Key research for medical device manufactures

Key research for medical device manufactures

by Jasminka Roth on 13 August 2019

How does regulation affect innovation?

The origins of humanity are nomadic. We are built to explore, to travel, to move forward. We have a drive to delve deeper than what we know, to improve upon what exists, to discover new spaces and revolutionize our present for the better.

For most industries, pursuing innovation is one of its highest priorities. In recent years, artificial intelligence, data collection and the widespread implementation of new technology mean that innovation has become a daily occurrence with digitalization transforming the world around us from processes to products.

In the medical devices industry however, the process of innovation is always considered in relation to regulatory requirements—as it should be. These standards are the gateway to the market, they protect patient safety and meeting their requirements is the highest priority in the development of new medtech.

Yet, research into the connection between regulation and innovation in medtech remains a relatively unexplored area. Questions, such as how does regulation affect innovation? Does it depend on the size of a company, the market or the specialist field? How do we see regulation and does that effect the way we approach innovation? What is it that we believe, and what will the data show us? And beyond that, how do we keep innovation in balance with new regulation?

For manufactures in Europe—with the pace of evolving technologies and the immanent application of the EU’s new Medical Device Regulation (MDR 2017/745) and In-vitro Diagnostics Regulation (IVDR 2017/746) from May 2020, radically redefining the regulatory landscape of the medical devices market in Europe to improve patient safety and secure market transparency—these questions are more relevant than ever before.

The Tao of Excellence has begun a research study on this very topic. An endeavor that is being supported and promoted by Health Tech Cluster Switzerland and ITS, and whose findings will be presented at a series of upcoming events in medtech, the first of which will be the MedTech & Pharma conference in Basel this October.

Are you a medical device manufacturer?

We are inviting professionals in the medical devices industry to take a short, 5-minute and anonymous survey on the effects of regulation on innovation. If you are a medical device manufacturer, we want to hear from you.

Your contribution will provide vital insight into current perspectives around regulation and innovation in the medtech industry that can help to improve strategic thinking, approaches to processes and procedures, inform regulatory bodies and influence future policy.

How to receive the report

By completing the survey we will send you a summary report of the research in thanks for your contribution. For those that take part from at least three different levels of the same company (for example, a CEO, a Quality Assurance director and an Operations officer), you will receive a bespoke and confidential report detailing your company’s results in relation to the wider market—giving your company its own personalized insight into a key topic for 2020.

We are available to answer any questions you might have regarding this initiative, so please do contact us directly. We would be delighted to hear from you.

Jasminka Roth
Founder and Director of The Tao of Excellence

+41 52 685 51 65

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Jasminka RothKey research for medical device manufactures