On a tangent, I imagine you have some good insight into the economics of test strips? Mature technology, high volume, visible easily addressed market, low marginal production costs => you'd think that retail prices for strips would be very low if the market were competitive? Or no? Is the R&D & process & production investment big & ongoing enough that you still need high prices even decades after launch? Or is it more a case of unfortunate consequences of a regulated market?
Its not that regulated. Whether UKCA or CE marked, this is a conformance mark, demonstrating that the device meets a design standard, is manufactured in a facility meeting a standard, and has a process to track and report failures. Every manufactured item on sale in the UK needs CE or UKCA. In Europe, CE has been strengthened through two new regulations replacing the previous directives, MDD and IVDR. Test strips fall under IVDR, which is in the process of being phased in.
The new regulations bring in a lot more requirement for clinical data, clinical trial data. High risk devices, such as Class III, have always needed that, so not much change. IVD (In Vitro Diagnostics). Before, under the old Directive, there was very little requirement to provide clinical data to get a test onto the market, it was more about user safety not patient safety.
2020 caused a twist in the UK 2016 vote. The EU exit date was set in stone, and on that date, EU law that was in UK regulations was frozen, and wasn't going to be unpicked. There was a delay to MDD, due to COVID, but its fully part of UK law. IVDR isn't, so technically the UK is following the inferior IVDD, though is accepting, for a good while yet, CE marked devices onto the UK market (though there is a cutoff). In principle, the UK is open for devices that don't meet an EU standard, but do meet a MHRA. The UK hasn't figured out what its going to do yet, the regulations are still in "stakeholder" consultation phase, with some pushing for stricter regulations that Europe, others arguing for less (its about safety v innovation. The new Regulations have lead to less innovation).
Previously, Europe was seen as an ideal market to launch new innovative devices, because of the relatively low bar to get onto market compared to the US. In many parts of the world, there is a perception that CE and FDA 510k are equivalent, especially in those markets where there is no local regulation. That's changed. China and India have immensely strengthened their local regulation, and CE marking might now be as expensive to gain as 510k approval (510k approval requires submission of clinical data to an expert body. This approval helps the CMS in determining if Medicare will reimburse, which then also guides the insurers). Previously, EU member states would conduct their own technical assessments to determine reimbursement (though in practice, Italy and Spain used to run with whatever the British were saying, and save money). Medical devices with CE can be marketed, but it doesn't mean public healthcare systems will pay for them.
In IVD, there are lots of small companies making niche tests for small markets. IVDR might see many exit the market, as they can't afford to commission the clinical studies to stay on the market. While test strips are almost commoditized (there is little difference in strip performance), we might see a reduction in brands, and less competition.
About 10 years ago, the CMS/Medicare investigated the sale of glucose test strips in the US. The big manufacturers were found to have an unhealthy relationship with the pharmacies, resulting in price fixing and too many strips being sold to people who didn't need them. Medicare covers pensioners and people with certain chronic conditions, and so reimburses the costs for a great percentage of test strips. The investigation resulted in big cuts to reimbursement rates. Within a few years, the big makers lost most of their market share, with patients switching to cheaper imported strips from China and Taiwan.
Medical devices are more expensive because they are medical devices; a test strip for a human costs more to make than an otherwise identical test strip made for cats and dogs, or test strips made for garden centres, because its a medical device, and we demand high design standards, high manufacturing standards, and proof of clinical effectiveness. Not so with animal products, where its more reputation that wins share.
