Why medical devices for rare diseases are the haute cuisine of the medtech world

A look at the menu of the medtech world

The medical device market is like a menu. At the top, printed in bold and marked with an asterisk: the Margherita pizza – simple, reliable, suitable for the masses. Below that, almost hidden: the truffle lasagne – rare, elaborate, but simply indispensable for some guests.

In reality, this means that pizza products are the standard – blood pressure monitors, catheters, surgical instruments, syringes, standard software. Things that everyone knows, that are produced in millions and on whose sale the industry thrives.

Truffle lasagne products are the niche solutions – highly specialised medical devices for rare diseases that are individually tailored, particularly challenging in regulatory terms and without which a certain group of patients simply cannot be treated.

Pizza fills you up – but not everyone

Pizza Margherita is the classic. You can order it almost blindly, knowing exactly what you're getting, and it works in almost any setting. For medical devices, this means broad applicability, high volumes, clear standards, and established supply channels.

But – and this is crucial – pizza does not fill everyone up. There are people whose medical needs are far more complex. People with rare diseases for whom standard products are not suitable.

This is where the culinary arts of the medtech world begin: the development of products that are not suitable for the masses, but are tailor-made. And the first regulatory steps are moving in the right direction: with the EU Guidance MDCG 2024-10, there is now a clear definition of when medical devices can be considered orphan devices – a small but important step to prevent innovation in this area from getting lost in the regulatory maze.

Truffle lasagne: the supreme discipline

Developing such products is like preparing a real truffle lasagne:

• Ingredients are hard to come by: special materials, personalised designs, niche expertise.
• Recipes are strictly tested: MDR, IVDR, FDA – every ‘gram’ must be just right.
• The number of guests is small: only a few patients need this product, but for them it is vital.

One trend that is particularly helpful here is 3D printing: patient-specific implants or surgical guide rails can now be manufactured precisely and individually – almost as if the lasagne sheet were cut to size for a single plate.

Projects for rare diseases are not about scalability in the traditional sense, but about excellence, precision and sometimes the courage to break new ground.

Economic reality: pizza pays for the kitchen

No restaurant could survive if it only served truffle lasagne. Pizza Margherita – in other words, standard products – finance the business.

In the medtech industry, the following applies:

• Standard products generate sales.
• Specialised products for rare diseases build reputation – and change lives.

The art lies in balancing the two. Because if you only serve pizza, you remain interchangeable. If you only offer truffles, you will not survive economically. The real strength lies in mastering both breadth and depth.

The underestimated complexity of truffle lasagne

Products for rare diseases require a unique approach:

• 1. Co-creation with patients: Development is not for ‘the average’ but for a handful of affected individuals whose voices make the difference.
• 2. Interdisciplinarity: Medical staff, engineers, software developers, regulatory experts, often even biotechnologists – everyone must sit at the same table.
• 3. Overcoming data silos: Since patient numbers are small, every piece of information is worth its weight in gold. But it is precisely this data that is often scattered or stored in incompatible systems.
• 4. Agility with responsibility: Iterative development is a must, but every prototype must be safe and compliant.

This is not standard cuisine. This is Michelin-starred cuisine – sometimes with improvisation à la ‘What's fresh at the market today?’.

Humour on the side: When the kitchen is on fire

Sometimes working on such projects feels like being in an Italian restaurant kitchen at rush hour:

• The regulator calls out from the next room: ‘The sauce does not comply with Regulation 1234/XYZ!’
• The CFO asks, ‘Can't we use mushrooms instead of truffles?’
• And the developers shout, ‘We can't write the recipe at all without a new database!’

In short: chaos, passion, pressure. But when the truffle lasagne is finally on the table and patients have actually benefited, every second of effort is worth it.

Where does adesso come into play?

The development of medical devices for rare diseases is not a ‘copy-paste recipe’. It requires individual concepts, digital intelligence and clever processes.

How we provide support in the following areas:

• Data intelligence for small patient groups: We develop platforms that enable robust analyses and studies even with low case numbers.
• Regulatory security: Our teams translate MDR and FDA requirements into pragmatic IT solutions – not ‘paper tigers’, but compliance in practice.
• Individual software development: From AI-supported diagnostic tools to patient apps – we develop tailor-made solutions that are not ‘off the shelf’.
• Agile project methodology: We know that time is a crucial factor – especially when patients are waiting for a solution. That's why we combine speed with the highest quality.

In other words: We are the digital kitchen crew that ensures that the idea of a truffle lasagne becomes a serveable, regulatory-compliant and, above all, effective product.

Conclusion: balance is everything

The medtech world needs both: pizza margherita and truffle lasagne.

• Without pizza, there is no business.
• Without truffles, there is no excellence.

And perhaps that is precisely the real art of our industry: reconciling everyday life and uniqueness – so that every patient gets what they really need.