Video Blog: Innovative medtech start-up meets regulatory safety requirements

Cardiobridge, located in Hechingen in southern Germany, has developed an innovative cardio pump for use in a hospital setting. The company approached Iftest in 2009 about developing a new product that would be ready to be launched into the European market including CE marking. Based on an initial product concept, requirements and hazards, the two companies worked together to create an appropriate system architecture. Iftest developed an electronic hardware and firmware product solution to mitigate those hazards, in particular concerning first-fault safety.

PARK INNOVAARE: The development of the cardio pump was a complex development project. How did Iftest begin to work with Cardiobridge?

Jürgen Schulz, Head of Development Iftest AG: We established contact at the Medtec Europe trade fair in Stuttgart about ten years ago. After Cardiobridge issued their request, we submitted a proposal and were awarded the contract.

What did you learn from the project and what do you want to share with others? What do you recommend others could do and what do you advise against?

It is crucial to consider the regulatory aspects and the associated influence on product realization at an early stage. An important part is properly documenting the requirements and architecture of a specification. Selecting the right partner who has expertise covering the entire product lifecycle – from development to industrialization and batch production to after-sales service – is essential. This helps you avoid unpleasant surprises and adhere to the time-to-market planned.

Can your project experience be used for other development projects? If yes how?

In the transition from purely functional development to the batch production of a market-compliant product, the number of topics to be considered increases significantly. This includes areas such as procurement, manufacturing processes, quality management, etc. These aspects have a major impact on specifications, risk management and regulatory approval. The advantage of having the entire electronics and firmware product lifecycle under one roof, together with many years of experience, enables customers to benefit from this expertise in an early design phase.

Event podcast from DISRUPTIVE MORNING with Iftest AG.