to improve quality of life for people around the world.

Custom-Tailored Healthcare: Short- and Long-Term Benefits

Whether you call it precision medicine, individualized medicine or customized medicine, all these terms refer to the same idea: Someday, all of us will be under permanent intensive care. All our vital and non-vital signs — body temperature, blood pressure, glucose level, cardiac rhythm, breathing pace, number of platelets or cells, etc. — will be continuously monitored. Warnings or alarms will be recorded and sent to us, and possibly to medical staff or close family members, whenever a key reading deviates too much from its standard. [1]

In the future, this level of participatory medicine will be the norm, and most of us will be sharing medical data and contributing to a pool of big data necessary for statistical analysis. The combination of available data and advanced methods to predict the outcome of a given treatment for a given patient will naturally lead to predictive medicine — and the opportunity to pay for treatment based on the expected outcome, rather than on an a priori imposed price. Our society will have all the components needed to ensure effective preventive medicine, where pathologies are cured before they break out or evolve. P4 medicine — personalized, participatory, predictive and preventive — a concept imagined a few years ago, will progressively become a reality.

While this might be a long-term vision, the trend toward personalized healthcare has already begun, and the short-term benefits are obvious. Numerous applications for smart phones and smart watches are already available, enabling the measurement of personal physiological parameters. These applications are too often considered gadgets, but in fact their role in monitoring and caring for patients — especially senior citizens and young children — could be significant.

Facing — and Solving — the Challenges of Personalized Care

Our society is already taking advantage of the first “baby steps” of personalized healthcare, but there are still many challenges to overcome before we benefit fully from this new paradigm. To fulfill this vision, the healthcare industry will need to address several bioelectronics technology gaps [2]. Among these are a few key areas where innovation is needed (Suggested solutions are discussed in the related White Paper: “Leveraging Engineering Simulation to Fast-Track Personalized Healthcare [1]”).

Measuring Target Parameters Reliably Across Patients

• While wearables are measuring specific healthcare parameters across patients today, they are not yet completely reliable. The variation between two measurements for the same patient can be so large that no meaningful insights or subsequent diagnosis can be obtained.

Optimizing the Size, Weight, Power and Cooling (Swap-C) of Medical Devices

• Smaller, lighter, more energy-efficient and cooler wearables or implanted devices are necessary for patient comfort and device reliability. In addition, today’s wearables and implants are increasingly incorporating automated “in vivo diagnostic” and Internet of Things (IoT) technologies — including pervasive connectivity and a higher density of electronic components. This means making strategic trade-offs to balance many aspects of performance for overall device optimization. As one example, Casey Murray, senior radio frequency design engineer at Starkey Hearing Technologies, recently noted, “Manufacturers are adding wireless technology and other features, while hearing aids are becoming smaller than ever.” [3]

Managing the Electromagnetic Interactions of Devices with Their Environment

• In today’s connected world, medical devices do not operate in isolation. Instead, they are surrounded by other electronics and thus electromagnetic activity [4]. Electromagnetic interference (EMI), electromagnetic compatibility (EMC), signal integrity and cyber security (CS) are all major challenges that can slow down or even stop the deployment of personalized healthcare. Interference or compatibility problems could endanger the life of numerous patients. Vulnerable electronic interfaces could lead to the possibility of devastating cyber attacks.

Ensuring Patient Safety and Regulatory Compliance

• Considering that future patients may have a greater number of body-worn or implanted medical devices, there is a serious risk that emitted energy, if not properly controlled, might exceed the specific absorption rate (SAR) and impact the patient’s health. Engineers need the ability to measure the electromagnetic absorption of the patient’s body to minimize harm. In addition, many medical products operate in safety-critical environments and need to meet relevant reliability and safety standards. Before devices are near or implanted within the patient, regulatory authorities require proof that they will not harm the patient in any possible way. [5] “Often it is simply impossible for us to perform experimental tests — as is the case with medical devices,” said Chris VanHoof, director at Imec, a nanoelectronics research company. [6]

Specific absorption rate (SAR) induced by a pacemaker

Delivering Flawless Embedded Software and a Patient-Friendly Interface

• Although healthcare is clearly lagging behind aeronautic and automotive applications in this area, there is no doubt that future connected medical devices will include software containing millions of lines of code required to properly interpret the large amounts of continuously acquired data and respond appropriately. Because many healthcare products and systems are safety-critical — defibrillators, for example — the control software must operate flawlessly. Devices must also be properly controlled by a user-friendly interface that’s easy for patients to interact with.

Wearable insulin pump interface

Engineering Innovation: Lessons from Other Industries

This list of challenges is intimidating, but the healthcare industry can make faster progress by studying other industries that are much more advanced in their use of engineering simulation technologies. The following list of engineering innovations in other industries may help inspire healthcare companies.

• Achieving product autonomy. The global automotive industry is certainly leading in product autonomy today, with its goal of engineering a selfdriving car — which is not that far away. For more than a decade, onboard computers have been providing a wealth of information such as the level of gas in the tank, water temperature, tire pressure, interior and exterior air temperatures to mention a few. Drivers receive warnings to service the car if the oil level is low or if they have exceeded the recommended mileage since the car’s last service. Increasingly, vehicles are equipped with numerous sensors to detect obstacles while parking, as well as to detect a passing vehicle or a car slowing down ahead. Ironically, we are investing much more to protect our car or prevent any deterioration in its functionalities than we are investing to protect the human body. [7]

• Increasing energy efficiency and capitalizing on renewable energy. Each year, billions of dollars are invested to use energy more intelligently, reduce unexpected energy leakage and identify sustainable and renewable ways to produce energy. Running out of power is not an option of a life sustaining implanted device, why not take advantage of the most advanced energy technologies for our own bodies? [8]

• Making healthcare products smarter. Today the high tech industry is leading in its efforts to increase the digital nature of products, making them smarter and adding new functionality. Most of the necessary components for future personalized healthcare innovations have already been developed by the high tech industry — and are in use in other products today. [9]

Simulation and Healthcare: A Healthy Outlook

There can be no doubt that personalization represents the future of healthcare. By customizing the performance of devices, wearables and treatment plans to individual patients, the quality of care can be significantly improved — while also cutting overall healthcare costs. With other industries leading in product autonomy, digitalization and electrification, it’s time for the healthcare industry to capitalize on these technology advances and move into a new generation of individualized, targeted care.

While personalization is quickly becoming a competitive imperative for healthcare companies, the cost of building product prototypes and testing them on patients is prohibitively high. Simulation is the answer, and it has already been proven as a best practice in many other industries.

By constructing prototypes in a low-risk, cost-effective virtual design space, healthcare product development teams can quickly create product models and verify their performance. Computer modeling accelerates the overall design process and regulatory approval process [10]; it supports the development of smarter devices that gather individual patient data and facilitate an appropriate response — laying the foundation for a new era of custom-tailored healthcare.

References and further readings:

1. Leveraging Engineering Simulation to Fast-Track Personalized Healthcare - White Paper
2. Digital system prototyping for medical devices - White Paper
3. Murray, C. I Hear You. ANSYS Advantage, 2015, Volume IX, Issue 1, pp.18–21. Retrieved July 17, 2017.
4. Buxton, B. Wearing a Wire. ANSYS Advantage, 2012, Volume VI, Issue 2, pp. 46–48. Retrieved July 17, 2017.
5. Engineering Simulation: A Promising Tool for Securing Regulatory Approvals - White Paper
6. ANSYS Advantage Staff. Small Systems, Huge Impact. ANSYS Advantage, 2013, Volume VII, Issue 3, pp. 1–3. Retrieved July 17, 2017.
7. Autonomy System
8. Engineered Electrical Systems
9. Digitalization
10. Engineering Simulation: A Promising Tool for Securing Regulatory Approvals - White Paper