Knightec: Adaptation, Regulation & Digitalisation

In the fast-evolving landscape of European life science industries and healthcare, companies and organisations are facing the dual challenges of adapting to rapid digital transformation and navigating shifting regulatory requirements.

This heightened reliance on digitalisation underscores the critical need for enhanced cybersecurity measures, while maintaining a steadfast commitment to sustainability is critical.

Knightec , with offices all over Sweden, combines an entrepreneurial approach with our deep business understanding and cross-functional expertise, driving clients' businesses forward commercially and competitively, creating new opportunities and fuelling business innovation.

We asked Quality & Management advisor Rickard S. , what he sees as the biggest challenges customers face in commercialising their products:

One of the major challenges is to meet and have the resources to handle all the required regulations, not only industry-specific ones but also those related to information safety, sustainability, etc.

Can you sense the change in healthcare and life science industries that is affecting the landscape?

With the rise of digital products and services, particularly software-based ones, there will be a greater need for regulatory adaptation to keep pace with this change. Digitalisation is materialising around us everywhere, and with AI, change is happening very quickly.

What factors contribute to successful commercialisation, beyond just having a strong clinical need and a good product idea?

Commercialisation is primarily driven by good ideas, but innovators must also have investors with good knowledge of what resources are required to fulfil all regulatory requirements which is something else that must be considered before choosing which market to enter first.

What is your perspective on recent changes in regulation and what it means for early stage companies?

Requirements for companies with low-risk products are very high, which can mean that it becomes impossible to begin product development or reach commercialisation. This also means that many good products never reach the market because the challenge is too great, and the investment is too high.

What advice would you give to a Medtech company just starting out on their journey to commercialisation?

Start with QMS and regulatory work directly, in parallel with product development and introduce an electronic QMS system including case management as early as possible.?

Offer comprehensive QA/RA training to all staff from the outset to preemptively address the necessity and procedures of their roles, ensuring that each function takes ownership of QA/RA responsibilities within their respective processes.

Key takeaway:

Meeting regulatory requirements presents significant hurdles for product development and market entry. To navigate these challenges, companies should integrate quality management and regulatory work early on, alongside comprehensive training to foster accountability across functions.

Huge thanks to the Knightec and Rickard S. for giving us an insight into the industry and it's challenges.

Now, we turn to you: Who else in the life science sector has a unique perspective on regulatory change?

Let's continue the dialogue. ?? #LifeScience #MedTech #healthtech #Marketaccess