A medical software product does not stop consuming engineering time once it ships. It has to be kept secure, kept maintained beyond its hardware goes end of life and under control for as long as it is on the market. Every product added to the portfolio adds another decade of that work.

Regulation sets that work, and none of it can be removed while the portfolio decides how many times you have to do it. When each product sits on its own technology and its own practices, the same job gets done several times over. A dependency update on one component can trigger the work again for every product that contains it. The people who can safely change a released product are usually the same few people needed on the next one. Each product was built for the hardware and the schedule in front of it, which was reasonable at the time. Across a portfolio it only becomes expensive and more complex to deal with.

This episode looks at how much consistency is realistic across related products, what a common software foundation can actually cover, and where standardisation has limits in a regulated portfolio, or does it? It also covers how to start when products are already in clinical use, and what building a foundation in house, taking it from open source, or paying for it asks of an organisation over the life of a medical devide or any other MedTech product.

Roger Mazzella spends his time inside medical software organisations in the US and Europe, looking at how their products get built and kept in service. Venla Pouru sees the same decision arrive company after company, and what it costs when it keeps getting postponed. Annika Packalén hosts, and pushes both of them on where the argument stops holding.

Annika Packalén is joined by Roger Mazzella and Venla Pouru. Roger works with medical software organisations on how regulated products get built and kept in service. Venla sees how these decisions get made and funded across many companies. The conversation tackles the burning questions about what it takes to build these highly regulated medical software products.