Identifying and tackling challenges when adding software to product portfolios of medical device manufacturers

5 February, 2019

When it comes to using software in medical device products, “classical” medical device manufacturers are often hesitant.

Although nowadays software is widely used internally for the design and development of medical devices, for managing the production, distribution and post-market activities, it is another deal when actually including software in the medical device or developing software as a medical device.


On the one hand there are good arguments for thinking about adding software to the product portfolio of “classical” medical device manufacturers:

  • Provide innovative solutions, e.g. software is often able to process information and detect patterns much better than human brains.
  • Provide new solutions for patients and doctors, e.g. home-monitoring via software app.
  • Stay competitive, e.g. innovative software solutions as the ECG app in the Apple Watch are cleared as a medical device by the FDA and now define the state of the art.

On the other hand, adding software to the product portfolio will bring new challenges:

  • Understand what regulatory requirements apply, e.g. there are confusingly many regulations for medical device software and depending on the distribution market, requirements may apply or not.
  • Decide on the type of software that supports your purpose, e.g. there is a variety of types of software (apps, firmware, standalone software etc.) and again regulatory requirements may differ dramatically.
  • Medical device manufacturers need to make big initial decisions, e.g. will they hire external software development companies or rather build up an internal software development department.
  • Understand the little differences, e.g. the software life cycle is different from classical medical devices and medical device software is likely to be changed more often.
  • Be prepared for change, e.g. based on the points listed above the Quality Management System that “classical” medical device manufacturers have implemented is required to undergo essential changes.

For “classical” device manufacturers, adding software to their portfolio will bring new possibilities and challenges.  At the same time, adding software seems inevitable as software is the future in many areas of the medical device industry.

Therefore, identifying the challenges specific to the company will be the first step to success in execution. When you are ready to diversify your product portfolio by adding software, knoell Germany GmbH can support you by providing skilled expertise specialized in medical device related software.

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