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Author Bio: MedTech Europe is an Alliance of European medical technology industry associations. The Alliance was founded by EDMA, representing the European in vitro diagnostic industry, and Eucomed, representing the European medical devices industry.

Articles by MedTech Europe

When design meets medtech: Three ideas in preventing and managing pressure ulcers

Posted by MedTech Europe on 02/04/14

The work we do at the Helen Hamlyn Centre for Design at the Royal College of Art in London focuses on developing projects with a strong emphasis on identifying and understanding everyday situations that people have difficulty with. Our approach is inclusive: we work with many ‘users’ of a product, service or system in order to develop design solutions for and with them.

Ultimately what we aim for is to create something that will improve lives in a small or big way.

Roughly a third of our work is dedicated to addressing current and future healthcare challenges by collaborating closely with patients, clinicians and industry. In this particular project, we partnered with ArjoHuntleigh (a company specialized in patient handling and care) and set out to look at the bedsore issue from a people centred design perspective, aiming to define a new approach to managing and preventing pressure ulcers outside of hospital care. Finding a solution to bedsores requires a deep understanding of the complexities of community healthcare delivery and a creative approach to problem solving, two areas where designers have a lot to offer.

Putting bedsores under pressure

Pressure ulcers, also known as bedsores, normally develop when an area of the body is under pressure for a relatively long time, and are usually an avoidable side-effect of poor patient care. While healthy people adjust their position when the body feels sore, patients in many cases are not capable to do so (they may not feel the pressure or won’t be able to shift position).

About 1 in 5 patients in hospital are at risk of developing pressure ulcers, adding to 320,000 new wounds annually (Bennett, G., et. al, 2004. The cost of pressure ulcers in the UK. Age and Ageing, 33(3), p.230-235.). Outside hospitals however, the numbers are much harder to calculate but there is evidence to suggest that there are more people suffering from pressure sores in care homes, their own homes and on long-term care than in hospital environments.

The creative process

Consulting with experts in the field and reviewing existing pressure redistributing technologies provided a baseline. To help define the problem, we employed a series of research methods including interviews, observations, role-playing exercises and workshops with experts, involving patients wherever possible.

Great insights on standards of care came by observing how nurses at the Royal Hospital for Neurodisability and the Wound Healing Centres in Eastbourne cared for patients. We discovered that the main barrier to achieving hospital levels of care at home lies simply in staff availability to perform key tasks at the right time. While it is a routine task for nurses to carry out activities such as changing, washing, feeding, or repositioning patients, doing this with the same consistency at home can become a logistical ordeal for care providers.

The next step was to conceptualise possible solutions around the challenges identified. A large number of ideas were sketched out or mocked-up and presented back to our expert contacts to get their feedback. We had to look into details, such as, material to be used on beds taking into account low mobility levels, logistical issues of caretakers, and ease of product use. After a few rounds of iterations and refinement three propositions were chosen for proof-of-concept development.

The solutions

Sensors to help scheduling – The first idea taken forward seeks to address the problem of ensuring a repositioning schedule. The prototype created helps carers determine patients’ positions and the time spent in each position. It also determines the pressure levels on different parts of the body by placing inexpensive sensors on the patient’s mattress.

The dashboard – The data collected by the “sensing surface” described above can also include the measurement of other vital signs and can be linked to a digital patient dashboard. Factors such as continence and position would be logged and alert carers when a patient is in need. This would also help in allocating human resources more efficiently by creating better patient routes for caretakers.

Cushioning – Thirdly, we developed a solution that helps mitigate pressure ulcers on patients suffering from spasticity and involuntary muscular contractures. Pressure is created when a patient is ‘curled up’ and the limbs force pressure on each other. This is a common problem especially among elderly patients suffering from dementia as well as in spinal injury patients of all ages. Our proposal is a small inflatable cushion with air chambers that can be inserted between the person’s limbs and alternate pressure in the chambers with the help of a connecting pump.

The three concepts outlined above are a result of in-depth user research into the practical issues surrounding care for patients with pressure ulcers in the community. Even though they are still in an early phase of development, end users believe it could show much potential in improving pressure ulcer management in the community.

- Gianpaolo Fusari, Senior Research Associate, Helen Hamlyn Centre for Design

(Photo credit: Jonathan West and Gianpaolo Fusari)

 

MedTech will not be wiped out by Apples or Googles – but here’s something to think about

Posted by MedTech Europe on 27/03/14

“Nihil novi sub sole” said the Vulgate. That could not be farther from reality when it comes to the MedTech Europe blog. And I am privileged to be the first author to “lay pen to paper” and contribute to MedTech Views, an initiative by MedTech Europe to establish a true platform for dialogue about medical technologies. No priority is given to any one healthcare stakeholder, and everyone has the opportunity to submit their view as we strive to have an open exchange of opinions on the new platform.

So if you have not yet subscribed to the MedTech Views mailing list, you can do so here. And subscribe your colleagues too to make sure they never miss a story.

The last story on our previous blog was a contribution by Dr. Sameer Bansilal who put the whole hype around Apple venturing into the realm of cardiac arrest prediction into perspective. That view could not have been more timely. While e-health and m-health have been a hot topic within our industry for decades, it seems like the last few months are really seeing a splurge of news, rumours and analyst predictions become front-page news.

Last year, everyone was raving about the Scanadu Scout, a sophisticated device packed with sensors that can measure not only your blood pressure and heart rate, but also your blood-hemoglobin levels, heart rate variability and urine composition, among other parameters. Or more recently, Nintendo’s investor call of last month was all about how Nintendo plans to make a foray into healthcare. 3 weeks ago, the media were abuzz with Google’s high-tech contact lens, and less than a week later, the rumour mill on Apple’s iPhone 6 being all about health tracking and quantified self, gathered steam. This was in the blogs of the Wall Street Journal and New York Times, not a geeky gadget website.

I did not read anything much about the medtech industry and how we can bring value with our e-health technologies.

And e-health has a lot to offer. To patients, making them more interested, more engaged and more empowered to manage their own health. To physicians, by making parts of their work more convenient and efficient. To healthcare budgets, by limiting rising healthcare expenditure (for practical examples, I recommend this infographic). And to society at large, by allowing people to return to an active lifestyle faster.

So knowing the value these technologies bring and knowing the environment we currently find ourselves in (patients and healthcare professionals growing up with digital solutions), I find it surprising not to see more activity from our end in this area.

Because while everybody is talking about Apple developing a heart monitor (apparently not going to happen, according to Forbes), Google’s intelligent contact lens (supposedly still years away) or Samsung’s foray into wearables and sensors (poor battery life, limited usability and too little interest from consumers, says The Verge), the real competition will, I believe, be coming from inventors and small companies within the medtech arena.

For example Given Imaging’s “pill camera” that has the potential to change the paradigm of laparoscopic surgery.

In the same vein, an “ingestible drug-delivery pill” currently in pre-clinical studies, would allow for drugs to be delivered inside the body with razor-sharp precision.

In short, I would agree with Dr. Bansilal who blogged a few weeks ago about how Apple is not anywhere near releasing a device that can “listen” to blood flow and predict heart attacks, despite what media are saying. It takes decades of experience and testing. It is not something that can simply be manufactured for the mass market in a few years’ time. And as such, I think the impact of consumer-oriented ICT-companies (Information and Communication Technology) on extremely sophisticated medical technologies will be limited for the foreseeable future.

Where the Apples, Googles and Microsofts of this world will be having a huge impact on healthcare and medical technology, is in their ability to write excellent software.

Being able to write an excellent app, robust firmware and secure, reliable code is quite straight-forward. Producing or obtaining the hardware to run that software is a relatively simple process too. Microsoft has shown it with Windows, which runs okay on both middle-of-the-road and high-end hardware. It does not work that easily the other way around, however.

Great hardware that runs on less than great software is like cooking in an amazing kitchen with bad ingredients: the end result will disappoint and leave you unsatisfied.

Apple saw it in the 90s, and it’s the reason why they control the entire experience pathway: they produce both their software and the hardware that runs it, and in doing so provide a superior experience to their customers. Microsoft is essentially doing the same thing with its purchase of Nokia. Pure hardware manufacturers are struggling… Where does medtech stand currently?

To place all this in perspective, our industry has decades of experience that ICT-companies often lack in this field. After the initial buzz of Google’s contact lens announcement, it became clear they are looking for partners from the medtech industry to actually turn their prototype into a viable, mass-market device. Additionally, sometimes only a few changes to our current offerings can bring about considerable benefits for our consumers, be they patients, healthcare professionals or payers.

I’m thinking for instance about making various devices talk to each other (remember Bastian Hauck’s talk at our 2012 MedTech Forum). Why does his Continuous Glucose Monitor (CGM) not talk to his iPhone, and why does his blood-glucose meter not talk to his CGM?

Luckily, we can learn from other industries such as the car and aviation industry. They had to undergo a similar evolution where hardware and software had to play together more nicely while still offering optimal security, safety and a high level of convenience.

So in the end, it’s great to see that several companies are already expanding into and claiming their place in the e-health arena. If we want to remain tier-1 players and ensure that our e-health solutions bring value to patients, the economy and society at large, we should perhaps become a bit more …, and a little less…

For some interesting reads on the topic, have a look at the following stories:

Serge

- Serge Bernasconi, Chief Executive Officer MedTech Europe, EDMA & Eucomed

iWatch: Not so fast Apple

Posted by MedTech Europe on 12/03/14

The lure of wearable technology and its application to health is tremendous- so tremendous that even the richest company on the planet-Apple, can’t resist it apparently. And so goes the recent insider news that has captured the attention of people worldwide “Apple is developing software and sensors that can predict heart attacks”. Not so fast Apple, not so fast….

As a cardiologist dealing in prevention and clinical research for the better part of the last decade, I will acknowledge that the concept of acoustic devices for measuring flow is not new (ultrasound imaging of the carotid arteries, aorta, peripheral arteries). The coronary artery is however a low pressure flow zone with intervening soft tissue, muscle and the rib cage. Also, it is critical to remember that not all severe blockages cause heart attacks, and many, so-called mild blockages can progress quickly to causing a heart attack from various mechanisms. Scientists have spent the last three decades attempting to identify the holy grail of heart attack prevention, the “vulnerable plaque”, with limited success.

The last few years have seen non-traditional big data players make forays into the healthcare segment. Google with its Google glass and extended applications such as Google helpout, IBM partnering with academic centers and insurance companies to leverage big data and Apple attempting to redefine mobile health monitoring with an A team of fashion designers, medical sensor gurus, sleep researchers, exercise physiologists, and fitness experts working on smart wearables.

I am by no means a pessimist or one to shy away from cutting-edge technology. I use the Alivecor on my phone for EKG screening as appropriate to provide information regarding cardiac rhythm, I encourage our trainees to use handheld echocardiographic devices to supplement their stethoscopes, and many such applications of modern technology to ‘assist’ the practice of good medicine. I might even get the Samsung S5 with its built –in heart rate monitor. I would love for wearable technology such as the iwatch or something similar on the wrist to magically predict heart attacks. Only, I find it hard to make the leap from surrogate information such as heart rate and peripheral resistance, captured from the wrist, to thrombotic occlusion of a coronary artery in the chest! The closest I have seen any technology come to this issue is the CADence device from AUM cardiovascular, which is currently undergoing clinical studies. My worry is that these devices will only swell the ranks of the worried well, increase unnecessary million dollar work ups, lead to unnecessary procedures and add cost to an already overburdened healthcare system.

And finally, a plug for my ilk. Technology has its place and pushes human limits. In medicine however, I firmly believe that it will never be able to fully replace the role played by a flesh-and bones doctor, with years of accumulated experience and judgment, and patients will never cease to want the ‘human touch’ element. That to me is half the battle in managing disease and prevention. 

-Dr Sameer Bansilal, Assistant Professor of Medicine at the Icahn School of Medicine at Mount Sinai and an Attending Physician in the Mount Sinai Cardiovascular Institute.

Improving access to medical technologies for diabetes care in Europe

Posted by MedTech Europe on 05/03/14

Access to quality healthcare and medical technologies has risen to the top of the international health agenda. In this regard, diabetes is a particular challenge as good management relies on continuous access to both medicines and medical devices. In its latest study, IDF Europe found that hundreds of thousands of people living with diabetes in Europe do not have access to the treatment they need, putting their health at risk. More particularly, the study identified several issues in terms of access to medical technologies used in diabetes treatment, ranging from lack of information to supply and affordability issues.

The information gap

Collecting information on access to medical technologies for diabetes treatment remains a clear challenge.  Publicly available information and research on access to pharmaceuticals is extensive. On the contrary, information on access to portable medical devices such as those used by people with diabetes is very limited: with few public databases or registers, few available reports and information scattered across a wide range of stakeholders. This directly impacts stakeholders’ understanding of the situation – making it harder to identify bottlenecks and advocate for change. Improving people with diabetes’ access to the technologies they need to treat their condition cannot happen without a clear assessment and understanding of where we stand now.  We therefore call on the actors of the medical technology field to share more information on the availability, accessibility and affordability of medical technologies.

The availability gap

While some European countries, are already discussing the latest technologies in diabetes treatment (such as Continuous Glucose Monitoring or the artificial pancreas), others still struggle to make existing technology available to people with diabetes: for example, re-usable insulin pens were only introduced on the Albanian market very recently while the actual presence of insulin pumps on several markets both within and outside the EU could not be confirmed. The causes behind this gap are many, ranging from marketing strategies to registration policies and prescription guidelines.  It is public and private stakeholders’ shared responsibility to work together to address this issue. Closing the availability gap should be as high on the agenda as inventing new products.

The education gap

As new technologies are becoming available and part of diabetes care is being transferred to actors including primary care professionals or families, the need for education is becoming more apparent. Access to available technologies and their potential in improving diabetes self-management are hindered by the lack of training or education of healthcare professionals, people with diabetes and their relatives. Gaps and inequalities in access to education for people with diabetes and their families remain a challenge throughout the Region. In a number of Eastern European countries, the transfer of certain responsibilities to General Practitioners in diabetes care has not come with associated training or resources. The lack of adequate training on insulin pump therapy was directly identified as a barrier to the spread of this technology in the UK and Denmark  Access to structured education on medical technologies for all the stakeholders involved in diabetes care is essential for proper diabetes management.

Patching supply

Even occasional disruptions in supply add to the burden of caring for diabetes, especially for healthcare professionals. Such disruptions affect both medicines and medical devices in at least half of the countries in the Region. The causes of such disruptions vary and involve all the actors of the supply chain, from regulators and manufacturers to suppliers and payers. Only improved cooperation between these actors can help ensure uninterrupted supply of diabetes products.

The spending paradigm

The cost of diabetes treatment requires public support to allow people to obtain the products they need to treat their condition. However, in times of financial hardship, cost containment has become a priority for governments which can no longer offer the health coverage they used to. Throughout the Region, newer medical technologies are the firsts to be affected by this situation. If carefully carried out, cost containment does not have to result in making people with diabetes pay more to access the medical technologies they need, which may create affordability issues. Other strategies to control public spending exist. Unfortunately, the capacity to conduct the required assessments is uneven and tends to be much less developed for medical devices than for pharmaceuticals.

This has implications for all actors in the health sector, starting with the industry. In the current environment, price control is unavoidable and essential to ensure that medical products are affordable to both people with diabetes and health systems. The current innovation and production models need to be adapted to this reality. In addition, to ensure limited health budgets are spent wisely, there is a need for reliable information on the comparative value of devices for the different groups to be produced. This “value” assessment should not only include economic factors but also quality-of-life gains in the long term. Each person with diabetes would then be offered the affordable solution that is the most appropriate for their condition, while making public spending more strategic.

Inadequate access to medicines and medical technologies has dire consequences for people with diabetes and health care systems, which are faced with spiralling costs. Poorly managed diabetes leads to serious and costly health complications -including blindness, stroke, kidney failure and amputations. With adequate treatment, people with diabetes can manage their condition properly and lead long, healthy and productive lives.

Urgent coordinated action from both public and private stakeholders is needed to reverse Europe’s diabetes epidemic and ensure access to medicines and medical technologies for all people living with diabetes in the region. 

- Elodie Besnier, Researcher for the IDF Europe study on Access to Quality Medicines and Medical Devices for Diabetes Care in Europe

Rare Diseases: Anything but rare

Posted by MedTech Europe on 28/02/14

In linguistics, describing a word as a false friend implies that despite similarity in spelling or pronunciation, it actually has distinct – sometimes even contradictory – meanings in different languages. Describing rare diseases as ‘rare’ creates a similarly false association, one which implies they have a limited impact and scarcely occur. Drawing such a parallel does not reflect the reality for the approximately 30 million European citizens who have received a rare disease diagnosis. For them, a rare disease is anything but rare. Instead, it is an often long and terrifying crossing into largely unchartered waters that are characterised by a lack of information, specialists’ know-how and effective treatment. 

Navigating the often lengthy diagnosis process is already an ordeal, but it is what comes next that can be especially debilitating, particularly when patients find that there are limited options in regard to therapies. The European Organisation for Rare Diseases (EURODIS) joins together patient groups to bring their voice to the European level, drawing attention to the 6-8% of the European population who fall into the category of rare disease patients. Yet, while creating a community for those who are directly impacted by an illness and bringing their perspective forward at the EU level is empowering, it needs support from wider society to truly improve the day-to-day life for patients. 

Likewise, the research and recognition brought forward by the International Rare Diseases Research Consortium (IRDiRC), European Union Committee of Experts on Rare Diseases (EUCERD) or the database of rare diseases and orphan drugs ORHPHANET has made important strides toward achieving a better status quo for European rare disease patients. However, academia and researchers, patients, industry experts, the medical community and policymakers cannot continue to work in silos with only occasional cross-sector discussion and exchange. Such a method of attempting to achieve what is essentially a shared goal, emphasises the societal perception that rare diseases exist on the outskirts of public health and are ‘not my problem’.  

The reality is that rare diseases are every European citizen’s problem. A single rare disease can affect as many as 245,000 people, slowly and progressively changing each of their lives as well as the lives of those around them. To truly bring the problems faced by these patients to the figurative home, more collaborative multi-stakeholder work must be undertaken. No single group has all of the answers, but each has their area of expertise or unique perspective that could be used to make strides forward in care. In fact, it is already clear that some of the very problems that lead to delays in diagnosis and treatment – relatively common symptoms across diseases and genetic triggers for as many as 80% of the 7,000 known rare diseases – also carry potential for transforming what a rare disease diagnosis means…provided that communication and data exchange between groups is enhanced. For instance, while each rare disease may have unique characteristics and specific make-up, many have similar baseline genetic composition, which can help to narrow the scope of diagnosis and develop treatment faster. As research in the field expands, diagnosis and treatment will also become more accurate.

In the meantime and alongside an emphasis on rare disease research and development of innovative diagnostic tools, multi-stakeholder initiatives are needed. Based on this, the Commission Expert Group on Rare Diseases, which will bring together experts from academia, scientific societies, patient representatives, industry representatives and individual experts from the field of public health, seems to be a step in this direction. It is now up to the members, of which EDMA is one, to ensure that the step is not the end of the journey, but rather a conscious and deliberate joint endeavour to increase public understanding of rare diseases and clarify misconceptions. 

It is high time for European society across all levels to understand that though unusual in their nature, rare diseases are not as few and far between as some may be misled to believe based on their name alone. 

- Magda Kalata, EDMA, Public Affairs Officer

The MedTech Europe blog rss

A blog on trends, issues, opinions and views about the medical technology industry. It is a collection of former Eucomed blogposts and brand new MedTech Europe ones. more.



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