Regulatory Consulting will change. Forever!

Michael M. Kania
March 6, 2024

Absolutely buzzing to take you on a journey through the revolutionary changes shaking up the world of regulatory affairs consulting, especially within the medical device and IVD sectors.One buzzword: Productization! But first things first…

Imagine standing at the edge of a colossal wave of transformation, with digital platforms like meddevo eTD as our surfboards. It's time to grab your digital life jackets; we're diving into an ocean of innovation that's reshaping our industry from the inside out! Trust me…

Look at some data the Morgan Stanley Research Academic Studies. How AI is impacting Consultant performance and writing time saving.

But we know that AI does not simply create regulatory structures and documents.Digital, structured technical documentation, however, can.

Riding the Wave from Hours to Value

The traditional consulting model, with its focus on billable hours and hourly rates or deliverables, will be washed away by a tide of change. We're moving towards a future where the true value of consulting isn't measured by the clock or a document but by the tangible outcomes and presistant successes they bring to clients. This isn't just a shift; it's a complete overhaul that's about to make waves across the regulatory consulting landscape.

Digital Consulting Transformation

Enter the era of digital platforms, where tools like meddevo eTD are not just changing the game but rewriting the rules. These platforms offer end-to-end management and automation of technical documentation and submission processes, turning decades of regulatory experience into accessible, productized solutions. It's a world where consulting services are not only digitized but reimagined to be more dynamic, accessible, reusable and efficient.

The Productization Revolution

The concept of productizing consulting services might sound futuristic, but it'll happen right before our eyes. This approach enables consultants to package their expertise in a way that's directly usable by manufacturers, democratizing access to high-quality regulatory experience, advice and data. For consultants all over the world, it opens new revenue streams and opportunities to scale their impact. For manufacturers, it means tapping into a wealth of collective wisdom and expertise, ensuring better outcomes at every turn.

What Lies Ahead: A Digital Dawn

The future of regulatory consultancy is bright and unmistakably digital. As we embrace these changes, both consultants and manufacturers stand to gain from more effective, outcome-focused services. The shift towards digital platforms and productized knowledge is not just a trend; it's the new reality of our industry.

Technologie and the demand of manufacturers will impact at least this areas of consulting businesses:

  • Process and Document Templates
  • Training Courses
  • Country Submission Services
  • General Regulatory Advice
  • Technical Writing
  • Medical Writing

Why? Because best practices and regulatory basics flows into more and more standardized software solutions. Allowing consultants to specialize more on specific regulatory areas, borderline cases, device genres. The opportunity to productize a wide range of assets will expand the value for manufacturers.

We are already in the middle of it. Digitalization is further along than some people think.Here, the data alone shows the efficiency impact, which amounts to a median of 55% for these surveyed companies. And that "only" concerns the use of AI. So let's combine this with digital technical documentation for a perfect digital regulatory affairs process.

So, what do you think about this incredible journey we're on? Are you ready to ride the digital transformation wave? How do you see these shifts impacting your role or business in the regulatory landscape? I'm keen to hear your thoughts and insights. DM me on LinkedIN!



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