In Europe, legislations have been adopted to drastically change regulation of medical devices

by HABHAJAN SINGH

The medical marketplace is generally slow in embracing technology, more so in view of the potentially high upfront cost as they dabble with potential new solutions.

When looking at the current digital healthcare landscape, an industry executive identified one major challenge: The disparity between product development life cycles on the pharma side and on the technology side.

High on their minds is the question of return on investment. How much does this cost? How many years will it take before the solution starts realising some real gains?

However, industry executives from both pharmaceuticals and medical technology (medtech) companies are cognisant of the painful effect of neglect. They open themselves to disruptors if they do not occupy the space fast enough.

“At the end of the day, we believe that digital innovation is more disruptive, less risky and has a higher likelihood of success than the traditional drug innovation model,” Flex Ltd senior VP of digital health Dr Kal Patel (picture) told an online healthcare news portal.

In an interview with MedCityNews, Dr Patel discussed the importance of getting physician’s buy-in for their solutions.

“The first thing to tackle is ensuring your solutions fit within the clinical workflow. When I was in medical school, we had an electronic medical report (EMR), but every time I wanted to see an X-ray, I had to minimise it and launch a separate application. If I wanted to see a CT (computed tomography) or an MRI (magnetic resonance imaging), I had to walk 10 minutes to radiology. Now, all that can be surfaced in the EMR.

“The same thing has to happen in digital health. As long as you have insights coming from a device, no matter how great the insight is, we’re not going to get widespread adoption by physicians until we integrate the data into their clinical workflow. In the future, your clinician should be able to see all these disparate pieces of information in the EMR, including data from your devices and apps,” he said.

This is an area of keen interest to Dr Patel who joined Flex in November 2016. Flex provides solutions for a connected world, including for the healthcare sector. Earlier, Dr Patel was the chief commercial officer at video telemedicine provider Doctor on Demand.

Changes in Europe

In Europe, legislations have already been lined up to bring about major changes to regulating medical devices. On April 5, 2017, the European Union (EU) adopted two regulations on medical devices which came into force a month later.

The regulations are meant to establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety, according to the EU.

In a commentary earlier, consulting firm Ernst & Young noted that the “sweeping reform” of the rules that govern the medical device sector in Europe represents one of the most disruptive changes to affect the industry in recent times.

“When the European Medical Device Regulation replaces the current set of directives, companies will have three years to comply with a broad swathe of new rules for almost every kind of product in the medical device spectrum.

“In total, they can expect significantly more costly path to compliance in the world’s second-biggest medtech market. The costs associated with compliance may force some companies to take drastic steps, such as putting themselves up for sale. The aftermath of the shake-up will be a stronger, more accountable medtech industry that may look substantially different from today’s,” it said.

That may force upon the pharma and medtech players to solve one perennial problem: Products working in silos.

“When you look at the marketplace today, you see a lot of siloed solutions that operate on their own, and that doesn’t integrate seamlessly with how we live,” said Dr Patel.

Hence, changes should already be in the pipeline.