The Misconception Section – Part One

It has become an unfortunate necessity these days to start an opinion piece with a caveat. This article does not apply to everyone and even if you recognise traits that are familiar to your company or organisation, I’m observing and commenting with good intentions, not maliciously judging and criticising – so cool your jets.

I’ve sat through countless presentations and read numerous articles about serious conditions, illnesses, viruses etc. where there is a critical need for affordable, portable, accurate and convenient diagnostic devices. It’s so common that I’m left wondering why the authors haven’t worked out why the need isn’t being fulfilled – especially when there is a very good chance that the solutions are reachable.

Bringing clarity and focus to the record

There are some very switched-on organisations who know how the CRO/CMO (contract research/manufacture organisation) in vitro diagnostics sector works – mainly because they’ve asked and listened – but it’s clear that there are many more who haven’t asked or didn’t listen and consequently, don’t know. Chief amongst the least aware are those who could potentially benefit the most… charities and charitable trusts.

Let’s start to straighten this out. As a CRO, we (and others like us) are structured to fulfil the need for development project work from organisations who need our experience, expertise and resources. As a rule, our revenue comes from project commissions and the services that we provide to develop rapid IVD devices. Some might charge licence fees for products that they develop, we don’t.

Unfortunately, we are not sitting on a mountain of cash to fund the development of a diagnostic device, put it through clinical trials and get it approved by a regulator. If we did, we wouldn’t be a CRO, we would be a ‘big diagnostics’ firm with our own range of products. Like the pharma lot, but a bit further up the ‘unwell’ stream.

Many of our prospective customers want to unlock the technology that can save and improve lives. We’ve got access to it and we don’t want to hold it back but we’re not staffed by volunteers in a rent-free lab that’s equipped to the gunnels with lots of free kit. For anyone hoping that their critical need for amazing (and cheap) diagnostics will be answered by someone with a bag full of tested and approved assays – the chances are very slim. There are companies who can help, but if they are anything like us, they need the R&D to be paid for.

To those who have taken the time to understand how contract R&D and manufacturing works in the IVD sector – thank you. To those who haven’t, feel free to blame us, we haven’t done a very good job of communicating what we do and how we do it.

I’ve called this the misconception section part one – mainly because there are many misconceptions surrounding our industry and we need to do our bit to help set the record straight. I’m sure part two will be along shortly.

Comments welcome.

Richard