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16th January 2017

Expert advice from Blackwood Embedded Solutions: Developing your healthcare app the right way

How to start your medical device software or healthcare application development the right way.

With dozens of new healthcare applications (apps) and medical devices available almost daily, we spoke to Anthony Giles, Managing Director of Blackwood Embedded Solutions, about how medical companies can ensure their products get to market safely and quickly.

“The level of innovation and application of technology in healthcare is encouraging to see for any product developer. Equally impressive is the ability of these devices to communicate with a number of different systems across the internet including those found within hospitals.

“However, we are also seeing a sharp rise in the number of ‘healthcare apps’ entering the market that are then used as medical applications due to their cost.”

These non-traditional uses of applications and devices are resulting in more challenges for manufacturers and the recently raised class-action suit against popular activity-tracker, Fitbit, should serve as a warning call to get things right from the beginning says Mr Giles.

“The Medicines and Healthcare products Regulatory Agency (MHRA) says that if an app is used for a medical purpose, it should be CE marked. Sadly we are regularly seeing apps purposefully called health apps to get around medical device regulations. The problem with this approach is that this results in the release of applications and products before they are rigorously and properly tested as would be required with medical products with a CE mark.”

Add to that the increased frequency and risk from cyber-attacks globally and Mr Giles strongly suggests that medical product designers and developers ask themselves as a matter of urgency whether it is realistic to expect a product to be ready within six months.

“Within six months, the maximum you should reasonably expect is a good prototype, most probably without any paperwork or verification and validation completed.

“Moreover the principles behind the IEC62304 software design process, addresses many of the patient safety and cybersecurity issues, by implementing good design practice.”

In considering the impact on your new product design, Mr Giles suggests companies start by looking carefully at the following guidance documents:

  • MHRA guidance on medical device stand-alone software including apps*
    for deciding whether your app is a medical device or consumer health app
  • FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices** – this provides an easy to follow tick box questionnaire to correctly identify the software Safety Class required for the device early on in the project
  • FDA General principles of software validation*** – overview of the software design life cycle for medical devices
  • FDA Content of Premarket Submissions for Management of Cybersecurity in Medical Devices****
  • FDA guidance on Off the shelf Software use in Medical Devices*****