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The US FDA has compiled a draft guidance to promote the development of brain-computer interface devices, which could give users the ability to control implants directly. We take a look at the benefits of such devices and the significant concerns that surround the concept of linking any device directly to the brain.

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Also, we speak to NHS innovation hub Health Enterprise East to find out how medtech start-ups can crack the all important NHS market with new innovations, explore med tech innovation in Israel, which has rapidly become a hub for high-tech development and spinout-friendly research centres, and examine the arguments for and against the controversial medical device tax in the US.

Plus, we investigate whether there is too much secrecy around the reporting of medical device failures after the FDA was found to have enabled companies to conceal reports of serious injury and malfunctions from public view, take a look at the science behind breath biopsies, and get the latest market trends and analysis from GlobalData.

 

In this issue

Regulating brain-device interface dilemmas
The FDA has published guidance laying out how brain-computer interface devices are to be regulated. These devices have enormous potential for returning mobility and independence to patients, but a lot remains unknown. Allie Nawrat finds out more.
Read more.

Selling into the NHS: HEE’s top tips for medtech companies
Med tech companies are major drivers of innovation in healthcare, however, they face a range of challenges and barriers when cracking into the UK’s primary healthcare provider, the NHS. Allie Nawrat talks to NHS innovation hub Health Enterprise East’s director of medtech consulting and business development Joop Tanis about gaining traction in the NHS.
Read more.

Israel: a medtech innovation hub for the world
Israel has long been renowned as a hub for high-tech innovation, with an active investment scene and spinout-friendly research centres helping to push the country’s medtech sector to new heights. Chris Lo examines the secrets behind the outsized performance of Israeli med tech in recent years.
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US medical device tax: should it be gone for good?
The basic theory of taxation says that the more you tax something, the less of that activity occurs. That logic is now behind a move to squash unpopular medical device taxes in the US for good. But is the tax as bad as it’s made out to be? Chloe Kent reports.
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Hidden figures: lifting the lid on medical device failure reporting
Post-market surveillance is a vital component of maintaining safety in the medical device market, but recent controversies have highlighted transparency concerns around device failure reporting. Is there too much secrecy in the reporting processes of regulators like the FDA, and how can the situation be improved? Chris Lo finds out.
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Take a deep breath: this could be the future of cancer diagnosis
Scientists have developed a breath sampler which is able to detect lung cancer at a far earlier stage than other tests, opening the possibility for faster, more effective treatment for patients. Could this non-invasive method become the new standard for lung cancer diagnosis? Chloe Kent reports.
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Next issue preview

In the next issue of Medical Technology, we take a look where the next breakthroughs may lie in the growing field of contact lens technology, speak with Dr Loubna Boufarna from Cambridge-based healthcare AI company OKRA Technologies about AI, start-ups and diversity in pharma, and find out how governments around the world are approaching the call for stricter device regulation.

Plus, we investigate how brands are getting away with illegally marketing devices and what can be done to stop them harming patients, find out how manufacturers can meet the standard of environmentally responsible production of devices, and examine a new blood management device that can be installed in operating theatres to collect a patient’s own blood and return it to them if needed.