Medical device manufacturers and designers continue to develop cutting-edge, highly sophisticated, and connected products. These products provide a wide range of benefits, including better treatments, more accurate diagnostics, improved patient monitoring, better reporting of data, and lower costs.

This continued innovation, however, comes with risks for both patients and providers. While companies invest heavily in the development of medical device technologies, they often lack the design and security expertise to ensure high levels of security are built into the final products, which is why wearable medical design consultants like Voler Systems are a big advantage for both startups and seasoned companies looking to build their next medical device.

What is a medical device?

The Food and Drug Administration (FDA) defines a medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them.

Its intended use is the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

Medical device security refers to practices and techniques that can prevent attacks against medical devices. Attacks may include unauthorized control or access of medical devices or exposure of the sensitive data they store.

A good starting point for securing medical devices is the FDA guidelines for medical device safety. The FDA said that the “need for effective cybersecurity to assure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and network-connected devices, and the frequent electronic exchange of medical device-related health information.”

Beyond patient privacy, issues with medical device security can lead to patient safety issues if an attacker compromised the apparatus. Medical devices can become the weak link in the network, becoming a gateway for attackers who want access to hospital networks and obtain valuable assets or blackmail healthcare providers.

Wearable technology cybersecurity issues?

Security risks to medical devices are continually studied and evaluated by multiple entities, including academic, governmental, and the industry. As healthcare is delivered more and more outside the hospital, medical device security challenges must be a huge consideration for manufacturers and designers.

Here are some of the main challenges when securing medical devices:

1. Lack of authentication
   Manufacturers often ship wearable devices without a built-in security mechanism such as user authentication or PIN system protection features, or users are allowed to keep a default PIN instead of changing it.
2. Lack of encryption
   Data collected by wearables can be very valuable and encryption is a basic requirement to protect it.
3. Insecure wireless connectivity
   Wearable devices connect to smartphones wirelessly via protocols such as Bluetooth, NFC, and WiFi, which may have security flaws. But the security of these wireless channels can be improved with the right technology.
4. Insecure Cloud data
   Data synchronized to cloud storage is also vulnerable to a number of threats such as distributed denial of service (DDoS) attacks, SQL injection (attacking the database), or back door attacks.

FDA guidance not only requires steps to prevent unauthorized access but ways to recover from hacking as well. Learn more about safeguarding the security of data from wearable devices.

Who designs medical devices?

Electronic product designers like Voler Systems help organizations proactively manage security risks associated with medical devices. Voler offers device manufacturers services to help build in security at all phases of the product development lifecycle. Pre-market technical testing can detect vulnerabilities and provide results that help to establish an organization’s overall security risk management program.

Understanding the potential cybersecurity failings of products and knowing how to prevent them are crucial steps in building a strong cybersecurity stance that can be used to protect the company’s reputation and revenue.

Voler Systems specializes in medical devices, sensors, motion control, and wireless communication. We build wearable devices, home health devices, and devices for the aging, among others.

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 highly experienced electrical engineers and firmware developers. Voler Systems ensures delivery of quality products, on time, on budget, and with low risk. All projects are undertaken with good specifications, the right people, quality design, constant communication, and a smooth transfer to manufacturing.