Industry – Health

Together to success with shared goals

Creating a medical device takes time. If you have an idea for one of such today, you should safely budget 1,5-2 years until it’s on the market (since one year goes typically to the certification process).

We are ready for long-term partnerships, and believe that real success requires sitting on the same side of the table. Having shared goals, feeling like our team and your team are on the same company, not just being a customer and a supplier.

An example of multi-year partnership is the development of OmaOlo, the Finnish national symptoms assessment service.

From vision to production and beyond

We are prepared to be your strategic partner to bring the fragile ideas to reality, taking care of your service throughout the lifecycle, all the way from vision to production and beyond to the post-market surveillance phase. You’ll bring the clinical knowhow and responsibility of being a manufacturer, we’ll bring the rest.

One of our customers made a strategic decision of not having any software development capabilities inhouse. Instead, they outsourced the whole ISO 13485 design, development and maintenance processes to Solita. We are designing their medical software, we will develop it, and eventually we will take care of it while it’s on the market.

Stress-free and fast release cycles

When you make a medical device, the most important thing is to make sure that it is regulatory compliant. Compliancy will ensure that the end result is safe and ready to the market. No wonder why it is typically the the biggest headache for anyone responsible of manufacturing such devices.

We have invested a lot of time and efforts to make our RegProof™ service model and processes very good and agile with fine-tuned workflows, high-level of automation in document and evince generation, so that we can have fast release cycles without stress. The goal is that after each and every development sprint you would be able to create a new release with minimum extra overhead regulatory work.

This improved efficiency has been also validated in real life. One of our customers asked us to help them, as with their existing process it took 6 months to get a new release published after the actual software was ready. We stepped in and guided them to make the process more agile and efficient: nowadays they can have new release every month.

Experienced industry thought leaders at your service

When you select Solita as your partner, you know that you will get a safe, secure and impactful end result. We will guide you through the process, and can help even with the trickiest questions.

We have and continue to invest a lot in the research topics of how to design medical devices, how to create them in agile way, how to combine machine learning with medical devices and so on. And that all is available to you once we will start working together.