Early-stage medical device idea and concept development

In the first phase, we can support you with technology scouting, identification of key functions in your idea, formulation of concept solutions, definition of product specifications and development of a project plan moving forward.

We help you determine whether your product qualifies as a medical device and identify the appropriate classification under the MDR. More advanced solutions may lead to a higher classification. It is also important to analyse the intellectual property landscape for the technology you plan to use. RISE has extensive experience supporting clients in developing an IP strategy together with legal experts.

At this stage, companies typically need to evaluate funding opportunities and define their business strategy. This includes identifying target markets, exploring procurement and reimbursement possibilities, securing intellectual property assets and identifying suitable collaboration partners.

Based on existing solutions and what makes your idea unique, we can begin simulations of critical components, select appropriate technologies and develop proof-of-concept solutions to evaluate the best path forward. If you plan to patent your solution, this is also a good stage to prepare a first patent application draft together with a legal expert.

During the continued development of your product concept, we gradually build prototypes together and establish your first Bill of Materials (BOM). We explore possible manufacturing methods and discuss suitable suppliers. If a patent application has been prepared, this is typically the stage where it can be submitted.

We can also validate key functions in the laboratory and conduct exploratory feasibility studies and user studies using design and functional prototypes.

A needs assessment is the starting point of a successful project and forms the basis of the usability engineering documentation and user requirements needed to ensure usable, efficient and safe end products and services according to IEC 62366-1:2015.

We can also help evaluate user requirements throughout all development phases according to relevant standards.

A Quality Management System (QMS) compliant with ISO 13485 is required for product approval. We can help implement such a system early in the product development process.

We can also support certification of your QMS.

If you are considering implementing digital solutions, we offer a range of expert services to support you.

Digital transformation contributes to the healthcare of the future
E-health – digital services for smarter healthcare
Biosensors and chemical sensors
Measurement for health – what RISE does

If you want to measure user experiences, emotions, behaviours or abilities as part of a mapping or decision-making process – for example when identifying target groups or expected outcomes – see:
Categorised measurements | RISE

RISE has also developed tools to support innovation procurement, as part of a project conducted together with Medtech4health.

What counts as a medical device?

A medical device is a product used to diagnose, prevent, monitor or treat disease or injury. Classification is governed by the EU Medical Device Regulation (MDR EU 2017/745) and depends on the product’s intended purpose and risk level.

How do I know which risk class my product belongs to?

The risk class (Class I, IIa, IIb or III) is determined according to MDR rules and affects requirements for clinical evaluation, technical documentation and potential review by a notified body. Correct classification early in development is crucial.

When do I need a Quality Management System (QMS)?

A QMS according to ISO 13485 should be established early in development. It facilitates documentation, risk management and future CE marking while reducing the risk of delays.

What do verification and validation mean?

Verification ensures that the product meets technical requirements and specifications. Validation confirms that the product fulfils user needs and intended use. Both are essential steps before CE marking.

Do I need to consider patents and IP early?

Yes. An early analysis of intellectual property and existing patents reduces the risk of infringement and strengthens your ability to protect your innovation.

Can you help with CE marking?

We support work with technical documentation, risk management, classification and regulatory preparation according to MDR – key steps towards CE marking.