News & numbers “Paradoxically, perhaps, a crisis that reveals the limits of globalisation can also help to
preserve it, or even foster it, as it encourages the diversification of supplies and markets.” Jean-Marc Siroën, PSL-Dauphine University
Regulatory change in the UK
The UK government has announced a consultation to gather perspectives on the regulation of medical devices, with a view for any amendments to come into force in July 2023. The consultation document written by the Medicines and Healthcare products Regulatory Agency (MHRA) sets out a list of proposed changes aimed to “develop a world-leading future regime for medical devices that prioritises patient safety while fostering innovation”. In the same month, the country is due to stop accepting CE-marked medical devices in Great Britain (England, Wales and Scotland) and will require the use of UKCA marking instead. Northern Ireland will continue to be governed by EU regulation, including the new MDR and IVDR rules.
“Our purpose is clear: to protect and improve patient health by enabling the earliest access to, and high-quality supply of, safe, effective and innovative medical
products through proportionate, data-driven assessment of risks and benefits,” the MHRA said in the executive document in the consultation. “Over recent years, patients and patient groups have emphasised the importance of patient safety, and the recent Independent Medicines and Medical Devices Safety Review… reinforces that maintaining this focus is paramount.”
Included in the consultation process, as well as a separate work programme released by the MHRA, was a call for perspectives on regulating Software as a Medical Device (SaMD) and AI as a Medical Device (AIaD) products. The regulator noted that the aim of this part of the consultation was to deliver “bold change” to the regulatory framework to protect patients and foster “responsible innovation” among creators of both product categories. The call for input from the industry will run until 25 November this year.
Manufacturing in space
The International Space Station (ISS) National Laboratory has unveiled a research announcement seeking proposals to demonstrate biomanufacturing activities in microgravity. Targeted fields such as tissue engineering and biomanufacturing provide use cases for how ISS National lab-sponsored research may lead to new biological products and tools that benefit humankind and drive a sustainable market in low Earth orbit. NASA made a similar announcement recently, offering funding to US businesses seeking to develop and demonstrate the manufacturing of advanced materials and other high-value products on the International Space Station (ISS). Microgravity can affect the physical properties of materials and fluids as well as biological systems, allowing for the creation of products that simply do not or cannot exist on earth. According to the ISS National Lab, the implications for both the discovery and manufacturing of
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health and technology products are significant, and have the potential to create a paradigm shift for a broad range of traditional industries here on Earth. While the ISS National Lab’s announcement was focused on biomanufacturing, NASA called for proposals in the fields of advanced materials, crystal production and thin film deposition – which encompasses semiconductors, graphene and artificial retinas. The research announcement from ISS National Lab will follow a two-step proposal submission process. Step one will involve interested investigators submitting a concept summary by 22 November 2021.
In step two, investigators with approved concepts will be invited to submit a full proposal by 14 February 2022. All final awards, conditions, and contractual agreements will be brokered by the Center for the Advancement of Science in Space, which manages the ISS National Lab.
$96.87bn
The size of the global in vitro diagnostics market in 2021, up from $80.43bn in 2020. Fortune Business Insights
Portable cancer diagnostic
Researchers at the University of Illinois Urbana-Champaign (UIUC) have designed a desk-sized instrument that can make the same measurements used in medical diagnostics. The goal of the device is so that a prostate cancer diagnosis can be made at the location in which samples are collected, rather than them having to be sent to a lab for analysis. For several years, the Cunningham group at the UIUC has been developing microscopes that use photonic crystal biosensors – nanostructured glass surfaces that brightly reflect only one wavelength of light.
“Although our original photonic
crystal microscope is very versatile, it’s the size of a ping pong table,” said Brian Cunningham, group director and the Intel Alumni Endowed Chair of Electrical and Computer Engineering at the UIUC. “We wanted to build a portable instrument that had the same detection capabilities. The new one we built can easily fit on a desk and costs around $7,000, compared to the non-portable microscope, which costs $200,000.”
The researchers had previously developed the larger photonic crystal microscope, so it could provide a strong contrast counting surface-attached gold nanoparticles, a feature the portable version also shares. “The photonic crystals act like a mirror, but only for the colour red,” said Cunningham. “The gold nanoparticles are non-reflective and show up as dark spots.” The microscopes can, therefore, be used to detect proteins or other biomarkers that are linked to the gold nanoparticles. The portable microscope was used to detect specific microRNAs (miRNA) associated with prostate cancer. But since almost every cancer has miRNAs associated with it, the microscope can, in theory, be used to detect different cancer types. The researchers are working to lower the microscope cost even further, hoping to use smartphone cameras to capture the images and bring it down to less than $100.
Medical Device Developments /
www.nsmedicaldevices.com
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