In today’s fast-evolving regulatory landscape, success isn’t just about compliance, it’s about building a team that can anticipate change, respond with agility, and drive strategic value.
And this is exactly why it is critical that you take care when you setup your team. Considering this, I take inspiration from Topiary: the art of clipping woody plants (trees and shrubs) into shapes. The goal of topiary is to create clearly defined shapes and forms that would not occur naturally.
Shaping Regulatory Teams with the End ‘Form’ In Mind
As with topiary basics, there are key areas where thought and consideration at the outset for what ‘shape and form’ the regulatory team, or indeed its goal(s), will need to look like will deliver a better outcome:
- Freehand Shaping: Developing a regulatory team utilising an existing employee, who has experience and understanding of the products as the foundation, enables building regulatory knowledge based on your specific and relevant IVD product types.
- Using Frames: A robust training programme is key to ensure comprehensive and accurate knowledge is expanded, along with ongoing development of regulatory intelligence and networks. Utilisation of trade association like BIVDA, or professional organisations like TOPRA or RAPS to support employee growth can be hugely beneficial to developing teams, and supporting budding teams by leveraging expert guidance via skilled consultancies as a learning tool can avoid costly errors.
- Regular Trimming: Implement regular check points to ensure that you have the right regulatory resources you need for your organisation. Particularly in the Medical Device and IVD sector, regulations change and evolve constantly, and as your organisation pivots to new markets or technologies, you may need to adopt new regulatory frameworks.
Patience and Planning: You may not have sufficient skills or expertise in-house to meet your regulatory needs. This is where external resource can be essential. External PRRCs, UKRPs, auditors and regulatory advisors can help you create and adapt your regulatory strategy, support and mentor team members, and identify a succession plan for getting the right regulatory expertise in the future.
How Does Your Regulatory Garden Grow?
Every gardener knows that success depends largely on the right conditions. However, with the right time, effort and skill, you can still get the desired result.
- Access to Sunlight: Keep the regulatory team aware of the organisational objectives, goals and opportunities, so that they can adapt and adjust the regulatory strategy.
- Water Frequently: Regulatory Affairs teams have touch points in many functions within the organisation. It is important to make sure that they are involved in key Quality Management System (QMS) activity including change control, risk management and vigilance, especially in an environment when ISO 13485 is required.
- Ensure Periodic Feeding: Make sure there are effective mechanisms in place for post-market surveillance, training, and regulatory intelligence pathways, to ensure that your organisation remains informed of changes and can adapt to any new standards or regulatory updates.
- Pest Control: Don’t get bogged down in other functional activities. Regulatory teams tend to get given the roles other departments don’t want. Be clear on what is expected of them and their goals so that they can protect their time and achieve their goals.
Your Regulatory Strategy Taking Shape:
A well-shaped regulatory team doesn’t just protect the business, it allows growth and opportunity. By investing in people, tools, and culture, you create a function that’s resilient, respected, and ready for what’s next.
By tapping in to trade associations and networks, and utilising specialised Regulatory Affairs professionals or consultancies to boost your team’s knowledge, skillset and outputs, you can maximise your chances of successfully gaining regulatory approval in your desired territories.
With the right support, in-house regulatory teams can build a culture of quality, resilience, and continuous improvement and protect your QMS from the inside out.
If you feel your team has knowledge gaps, or you’re not sure where to start with growing one, reach out to our experienced IVD Regulatory Affairs consultants to discover how strategic partnership can accelerate your journey and help you achieve your business goals. Contact us to discuss your specific requirements and discover how we can integrate our services to support your in vitro diagnostic (IVD) Quality and Regulatory Affairs success.
Authors note: for more tips on Topiary visit: Topiary | The Huntington!