Innovating & Mastering IVDR/MDR

Innovation is a key process in the human evolution. From the discovery of the fire and the wheel, all the way to the penicillin or the genetic code, the humanity has always found ways to excel, improve and evolve. Today, where the acceleration of the discovery in all areas, from AI to Medicine, from nanotechnology to biology, has increased the speed of new technologies accessing the IVDR and MDR markets, the legislators are forced to set the rules and the future stage for the avalanche of opportunities to improve patient health and safety brought by dozens of companies.

The regulation of the IVDR/MDR products is putting pressure on the quality systems of the companies, where the need of expertise and well-trained team members is key for the market access success and ultimately for the company survival.

Companies’ innovation is driven by the background of their founders in the hardware, biologicals/Chemicals, and software areas. When founders hail from life sciences, the focus often gravitates towards the biological aspects of products, whereas hardware-oriented background tends to steer innovation towards engineering solutions. This leaves, the third dimension, the software, overshadowed and left behind.

For the companies, it's crucial to control and enhance these three key elements in parallel, however experience indicates an important imbalanced development and adjustment to the current regulatory demands, especially when it comes to regulated software.

Software development, particularly in compliance with IVDR/MDR, is often sidelined until the final stages, shortly before market access. This poses a serious imbalance between the 3 legs of the product regulatory path. In Repado experience, a GAP analysis in the aftermath, is always bringing severe delays in market access for our customers and represent a relevant increase of cost.

The medical software market is estimated to be 16 billion USD at 7% CAGR grow. There are 11.418 new product applications for the MDR market, and still more than 40.000 products are available currently as IVD. Most of these products are in strong need of regulated software. With only 42 Notified Bodies, the market growth, and the transition to IVDR/MDR looks like we are in front of the perfect storm. Are you prepared?

Repado can provide you a free consultation meeting to address your regulated software needs. Are you ready? Find the support your software needs by sending an email and rest assure on your marketing access strategy.