HealthTech IP & REGULATION

Understanding IP position, commercialisation strategies and regulatory requirements for investment and growth

IP, Commercialisation Strategies & Regulation

Health Tech Enterprise has extensive experience helping clients gain a greater understanding of their intellectual property (IP) position and jointly developing a plan to defend and protect their assets. We advise also on commercialisation strategies and understand the route to market for health technologies in the UK and abroad.

Understanding the roadmap to regulatory approval in different markets is an essential part of any business plan for a new medical technology. Developing the right regulatory strategy enables you to get your products to market quickly by achieving compliance with UK, EU and international standards.

Service Offerings:

IP & Commercialisation Strategies

A rigorous IP & Commercialisation strategy will maximise your innovation’s commercial potential. HTE’s services include:

  • Evaluating and advising you, based on the specific attributes of your technology, on what and how to protect your technology to safeguard your potential future revenue streams and maximise the value of your innovation.
  • Assessing the IP and competitor landscape – working collaboratively with you, we develop specific searches to explore potential areas of prior art which might affect the likelihood of securing IP protection.
  • Undertaking commercialisation options analyses by reviewing and exploring the opportunities and challenges of the principal routes to market.
  • Working with you to devise a commercialisation plan and how best to implement it.
  • Developing investor pitch decks and business plans to support your commercialisation strategy.

Regulatory Guidance Roadmaps

We provide relevant, up to date and bespoke guidance and roadmaps on the latest regulatory requirements for medical devices, IVDs and digital health products. Our services include:

  • Device classification signposting, regulatory roadmaps and associated timelines.
  • An overview of the medical device regulations (MDR/IVDD) that apply in different markets (Great Britain, Northern Ireland and the European Union, the USA).
  • Guidance on data protection and data security regulations, as well as clinical risk management and clinical safety standards for digital health products in the UK.

Regulatory Strategy Reports

In partnership with our Medical Regulatory Associates, we are also able to provide:

  • A comprehensive report reviewing the Medical Device Regulations in the UK, EU & USA, Medical Device classifications and advice regarding Competent Authorities, Notified Bodies and the role of Economic Operators (including Manufacturers, Authorised Representatives (EU) and/or UK Responsible Person, Importers and Distributors).
  • International Regulatory Strategy for compliance with UK and EU MDR/IVDR, FDA and global regulatory requirements.
  • Quality Systems development to meet European, US and International standards (ISO 9001 / ISO 13485 / FDA Quality System Regulation).

 

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