Olaf Schneider / pixelio.de

Earlier this year, I was visiting a presentation by the Basel business development agency on the challenges of Medical Device Regulations (MDR) for the providers of health apps. There had been around 30-40 IT guys locally supporting pharma with the development of health-related digital solutions, some from agencies, some freelancers. What they all had in common were shocked faces at the end of the presentation.

I was not really surprised. During many years I have now been involved in the development and realization of various digital tools and solutions in pharma, I got used to digital agencies’ naivety if not reluctance to deal with regulatory requirements. Sometimes there was not even basic knowledge about MDR and CSV. Guys, you really should know what an audit trail is.

I frequently met a thinking that this ‘annoying, boring and painful stuff’ should stay with the client who is obliged to all those pharma regulations, where digital is not.

You thought wrong!

Let me summarize some general developments I claim to watch …

• In pharma industry, there is an accumulated innovation gap for digital solutions and tools. It does not matter why, at least there will be a lot of money to be earned by agencies supporting digital (r)evolution.
• For pharma-related software and data, expectations and requirements by regulatory bodies have constantly been increasing. And especially for health-related apps and websites, authorities are just discovering the blind spot they had for many years.
• Most pharma companies – especially the big ones with the big money – aim to overachieve and to internally have even higher expectations and rules in place.
• At last after the release of the new EU medical device regulation 2017/745, MDR applies to everybody who is providing a health-related digital solution which is – even partially – accessible in a EU country.

So, no let’s calculate 1+1+1+1 = … there is a huge market for digital solutions in pharma, but companies more and more take for granted that vendors meet their high level expectations regarding regulatory requirements. This is not going to happen in the future. This happens now, and has happened already.

I dare to predict that in 5 years ahead …

1. Most digital solutions agencies support pharma today … will have disappeared
2. Those few having already an acknowledged quality system including validated processes in place … are going to earn money like hell
3. And all those which – starting today – forcefully get their stuff together … might have a chance still catching the train

You want to do digital business with pharma in the future? Then stop being reluctant and learn to love MDR and CSV.