Masterclass

Documentation: Why is it so hard?

And what can you do about it?

Sruggling with documentation?

Medical device startups often struggle with documentation due to regulatory complexities, resource constraints, and the intricate nature of product development.

Many underestimate the importance of documentation, treating it as an afterthought rather than a core requirement for regulatory approval and market access.
The complexity of medical devices requires extensive, multidisciplinary documentation that must be continuously updated with design changes, increasing the risk of inconsistencies.
Limited resources mean documentation tasks often fall to engineers without compliance expertise, leading to gaps and delays.
Many startups lack a formal Quality Management System (QMS), resulting in disorganised and non-compliant records.
Navigating evolving regulatory and payer requirements adds another layer of difficulty, making it challenging for startups to align their documentation with compliance and reimbursement expectations.

Agenda: Documentation best practices

By recognising the importance of documentation and integrating best practices into the development process from the early stages, medical device startups can minimise delays and enhance their chances of successful product approval.

Prioritise Documentation: Treat technical documentation as a fundamental part of the development process, rather than a last-minute or retrospective task. There is no universally perfect approach to documentation; it should be tailored to the device being developed, the organisational culture, and the available resources. Take time to consider how to structure your documentation so that it scales with the company and can be maintained throughout the product lifecycle.
Adopt a QMS Early: Implementing a straightforward, scalable Quality Management System at an early stage can help avert organisational chaos as the company expands. Documenting processes as they naturally evolve within the company is often beneficial. Establishing a process for document control should be one of the initial steps.
Invest in Expertise Early: Engaging with regulatory consultants or experienced professionals can be invaluable in ensuring that documentation is constructed correctly. Stay abreast of regulatory updates and industry best practices through continuous learning, training, and participation in industry events.
Leverage Regulatory Tools: Utilise specialised software or platforms to streamline the management of regulatory documentation and compliance.