Early-stage medical device idea and concept development

In the early stage of medical device development, you need to assess technical feasibility, user needs and market potential. We support you in turning your idea into a feasible and regulatory-ready concept.

Together, we define the intended use, target users and technical feasibility of the product. We also help you conduct technology scouting, identify key functions and develop concept solutions. Based on this work, we define product specifications and create a roadmap for the next stages of development.

To successfully develop a medical device, it is essential to understand the regulatory requirements early in the process.

We help you classify your product according to the Medical Device Regulation (MDR), analyse the regulatory landscape and assess intellectual property opportunities. Together, we develop a strategy to protect your innovation and establish a clear path towards regulatory approval and market entry.

Bringing a medical device innovation to market requires a clear business strategy and the right collaborations.

We help you identify funding opportunities, define your target market and business model, and analyse procurement and reimbursement systems. Through our network within the medical device sector, we can also help you identify relevant partners for development and commercialisation.

As the concept begins to take shape, we analyse potential technical solutions and evaluate feasibility.

We can develop simulations, proof-of-concept models and technical options to support further development decisions.

A key part of this phase is needs analysis and user-centred design. We help you map user needs and integrate usability engineering according to IEC 62366-1:2015, ensuring that the product is safe, effective and easy to use.

In the next step, the concept is developed into functional prototypes.

We support the development of design and functional prototypes, define an initial Bill of Materials (BOM) and provide guidance on manufacturing methods and potential suppliers.

We also perform laboratory testing, exploratory studies and user evaluations to validate key functions and demonstrate the product’s potential before moving into the next development phase.

A Quality Management System (QMS) is a fundamental part of medical device development.

We help you establish and implement a QMS according to ISO 13485 early in the development process. This facilitates regulatory compliance and can significantly reduce delays later in development.

We can also support preparations for certification and ensure that your quality processes meet the requirements for medical devices on the European market.

Digitalisation is playing an increasingly important role in medical device innovation. Technologies such as data analytics, artificial intelligence, IoT and smart sensors can enable new functionality, improve product performance and enhance the user experience.

We help you integrate digital solutions into your product development — from concept and system architecture to testing and verification.

What qualifies as a medical device?

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

How do I determine the risk class of my product?

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

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

A Quality Management System according to ISO 13485 should ideally be established early in development. It supports documentation, risk management and future CE marking while reducing the risk of delays.

What is the difference between verification and validation?

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

Should I consider patents and intellectual property early?

Yes. Early analysis of intellectual property (IP) and existing patents reduces the risk of infringement and strengthens your ability to protect your innovation.

Can you help with CE marking?

Yes. We support work related to technical documentation, risk management, classification and regulatory preparation according to MDR — key steps in preparing for CE marking.