Medical Device Industry Update September 2022  

Augmented Reality in Healthcare – Is Metaverse-based Training on the Horizon?  

In October 2021, Facebook’s Mark Zuckerberg announced that the company would be changing its name to ‘Meta’ and along with this announcement, described a future based around the metaverse. The metaverse is a digital universe that uses elements of virtual reality (VR) and augmented reality (AR) to create a more immersive virtual environment. 

Right now, this may all seem like the stuff of fiction or the next evolution of gaming. However, the metaverse is set to disrupt several industries in the coming years including retail, financial services and manufacturing. It could also have a huge impact on healthcare. 

According to an article published on the Medical Device Network in August, the way students undertake training could be about to change. When it comes to medical training, students are expected to gain familiarity and hands-on practice with actual bodies. Up until now, this mainly involved dissecting cadavers which is expensive for medical institutions and a rather unnatural experience for students. Further down the line, training surgeons must learn by doing — treating actual living people and taking on all the inherent risks that brings.  
There is another way of gaining experience. Following the example of the aviation industry, medical institutions have been moving towards simulation-based training. And this is where the metaverse comes in. 

“We have noticed that medical residents who want to specialize in interventional cardiology don’t have many opportunities to get hands-on experience,” says Dr Ioannis Skalidis, of the department of cardiology at Lausanne University Hospital in Switzerland. “In the metaverse, a lot of people at the same time can participate in operations and familiarize themselves with being the first operator.”  

While it is still early days investment is on the rise. GlobalData expects the AR and VR market to rise from $11bn in 2020 to $204bn by 2030. While there’s lots of different takes on the metaverse and what it’ll mean for society, there is no doubt that it is an intriguing space with some fascinating prospects for our future.

To learn more, check out this blog post 

Medical Device Regulation – Bureau Veritas Italia becomes the latest notified body to be designated under the EU’s Medical Device Regulation 

On August 2nd, Bureau Veritas Italia became the 32nd notified body in the EU and the 8th in Italy. A notified body is an organization designated by an EU country to assess the conformity of certain products before being placed on the market.

Notified bodies are responsible for assessing medical devices (MDs) and diagnostics (IVDs). These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation when the intervention of a third party is required. They are an indispensable part of the regulatory system since they grant a CE mark to each device before it can be placed in the EU market.

The EU now has the following distribution of MDR notified bodies: Germany 8, Italy 8, the Netherlands 3, Finland 2, and one apiece in Belgium, Croatia, France, Hungary, Ireland, Norway, Poland, Slovakia, Slovenia, Spain and Sweden. 

While this is welcome news, the consensus throughout the industry is that many more notified bodies are needed to help manage the growing demand. To learn more about the EU’s Medical Device Regulation and Europe’s regulatory landscape, check out this post from our blog  

Medical Devices – UK Government calls for investigation into discrimination and bias in medical devices 

The government in the UK has launched a call for evidence, open until October 6th 2022, to discover if and how medical devices and technologies may be discriminatory. In an Independent Review on Equity in Medical Devices, led by Prof. Dame Margaret Whitehead, the government is aiming to tackle healthcare inequalities. It is doing this by collecting evidence on how medical devices and technologies may be biased against patients of different ethnicities, genders and other socio-demographic groups.  

An example of this kind of bias might be devices employing infrared light or imaging that does not work well on patients with darker skin. In these cases, devices aren’t being tested on a variety of skin tones and medical devices are being marketed that work ineffectively on people of a certain race. This investigation is being performed to tackle disparities in healthcare. The review will cover various types of medical devices. 

When speaking on this, Professor Whitehead stated that: “We aim to establish where and how potential ethnic and other unfair biases may arise in the design and use of medical devices, and what can be done to make improvements. We especially encourage health, technology and industry experts and researchers to share their views and any evidence concerning medical devices in order to help us tackle inequalities in healthcare.”

Gillian Keegan, Minister of State for Care at the Department of Health and Social Care had the following to say about the review: “I am committed to ensuring all patients receive high-quality, innovative healthcare without discrimination. The independent review is part of our vital work to tackle healthcare inequalities, and I invite the industry to share their expertise in the call for evidence so we can ensure medical devices are free of any form of bias.”  

As mentioned above the call for evidence will be open until October 6th 2022. The independent review board is hoping to hear from those who work most closely with medical devices. Academics, researchers, health professionals, engineers and device developers, as well as patients and the general public, are being invited to contribute. More information on this review can be found here. 

Cybersecurity in Healthcare – Over 22 million US health records breached so far in 2022 

A recent report by GlobalData Healthcare titled ‘Cybersecurity in Healthcare 2022’ has underscored how the healthcare sector continues to be overwhelmed by cybersecurity breaches. Over 41 million individuals in the US alone were affected by healthcare data breaches in 2021. This is according to reports of breaches affecting 500 individuals or more by the US Department of Health and Human Services (HHS) Office of Civil Rights. 

So far in 2022, cases affecting more than 22.5 million individuals in the US are under investigation. This represents an increase of 4.6% compared to the same time last year. The HHS reports the largest breach for 2022 so far was the network server breach at Shields Health Care Group, affecting as many as two million individuals and involving personal information, home and billing addresses, diagnoses, and other medical or treatment information.

In a recent article, published on our blog, we referenced this report and outlined one of the key ways in which government bodies are trying to strengthen medical device software supply chains.  

Read more here. 

Finally, some upcoming medical device events 

Below are some upcoming events in the medical device events calendar:

1/ LSI Emerging Medtech Summit Europe 2022 – London, UK Sep 21-24  

This event brings together the most innovative MedTech start-ups, active investors, and strategic buyers to discuss the future of medical technology. Three full days of connecting with industry leaders and hearing from the most exciting new companies in the industry.  

2/ Medical Technology Ireland Expo and Conference – Galway, Ireland Sep 21-22 

Showcasing innovative medical technology products and solutions for the Irish medical device manufacturing industry. Ireland’s premier medical device design and manufacturing conference. 

3/ BIOMEDevice Boston – Boston, MA Sep 28-29 

BIOMEDevice Boston brings engineers, business leaders, disruptive companies, and innovative thinkers from the region’s top start-ups and medical device OEMs together to inspire the next life-changing medical device.

4/ American Medical Device Summit – Chicago, IL, Oct 18-19 

Setting the standard on how the industry should connect and exchange ideas, the American Medical Device Summit provides insights and strategies to enhance the professional development of executives involved in the design, product development, innovation, technology and quality/ regulatory aspects of medical devices. 

5/ The MedTech Conference – Boston, MA Oct 24-26 

The MedTech Conference will bring together the world’s top MedTech executives and innovators for three days of programs, networking and business development opportunities. 

That’s all from this month’s Nova Leah Industry Update.

Check out our blog for more news and updates related to the medical device industry