Medical technology: Advancing too fast for its own good?
By Paula Dear
The rapid advancement of medical technology has contributed to people living longer, healthier lives but consumer and campaign groups say devices should come under more scrutiny before they are used on patients.
Those calling for tighter rules in the EU will get a step closer to their aims when the new Medical Device Regulation (MDR) - due to enter into force in May - will include requiring manufacturers to give more information about devices and making it easier to trace and recall faulty products.
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Industry representatives say they agree there should be a tougher legal framework but are wary that adding too much bureaucracy could “block innovation”. Campaigners say they await "the devil in the detail" but don’t believe the MDR has gone far enough.
Everyone agrees that medical advancement is welcome, but debate the best way to manage it.
Medical technology has helped “create our own problem” because we’re living longer, says Serge Bernasconi, CEO of MedTech Europe, a trade association representing the industry.
As society copes with the ageing population, an ever-increasing disease burden, and cash-strapped healthcare structures ill-designed to deal with such an unrelenting pace of change, can medical technology deliver the solutions?
Beeping machines and robotic surgery
For many, the phrase ‘med tech’ conjures images of inscrutable beeping machines at the hospital bed, or the kind of pioneering robotic surgery that periodically hits the headlines.
Billions of people encounter medical technologies every day without giving it much thought. It’s the spectacles on their nose, the plaster on their finger, the plastic tube in their arm, their wheelchair or hearing aid.
Others find themselves unambiguously at the front line - receiving life-saving organ transplants, walking with the aid of a prosthetic leg, or coping with chronic illnesses like diabetes thanks to a sensor that tracks glucose levels and delivers insulin via a pump.
Med tech is also pacemakers, MRI scanners, hip replacements or breast implants. It’s anything used to diagnose an illness from fluids or tissue. It’s the software, cloud computing, algorithms and artificial intelligence used to target disease. Scientists are even harnessing the tiniest of matter to develop ‘nanorobots' to travel around the bloodstream, repairing cells and delivering drugs directly to the right place.
“It’s an immense domain,” says Bernasconi. “It’s everything that takes care of health which is not something you swallow or inject.”
More than 500,000 medical technologies are registered in the EU market, covering the diagnosis, prevention, monitoring, management and treatment of diseases and injuries.
“The new thing we are seeing is the connectivity between all these developments,” Bernasconi adds. “Now we can travel across Africa, do diagnostic testing and the information is immediately conveyed to a centre which can determine whether we need to intervene.”
The pace of innovation in healthcare is dizzying, with upwards of 12,000 med tech-related patent applications filed with the European Patent Office in 2015 - higher than all other technical fields.
Health industry experts say it’s crucial to get to grips with what needs to change, to make the most of all these inventions.
At a MedTech Europe conference in Brussels, debates focused on how technologies could help people not just live longer, but live long, healthy lives in a sustainable way.
Most agreed that could only come from revolutionising how healthcare is delivered.
“New technology…forces the healthcare system to reconsider itself. But the changes needed to really get the full benefit…are difficult - it takes courage, because it might mean we need fewer hospital beds,” says Bernasconi.
“The [existing healthcare] ecosystem is chaotic and a terrible design… it’s a hospital-based, doctor-focused model which is fundamentally flawed. It’s unsustainable”, interventional radiologist Johnny Walker told the MedTech forum. A healthcare entrepreneur who aims to “disrupt healthcare for the better”, he said there needs to be a “massive paradigm shift from the hospital to the home”.
By using simple technologies like electronic health platforms, wearable monitoring and communication devices, patients can stay connected to health professionals, spend less time travelling to clinics or staying in hospital, and play a central part in managing their own health, he said.
The idea of remote healthcare is already taking hold, through phone and internet consultations or home machines that transmit data - such as blood oxygen levels - to medics.
Meanwhile mobile health apps are exploding in volume but remain largely unregulated.
Some 165,000 apps exist, with the bulk dedicated to fitness and diet, and around 15% focusing on diseases like asthma or medication management, according to the IMS Institute for Healthcare Informatics.
‘Smart’ clothing is even being developed, with weaved-in sensors that can check vital signs.
By 2018, an estimated 50% of 3.4 billion mobile device users will have downloaded health apps, said Deloitte’s 2016 global healthcare report.
Tougher EU regulation
With every wave of ideas comes new concerns. A recent report by consumer organisation BEUC has warned of issues with unregulated mobile health apps, and called on the EU for more safeguards.
While some mobile solutions with a defined medical purpose come under the scope of the MDR, many ‘lifestyle’ apps are not covered.
Self-management can “potentially unburden the healthcare systems”, said BEUC, but is concerned about risks around the quality of information, accountability, privacy and data protection, and equality of access.
An arena that’s seeing rapid change and innovation on such a scale is inevitably crackling with questions, fears, and ethical and political dilemmas. Even if we could, would we want to know what diseases we’ll get later in life? Can we trust ‘the cloud’ to secure our personal health data? Should we trust ourselves to manage our own health? Will we lose more than we gain if we bypass the doctor-patient relationship?
Regulating an industry such as this can be fiendishly complex.
The MDR will replace two directives on active implantable medical devices and medical devices with one Medical Devices (MD) directive, while revising the current regulation on in-vitro diagnostic medical devices, or IVD directive.
It’s been in the pipeline for five years, having been launched in the wake of a scare over rupturing breast implants, known as the PIP scandal.
“We support tougher regulation,” says Bernasconi.
“But we get concerned when a 100 page regulation turns into 1000 pages. The risk is that you block the innovation cycle.”
Devil in the detail
Consumer and campaign groups have argued the current regulation is weak and want med tech products to come under more scrutiny before they are approved for the market - especially ‘high-risk’ devices that are implanted inside the body.
Campaign group Health Care Without Harm (HCWH) focuses on chemicals contained in devices, such as PVC intravenous tubes, which they say can leech hazardous substances.
“We can do a lot by having higher transparency and responsibility. Companies should be forced to give information, and prove why they are not using alternatives,” says HCWH’s executive director for Europe, Anja Leetz.
The new regulations are set to increase the information provided, but Leetz says the “devil will be in the detail”.
Pauline Constant of consumer organisation BEUC said they were happy with some of the changes, but they didn’t go far enough.
“The manufacturers will need to deliver stronger clinical evidence and more data, but we think it should have gone further to ensure that only the safest devices end up on the market.”
Referring to the system of private firms approving products she said: “There will be more oversight of the status of the companies that give products their CE (conformity) marking.
“But we want independent specialists, not commercial organisations, to assess devices that will end up in consumers’ bodies”.