SBRI: Digital Regulatory Navigation Platform (Health Products)

This is a Small Business Research Initiative (SBRI) competition funded by Innovate UK. The aim of the competition is to support proof of concept projects to develop an intuitive medical device digital regulatory navigation tool.

Projects must:

• demonstrate the principle of an intuitive digital platform that enables users to understand and explore the regulatory pathways for the healthcare product they are developing
• provide users with information and access to UK support structures that are relevant to their commercial R&D, for example, standards, UKAS accredited test labs and Notified Bodies

This is phase 1 of a potential 2 phase competition. A decision to proceed with phase 2 will depend on the outcomes from phase 1, availability of further funding and assessment of a separate application into a subsequent phase 2 competition. The potential phase 2 will support extended data collection and beta testing activity with end users.

Adoption and implementation of a solution from this competition would be subject to a separate, possibly competitive, procurement exercise. This competition does not cover the purchase of any solution.

Projects must:

• start by 1 November 2021
• end by 31 March 2022
• last up to 5 months
• have total eligible project costs from £250,000 to £1 million inclusive of VAT
• demonstrate a deep understanding and expertise of the regulation of health products within the UK and EU
• understand challenges facing innovators or businesses seeking to bring innovative products to market

Applicant

To lead a project, you can:

• be an organisation of any size
• work alone or with others from business, research organisations, research and technology organisations or the third sector as subcontractors

Contracts will be awarded only to a single legal entity.

Research and development

Your application must have at least 50% of the contract value attributed directly and exclusively to R&D services, including solution exploration and design. R&D can also include prototyping and field-testing the product or service. This lets you incorporate the results of your exploration and design and demonstrate that you can produce in quantity to acceptable quality standards.

R&D does not include:

• commercial development activities such as quantity production
• supply to establish commercial viability or to recover R&D costs
• integration, customisation or incremental adaptations and improvements to existing products or processes

The aim of this competition is to:

• demonstrate the value of an intuitive digital platform that enables users to understand and explore the regulatory pathways for the product developed
• provide users with information and access to UK support structures that are relevant to their commercial R&D, for example, standards, UKAS accredited test labs, and Notified Bodies

Your project must deliver an intuitive proof of concept digital regulatory navigation tool for medical devices that specifically includes UKCA requirements. These are outlined in Medicines & Medical Devices Act 2021 along with EU CE Mark requirements set out in Regulation (EU) 2017/745 and Regulation (EU) 2017/746

You must consider how externally maintained nomenclatures will be used. Examples of relevant nomenclatures include Global Medical Device Nomenclature (GMDN), Notified Body Operations Group (NBOG), Systematized Nomenclature of Medicine (SNOMED), International Classification of Diseases (ICD) and Anatomical Therapeutic Chemical (ATC) code.

Your project must:

• demonstrate a credible and practical route to market
• include a plan to commercialise your results
• utilise externally maintained nomenclatures
• focus on healthcare products for the UK and EU

The initial focus of the platform should be on healthcare products for UK and EU but the platform should be scalable to other sectors and global markets in the future.

At the end of the phase 1 contract period you must deliver a functioning proof of concept digital regulatory navigation platform.

You must demonstrate a credible and practical route to market, so your application must include a plan to commercialise your results.

Your project can also include any of the following:

• medicines
• products that combine medicines and medical devices
• health related products such as cosmetics, nutritional products, biocidal products, PPE
• other sectors such as aerospace, automotive, finance
• regulatory requirements for other geographies, for example, US, China, Japan, India
• creation of ‘trusted service provider’ marketplace
• training and education resources that underpin the platform and provide granular information to users that is specific to their product.

An online briefing event will be held at 12 noon on Wednesday 25th August: click here for the joining link (held on Zoom).

If you want help to find an organisation to work with, contact KTN’s Health team.