AHMED project started creating RegOps

Taipuva partners in a consortium improving agile medical software development

We believe that it is possible to considerably speed up software development and deploying it to production in health technology, healthcare and other regulated industries. This is what the research and development project AHMED is for. AHMED stands for “Agile and Holistic MEdical software Development”. The project will run for two years and is coordinated by VTT Technical Research Centre of Finland and participated by Helsinki University and six companies.

Agile software development and DevOps are mainstream today. The advantages are quick feedback and introducing rapid changes. However, this is in contrast with today’s practises how software and machine-learned datasets are usually taken into use in regulated industries, such as medical devices or automotive. Checking regulatory compliance takes a lot of time, being mostly manual and document-oriented work. Deploying software to operations is on hold all this time, although the software is ready.

AHMED project aims to create a continuous development approach to software and data engineering that complies with regulatory requirements. It can be called RegOps, combining regulatory compliance (Reg) and IT operations (Ops). The project involves development methodologies and digital tool chains. The benefit of the project results is that then it is possible to employ fast development and deployment cycles also in regulated industries. Safety of the products will be improved through making the development process and regulatory checks more secure by replacing error-prone manual work by automation.

The project received funding from Business Finland and it’s part of the Smart Life program. The organisations invest their own resources into the project, meaning money and most importantly time and effort.

“We are very excited, because this is our first major R&D project. With Business Finland’s support we can bring very advanced solutions to market and prove that they solve the problem. The project consortium is excellent for sharing expertise, collaborating, co-creating and demonstrating solutions together”, says Pasi Ahola, CEO of Taipuva Consulting.

The results of the project will be highly important for public and private healthcare providers and the users of many of health-related software. The new EU’s Medical Devices Regulation (MDR) becomes effective in May 2021. It states that specific software systems will be treated as medical devices. This forces the actors in this industry to fulfill the regulation, which in turn creates a need for them to find the most efficient and robust methodologies.

“Taipuva has already been able to significantly speed up product development and regulatory compliance processes with our clients. The project goal is no less than to approach the continous cycle of DevOps – enabling true RegOps. It ramps up the competitiveness of our industry even further and saves taxpayers’ money in the development of public healthcare information systems. The main driver behind the MDR and this project is patient and user safety, which gets improved by the more reliable development process”, says Pasi Ahola, CEO of Taipuva Consulting.

 

If you want to stay updated of the results and discussion around the AHMED project, join this open LinkedIn group RegOps or subscribe to Taipuva’s newsletter from below.

 

For more information about the project, please contact:

Pasi Ahola, CEO of Taipuva Consulting: pasi.ahola@taipuva.com
Jari Ahola, Smart Health Research Team Leader at VTT: jari.ahola@vtt.fi
Tommi Mikkonen, Professor at Helsinki University: tommi.mikkonen@helsinki.fi

 

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