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News & numbers


“The administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for Covid-19 vaccines.”


Katherine Tai, US trade representative Medical device industry faces global chip shortage


Medical device manufacturing is beginning to feel the effects of a severe global semiconductor shortage that has at least 169 industries competing for the chips that power modern electronics. Already, the automobile industry is undergoing arguably the most significant supply chain disruption in its history, with some projecting a total of 2.5 million ‘lost’ cars. Even the world’s largest chip producers, tech companies like Samsung and Apple, are having to delay product launches. According to research by Gartner,


Lighting up the brain


By shining lights on genetically targeted neurons in the brains of mice, engineers and neurobiologists at Northwestern University have programmed – and deprogrammed – their social interactions.


When mice were physically near one another in an enclosed environment, simultaneously activated sets of neurons in a brain region related to higher order executive function caused them to increase the frequency and duration of social interactions. Desynchronising the stimulation decreased them. In a group setting, researchers were able to bias an arbitrarily chosen pair to interact more than others. The use of 0.5mm-thick wireless optogenetics implants meant that the mice were free to move normally and looked no different from their peers.


the dearth will continue into the second quarter of 2022. The company recommends OEMs mitigate the impact of shortages by extending supply chain visibility ‘to the silicon level’. Partnering with similar companies to gain leverage in negotiations with chip foundries and ‘pre-investing’ in commoditised parts of the supply chain for longer term security are also options for securing supply. Equally, diversifying the supplier base will help reduce the risk of stock-outs, and developing tighter strategic relationships with distributors, resellers and


traders can help OEMs find small volumes of components urgently.


“Since the current chip shortage is a dynamic situation, it is essential to understand how it changes on a continuous basis,” added Gaurav Gupta, research vice-president at Gartner. “Tracking leading indicators, such as capital investments, inventory index and semiconductor industry revenue growth projections as an early indicator of inventory situations, can help organisations stay updated on the issue and see how the overall industry is growing.”


Are you ready for MDR?


The implementation deadline for the EU’s new Medical Device Regulation finally passed on 26 May 2021, after a year’s delay for Covid-19. The extra time hasn’t necessarily helped the industry adapt. A survey of 115 medical device industry players by Munich-based software company Climedo Health between March and April 2021 found that 81% consider MDR to be “very challenging”, up from 77% in 2020. Moreover, 43% stated outright that the MDR delay has not made their daily work easier, while 32% saw “no benefits at all” to the new regulatory framework. The top challenges cited in the survey still


Sensors soon to be everywhere


With the launch of its first smart knee implant approaching, Zimmer Biomet plans to turn patients’ joints into IoT nodes. “It’s going to be for hip, it’s going to be for shoulder, there’s going to be a whole pipeline of technologies,” CEO Brian Hanson told investors during the company’s Q1 earnings call. To do so, ZB has secured a long-term partnership with Canary Medical, while Stryker recently acquired OrthoSensor. Both are looking to combine sensor technology with data analytics to quantify orthopaedics and improve robotic surgery.


The orthopaedics sector was among those most affected by the pandemic, pushing


10


companies to take innovative approaches to strengthen their positions and portfolios. Analytics company GlobalData estimates that the market lost over $4.8bn in revenue and decreased in size by around 10%. “The Covid-19 pandemic not only sped up the integration of data collection into the orthopaedic market, but also provided an opportunity to gather valuable data during an unprecedented time,” said Kamilla Kan, medical analyst at GlobalData. “With more companies starting to implement new technologies and tools, the medical device market will see a surge of investment and opportunities in the coming years.”


include “increased resources and costs” (70%), “lack of clarity” (59%), and “required clinical investigations” (54%). Almost a third of companies estimate that MDR will cause additional costs of between 5% and 10% of their annual revenue, with 13% even suggesting the extra expense will exceed 10%. More positively, 72% of respondents had an MDR-certified notified body, up from 52% a year prior. From here, 75% would like to see “clear guidelines” from the EU Commission, 50% would like to see more “professional support” and 39% would like to see more “training or informative events”.


44.9%


Average proportion of consultations US doctors want to conduct virtually after the pandemic. Only 13.9% of visits were virtual before Covid-19. Journal of Medical Information Research


$6.5bn


WHO’s estimate of the money needed to address the global oxygen shortage in May 2021, up from $1.6bn in February. New York Times


Medical Device Developments / www.nsmedicaldevices.com


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