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EpiPen shortages: prospects brighten for UK supply

Patients in the UK have been experiencing difficulties acquiring EpiPens since April 2018, after manufacturing issues caused a series of supply problems. Nearly two years later some pharmacies are still experiencing difficulties getting hold of them, despite supposedly sufficient EpiPen supplies in the country.

In an October 2019 survey of 100 community pharmacies in England, carried out by Channel 5 News and reported in The Pharmaceutical Journal, 31 pharmacies reported that they were unable to order auto-adrenaline injectors (AAIs) because they were out of stock, and a further 22 were unsure if they could supply them.

EpiPen supply issues since April 2018

EpiPen manufacturer Mylan first acknowledged issues with its supply of 0.3mg EpiPens in May 2018, and in September that year confirmed that the supply chain issues were also impacting EpiPen Junior 0.15mg. Following this, pharmacies were allocated EpiPen products on a prescription-only basis, and could only order two pens per prescription.

Mylan says: “With patient access as our priority, we will continue to proactively and diligently update pharmacies, healthcare professionals and patient advocacy groups across the country regarding any changes in stock availability. Additionally, timely supply updates can be found on our website.

“We continue to work closely with Meridian Medical Technologies to stay informed of anticipated shipments and future supply, with the aim to achieve a steady state of supply. We expedite shipments upon receipt, however at this time we cannot commit to a specific time when the supply constraint will be fully resolved.”

Cautious optimism for UK patients

Ben Beckles, who carries an EpiPen, is now able to access the medication he needs. However, he spent a year of the shortage struggling to get hold of it. During this time he was instructed to carry his out-of-date EpiPens.

Beckles says: “It’s been a bit of a pain having to traipse from pharmacy to pharmacy in the hope one of these places might have one. However, my allergies have got better with age, I’m very sensible with what I can and can’t eat and I’ve been fortunate having only ever had to use my Epipen once when I was in infant school.

“For those without an Epipen and with more severe allergies the psychological impact must’ve been way worse.”

The ongoing validation process means that pharmacies cannot keep any EpiPen products in general stock, but must order them in for every individual prescription. An anonymised copy of the script must be sent to Alliance Pharmaceutical, EpiPen’s sole UK distributor, after which two pens per script can be sent to the ordering store.

This means patients often need to pay their pharmacy multiple visits to get hold of the life-saving medication they need. The inconvenience is understandably distressing for people with severe allergies who rely on the pens for their safety and wellbeing.

Ensuring equitable distribution

A Department of Health and Social Care spokesperson says the validation process remains in place to ensure equitable distribution of supplies to all patients in the UK who require an EpiPen. It prevents any pharmacies from ordering in more pens than they need, which could potentially leave other suppliers without.

Britain’s LloydsPharmacy chain said that it hadn’t experienced any issues since the introduction of the prescription validation process.

Leading British pharmacy Boots UK expressed similar sentiment, saying: “Although not all stock is freely available, patients with a script can access prescriptions from their pharmacy via the Script Validation service for many lines, with a 36-hour turnaround. Our supplier, AHDL, has confirmed that there’s currently no backlog on this service.”

However, the fact remains that just three months ago, 53 out of 100 pharmacies found themselves unable to order the devices or unsure if it would be possible to do so. Pharmacies appear to be on stronger footing than they were in late 2019, but for now it appears that issues with the nation’s supply of EpiPens will unfortunately persist.



Seriously ill wait more than hour for ambulance

Thousands of emergency calls are taking ambulance crews more than an hour to reach, a BBC investigation shows.

The delays – affecting one in 16 calls in England for conditions such as strokes, heart attacks and fits – are putting lives at risk, experts say.

It amounts to over 4,000 “unacceptably” long waits a week for the second-highest category 999 calls. Wales also reported significant problems.

NHS bosses blamed rising demand and delays handing over patients at A&E.

Many ambulance services have increased staffing – only to find the extra resource largely being swallowed up by the rise in delays faced by crews queuing outside hospitals.

This has meant they have had to prioritise the most serious immediately life-threatening cases, such as cardiac arrests.

But these represent just a small proportion of the high-priority 999 calls.

Some of the longest waits exceeded five hours – crews are meant to arrive within 18 minutes on average.

‘My partner died while waiting’

Derrin Cozart, 55, was at home in Northumberland on his own last year when he collapsed. He came to and rang 999.

That was the last time anyone spoke to him.

It was over an hour before an ambulance crew arrived. By the time they did, he was dead.

He had suffered a gastrointestinal haemorrhage, which causes internal bleeding.

Thirty minutes after his call the ambulance service had rung back, but could not get hold of him.

It took another 48 minutes for paramedics to reach him – two crews had to be diverted while they were on their way.

His partner, Mark Mitchell, was out of the country on business at the time.

“It was devastating. I’ve been left wondering if the ambulance had got there more quickly he may have survived.

“We just don’t know – and that’s heartbreaking.”

The North East Ambulance Service said a full investigation was being carried out into the case.

Patients ‘let down badly’

The BBC investigation, which used the Freedom of Information Act to obtain data, has also uncovered other worrying cases, including a 70-year-old man who waited more than two hours after suffering a heart attack – he was taken to hospital and then faced even more delays before he could be admitted on to a ward

Rachel Power, chief executive of the Patients Association, said patients were being “let down badly at their moment of greatest need” and getting a quick response could be “a matter of life or death”.

She said the delays were “undoubtedly” related to the sustained underfunding of the NHS.

Mark MacDonald, of the Stroke Association, described the findings as “alarming”, saying a quick assessment and transfer to hospital for brain scans was vital if a patient was going to make a good recovery.

“When stroke strikes, part of your brain shuts down. And so does a part of you. Around two million neurons are lost every minute that a stroke is untreated.”

How many long waits are there?

Chart showing regional ambulance performance

The BBC asked for long waits for the two highest priority groups of 999 calls – the immediately life-threatening category ones and the emergency category two cases – from the start of 2018 when a new system of measuring response times came in.

Two of England’s 10 ambulance services – the West Midlands and East of England – refused to provide the information.

Long waits for immediately life-threatening cases were unusual – just one in 270 cases took longer than 30 minutes to reach. That works out at less than 40 a week.

But the records for category two call logs showed long waits for these emergencies were much more common.

The data showed there were 385,000 waits of over an hour from January 2018 to September 2019 out of just over six million incidents responded to.

That works out at more than 4,000 a week on average – or one in 16 calls.

East Midlands Ambulance Service had the greatest number of long delays – one in eight calls took over an hour.

Director of operations Ben Holdaway said crews were often facing long waits at A&E to hand over patients which means they “haven’t been able to get back on the road quickly”.

“Every part of the system wants to tackle these issues, but it’s clear we need more staff and beds and well-functioning social care.”

In Wales there were more than 1,000 cases a week on average – nearly a quarter of callouts – although their second-tier emergency calls category is a little broader than England’s and includes less urgent cases like diabetes complications which could account for some of the long waits.

Lee Brooks, from the Welsh Ambulance Service, accepted that some patients were waiting too long, describing it as as “frustrating for staff as it is for patients”.

Ministers are in the process of setting up a taskforce to tackle the delays.

Comparable data was not available in Scotland or Northern Ireland.

NHS national ambulance adviser Anthony Marsh said: “It is not easy to reach everyone as quickly as we would all like. All our staff are working flat out.”

The Department of Health and Social Care in England said the government was increasing funding for the health service and had set aside a dedicated pot to invest in ambulance services.

It also said it was investing in the workforce – from September student paramedics will be entitled to a £5,000-a-year grant to support them during their studies.

Data analysis by Felix Stephenson and Christine Jeavans



“Potential to eliminate” cervical cancer in England thanks to NHS Long Term Plan

Hundreds of lives will be spared every year in England thanks to a more sensitive cervical screening test rolled out as part of the NHS Long Term Plan.

NHS experts said that there is “potential” to eliminate cervical cancer completely thanks to the change in primary test within the NHS Cervical Cancer Screening Programme, combined with the effectiveness of the HPV vaccine.

The new and more sensitive test now looks for traces of high risk Human Papillomavirus (HPV), which causes nearly all cases of cervical cancer. Any tests that are HPV positive are then checked for abnormal changes of the cervix.

HPV is a group of viruses with more than 100 types, but 14 types can cause cervical cancer as well as some head and neck cancers.

It means that any sign of infection will be spotted at an earlier stage before it could potentially develop into cancer.

Since the beginning of December, every part of the country has had the new way of screening in place.

There are 2,500 new cases of cervical cancer in England every year but research says that a quarter of those could be prevented with this new way of testing.

The introduction is part of the NHS Long Term Plan’s ambitions to catch tens of thousands more cancers earlier, when it is easier to treat and the chance of survival is higher.

Professor Peter Johnson, national clinical director for cancer said: “Screening is one of the most effective ways of protecting against cervical cancer and there is no doubt this new way of testing will save lives. It is vitally important that all eligible people attend for their screening appointments, to keep themselves safe.

“Combined with the success of the HPV vaccine for both boys and girls, we hope that cervical cancer can be eliminated altogether by the NHS in England. The chances of surviving cancer are at a record high, but there is always more we can do, as we continue to deliver our Long Term Plan.”

Professor Johnson added that cervical cancer often causes no symptoms during the early stages of the disease, which is why it is “especially important that people attend their tests and that those who are eligible get vaccinated against HPV.”

Robert Music, Chief Executive, Jo’s Cervical Cancer Trust said: “It is exciting that we are seeing advances in cervical cancer prevention and must continue to look to the future to make sure our cervical screening programme continues to adapt and evolve.

“The day that cervical cancer is a disease of the past is one we should be aiming to get to as soon as possible. Cervical screening is such an important test, but there are many reasons it can be difficult to attend. We must continue to understand and tackle these to ensure as many women benefit from this far more sensitive test and we save as many cancers diagnoses and lives as possible.”

Professor Anne Mackie, Director of Screening at Public Health England said: “With HPV vaccinations for all year 8 pupils and HPV testing available nationally, cervical cancer promises to become very rare indeed. This is a truly momentous achievement, but to ensure we consign this disease to the past we must keep vaccination rates high and continue to provide safe and acceptable screening for all women.”

Jo Churchill, Public Health Minister said: “Thousands fewer women will be diagnosed with cervical cancer as a result of improved screening services and the HPV vaccine and it’s incredible to think that cervical cancer could be eradicated for good.

“The NHS Long Term Plan has committed to an overhaul of screening programmes, new investment in state of the art technology and a boost in research which will help more people survive cancer each year. I encourage all women to attend screening appointments.”

Joanna Gray, 30 from Manchester said: “I still remember being told that I had HPV and cell changes. It was really scary and made me panic. The doctor at the hospital told me that if I’d left this for another three years then it could have been very, very different. However now I’m all clear and am really grateful that it was caught so early. I think it’s amazing that smear tests prevent cervical cancer before it even has a chance to begin”

The latest figures show that seven in 10 people attended their cervical screening appointment last year but that one million people didn’t attend their appointment.

Women and people with a cervix aged between 24.5 and 49 are eligible for screening every three years, whilst those aged between 50 and 64 should be screened every five years.

The NHS Long Term Plan will transform cancer care across the country with a renewed focus on improved screening to catch three quarters of all cancers at stages one and two.



Could running a marathon make your blood vessels ‘younger’?

“First-time marathon runners can ‘reverse ageing’ on blood vessels by four years,” reports the Daily Mirror.

The headline follows a UK study that recruited 138 healthy adults with no previous marathon experience. The participants then spent 6 months training for the London Marathon.

At the start of the study, researchers used a type of heart scan that measures the stiffness of the aorta – the major artery that takes blood from the heart to supply the rest of the body.

Increased artery stiffness is linked with increased risk of high blood pressure and heart disease. It’s also considered to be a sign of ageing. The researchers repeated these scans after the participants completed their first marathon.

The study found that training was associated with decreased stiffness of the aorta. This was calculated to be the equivalent of up to 4 years’ decrease in the “biological age” of the blood vessel. The effect seemed to be greater in:

  • older participants who had stiffer arteries to start with
  • those with slower marathon running times

It’s worth noting that we do not know the health outcomes of the participants in the longer term, so we do not know if the decreased artery stiffness definitely translated into improved heart health and longevity. However, we do know that regular physical activity boosts health.

Running is not for everyone, and just over half of the people who signed up completed the study. Other forms of exercise such as cycling, swimming or walking may be just as beneficial. The important thing is to do regular physical activity in line with current recommendations.

If you are planning to get fit for the new year, running a marathon may be a little too ambitious as your first exercise goal. Other ways you can gradually increase your fitness levels include running shorter distances, swimming and cycling.



Clinical Waste Disposal: Reducing Single Use Plastic within the NHS

The environmental, legal and financial benefits of the switch to a clearly identifiable non-hazardous pharmaceutical waste stream have been appreciated by the trust for a number of years now. We were able to switch from rigid plastic to rigid board-based containment for this waste stream which has helped our trust address the requirement to improve our environmental performance, generate savings whilst continuing to move towards fulfilling our sustainability objectives

Jason Mitchell, Waste Manager
Newcastle Upon Tyne Hospitals NHS Foundation Trust

The challenge

Prior to this implementation several years ago, Newcastle Upon Tyne Hospitals NHS Foundation Trust did not have a fully defined process in place for segregating some elements of healthcare waste. Non-hazardous pharmaceutical waste was disposed of in the same bins as hazardous waste. As the disposal for hazardous waste is more expensive, their costs were being impacted. This practice was also non-compliant with HTM Guidance.

Following an internal review, the trust introduced blue-lidded plastic bins to allow pharmaceutical waste to be disposed of separately to other waste streams. With an increased focus on sustainability, they began looking at ways to reduce single use plastics; adopting board-based rigid containers for pharmaceutical waste. It was also apparent at the time that board-based alternatives were cheaper to purchase than plastic containers.

To successfully implement this new approach to clinical waste disposal, the Trust needed buy in from key stakeholders. There was a lack of awareness about the benefits of segregating pharmaceutical waste from its current method. Questions were raised regarding the quality and durability that board-based waste bins could provide when compared to plastic.

What were our objectives?
  • Raise awareness of the effective benefits when using board based clinical waste disposal streams, across key hospital departments.
  • Reduce the utilisation of single-use plastics when disposing of medical waste.
  • Generate savings on pharmaceutical waste disposal.
  • Successfully implement a segmented approach to waste disposal in line with Trust policy within 6 months of completing a successful product trial.
What is the process?
  1. Recognising the need to implement a more structured approach to waste segregation to reduce plastic usage in the waste process and to generate savings.
  2. Procurement and Waste Management worked together to identify opportunities and then engaged with stakeholders from across the Trust to increase awareness and adoption of waste segregation.
  3. Implemented a board-based blue non-hazardous pharmaceutical waste stream.
  4. Identified that board based bins offered a cost effective alternative – The specific products were selected due to in part the inclusion of an absorbent pad within the bin, allowing for medicinal waste to be added.
  5. Implemented to ‘friendly’ wards and departments including Pharmacy Stores, Clinical Research, specialist wards.
  6. Full implementation across 200 wards was achieved in a matter of weeks. Very straightforward roll-out.
What are the overall benefits?

Upon completion of the trial, 6 months implementation was anticipated – however uptake was very quick, and this was actually achieved within a matter of weeks.Jason Mitchell, Waste Manager
Newcastle Upon Tyne Hospitals NHS Foundation Trust

  • Board-based waste bins were successfully introduced in to 200 hospital wards across the Trust.
  • Based on current waste costs for the Trust 20% savings are achieved by having a separate channel for pharmaceutical waste disposal.
  • 29% of consumables saving were delivered by moving from plastic to board-based waste bins at the time of the trial.
  • There was a reduction in inventory usage due to the flat pack option available with board-based bins.
  • At the time of the trial an estimated 46% reduction in carbon emissions was achieved due to board-based bins being 96% more renewable than plastic.

A point to note is that there have been recent developments in the healthcare waste industry, particularly around incineration outlets which, has led to a reassessment of pharmaceutical waste disposal. As it is non-hazardous, the understanding is that it can be disposed of in permitted municipal incineration plants instead of specialist healthcare waste incinerators; providing it is clearly identified and appropriately labelled. For the most part, this will bring cost savings and be completely compliant if the receiving site is permitted for 18 01 09 waste.

The blue pharmaceutical waste stream was very easy to introduce once ward and department managers understood the need for a compliant and cost-effective system for waste containment and disposal. Introducing board-based containers can be the standard for this system in any hospital.Jason Mitchell, Waste Manager
Newcastle Upon Tyne Hospitals NHS Foundation Trust

Useful insights
  • Board-based clinical waste disposal should be considered when looking at the reduction of single-use plastics.
  • Implementing the change in a small number of departments before rolling out on a larger scale will enable any issues to be addressed early on.
  • Issues will need to be considered around, security of open containers, movement by porters and on-site storage prior to disposal.
  • Pharmaceutical waste does not have to be consigned to a clinical waste incinerator if an alternative permitted municipal waste recovery facility is available which can save a significant amount of money.
  • As board-based bins can’t be wiped clean, it may be that they aren’t be suitable for all Trust departments. Ensure that key stakeholders are identified and engaged with from the outset so that requirements can be captured.
  • Most suppliers provide Floor stands to accompany board-based bins; preventing the bin from splitting if the base becomes wet. This can be caused when floors are frequently mopped.
What is the NHS long term plan?

The NHS Long Term Plan was published in January 2019. It outlines some key commitments to help the NHS be a low carbon institution and lead by example in sustainable development. These commitments include:

  • Reducing carbon emissions
  • Improving air quality
  • Reduction of single use plastics
  • Improving efficiency and adopting new innovations to reduce waste, water and carbon.

Despite a 27% increase in activity, the carbon footprint of health and social care has reduced by 19% since 2007. This still leaves a significant challenge to deliver the Climate Change Act target; the target of which is 34% by 2020 and 51% by 2025. The NHS as an organisation has a huge carbon footprint. A large percentage of which is from the procurement of goods and services. Waste is a contributor to that carbon footprint. In addition, the plan responds to the global concern over single use plastics. Any activity which reduces plastic and reduces waste will be helping the NHS to deliver on its carbon reduction commitment. This will help make the NHS an anchor institution in sustainable development.



Mindray Medical introduces new point-of-care ultrasound system

China-based medical device company Mindray Medical has launched the TE7 ACE point-of-care ultrasound system to deliver targeted solutions in various point-of-care scenarios, such as anaesthesia, critical care and emergency.

The touchscreen ultrasound system comprises complete disinfection solution, smart fluid management tools and safe needling toolkit, offering seamless data connectivity.

Mindray medical imaging system business unit general manager Xujin He said: “Having identified the clinical challenges, Mindray developed this solution to empower clinicians with more confidence to focus on patient care.”

Mindray states that early assessment will help execute the fluid therapy plan and save lives by managing patient body fluid.

The advanced fluid measurement tools of the system speeds-up patient assessments accurately and efficiently based on deep learning algorithms.

Mindray’s system features Smart VTI that can automatically calculate the velocity-time integral, cardiac output and stroke volume variation. The trending graph assists in efficient recording and guides fluid therapy.

The Smart IVC can automatically trace the IVC diameter change, as well as calculate the collapsibility index or distensibility index and IVC variation to evaluate volume status and responsiveness.

The Smart B-line can automatically calculate -lines number, percentage and distance. It offers a visual scoring map for intuitive overall lung water assessment, helping to guide fluid infusion and prevent pulmonary oedema.

The newly introduced L12-3VNs with three programmable buttons brings together eSpacial Navi and remote controls to helps clinicians carry out puncture without touching the system.

Furthermore, the eGateway connectivity solution allows TE7 ACE to fit into the existing hospital network and integrate patient’s clinical data collected from both ultrasound equipment and patient monitors. Due to the paperless process, productivity becomes enhanced and the risk of transcription errors minimise.



The 10 greatest medtech advances of the 2010s

10. Neurostimulation for everything

Medical device companies already had a few devices out in the early 2000s that used pacemaker technology to treat a few brain and nervous system disorders such as Parkinson’s. But the 2010s were the decade when they sought to harness neurostimulation or neuromodulation to treat a whole host of conditions.

Here’s just a sample of how it’s being used:

  • In 2018, for example, FDA approved the Medtronic Deep Brain Stimulation for Epilepsy. Medtronic says the system can reduce the frequency of seizures in adults with medically refractory partial-onset epilepsy.
  • Silcon Valley–based NeuroPace, meanwhile, touts its RNS System as the only closed-loop brain-responsive neurostimulation system designed to prevent epileptic seizures. The company is studying whether the system might also help treat binge eating in certain people.
  • CVRx (Brooklyn Park, Minn.) scored a success last summer when it secured premarket approval to market its Barostim Neo device for heart failure in the United States.
  • Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system for chronic pain treatment.
  • SPR Therapeutics launched its Sprint peripheral nerve stimulation (PNS) system in November 2018, with indications for treating both acute and chronic pain.


9. Disposable endoscopes

The 2010s saw the rise of endoscopes that were inexpensive enough that they could be used once on a person and then thrown away — avoiding the reprocessing challenges and related infection risks that come with reusing scopes. The global market for disposable scopes reached $515.7 million in 2017, and it’s expected to grow to $3.1 billion by 2026, according to Acumen Research and Consulting.

Leaders in the space include Boston Scientific, Hillrom, and Ambu. – CN


8. Advances in treating hearing and sight loss

Frequency Therapeutics

[Image courtesy of Frequency Therapeutics]

Thanks to biotech advances, device miniaturization and better computing power, the past decade has also seen potentially disruptive advances in treating the loss of hearing and sight.

Rising stars include Frequency Therapeutics, which priced an $84 million IPO in 2019. Frequency’s hearing loss treatment drug FX-322 is meant to activate progenitor cells — mature stem cells that can proliferate into different types of cells. A health provider injects the drug into the middle ear in a slow-release gel.

Early in 2019, Second Sight Medical announced the first trial implantation of its Orion cortical visual prosthesis system. The implanted Orion system converts images captured by a miniature video camera mounted on glasses into a series of small electrical pulses delivered to the brain — bypassing diseased or injured eyes.

“This is the first time that we’ve had a completely implantable device that people can go home with and use in their own living conditions without having to be plugged into an external device,” ULCA Health neurosurgeon Dr. Nader Pouratian said in a news release. “It helps them recognize, for example, where a doorway is, where the sidewalk begins or ends or where the crosswalk is. These are all extremely meaningful events that can help improve their quality of life.”


7. Tiny pacemakers

Medtronic (NYSE:MDT) scored a major advance in pacemaker innovation in 2016 when it achieved FDA approval of its Micra transcatheter pacing system, which is about the size of a vitamin pill. Implanted via catheter into the heart’s right ventricle, it delivers single-chamber pacing without the need for the wires and leads that have proved challenging for pacemaker manufacturers.

St. Jude Medical recalled its leadless pacemaker, Nanostim, in October 2017. Now part of Abbott, it’s competing with Medtronic to produce a leadless dual-chamber pacemaker. – CN


6. Brain-computer interfacing

People who have lost the ability to move or their sense of touch got a boost in March when the FDA released draft guidance to help developers of brain/computer interface (BCI) devices to pass regulatory hurdles on their way to investigational device exemptions

The FDA defines (BCI) devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. Examples of these devices are being developed worldwide.

Companies including NeuroSky and Emotiv have developed EEG headsets that not only work for gaming, but help people recovering from a stroke or who have neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) to regain their independence.

Researchers at Battelle and  The Ohio State University Wexner Medical Center worked together to develop a BCI called NeuroLife that helps paralyzed people to regain conscious control of their fingers, hand and wrist.

A Swedish woman with a hand amputation recently became the first recipient of an osseo-neuromuscular implant to control a dexterous hand prosthesis. In 2017, an international research team developed a BCI that can read brain chemistry to enable communication in patients who are paralyzed and unable to talk. The FDA has put a particular focus on helping paralyzed military veterans and those who have amputations to regain physical function.

Having clear direction early in the process may help device developers in this rapidly evolving field save money and reduce risk, then-FDA Commissioner Dr. Scott Gottlieb said in March.

“There are many ways we identify these areas,” Gottlieb added. “Once we do, we work to ensure that the tools are in place to advance the development of these new technologies, by providing clarity and direction to medical device developers to help reduce the barriers of bringing new treatments to patients.” – NC


5. 3D printing

3D printing, or additive manufacturing, has been around for decades. But it was only in the 2010s that medical device designers truly embraced it as an effective prototyping tool. Now it holds the promise to also enable the creation of customized medical devices.

3D printing company Carbon, for example, has a business partnership with Johnson & Johnson to develop “digitally printed material that serves a mechanical function in the body, but after a few months it’s fully bio-absorbed and transitions to your own tissue,” Carbon co-founder and executive chairman Joseph DeSimone told CNBC in November.

More than 100,000 hip cups have been made in Arcam printers and implanted in patients, according to GE Additive’s Arcam businessSmith & Nephew for the past few years has had its 3D-printed titanium Redapt revision acetabular fully porous cup with Conceloc technology. Stryker has invested heavily in 3D printing research, with the technology supporting its Trident II hip cup and much more.

“Next-generation approaches include Tissium‘s high-resolution 3D printing platform that harnesses fully synthetic, biomorphic and programmable polymers to create implantable devices that can guide tissue growth,” said serial medtech entrepreneur Jeff Karp, a professor of medicine at Brigham and Women’s Hospital and Harvard Medical School.

On top of customized medical devices, 3D-printed models are becoming an important presurgical planning tool. At Mayo Clinic, for example, the health provider’s Anatomical Modeling Lab makes thousands of models a year to help surgeons prepare, as well as educate the people who need the operations.


4. Digital health — and AI hype

More than a decade after the launch of the iPhone and Amazon Web Services, the greater access to ever-increasing computer power is rapidly transforming medtech. A cell phone with a camera has the potential to replace a bulky diagnostic machine. Health providers are also increasingly embracing telehealth.

“Hospital systems are setting up telehealth departments and reimbursement codes are being added and refined. The next decade will see us all receiving healthcare over our mobile devices,” Scott Thielman, CTO at Product Creation Studio (Seattle), told MDO.

It’s little wonder that this year’s CES has companies touting 546 digital health and 635 wearable devices.

Traditional medical device companies are also seeking ways to package sensors into a host of implantable medical devices in order to glean insights. Boston Scientific, for example, has its HeartLogic heart failure diagnostic sensors packaged into implantable CRT-Ds and ICDs.

Next on the horizon is artificial intelligence — with the open question of whether AI can deliver on what companies are promising when it comes to improving healthcare. – CN


3. Getting closer to an ‘artificial pancreas’

Researchers in the field of diabetes management have been working to create a closed-loop system that can measure glucose and inject insulin as needed. The idea is to have the system work as an “artificial pancreas” for people with diabetes, using a combined glucose sensor, control algorithm and an insulin infusion device.

The FDA describes an artificial pancreas as a system of devices that mimics the glucose-regulating the function of a healthy pancreas. Computer-controlled algorithms connect the CGM and insulin infusion pumps to enable continuous communication between the two devices. The system can monitor glucose levels in the body while adjusting insulin delivery to reduce high blood-glucose levels and reduce low blood glucose without the need for patient interference.

Medtronic was one of the first companies to win approval for a hybrid closed-loop system back in 2016. The MiniMed 670G system was the first system of its kind to win clearance globally. While it wasn’t a fully standalone artificial pancreas, the system was one step closer toward developing a fully capable closed-loop system.

Companies in the race to make the first artificial pancreas include Bigfoot Medical, which has a partnership with Abbott. Other companies include Tandem Diabetes, Insulet, Beta Bionics and more.

However, with the hype of closed-loop systems, some people have taken on the task of hacking and DIY-ing their own diabetes devices. The FDA warned in 2019 against using unauthorized devices for diabetes management as it could lead to incorrect insulin dosing, which can be fatal.

There’s also a rise in continuous glucose monitor clearances. Continuous glucose monitors, like the implantable Eversense system, could replace the tedious fingersticks diabetics are tasked with to measure blood glucose levels. Abbott has already seen success with its FreeStyle Libre glucose monitoring system; the company in early 2019 touted real-world data showing reduced prolonged hypoglycemia and better glucose control among system users.  – DK



Transcatheter aortic valve replacement (TAVR) is a minimally invasive surgical procedure that replaces and repairs damaged heart valves. The procedure places a replacement valve where the aortic valve is, according to the American Heart Association. It is inserted similarly to a stent in that the valve is fully collapsible and delivered to the valve site through a catheter.

The procedure was initially used as a last-chance option for people with severe aortic disease, but the procedure saw ever-expanding indications through the 2010s. Recent studies suggest TAVR overall could be a safe alternative to traditional surgery. The FDA in August 2019 cleared heart valves made by Medtronic and Edwards Lifesciences for use in patients at low risk from open-heart surgery.

The success of TAVR has sparked a race to commercialize transcatheter mitral valve replacement devices. – DK

1. Robotic surgery expands

Pioneered by Intuitive Surgical through the early 2000s, robot-assisted surgery became a hot medtech area in recent years, with a host of major medtech companies seeking to break into the space.

“The 2010s served as validation of the robotic surgery hypothesis: Providers, payers and patients will embrace an expensive platform technology that effectively gives the surgeon superpowers in the operating room. The stage is set for a battle over platforms among the big players and a myriad of procedure-specific systems from smaller innovators,” said Thielman at Product Creation Studio.

Medtronic in 2019 unveiled its much-awaited Hugo RAS system — which the medical device giant touted as more flexible and cost-effective than systems currently on the market.

Johnson & Johnson closed the year by announcing its purchase of the remaining stake in Verb Surgical, following what J&J described as a successful strategic collaboration with the Alphabet life sciences unit Verily. J&J’s Ethicon subsidiary in February inked a $3.4 billion deal to pick up surgical robotics pioneer Dr. Fred Moll’s newest robotic surgical play, Auris Health, and its FDA-cleared Monarch platform.

Intuitive, meanwhile, continues to innovate when it comes to robot-assisted soft-tissue surgery. Its da Vinci SP robot for single-port surgery has a tube that is about an inch wide and delivers fully articulating instruments: three that can manipulate things and one that’s a steerable endoscope. The robot is in the process of launching in the United States.

Robots are also hot in the orthopedic surgery space. More than six years after spending $1.7 billion to acquire Mako Surgical, Stryker is leading the way. Big competitors including Johnson & Johnson’s DePuy Synthes business, Zimmer Biomet and Smith & Nephew, which have either launched or are preparing to launch their own robots.

In December 2018, Medtronic closed on its $1.7 billion purchase of Mazor Robotics and its robot-assisted surgery platform for the spine. A month later, Medtronic launched its Mazor X Stealth robotic-assisted spinal surgical platform in the U.S.



5 tips to raise funding for your medical device

Securing funding can be a long and tedious process, and medical device businesses must work to position themselves as especially attractive to potential investors to maximize success and accelerate the fundraising process.

Jon Speer, Greenlight Guru

According to Alejandro Cremades, author of The Art of Startup Fundraising, it can take from six to nine months to secure funding for a business. For organizations in highly regulated industries such as medical devices, the fundraising process can present a unique set of challenges and mountains to climb.

These three tips that can help you stand apart from the rest to secure adequate funding:

Build a robust regulatory strategy

About 80% of U.S.-based medtech companies have 50 or fewer employees. Medtech startups often seek funding to cover the research, development and manufacturing costs of their devices.

One of the biggest challenges these companies face is developing the executive summary of their regulatory strategy. A strong regulatory strategy is one of the most valuable assets to have during the fundraising process because it allows easy access to milestones and other deliverables when pitching investors. A regulatory strategy should demonstrate that you know how to position the device to elicit interest from investors and that you have the knowledge and experience necessary to secure funds.

Keep in mind that regulatory requirements for medical devices keep changing, including ISO 13485:2016, EU MDR and the upcoming release of a third version of ISO 14971. Rising expectations for medical device capabilities will only continue to make these regulatory changes more commonplace. Building a solid regulatory strategy will become more critical than ever to ensure compliance.

Establish a business case for the device

You don’t need an elaborate, detailed business plan to interest investors. Thorough market research and a prototype to provide proof of concept are what they want to see.

Here are six market research questions to get started:

  • Why is this medical device necessary?
  • Does this medical device have a proven clinical need?
  • Are there any other similar devices?
  • Who is the end-user of the medical device?
  • Who will purchase this medical device?
  • What is the market size for the device?

Produce an adequate prototype

The prototype does not need to demonstrate its final, go-to-market state, but it should provide proof-of-concept to potential investors. When developed effectively, prototypes communicate the vision of the device throughout product development and allow all external stakeholders to gain a better understanding of long-term goals.

Know what investors want

All investors are trying to make money with minimal risk, but there are three specific types of risk most are concerned about:

  • Business risk — Is there a market for the device?
  • People risk — Does the company have the right people for the job?
  • Technical risk — Does the idea work?

To maximize success in the fundraising process, it’s crucial that medical device companies familiarize themselves with these types of risk and also the types of investors. For example, some may look for low-risk opportunities while others opt for a high-risk, high-reward approach. In the latter case, they may be willing to invest solely based on ideas and prototypes, rather than concrete processes or finalized paperwork.

One more thing

Put yourself in the shoes of a potential investor. What do you think they need to see to write a check? From there, demonstrate the technology in a way that meets these needs. If you can assure a potential investor that a device will more than likely be successful, there’s a good chance you will secure funding.


Is AI a Fad or a Sure-Fire Thing in Medtech?

The growing popularity of artificial intelligence in medtech was pretty obvious in 2018. The use of AI in creating new applications or enhancing existing ones was perhaps the hottest trend in the medical device industry last year. But that was 2018. What about this year and just what does the future hold for AI.

One medtech executive/entrepreneur thinks that 2019 will be the year of validation for AI. Yann Fleureau, the co-founder and CEO of Cardiologs, a Paris-based company building deep learning algorithms for ECG analysis, spoke with MD+DI about one of the AI and its expected impact.

“I think we will see the validation of clinical adoption and early proof of economics or outcome benefits for AI solutions,” Fleureau said, who was recently listed as one of Forbes 30 under 30 in Europe.


The 29-year-old launched Cardiologs about five years ago. The firm has raised at least $10 million to date. In that time, he has seen a great deal of change in AI-based medtech applications.

Fleureau said that AI has the potential to help clinicians with mundane and time-consuming tasks. The applications also have the ability to make the workload more efficient.

“I think AI will save caregivers’ time,” he said. “Also, it will enable caregivers to spend time on tasks that require a level of skill. Caregivers will be able to focus on the cases that really need clinical attention.”

The promise of AI catapulted medtech mainstream in 2018 when it was reported Cupertino, CA-based Apple received a nod from FDA for an ECG application for the iPhone 4. While Apple’s app isn’t as robust as AliveCor’s KardiaBand or IRhythm Technologies Zio Patch, the company can do a better job of bringing innovation straight to the consumer’s door. The firm’s app contains some machine learning which in some circles could be considered as a main staple of AI.

“It will always be easier to introduce a medical-grade ECG sensor into a consumer device rather than convincing the medical community to use another sensor to effectively start treatment of a patient,” Fleureau said. “Apple sells a thousand times more smart watches than the number of ECGs. So, it means the capacity to record ECGs would be multiplied [significantly] in the coming years.”

Larger Companies Coming Around Quickly

Some of the larger medtech companies are enhancing their existing devices with AI – or in other words turning dumb devices smart. But to do this many have to enlist the role of other companies and innovators more familiar with the space, either through investments, collaborations, or acquisitions.

Recall that in November of last year, MD+DI reported that Medtronic was acquiring its frequent collaborator, Nutrino, a company that uses AI for nutrition related services. Prior to the deal, the Tel Aviv, Israel-based-company played a role in some U.S. product introductions from Medtronic, including the updated iPro2 myLog app used with professional CGM solutions as well as the Sugar.IQ diabetes assistant app used with the Guardian Connect smart CGM system.

Nearly a month after the Nutrino acquisition was reported, Irvine, CA-based Edwards Lifesciences formed a partnership to integrate Bay Labs’ EchoMD into the CardioCare quality care navigation platform.

Just recently (last week actually) Boston Scientific announced the winners of its Connected Patient Challenge, a competition that fosters and supports innovations by digital health companies. This year’s theme was Digital Solutions for Chronic Care, and Nutrimedy, a Brookline, MA-based company that has developed a telenutrition platform that connects users to registered dietitians and ongoing support based on personalized goals, won the competition.

BreathResearch, a company that has developed a technology to detect early signs of respiratory attacks to reduce hospitalizations.

These Hurdles Aren’t Artificial

During Cleveland Clinic’s Health Innovation Summit last year, a panel of experts said AI would be the second greatest innovation to impact healthcare in 2019 . However, that in itself presents challenges.

Fleureau said that he wasn’t sure there would be one general obstacle for every single AI category – noting that there could be several issues depending on the application or the approach of the company developing the technology.

In an interview with MD+DI, during the Cleveland Clinic Innovation Summit, Eric Hargan, Deputy Secretary, Health and Human Services touched on one obstacle for AI solutions that isn’t discussed enough – reimbursement.

During the October 2018 interview, Hargan noted the biggest issue was determining how to reimburse a technology that could move so rapidly. He gave the example of a hospital system with two million patients. He asked what happens when you reimburse a hospital system for using a solution that will give a second opinion on each patient.

During the interview, he gave a hypothetical example of where the AI solution could be run every two-to-three days on the two million patients, noting that in this scenario reimbursement costs could be astronomical.

While there are no hard and fast solutions these stumbling blocks will probably do precious little to impede the progress of AI in medtech.


Hernia mesh implants used ‘with no clinical evidence’

“Too many” types of hernia mesh implants are being used on NHS patients with little or no clinical evidence, the BBC has been told.

New data shows more than 100 different types of mesh were purchased by NHS Trusts from 2012 to 2018 in England and Scotland, leading to fears over safety.

The meshes can cut into tissue and nerves, leaving some people unable to walk, work or care for children.

The regulator MHRA said there was a clinical need for the devices.

The new figures were taken from the responses of 56 of the 159 NHS Trusts that replied to a Freedom of Information request by the BBC’s Victoria Derbyshire programme.

Currently, hernia mesh devices can be approved if they are similar to older products, which themselves may not have been required to undergo any rigorous testing or clinical trials in order to assess their safety or efficacy.

‘Children want their mum back’

Hernia repair is one of the world’s most common surgical procedure.

In England, around 100,000 such operations are performed each year, the majority using mesh. Many go well.

But the Victoria Derbyshire programme has heard from nearly 300 people who have experienced complications – including chronic pain, infections and organ perforations.

International guidelines estimate one in 10 patients will experience “significant chronic pain” following a mesh repair.

Roseanna Clarkin with family
Image captionRoseanna says her children want their “fun mum back”

Roseanna Clarkin is now registered as disabled. She had to give up her job due to complications after her repair.

She says she was initially told by doctors the pain was “in her head”, and wanted to end her life because “nobody was listening”.

It was only after seeing the programme’s coverage of the mesh scandal that she discovered it had been used on her.

Aged 36, she said she was no longer able to look after her children as she had before.

“My kids wrote a letter saying they want their fun mum back,” she said, breaking down in tears.

“My husband said he married a wife and became a carer. I shouldn’t be living the life I’m living.”

‘Tested on rabbits’

There is a lot of secrecy surrounding the approval of hernia mesh, with even doctors unable to access the clinical data.

Prof Carl Heneghan, a medical device expert at the University of Oxford, explained that in some cases devices have only been required to be tested on animals – such as rabbits – for a short period of time, with the mesh being implanted and left in for several days.

“If there’s no remaining immune reaction, you pass the test,” he added.

Prof Carl Heneghan
Image captionProf Carl Heneghan is calling for the NHS to “immediately” stop using types of device that have “no evidence attached to them whatsoever”

Prof Heneghan described these tests as “completely inadequate” as they can’t test for pain.

And he said there was “no chance” that the more than 100 types of device used on the NHS were all individually supported by medical evidence because there had not been 100 randomised trials in this area of medicine.

He has called for the NHS to “immediately” stop using those that have “no clinical evidence attached to them whatsoever” and said ideally trusts should only use two or three devices where the benefits are clear.

Mesh example
Image captionAn example of the mesh devices used

Hernia mesh implants are meant to be permanent but, when necessary, can be removed in some patients.

But of the patients the Victoria Derbyshire programme spoke to, most said they had been told there were no trained removal surgeons – or that they had been told removing the mesh could lead to further serious issues.

The programme has learned that one man died years after he developed an infection following his hernia mesh repair.

The hospital said in a letter to his wife that the mesh “could have been a cause of the infection”.

One of the many causes of death given was chronic abdominal-wall infection.

‘Hard as stone’

The BBC has also seen a leaked promotional video, probably for the medical community, funded by Ethicon – one of the biggest mesh manufacturers in the world.

In the footage, made over a decade ago, a surgeon is shown discussing how some older varieties of mesh can become “hard as stone” after only one year inside a patient and can cause damage to the body and chronic pain.

But the product featured is still being sold by Ethicon, and used by the NHS in England and Scotland.

In a statement, Ethicon did not comment on the video, but said it stood by the safety and performance of all its mesh products.

It also stressed the importance of looking at all clinical and scientific data before drawing conclusions about a device.

‘Monitor for evidence’

Currently the use of mesh for vaginal repairs is suspended for most women in England, pending the outcome of a government review.

Its head, Lady Cumberlege, has said any recommendations made when it is published in March will also be relevant for hernia mesh.

The director of devices at the Medicines and Healthcare products Regulatory Agency (MHRA), Graeme Tunbridge, told the BBC: “The benefits and risks of using mesh for hernia repair have been considered in detail by clinicians and the professional bodies who represent them.

“We continue to monitor and review evidence as it becomes available and will take any appropriate action on that basis.”

Mr Tunbridge said he recognised the system “does need strengthening” and said new legislation on medical devices would take effect from May 2020.

This will include strengthening the requirements on manufacturers to ensure that sufficient clinical evidence is in place for their products.

The Royal College of Surgeons of England said: “Our duty is to explain the options and risks to patients, so they can decide what the best course of action is for them.”

It is campaigning to improve regulation and monitoring of new devices and implants.

A Department of Health and Social Care spokesperson said: “On the rare occasion where a patient has suffered as a result of a mesh procedure, we are taking steps to improve patient safety – including improving how we listen to patients and how the system learns when concerns are raised.”


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