Month: October 2019

Safe and sound: how secure are IoT-enabled medical devices?

by
IOT medical tech

Last month the Cybersecurity and Infrastructure Security Agency (CISA) issued an advisory warning of vulnerabilities concerning several medical IoT devices that could lead to data breaches.

These insecurities included buffer overflows, integer underflows, the improper restriction of operations, race condition, argument injection and null pointer dereference.

What’s more, all were described as being remotely exploitable by anyone with a low level of skill and knowledge.

So, how secure are the IoT-enabled medical devices already in use or in the pipeline?

And, aside from the obvious patient care benefits, what risks may IoT also be delivering?

The IoT revolution in healthcare

IoT has been given a clean bill of health in terms of its potential for growth in future medical device applications.

Between 2018 and 2024 it is expected to see a CAGR of 24% – and some uses, such as implants, scaling up each year by 30%.

It’s not all directly about saving lives, however.

One of the biggest drivers of growth is the rapid adoption of healthcare information systems. In addition, there has been widespread adoption of IoT devices for connected security cameras – according to Aruba Networks, 87% of US healthcare organisations use these devices for tracking high-value medical equipment.

Other cases have more direct relevance to patient care. These include monitoring vitals, an increasing reliance on cloud-based big data for diagnostics and improving device accuracy and connectivity.

What IoT technology offers, above all, is remote monitoring, accuracy, speed and efficiency. It promises to revolutionise the traditional paper-based healthcare treatment by simplifying access to real-time patient data and remote patient monitoring.

IoT devices in healthcare

A quick review of some of the remarkable devices that are already being trialled – or are already in use – would include:

  • CycoreThis remote monitoring cuff reduces the severity of disease-specific and general symptoms among patients with head and neck cancer during radiotherapy.
  • OpenAPSThis open-source initiative stands for Open Artificial Pancreas System. It not only gauges the amount of glucose in a patient’s bloodstream, but also delivers insulin when required.
  • Ingestible sensorsProteus Digital Health leads the way here. It has developed the first FDA-approved drug with a digital tracking system. Its pills dissolve in the stomach and produce a small signal that is picked up by a sensor worn on the body. This data can confirm the patient is taking prescribed medication as directed.
  • Cardiac careThere are many wearable and invisible devices in development that allow real-time data from a patient’s heartbeat to be analysed by AI. Alerts can be instantly issued to the medical support team.
  • RadiologyDevelopments are being made to combine IoT, machine learning and cloud technology to better manage workflows which are dependent on medical scanning devices. These optimise their availability and required downtimes.

Will secure data be an IoT casualty?

Electronic medical devices are already subject to intense scrutiny.

  • Risk control is placed squarely at the feet of medical OEMs by the European Medical Devices Regulations (MDR).
  • The updated ISO13485 has a similar focus on better risk control, improved supplier management and more detailed record of each stage in the device’s design and development.
  • The complex rules of CE marking also need to be adhered to for any devices intended for sale in European markets.

The medical market already requires better traceability of components used in devices throughout the supply chain, more detailed technical documentation and more rigorous auditing during design and manufacture. It also necessitates ongoing clinical evaluation and post-market clinical follow-up.

And now, medical OEMs also need a partner who fully understands and can implement the strictest security processes and procedures for data transference.

The challenge of IoT

Healthcare data security breaches is rapidly becoming one of the biggest challenges that healthcare organisations face – hacked healthcare data fetches 10 times as much on the criminal market as credit card data does.

What’s more, a research group did not need too long to hack into a connected pacemaker, where they found several potentially life-threatening vulnerabilities caused by inadequate authentication and encryption practices.

In recent years in the US alone, there have been nearly 500 breaches reported annually, affecting 5.6 million patient records.

The recent Vectra 2019 Spotlight Report on Healthcare indicates that one cause of this is the proliferation of healthcare IoT devices.

It also goes on to identify other equally significant causes unrelated to the devices themselves:

  • A lack of network segmentation
  • Insufficient access controls
  • A reliance on legacy systems

In addition, the report identifies gaps in policies and procedures that can result in errors by healthcare staff. Another investigation discovered that the majority of breaches are created by unwitting internal actors (59%) rather than criminally-minded external ones (41%).

Let’s just pause here: as important as data security must be taken by medical OEMs there is also a much wider problem at play.

This can be summarised as:

  • Healthcare organisations often can’t afford to have their systems down to be patched, even for just a few hours – they need to be able to operate at all times.
  • As a result of this, outdated systems and software have become common – and many legacy systems lack what are, in today’s environment, essential cybersecurity controls.
  • Compounding this is that, due to a lack of training or the needs of emergency situations, a lot of well-planned protocols, procedures and security controls are being overlooked by medical staff.

The healthcare IoT: our part in protecting patients and patients’ data

It is clear that ensuring security in an IoT-driven healthcare system requires joint efforts from the providers and manufacturers of IoT devices and the healthcare organisations themselves.  

Yet, it remains the responsibility of those who sell medical IoT devices – and their manufacturing partners – to ensure that two thorough health checks are always undertaken.

The first is to introduce new ways to monitor patients and equipment while improving care and lowering costs.

The second is to ensure that these devices are 100% data secure in their operation. Connected devices – from Wi-Fi enabled infusion pumps to smart MRI machines – must not increase the attack surface of other devices that are sharing their information.

Here are the basic security actions that must be taken at the design and production stages:

  1. AuthenticationOEMs should issue certificates for healthcare devices. These will validate identities to make sure that only authorised users or services can access the device. 
  2. EncryptionDevices must communicate via an encrypted link to ensure that healthcare data is transmitted privately. 
  3. IntegrityA certification process must be in place so that messages can be signed. This ensures that when the message is received by another device it can be verified as unaltered and to have not been intercepted. 

If you’d like to discuss your latest IoT-enabled medical NPIs, our team are always happy to connect

Medical miracles: the British and Irish med-tech start-ups making waves in 2019

by
Medical electronic manufacturing

Med-tech is booming.

And while established market players continue to innovate and scale their businesses, the sheer numbers and stability of med-tech start-ups establishing themselves is sure to see a significant dint in the market share of the larger companies over the next few years.

Let’s take a look at the med-tech market across the world to see:

  • Which sectors are driving this growth
  • Who the established OEMs are
  • Which British and Irish start-ups look like being the ones – among literally thousands – to watch

Med-tech under the microscope

In 2016, approximately 12,200 patent applications filed with the European Patent Office in the field of medical technology – this represents nearly 8% of all applications.

At the same time, it has been estimated that as much as 10% of gross domestic product is spent on healthcare. And around 7.2% of this is accounted for by medical technologies.

 

Med-tech is big business: the European medical technology market, responsible for about a third of the world market, has been estimated at roughly €110 billion.

What’s more, it’s growing at a phenomenal rate as new technologies, new materials and new ways of delivering health care rapidly coalesce.

In vitro diagnostics is the largest sector, followed closely by cardiology – with both these areas predicted to see around 6% CAGR leading up to 2022.

 

Below we survey other key areas where med-tech is stridently on the rise.

Oncology

 

Global oncology spend is forecast to continue rising and to reach $200 billion by 2022.

Growth is centred on new emergent techniques such as:

  • Gene therapy
  • Nano-technology
  • Immuno-oncology
  • 3D cell printing

Key players include:

  1. Prostmate
  2. Litebook
  3. Genentech
  4. Arcus
  5. Rakuten

Imaging Diagnostics

In the UK alone, the NHS performs over 45 million imaging procedures each year.

These include:

  • 25 million X-rays
  • 5 million ultrasound scans
  • 5 million CT scans
  • 4 million MRI scans

The UK’s diagnostic imaging equipment market is predicted to reach $2.63 billion by the end of 2020, with key players including:

  • Carestream Health Inc
  • Fujifilm Holdings
  • GE Healthcare
  • Philips Healthcare
  • Siemens Healthcare

Medical wearables

More than 80% of consumers are willing to wear fitness and health technology devices, such as smartwatches, ECG monitors and blood pressure monitors.

 

The wearable medical device market is forecast to be worth €24.4bn by 2023, with key players including:

  1. Fitbit
  2. Apple – iWatch
  3. Xiaomi
  4. Samsung
  5. Omron

Cardiology

 

With real-time imaging now available to be used during surgery and other procedures, the increasing uptake of such devices will see the global cardiac imaging software market reaching the $530 million mark by 2023.

Key players include:

  1. Siemens AG
  2. GE
  3. Koninklijke Philips
  4. Canon
  5. Fujifilm

Enter the start-ups

Surveying the UK health tech scene, the Office for Life Science calculates that 80% of the businesses in the industry are SMEs. These employ 23% of the industry total and generate 10% of the turnover.

It seems highly likely that, as these grow and new start-ups join them, their share of employees and turnover will grow.

Information stateside corroborates this with med-tech start-ups appearing in the top 10 industries of the most profitable small businesses – returning an extremely healthy net profit margin of 12.1% on average.

In many ways the rise of the start-up is facilitated by the agility of small businesses to move fast – and in this they are helped greatly by partnering with sophisticated and experienced EMS partners.

At Chemigraphic we offer:

Five start-ups to watch out for

When it comes to choosing start-ups that are going to disrupt the med tech sector there is no shortage of candidates.

We wouldn’t particularly disagree with any of the choices in the following three lists, even though there is minimal crossover between them.

  1. Valuer’s Best med-tech start-ups in Europe
  2. EU Start-up’s 10 European start-ups revolutionising healthcare
  3. Silicon Republic’s 20 of Europe’s top health and med-tech start-ups

We’ve decided to cast our net narrower and name five start-ups turning heads and profits in the UK and Ireland.

And we’ve picked just one from the five main areas of growth in the sector.

Ladies and gentlemen, the winners are…

Oncology: Kheiron Medical Technologies

According to Breast Cancer Now 62,000 people are diagnosed with breast cancer every year in the UK. These figures include diagnoses of DCIS (ductal carcinoma in situ), an early form of breast cancer.

Breast cancer survival in the UK is improving, and has doubled in the past 40 years due to a combination of improvements in treatment and care. But earlier detection through screening and a faster diagnosis can still drastically improve these figures further.

The problem is that radiologists are overworked and in short supply.

Kheiron Medical Technologies, a London-based med-tech start-up, founded in 2016 by Dr Peter Kecskemethy and Tobias Rijken, uses machine learning to help radiologists detect early signs of cancer with greater accuracy and faster than ever before.

The start-up has won Best New Radiology Software in the 2019 EuroMinnies and Best AI Product in Health at the CogX 2019 Innovation Awards. Its breast screening product, Mia (Mammography Intelligent Assessment), is the first to receive a CE Mark in deep learning and radiology.

Kheiron has just raised $22 million in a Series A funding round that will be used to scale the already impressive clinical validation of Mia achieved in multi-centre clinical studies. It is already working closely with the U.K. National Health Service (NHS), supported by government funding, to deploy Mia across pilot sites both in England and Scotland. In addition, it has also received funding from the E.U. Horizon 2020 Research and Innovation programme to scale across the EU.

At present, there are numerous start-ups raising funding to use AI and machine learning to help identify new treatments and diagnoses for other diseases, but Kheiron has achieved significant backing and interest from professional quarters, commercial backers and medical organisations.

Medical wearables: GiveVision

As we’ve highlighted before wearables are set to transform the med-tech field.

As devices and battery requirements reduce in size and data collection becomes more sophisticated, what started as a consumer trend is quickly realising potential in the medical field to monitor patients remotely.

The med-tech start-up we are singling out is taking the concept of wearable glasses, rather than monitoring devices, in a much more successful direction than Google has managed in its consumer-focussed augmented reality glasses.

London-based GiveVision is dedicated to providing innovative solutions that empower blind or visually impaired people to eradicate the barriers that prevent them from experiencing full and independent lives within mainstream society, education and employment.

With over 285 million people blind or visually impaired people across the globe, GiveVision has been working with organisations such as the RLSB, RNC, and centres and societies for the blind to develop a solution for people diagnosed with low vision due to central vision loss (e.g. AMD, Stargate’s) and conditions affecting the whole visual field (e.g. albinism, optic neuritis).

It has already brought a product to market in its software suite that powers smart glasses to be used as eyes for blind people. Specifically, SightPlus is designed to convert visual information into audio cues and vastly magnify visual perspective. The software gives access to printed text, assists the wearer to find a seat on a bus or train, allows them to shop confidently with recognised banknotes, and more – including integration with other smartphone apps for messaging.

Cardiology: Vivasure

Vivasure is based in the heart of Europe’s largest med-tech hub in Galway, Ireland. It makes polymer implants and delivery systems – primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery.

Established in 2009, Vivasure operates a fully-integrated, ISO 13485 certified, R&D and manufacturing facility. In 2016, its first European product – a vascular closure device – attracted investors to back it to the value of over €16 million.

Its patented PerQseal technology promises many further uses, but its lead product is the world’s first fully absorbable, patch-based large-bore percutaneous closure device. This easy-to-use device enables closure of large arteriotomies in transcatheter procedures.

“Closing the artery has been a concern since we started using transcatheter techniques for valve implantation,” says Prof. Horst Sievert, of the Cardiovascular Centre in Frankfurt, Germany. “The PerQseal device is a very innovative solution for closing large holes, and we are enthusiastic to make it part of our armamentarium.”

Similarly, Dr. Saib Khogali of the Heart & Lung Centre in New Cross Hospital, Wolverhampton, England, commented that: ‘I find the device intuitive and well controlled, which helped me quickly learn how to use the technology safely and successfully. I believe the PerQseal has the potential to be an important large-hole closure device in many TAVR and EVAR patients.”

Imaging and diagnostics: Incereb

Another Irish start-up, this time based in Dublin, has developed a range of paediatric, neonatal and foetal sensors for EEG monitoring that can be applied in minutes, with minimal training.

Incereb has found an innovative solution to attaching EEGs to a baby’s head to determine brain function. At the moment this is a process that takes a lot of time and requires a trained member of staff to oversee the procedure as the process can cause discomfort for the baby.

Founder Jim Roche explains that ‘having worked in neurophysiology for almost 20 years, with almost eight years in paediatrics and neonatal ICU, it was obvious that many NICU devices were simply adult devices scaled down for use on tiny babies. Incereb is the first EEG device of its type to be designed specifically for use on neonates in the NICU. It’s faster to apply, accurate, kinder to the baby, and makes EEG brain monitoring in the NICU available 24/7/365.”

The Incereb design has already gained a strong foothold in America, with FDA approval, and is seeing increasing uptake in the South American market.

The way the device makes neonatal brain monitoring made easy, quick and accurate through its non-invasive application is that it radically simplifies the electrode application into an innovative single electrode array.

This allows nursing staff with minimal training to align the central reference lead to the baby’s scalp, and confidently know that all other electrodes will be symmetrically placed.

Additional services offered now include EEG solutions with real-time support for pharmaceutical, therapeutic device and other research trials. This has already seen ‘Lifelines Neuro Research Services’ to become the global leader in cloud-based EEG for clinical trials requiring brain monitoring. Its solution allows clinical researchers to gain real-time access to data from anywhere in the world. This can significantly reduce turnaround times for video EEG recording and review, helping companies reduce the time-to-market for critical drugs.

General med-tech: Coroflo

Coroflo is a start-up that crosses the boundary between med-tech and consumer devices. It is also a universally-applicable device that was born from a very personal problem.

Here’s Dr. Helen Barry, Co-founder and ​Chief Research Officer at Coroflo:

‘I knew I wanted to give breastfeeding a go but when my son was born he was tiny. The only way to check [his weight] was week to week weigh-in and pre- and post-feed weight checks.

Waiting for results was extremely stressful for me and it was immediately clear that pre- and post-feed weights varied wildly with little accuracy.

My husband Jamie and I searched the market, but no product existed to tell me how much breastmilk my son was getting. And I needed immediate and accurate information!

Jamie coincidentally had worked on flow monitoring in another sector; he had an idea of a ground-breaking technology that could be the answer.’

Although the inspiration was personal – the need was much wider.

In the UK more than 75% of women who start breastfeeding have stopped by six weeks – and by six months only 1% exclusively breastfeed. These sorts of figures are far from unique to the UK.

Even though it has been widely publicised that breastfeeding offers nutritional, immune system, developmental, psychological, social, economic and environmental benefits, many abandon the practice very early on in their child’s life.

The number one reason identified for premature weaning is fear of low supply – given by ​60% of women as the main reason for stopping breastfeeding.

Coroflo has developed a breastfeeding shield and monitor, the Coro, which can accurately measure exactly how much breast milk a baby is consuming. It is the first breastfeeding monitor in the world that can give mothers accurate, precise, and real-time data about milk supply.

The patented sensor is non-invasive, easy to use, comfortable and tiny.  There is no need for wires or chargers: the unit is completely self-contained. It connects via an app to your phone to monitor feed volumes and store the data. Using cloud-based analytics you can see how your feeds have varied over time and how they compare with other babies of a similar age.

Coroflo has already received Richard Branson’s seal of approval and raised €900,000 in seed funding at a €4 million valuation. It has recently been among the winners the 2019 Google Adopt a Start-up programme and received European Innovation Council funding.

Med-tech and consumer tech: cross fertilisation

As can be seen in many of the start-ups we have highlighted there is a fluidity between tech innovation in consumer devices and those in med-tech.

Sometimes the waters of change flow one way, and at other times the flow is reversed.

A recent Deloitte report suggests that relationships between consumer and med-tech companies, may increasingly flourish. Partnerships between the two sectors could help successful medical OEMs ensure that data collected from the hardware is enriched by data collected from consumer devices.

According to this authoritative report:

‘What could separate med-tech companies apart from each other will be their ability to harness data gathered by their devices and use it to improve well-being, anticipate health issues, and help patients change the day-to-day behaviours that affect their health. Access to consumer-generated data (non-health data that leads to health insights) … can give some technology companies an advantage over established med-tech companies.’

We believe that this cross-fertilisation will develop – and to some extent already has developed – beyond data.

Innovations in medical devices will find uses in new consumer products and vice versa.

And we can expect start-ups, working alongside agile EMS partners, to be at the forefront of grasping these opportunities.

Capturing our attention: the TV series that has us all debating CCTV

by
Security surveillance devices

John Johnston, NPI Director, Chemigraphic

After the 8th October 2019, Tuesdays will never be the same again for many people. Not until the inevitable (surely?) series 2 of The Capture arrives on our screens.

The tense, unpredictable BBC thriller has had millions of us on the edge of our seats for almost six weeks now and is set to conclude in what will surely be a dramatic and maybe even frustrating finale.

The reason so many of us have been (ahem) ‘captured’ by the series is how creepily close it is to events happening in our own lives, as we live in the ‘post-truth’ era of fake news and doctored evidence. The premise that once concrete evidence such as video footage and CCTV ‘captures’ can indeed be flawed and even corrupted, seemingly live, is at once terrifying and yet completely plausible.

So what does this mean for the manufacture and development of modern surveillance systems?

Will programmes such as this fuel an already burning fire in us about the validity and even the morality of such technology?

An issue of trust

The short answer is yes and no.

With every technology developed and deployed in our everyday lives, there is always the potential for it to become compromised and abused at some point. From telecoms to mobile phones to written communications, every form of data capture and transmission is sadly open to interpretation, misunderstanding and tampering – it’s a fact of life. The key is to understand and accept the possibilities of flaws and to have a plan in place to identify, uncover and prevent them.

Emerging trends in surveillance

Surveillance and security is now home to a host of new technologies and methods which are opening up possibilities and increasing the accuracy of how we view, record and transmit sensitive information. AI, the IoT and Big Data are all transforming surveillance from being passive recording devices into live, intelligent systems which can make decisions and adapt to situations as they occur.

Devices already on the market act as Google for CCTV. They are instantly searchable and capable of recognising hundreds of thousands of natural language queries, eradicating the need for somebody to physically sit and review hours of footage.

And face recognition looms very close on the horizon, further enhancing the specificity of surveillance footage searches. As we’ve seen in The Capture, this is still very much a point of ethical discussion and tampering with such evidence isn’t beyond the realms of possibility.

The real meaning of data ‘intelligence’

Increasingly, it’s not just about surveillance devices but connected intelligence.

The defence sector is discovering how the ability to analyse Big Data will make it more efficient and more effective. And during live combat the ability to assess, assimilate and act on the insights big data can provide can save lives.

Sensors for telemetry (the automatic measurement and wireless transmission of data from remote sources), drones and other military and airborne surveillance and connected surveillance tools can help the military generate vast amounts of data. If this can be intelligently and automatically linked it will play a highly significant role in improving how and where people and assets are deployed.  In modern combat and counter-terrorism, data analytics is now emerging as one of the defence industry’s most effective weapons.

As specialist sensor devices become smaller, higher resolution and less expensive, surveillance equipment is becoming increasingly more sophisticated. Merging multiple measurable inputs such as video, audio, vibration, ultrasonics and lidar (laser surveying) means that data collection and analysis is now possible to a much greater degree of accuracy and under a wide range of conditions and circumstances.

And it’s not just the data capture that is intelligent, the analysis and processing aspect is also now extremely advanced. New techniques mean that vast amounts of data can be filtered to identify and isolate one tiny occurrence which could be crucial when looking for vital evidence. Millions of people will pass through an international airport in a day, so why is that one passenger or package worthy of attention? This emerging technology can help to make that distinction.

With progress comes responsibility

As always, we have a responsibility with this technology to treat it with the utmost respect and use it for good. Unfortunately, there will be those who flout this responsibility, as our current Tuesday night TV fare continues to remind us, but the balance has to be achieved. So much good can be done with this technology: so many plots uncovered, so many lives saved, that we have to believe in the power of good instead of being sucked into paranoia about the possibility of the bad.

One thing is for certain though. The Capture has got us talking. Let’s see where the discussion will take us.