A Business Insider article published this week documents a growing community of diabetes sufferers and their families turning to DIY versions of the ‘artificial pancreases’ that retail on the market at upwards of £5000. The DIY ‘biohack’ versions, that consist of a blood sugar level monitor, automated pump and smartphone app can be put together for as little as £200.
In recent years the biotech sector is leading medical breakthroughs at an impressive rate, many of which are drugs or tech-based solutions to medical issues for which there was previously no effective alternative. However, with major companies withdrawing from the artificial pancreas market, partly as a result of DIY competition, major questions are raised.
Why have diabetes sufferers been pushed towards bio-hack DIY versions of biotech solutions, what sector deficiencies does the trend highlight and what are the potential long term implications for the sector and patients?
Type 1 diabetes sufferers, or the parents and guardians of those too young to do so themselves, are obliged to continually monitor blood sugar level. This is traditionally done by pricking a finger and checking the blood regularly throughout the day. One solution to ease this burden is an artificial pancreas. This consists of a glucose monitor attached to the person which, via Bluetooth, streams the data to a smartphone app. If the data indicates that blood sugar level needs to be regulated the app sends a radio signal to an insulin pump also attached to the person and the appropriate level of insulin is delivered into their bloodstream. The system keeps insulin levels regulated on an ongoing basis throughout the day or night, automating the process and letting the diabetes sufferer get on with their day-to-day life.
The market for diabetes devices is worth over $8 billion and individual units made by market leader Medtronic start at $7000 (£5500). It’s also, according to feedback provided by users, not very comfortable to wear (the pump can itch where inserted into the skin) is bulkier and less flexible – it is not allowed to be sold for use by children.
A security flaw in the coding of the Medtronic device allowed the communications code receiving the data from a glucose monitor and send instructions to the pump to be hacked and reverse engineered. Online groups now provide detailed instructions that, combining the hacked code and the various hardware components, allows diabetes sufferers to build their own DIY artificial pancreas systems for a few hundred pounds.
This raises obvious safety concerns. Medtronic products have to go through years of rigorous testing and clinical trials to obtain regulatory approval to be brought to market. This is an expensive process and takes time. The DIY device circumvents all of those controls. So far there is no evidence that any user has suffered serious
consequences as a result but it clearly raises the question if something is broken in the biotech market. Johnson & Johnson, for example, last year shut its artificial pancreas project down citing the fact the company was unable to charge enough to make research and development commercially worthwhile.
The case demonstrates a schism between the need for biotech solutions at a reasonable price and the cost burden placed on commercial companies to gain regulatory approval for products. Some companies, such as Medtronic, are trying to work with the ‘DIYers’ to improve their own products. Others are leaving the market, reducing the competition that is also key to end consumers benefiting from lower prices. It’s a complex conundrum but one that the case of the DIY artificial pancreases highlights as one that needs attention if the gains that biotech breakthroughs are bringing to medicine can be taken full advantage of.