Product development and processes

Well designed is half done in product development and commercialization of health tech innovations. You can ensure the success of your product, save time and control total expenses when the product development is done according to the health tech requirements and in co-operation with users from the very beginning.

We can support your team in different phases of product development process.

We will walk all the way with you and make sure that your product can be CE-marked and certified.

From our offering you can find services related to development of medical software life cycle processes (IEC 62304), health tech innovation process, product development consultation, and technical realization.

Medical software life cycle processes IEC 62304

Software development according to the health tech field’s standard

IEC 62304 -standard extensively covers processes of medical software lifecycle: development, maintenance, risk and configuration management, and problem resolution.

Clinipower helps develop a life cycle model for your medical software according to IEC 62304, and apply the standard processes in practice within your organization. We make sure that the software development will be documented according to regulatory requirements.

Innovation process

A tailored process for health tech innovation journey to market

Health tech innovations result from co-operation of various actors and as an outcome of complex processes. The innovations are used in high-risk environments and placed on strictly regulated markets.

We at Clinipower have developed an innovation process that models the journey of a new health tech innovation MVP-version, from an idea to market. The process considers especially the beginning of the journey: recognizing opportunities and creating solutions. The process includes check lists for each phase for following progress.

You can contact us already when your product is on idea or concept level: we can map the potential journey to market with you.

Product development consultation

Utilize our extensive experience from the health tech field

Do you wonder what might be the best way to organize product development processes in the health tech field? We can offer your team coaching and consultation about organizing product development on practical level.

The consultation is carried out according to your needs and it can cover for example the following topics: defining product risk class as part of development, utilizing clinical and post-market data in product development project, and utilizing agile methods.

Technical realization

Evaluate feasibility and map out product realization methods

Medical devices are technological solutions which can be realized through various methods.

In terms of technical realization, we conduct technology mapping and can evaluate feasibility of a product concept from different perspectives. Our services also include technical architecture planning of products.

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Our experts

Pekka Kola

Senior Advisor, Technology and Architecture

Aki Tirkkonen

Senior Advisor, Project Management and Solution Architecture

Kimmo Vauhkonen

Senior Advisor, Quality and Regulatory

Juha Kaasinen

Senior Advisor, Usability and User Experience