This week we hosted the first in our series of #digitalhealth webinars and we were delighted to be joined by Aman Dhesi from the Patient Blood Management team at NHS Blood and Transplant. In a whirlwind 45 minutes that was packed with information, registrants from all over the globe logged in to participate in the discussion – we even reached as far as Australia!

Aman and I discussed the Blood Choices project which has involved the creation of an app to support clinicians in making the decision when to transfuse red cells.  The purpose of the app is to determine whether technology can effect behaviour change in junior doctors by aligning their practices with NICE guidelines and the principles of Patient Blood Management where a team approach involves the patient, their GP and hospital staff and only considers transfusion when there is clear evidence that it is the best therapeutic treatment available.

The app is currently going through the CE marking process and will be submitted to MHRA next week for class one medical device review.

Throughout the webinar, Aman shared his knowledge, advice and what he’s learnt along the way whilst he talked us through his experience of the app development process and I’ve tried to summarise a few of the key points below:

    • The doctor/patient relationship is not a simple one – each interaction is unique and trying to bring a complex set of variables used to make a decision into a single model is a difficult task.
    • It’s key to development to have a range of appropriate healthcare professionals involved in the design of any digital health tool.
    • To make digital health tools of this nature a success, technology should not replace a clinician’s judgement but instead, support their training and improve knowledge to enable them to make informed decisions.
    • Nobody reads T&C’s! So ensure this is considered in the user journey during the design stage.
    • The CE marking process should not just be seen as a ‘rubber stamp’ and doesn’t necessarily mean a product is safe! – the ‘Total Quality Management’ role of the team involved should be ingrained in the project from the very beginning to make any validation or accreditation process run smoother.

  • Risk management is integral to ensuring patient safety; from consideration of information governance to quality control measures and post-market surveillance – the project doesn’t end when the app is launched.

We closed the webinar with Aman’s key pieces of advice for those embarking on a digital health project of this nature which included…

  • Don’t be put off by the CE marking process or emerging regulations – they will support your development, not hinder it.
  • Double your development time by doubling your end user and expert input – it will save you time and money in the long run.
  • Use an agile/iterative approach as the improvements made as a result of feedback will make for a better product.
  • Just do it and don’t hold back! Technology can improve care and outcomes for patients and citizens so embrace it and make a difference.

This only just scratches the surface of the discussion and there’s too much to share in one blog post so below is a recording of the webinar for you to listen to at your leisure.

We hope you find this useful but if you have any questions or would like to make sure you’re kept up to date with the next in our series of webinars, please get in touch!

You can follow the Twitter activity from the event at #hmawebinar

Useful resources

European Directive 93/42/EEC – Medical Devices Guidance on Class 1 Medical Devices

Royal College of Physicians Guide to ‘Using Apps in Clinical Practice’

PAS277:2015 Health and wellness apps quality criteria across the lifecycle

Medicines & Healthcare products Regulatory Agency (MHRA)

NHS England Standard for Clinical Risk Management SCC1 0129

NHS Blood and Transplant website

NICE Guidelines for Blood Transfusion