The Bleeding Edge

by Chris Lewis

Working extensively in the medical device arena, I hear an abundance of anecdotal stories from candidates and clients of lives being saved and improved with revolutionary new technologies in the market. As well as this, the importance that the ‘established’ products in the market have on continuing the great work that clinicians do within the NHS on a daily basis.

To some degree, I do envy the life of a medical device professional getting the opportunity to see these great things on a daily basis.  

It has to be said however that watching a certain programme called ‘The Bleeding Edge’ recently, as well as reading regular news articles on certain medical devices failing the patient and clinician with poor quality and usage, it raises the question….Is the medical device market regulated and monitored enough to ensure the highest quality and standard of products are being used?

‘The bleeding edge’ details five different products that have failed to keep the manufacturers promise, leading to multiple issues from clinicians being dismissed, ongoing chronic health issues and in some cases fatalities. From someone who knows the market but has never been ‘hands-on’ selling a product range to the NHS, it makes me wonder if stricter guidelines are needed, to ensure the utmost quality is being met at all times. The thing that concerned the most was that the products were from some of the biggest players in the market, with reputable and blue-chip names.

The pharmaceutical market has strict ABPI guidelines and seems to be regulated to the nth degree, so does the same need to be applied to the device market?

Do products get into the UK healthcare market ‘under the radar’ too easily without comprehensive checks?

GS1 barcoding and ‘Scan4Safety’ seems to be going a long way to ensure the tracking and traceability of medical devices, ensuring stock is tracked per patient and out of date products are not accidentally implanted. A large aspect of GS1 and SFS is that when a problem occurs and there is a product recall, they identify where the products are and act upon that information quickly. The questions to raise must be…What is the best way to stop the issue happening in the first place?

'The Bleeding Edge' is designed to shock and create an audience which is understandable given its media (Netflix) but it does raise genuine questions that need to be addressed unless I am missing something?  

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