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Best Practices in Designing Wearables Devices for Healthcare

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The wearable medical device market will hit $89.45 Bn by 2027, as predicted by Precedence Research. The global wearable medical device market size was valued at US$ 14.44 billion in 2019. A projected 5 million individuals will be remotely monitored by healthcare providers by 2023. Patients and healthcare professionals now rely on medical wearables for early diagnosis, medical adherence, remote patient monitoring, and even treatment of illnesses.

Wearable devices used in healthcare are referred to as medical devices. A medical device is defined as autonomous, noninvasive, and performs specific functions like supporting or monitoring specific data over a long time. These are essentially smart devices built with sensors & other technologies and designed to be worn on a human body.

Any electronic device aimed to be used in a healthcare setting must be developed with best practices that include strict design procedures and follow the Food and Drug Authority (FDA) guidelines. Without these, a company will only waste time, opportunity, and budget with the product not seeing the light of production.

Let’s discuss some of the best practices in designing wearable devices for healthcare:

 

Using Secure by Design Philosophy

Cyber-attacks on connected medical continue to increase — and they are even more sobering than medical systems hacks. As Harvard Business Review (HBR) puts it, “medical systems hacks are scary, but medical device hacks could be even worse.” Wired, on the other hand, wrote that “medical devices are the next security nightmare.”

Privacy and security measures for wearable devices should be built-in and not merely an afterthought, so it is imperative to choose devices manufactured with a “security by design” approach.

Meanwhile, here are some best practices that organizations can use to ensure the security of their devices.

  • Ensure defensive device capability. Manufacturers should provide built-in security to the device, such as secure boot, certain chipsets, and functions for secure data storage.
  • Build malicious device detection and isolation. Manufacturers should reinforce device weaknesses by designing them with built-in encryption and authentication measures and controlling data flows using whitelist and blacklist policies.
  • Provide a way to do firmware and software updates. After a security problem is detected, this provides a way to update the devices in the field to resist future attacks.
  • Insist on a “security-by-design” approach. Security should be part of the design blueprint, so vulnerabilities are anticipated and risks addressed — even before they happen. Manufacturers who follow a security-by-design approach simulate threats during the early stages of device development, so they are addressed proactively instead of reactively.

 

Design with Compliance in Mind

The U. S. Food and Drug Administration (FDA) has become more proactive and supportive of test development by all comers due to the COVID-19 pandemic — including laboratories and large and small commercial manufacturers — to speed development and to authorize tests that the science supports quickly.

To fool-proof the security of your medical devices, you need to make them meet the requirements of the FDA and other security standards, which is easier said than done when designing medical wearable devices and IoT devices for healthcare.

Voler has a broad understanding of sensor and measurement electronics in medical devices and can address them effectively in the integrated design, development, and risk assessment of new medical devices. In particular, Voler is familiar with regulatory processes and procedures and has the expertise to apply them within the context of a multidisciplinary team.

Voler has demonstrated these capabilities by delivering quality products on time and budget:

  • Catheter to measure the temperature inside the body
  • Heart valve tester
  • Proof-of-concept device with specialized sensor electronics
  • Prototype circuit in a catheter to measure the impedance of heart muscle

 

End Note

As cybersecurity and privacy issues increase in healthcare, companies need to make security and compliance a top design priority. Meeting FDA, C.E., and other requirements through the help of experts like Voler will ensure your devices are fool-proof and avoid the costly consequence of security breaches.

Voler can help you develop secure-by-design medical IoT and wearable devices. We offer expert guidance on designing and developing next-generation IoT and wearable devices. We help select the right technology for your device and determine the right combination of electronics for guaranteed security and reliability.

 

About Voler

Located in Silicon Valley and with more than 40 years of electronic design experience, Voler Systems continues to be a leading custom product design consulting company providing high-quality electrical engineering and firmware development. Voler Systems ensures delivery of quality products, on time, on budget with low risk. All projects are undertaken with good specifications, the right people, quality design, constant communication, and a smooth transfer to manufacturing.

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