Connected devices.
Chronic disease is on the up. In the UK alone there are 3.2million people diagnosed with the condition, according to Diabetes UK. The organisation estimates that by 2025 there will be 5 million people with diabetes – that’s 17 people diagnosed every hour. Add to this diseases such as cardiovascular disease and hypertension, and their related risk factors including asthma, chronic pain, obesity and sleep apnea, and the problem becomes very real. As patients require increased monitoring, healthcare systems across the globe become stretched and we look to improve the patient experience, the drive to develop connected medical devices increases as does the market for wearable medical devices.
The glucose monitoring market is strong. In the UK the Freestyle Libre system has been designed to automatically measure glucose levels through a sensor and has been approved by the NHS. We have also had news of the Apple Dexcom partnership meaning that the Dexcom G5 mobile app now supports the Apple watch so users can see their glucose reading.
The opportunities in the connected device market are clear with big names such as Phillips-Medisize opening a manufacturing facility for these devices last year.
Distance health
Obviously we’re still talking connected devices here but this has become a term in its own right and one which Cleveland Clinic, led by Michael Roizin, drew our attention to a few months back.
“Due to an increase in connectivity through mobile technology and consumer demand, hospitals are getting ready for widespread adoption in 2018. 90 percent of healthcare executives reported to have or are currently building a telehealth program. Reports also predict seven million patient users in 2018, a 19-fold increase from 2013.
“These technologies are also expanding beyond the simple two-way video platform. More patients are now equipped with attachable devices that record and report medical information to doctors to monitor their condition. Over 19 million patients are projected to use these remote monitoring devices in 2018. With momentum building, the clinic believes that the emergence and acceleration of distance health technologies and services are assured in 2018.”
The market is strong and increasing. As the population across the globe lives longer, contracts more illnesses and healthcare problems, the need for technological to cope with demand in key.
Recycling
The recycling of plastics is big news in the UK at the moment. Of course, it’s an issue on a global level. We’ve been told there’s a good chance we’re swallowing plastics with every mouthful of water we drink - a recent survey, found that around 83% of our water supply is likely to contain plastic. It’s not good news.
Of course, making medical devices out of recyclable plastic isn’t simply the answer. We have issues of contamination to address putting this sector in a different camp to the juice carton and food packaging industries, for example.
So where does the medical plastics sector fit in? While it’s a niche market, the sector offers great potential and opportunity – figures suggest it’s global value will hit $33.6bn (£25.27) by 2025. Meanwhile the global plastic recycling market looks likely to hit $66.9bn (£50.30bn) also by 2025.
The medical plastics sector does have ‘single-use’ at its core. And with good reason. Given the applications for many medical plastic devices, and the risk that re-use would pose to health, the argument for throw-away products is clear.
But what is the industry doing to address issues of waste and how far is it going to develop new materials? Bioplastics are talked about general as a way to tackle the issues we have with biodegradability and plastic.
Polyhydroxyalkanoates (PHAs) are bioplastics used within the medical industry for applications including bandages to help with skin regeneration, surgical pins and stiches. They also have applications in orthopaedic devices and implants.
In an issue of MPN North America, Pyam Ramnes, outlines the plus points of bioplastics.
He says: “Plastics are fossil-based and suffer biodegradability. Bioplastics, however, are organic-based and biodegradable. These kind-to-the-environment materials are from resources like plants and animals which are far more sustainable resources than the fossil-based resources like oil and gas. As a result, the biodegradability of bioplastics combined with the sustainability of their resources, make them a great candidate in the medical field.
“Whether for artificial eyes or modern implants, several materials have been used in the medical field. But, a material that benignly disappears in the body would be a panacea. With the emergence of biodegradable and bio-absorbable polymers, temporary prostheses, tissue engineering, and drug delivery vehicles began to rise.”
Industry 4.0, robots & automation
Being hailed as the ‘fourth Industrial Revolution’, it’s pretty hard to ignore Industry 4.0.
Industry 4.0 will see industry and manufacturing moving towards increased digitisation, automation and integrated control systems, creating smart factories. It looks set to transform the manufacturing sector via use of the Internet of Things (IoT) and artificial intelligence (AI).
Some countries are gearing up for the manufacturing shift. In the medtech sector Ireland is preparing business for the change with the opening of the Irish Manufacturing Research, Ireland’s first Independent, industry driven, Research and Technology Organisation, creating 40 jobs. The centre specialises in advanced manufacturing technologies and the positions will be high tech research roles in the areas of Industry 4.0, collaborative robotics, industrial IoT, data analytics, additive manufacturing/3D printing, design thinking and knowledge management.
The centre’s aim is to carry out cutting edge research, development and innovation in collaboration with manufacturing companies to ensure industry in Ireland can become, and remain, world-class using in next generation manufacturing.
The move to embrace Industry 4.0 is becoming evident with companies such as B. Braun announcing its plans and the way that critical manufacturing will help it Medical Industries to future proof and prepare its manufacturing operations for Industry 4.0 using the latest technology.
Human factors
Human factors have been a key topic on MPN for some now. Companies such as Phillip-Medisize have been flying the flag for this concept, sharing knowledge and expertise with readers.
In the UK the MHRA recently published guidelines on for medical device manufacturers to take into account on this subject so their products are able to be used safely and effectively by any intended users.
Medical device manufacturers must consider how people interact with their products, what education and training the person has and what environment the product will be used in. MHRA states that the guidance looks at how ‘human factors can be applied to medical devices, so that they are designed and optimised for use by intended users, in the environment in which they are likely to be used, for safe and effective performance’.
Human factors considers aspects of the intended user population, including age, size, strength, cognitive ability and training. It also examines what other aspects might affect the use of the device including the intended environment and potential distractions such as lighting or urgency of use.
MHRA says that considerations into human factors for medical devices ‘are more pleasing to use, and are therefore likely to lead to better adherence to correct use’.
Sensor technology
From microdfluidics to the proliferation of connected devices, sensor technology has never been more important.
According to Allied Market Research (AMR), the global market of sensors is set to reach $241 billion in 2022. The key drivers are cited as the Internet of Things and wearables.
Harvard's Wyss Institute recently launched the human organ chip project to mimic human influenza infection and pathogenesis in vitro, and identify new drug leads that target host response factors.
The development of anti-influenza drugs has been limited by the fact that animal models do not accurately reflect the infection mechanisms influenza viruses engage in humans. The Wyss Institute's team will use lung small airway and alveolus chip devices lined by living human lung cells that they previously showed to reproduce normal lung physiology as well as diseases that affect these regions, including chronic obstructive pulmonary disease (COPD), asthma and pulmonary oedema.
The weird and the wonderful
MPN has covered a range of developments over the last year that sometimes seem to border on the absurd. Yet look closely and this work, carried out in research teams across the globe, will one day benefit the sector as well as improve healthcare across the globe.
For example take the Wolverine-inspired inspired transparent, self-healing, conductive material with a range of potential uses including powering artificial muscles, that’s come out of the University of California.
It's an ionic conductor, so a material that ions can flow through. Chao Wang, one of the scientists working on the project combined a polar, stretchable polymer with a mobile, high-ionic-strength salt to create this unusual material.
Wang admits to a life-long love of Wolverine, a comic book character who boasts the ability to self-heal. This mutant character with animal senses and an ability to regenerate, led Wang to develop a similar material.
The result is a soft low-cost, easy to produce rubber-like material that stretch 50 times its original length. When cut the material can heal itself at room temperature, in fact, the university says that within five minutes of this happening, it can be stretched to twice its original length.
Or how about the way that bacteria tests using smartphone screens may offer a breakthrough in medical device coatings? Conducting plastics found in smartphone screens can be used to trick the metabolism of pathogenic bacteria, report scientists at the Swedish Medical Nanoscience Center at Karolinska Institutet. By adding or removing electrons from the plastic surface, bacteria may be tricked into growing more or less. The method may find widespread use in preventing bacterial infections in hospitals or improve effectiveness in wastewater management.