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Experts at AdvaMed’s MedTech conference probe future of IVD
IVD innovation can revolutionise disease detection, monitoring and management, enabling earlier diagnoses and improved patient outcomes.
Healthcare demand has shifted to patients wanting full awareness of their healthcare status, and telemedicine. Credit: gopixa / Shutterstock
Innovation is afoot in the field of in vitro diagnostics (IVD), driving a transformative shift in healthcare and propelled by advances in medtech. These innovations are revolutionising how diseases are detected, monitored and managed, leading to earlier diagnosis, personalised treatments and improved patient outcomes. Key topics include digital and AI integration, point-of-care (POC) testing and novel biomarkers, all of which are improving the precision and accessibility of medical care.
Attendees and speakers at AdvaMed’s MedTech Conference in Toronto, held from 15 October to 17 October 2024, stressed the importance of using data to inform research and development, and to improve the efficiency of medical devices. For example, Jennifer Schneiders PhD, president of diagnostic solutions at Hologic, mentioned that the decreasing number of cytologists in cytotechnology is an important factor in driving Hologic to create an innovative AI platform to identify abnormal cells and lesions in pap smears, called the Genius Digital Diagnostics System. Dr Schneiders emphasised the intricate relationship between customers and health care professionals (HCPs) and regulations. This multifaceted approach is intended to serve patients better while maximising HCPs’ time savings and expertise, all while meeting existing regulations.
AI can free up clinicians’ time
Other speakers highlighted that AI can be used in mundane ways such as to reduce clinicians’ work on documentation, which in turn frees up their time to treat more patients, and spoke about improving the medical access ecosystem with medtech to reduce fragmentation of healthcare access.
Other topics discussed included the importance of decentralised testing in improving patient access to care, detecting diseases earlier and monitoring patients. These POC tests include over-the-counter tests, direct-to-consumer tests and bedside tests, typically performed by non-HCPs. The speakers at the seminars titled “Continued Growth of Decentralized Testing: Fact or Fiction?” and “Exploring the Frontiers of IVD Innovation” stressed the ongoing issue of healthcare “deserts” and how expanding alternative care outside doctors’ offices is crucial to reach at-risk populations.
Since the Covid-19 pandemic, healthcare demand has shifted to patients wanting full awareness of their healthcare status, and telemedicine. Medical device manufacturers are taking advantage of this forward momentum and releasing diagnostic testing to be available at patients’ fingertips.
Big-ticket areas include women’s health, neurology, sepsis and cancer screening
“Continued Growth of Decentralized Testing: Fact or Fiction?” focused on how testing needs to go beyond respiratory testing to gain traction. Testing in chronic disease monitoring, cardio health and sexual health were mentioned. One barrier for some POC tests is reimbursement: access to care is improved if patients can purchase an STI [sexually transmitted infection] test at a local pharmacy, for example, but the lack of reimbursement in this space adds another layer of inaccessibility to the landscape. The overall goal of increased decentralised testing is to bridge the gap between patients and healthcare systems so more individuals overall can be aware of their health status.
Lastly, leaders in the IVD space speaking at the seminars, including manufacturers, heads of laboratories and investors, emphasised key future growth markets. The big-ticket areas were women’s health, neurology, autoimmunity, minimal residual disease (cancer), sepsis and cancer screening (particularly in liquid biopsy). Speakers and attendees emphasised the importance of clinical utility when developing IVDs, focusing on whether test results are actionable, if appropriate actions are taken and whether these actions lead to improved patient outcomes.
Innovations in IVD are revolutionising disease detection, monitoring and management, enabling earlier diagnoses, personalised treatments and improved patient outcomes. Key developments and investments into digital and AI integration, POC testing and novel biomarkers are significantly improving the precision and accessibility of medical care, shaping the future of healthcare.
“We do this all virtually on the computer, so we can make the osteotomy in multiple different places to decide where the most appropriate place to do the correction is.”
From here, relevant standard orthopaedic plates are selected for use in the surgery.
Following these preliminaries, surgical guides, jigs, and plastic models of the patient’s anatomy, in this first case the radius, are 3D printed and then sterilised for use in surgery.
“We make sure that the guide fits the bone in the patient exactly the way we planned for it to fit on the plastic bone. Once we have made sure that’s the case, we secure the guide to the bone with wires, and then we do whatever the plan has been,” says Lattanza.
In osteotomy, such plans generally involve drilling holes and then making the necessary bone cuts.
The great thing about this approach, Lattanza states, is that all that needs to be done to ensure the correction has been completed as planned during the surgery is to line up those holes.
She explains: “If the bone is rotated off 90° and when we drill those holes, they’re off 90° on the bone, we make the cut then we rotate and line up those holes to put the plate on because the plate holes are straight, and that’s how we know that we’ve got the correction.”
Beyond making relatively common osteotomies more accurate, a 3D provision also allows for more complex cases to be worked upon. Lattanza relays a recent case in which a child had broken the radius and ulna bones in their forearm.
“During the time that she was growing, this deformity got ‘very 3D’, meaning it was off in the sagittal, coronal, and axial plane,” says Lattanza.
“You can’t see the axial plane on an X-ray, and if you can’t see it, you can’t correct it.”
In this case, the procedure required two cuts in the radius to restore it to normal anatomy, and one in the ulna.
“In my career prior to having the 3D technology, that’s something that is difficult or impossible to plan and to execute in the operating room, because you wouldn’t even be able to see that you needed two cuts to make it normal again,” explains Lattanza.
Lattanza is keen to add that the influence of 3D printing on preoperative planning and during surgery should not be a cause for complacency, particularly given that there remain limitations to 3D visualisations of CT scans, chiefly in that the current technology cannot show soft tissue.
“Some people think that this is kind of a phone it in now, but that’s not how it works,” she says.
“This is a collaboration between an engineer and a surgeon, and it has to be that way to get a good result.”
Once we see where those changes are, we can plan where we’re going to cut the bone.
Dr Lattanza
Astrocytes are a type of neural cell that builds the BBB, and Excellio plans to derive exosomes from them to make them even better at targeting the brain. Credit: ART-ur / Shutterstock
Caption. Credit:
Phillip Day. Credit: Scotgold Resources
Total annual production
Australia could be one of the main beneficiaries of this dramatic increase in demand, where private companies and local governments alike are eager to expand the country’s nascent rare earths production. In 2021, Australia produced the fourth-most rare earths in the world. It’s total annual production of 19,958 tonnes remains significantly less than the mammoth 152,407 tonnes produced by China, but a dramatic improvement over the 1,995 tonnes produced domestically in 2011.
The dominance of China in the rare earths space has also encouraged other countries, notably the US, to look further afield for rare earth deposits to diversify their supply of the increasingly vital minerals. With the US eager to ringfence rare earth production within its allies as part of the Inflation Reduction Act, including potentially allowing the Department of Defense to invest in Australian rare earths, there could be an unexpected windfall for Australian rare earths producers.
