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MEDTECH UPDATE

www.polyone.com PolyOne develops alternative TPE to silicone

PolyOne, a global polymer material provider, has developed an alternative ThermoPlastic Elastomer (TPE) to silicone.

There was a real need for an alternative following the FDA’s reports of siloxane shortages - a key ingredient in silicone. Additionally, the news regarding the closure of ethylene oxide facilities was resulting in longer lead times and higher prices for medical tubing. In response, PolyOne launched its Versaflex HC BT218 at MD&M West earlier this year. The company claims the material is able to deliver the critical demands for biopharmaceutical tubing applications, including weldability, kink resistance and tensile strength performance to the same standard as silicone and other TPEs.

Jim Mattey, global marketing director, specialty engineered materials commented: “We’re excited to add the new Versaflex grade to our expanding set of solutions that enable customers to continue pursuing product innovation and meet market demands.” He added: “We are committed to leveraging our material science expertise to formulate alternative and customised solutions that meet regulatory demands and functional necessity for life-saving medical devices, especially in the face of market uncertainties.” The material is currently available in the United States and has been submitted for USP class VI and ISO 10993-4,5 certifications.

www.skyrora.com plastic POWER S kyora, a rocket launch start-up based in Edinburgh, UK, has successfully tested a 3D-printed rocket engine using power from plastic waste.

“Ecosene” is the name given to this new type of fuel which the company claims is making its vehicles greener and more ecologically sound than competition.

Skyora says it can create around 600kg of kerosene from 1000kg of plastic waste, whilst also stating that its fuel results in around 45% less greenhouse gas emissions. A key benefit of Ecosene is that it can be stored in tanks for long periods of time as it doesn’t require cryogenic freezing.

Volodymyr Levykin, CEO of Skyrora said the fuel had transformative potential for the entire space sector.

The company believes the results are encouraging with its first vehicles set to fly in 2022 from the UK based launch site. WWW.SKYRORA.COM

REGULATORY UPDATE

NSAI NAMED AS A NOTIFIED BODY N ational Standards Authority of Ireland (NSAI) was awarded Notified Body (NB) status under the new EU Medical Device Regulation (MDR) which comes into effect on 26th May 2020. The new regulation consists of stringent requirements around devices, clinical data and post-market surveillance. than anticipated. For example, the NSAI applied in November 2017 (over two years ago). A shortage of NBs could result in a large number of devices not being re-certified in time, and therefore possible shortages. ec.europa.eu

As part of its role as a NB, the NSAI is now able to inspect medical devices and other products for safety and compliance. Having a NB within Ireland means that multinationals and local businesses will be able to have their devices checked in Ireland.

Currently there are only ten other NBs. This is thought to be because all NBs require approval by European officials. A delay by the European Commission has meant there are much fewer NBs at this stage

Global packaging company Amcor has partnered with the Healthcare Plastics Recycling Council (HPRC) in an attempt to ensure more sustainable practices and innovation across the healthcare industry.

The HPRC is a coalition of industry peers across healthcare, recycling and waste management, who are seeking to improve recyclability of plastic products within healthcare.

“The healthcare industry poses a unique recycling opportunity,” according to David Clark, vice president sustainability, Amcor. “Amcor has global experience in developing more easily recyclable packaging, and we share HPRC’s vision of improving recycling rates of healthcare plastics.”

In January 2018, Amcor reportedly became the first global packaging company pledging to develop all its packaging to be recyclable or reusable by 2025. Peylina Chu, executive director of HPRC commented: “As a packaging leader, Amcor is highly focused on creating a circular economy as shown in their 2025 pledge. With their technical expertise and their commitment to developing responsible packaging in collaboration with likeminded partners, Amcor is a fantastic addition to HPRC.” Company promises recyclable and reusable packaging by 2025 www.amcor.com and www.hprc.org

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MEDTECH UPDATE

www.gehealthcare.com

New technology offers better protection for hospitals against cybersecurity threats

The new system launched by GE Healthcare, a manufacturer and distributor, aims to help hospitals monitor and mitigate cybersecurity threats. The technology, called Skeye, brings together medical device expertise, artificial intelligence and process management tools to enable hospitals to detect, analyse and respond to cybersecurity threats in real time. Skeye will provide customers with a complete medical device security assessment. This will include identifying potential risks and vulnerabilities, as well as recommending action plans. Matt Silva, chief information security officer, GE Healthcare believes, “this new offering provides customers with 360˚ threat visibility and a resolution roadmap to help defend and protect against vulnerabilities.” He added: “We strongly believe that security is a shared responsibility across various stakeholders,

and with this new solution, hospitals will now have access to a range of proactive and reactive

cybersecurity services to support their own security programs.” DIGITAL SPYDIGITAL SPY

talking POINT

Chen Gu Lab, UCLA ©

www.nature.com/natbiomedeng

Could this technology revolutionise the patient experience for diabetes management?

WHAT IS THE MEDICAL DEVICE? The adhesive patch is able to monitor the blood sugar level of the person and deliver insulin dosages based on this level. It is designed to be used once-a-day.

HOW DOES THIS MECHANISM WORK? Within the device there are micro-needles which are less than 1mm long and made from a glucose-sensing polymer. These microneedles are pre-loaded with insulin. The amount of insulin which is released depends on the person’s blood sugar levels.

WHAT ARE THE BENEFITS OF USING THE PATCH TO MONITOR BLOOD SUGAR LEVELS? Besides from the convenience of this method of insulin delivery for people, the device aims to prevent the chance of an insulin overdose.

HOW WAS THE PATCH DEVELOPED? The technology was developed by researchers at the University of California Los Angeles (UCLA), the University of North Carolina School of Medicine and Massachusetts Institute of Technology. The research has been published in the journal Nature Biomedical Engineering.

IS THE PATCH READY FOR USE IN THE REAL WORLD? Not quite. Following successful testing on animals, the researchers have applied for FDA approval to conduct clinical trials in humans, which they anticipate to begin within a few years.

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