GXP Systems

Is Over Regulation Stifling Innovation?

  • Wednesday, April 19, 2017

The Medtec Europe 2017 show took place in Stuttgart on April 4th- 6th, bringing together individuals and organizations from around the globe to showcase new and innovative products & services. I was delighted to attend on behalf of Stericycle GxP.

On day 1 of the event, I took part in a focus group which discussed emerging market trends and developments. Other professionals from Sales, R&D, Manufacturing and Regulatory Affairs shared their opinions and thoughts on topics such as data integrity, cyber security, Donald Trump (no escaping him!), and the interoperability of devices.

Quite a lot of the group had dealt with, or were in the process of dealing with, new start-ups who were attempting to bring new medical device products, software or systems to the market but were faced with an increasing challenge and burden of making everything compliant with either FDA or EU guidelines. It’s a difficult task, as well as being an expensive one - unless the organization is lucky enough to have a regulatory expert as part of the start-up team.

As a result of this, much of the group were of the opinion that over regulation is hindering innovation, and that European regulators are much more inhibiting than their US counterparts. The evidence here is provided by the amount of small device producers being acquired by the huge market leaders.

Because of the cost of bringing a product to market in a fully compliant manner, a lot of small companies find themselves unable to afford the appropriate level of investment required, and have to explore alternative options. Sometimes, the final straw can be to sell out to a larger organization in order to safeguard the future of the company and ensure that patients are able to have access to the new technology. The larger organization usually has the budget necessary to ensure compliance.

These types of regular occurrences beg the question – are innovative individuals being turned off from product development because of regulations that are far too rigid, complex and seem to exist with little regard for patient safety?

 

Author:

Damien Hanley

Marketing Manager

Stericycle GxP

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