When risks need to be managed to prevent adverse health effects, systems of regulation are required. Only a fool would lobby for deregulating the development of medical devices.
However… given that eliminating risk is impossible, if managing it prohibits vital rewards (such as saving more lives), the balance needs adjusting.
The existing regulatory pathways for medical devices are expensive and time consuming. In a previous blog, we highlighted how this is stifling entrepreneurship in the IVD sector (Ideas in Coffee Cups – June 2024), but it is also stifling innovation across the IVD industry and destroying the viability for developing products that could detect and monitor rare conditions.
The often-heard claim that IVD products haven’t fundamentally changed in 40 years isn’t far from the truth. A significant barrier to innovation is the regulatory environment. The relative safety of pursuing incremental improvements to established technologies is preferable to developing something completely novel.
Even if there is a market demand to satisfy, it is one heck of a gamble that the demand will still exist after the device has been through development, testing and trials. That could easily be in three years’ time. Three years of investment and zero income. If you then find that your product is already obsolete, it wouldn’t be easy to shrug off as a learning experience.
The investment alone is in the £millions. Financially, the stakes are high. In a sizable market, the right product, well positioned and at a competitive price-point, could deliver financial rewards. Where the market is known to be small, but where a functioning device would be life-changing, even life-saving, time and money are luxuries that simply don’t exist. Even if the financial burden could be eased by funding, the bid process is often long and unpredictable. Without charging ridiculously high prices to recoup the investment, financial returns would be impossible, so the time and money gravitate elsewhere and the opportunity to improve and save lives is lost.
We’ve also got to consider the intended use of IVD devices. If medical diagnoses relied exclusively on them, it would be easier to understand investing vast amounts of time and money in testing and trials before they reach their user groups. I would argue that most IVD assays should be designed as an aid to diagnosis that contribute to a range of information before users and medical professionals prescribe a treatment programme. No device can claim to be infallible, so a false test reading for a critical illness shouldn’t rule out a correct diagnosis if other evidence points towards further investigation.
So, if an IVD test can help to identify a problem that can improve and save lives, finding a way to reduce the time and money required to get a product from concept to market is surely desirable. This would give the IVD sector a chance to help more people, cheaper and quicker.
Unless I’m missing something, there can’t be too many objections to a ‘regulatory approval pending’ status for a product if it has the right technical documentation, passes independent tests and has a solid system for post-market surveillance.
This could result in getting a product to market three times quicker and ten times cheaper than at present, product sales and customer feedback could fund and inform the remainder of the regulatory approval process. This would encourage more investors, the development of more products, greater innovation and improve the commercial viability of assays that are aimed at rarer conditions.
The alternative is to accept the handbrakes on progress, tolerate the status quo and continue to sympathise with people for whom IVD technology could help if only the system would allow it.
Rob (RAPIvD’s CEO) recently asked experts at an IVD industry conference “if the panel agreed that the current industry regulations were adversely affecting innovation and preventing potentially life-saving products from reaching the market quickly?” The resounding response was, (perhaps unsurprisingly) yes.
There is an appetite for positive change. No one is suggesting a free-for-all and I think that everyone sees the need to filter-out low-grade operators and products, but when regulations prevent solutions that improve and save lives, it’s time to act and put it right.
At RAPIvD, we are really interested in your opinion because if regulations are preventing progress, we would like to help bring about improvements. Have we over-exaggerated the extent of the problem? Are there bigger reasons preventing IVD solutions from reaching the market? Is the situation worse than we think? Are there better ways to get quality products to market whilst filtering out those that are sub-standard?
Please let us know. info@rapivd.com
Richard
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