As medical devices manufacturers are beginning to understand the power and benefits of big data, AI and other digital tools, the industry is facing a new wave of opportunities and challenges.

Here are 3 trends that will certainly make the news in 2018.


Digital health was always the “black sheep” of the healthcare industry. Over the past 5 years, a lot of medical manufacturers and professionals have launched leading technologies like telemedicine and wearables for their disruptive potential. However, even though there was a small increase in popularity in small wearable devices, the development of new digital health tools is highly regarded as unsafe due to uncertainty surrounding regulation policies. This changes now!

Good news! Digital health is about to take off. Last June, the FDA announced the “Digital Health Innovation Plan”. According to Scott Gottlied, M.D., Commissioner of the USA Food and Drugs Administration, FDA wants to encourage entrepreneurs to develop new digital health technologies supported by safety and efficient innovation through new regulations.

“As part of a comprehensive approach to the regulation of digital health tools and in collaboration with our customers, FDA will pilot an entirely new approach toward regulating this technology. This will be the cornerstone of a more efficient, risk-based regulatory framework for overseeing these medical technologies.”

This initiative not only supports entrepreneurial companies but also pushes big pharma and medical devices companies to continue adapting to current trends and adopting new technologies to reach a wider audience, leaving behind old “promotional” strategies. For example, last year Pfizer launched the BeLive App, a mobile app that helps patients track chronic pain. BeLive, is one in a series of mobile and wearable technologies aimed at consumers instead of Pfizer’s usual customer base of doctors and health-care providers.

Personalized Care

With over 1/3 of patients using medications and therapies whose real benefits are outweighed by the usual side effectsmedical devices companies are aiming to make healthcare a more individualized experience for patients. Improved wireless and mobile solutions are setting in motion a new era with more effective patient monitoring solutions. MedTech companies have the chance to discover potential new therapies through data processing from each patient’s device. This not only helps patients to take advantage of additional benefit but also opens the door to more disruptive devices that are not yet developed.

Security Issues + Cyber Security

In 2016, Johnson & Jonhson revealed that its Animas OneTouch insulin pump is vulnerable to cyber hacking.As the pump is using radio signals, hackers in close proximity to it, can find the unencrypted radio signal and program the supply of insulin.

Any digitally connected medical device gives medical personnel unparalleled access to patients’ medical records which helps them understand their needs and ultimately, provide better care. But with great power comes great responsibility.

With millions of medical records exposed to hazards of security vulnerability, “there is a need to balance protecting patient safety and promoting the development of innovative technologies and improved device performance”. According to FDA:

“Medical device manufacturers and health care facilities should take steps to ensure appropriate safeguards. Manufacturers are responsible for remaining vigilant about identifying risks and hazards associated with their medical devices, including risks related to cybersecurity. They are responsible for putting appropriate mitigations in place to address patient safety risks and ensure proper device performance.”