Setting standards in medical technology


Already a center of pharmaceutical and, increasingly, medical device production, Ireland is in the midst of a medical technology, or medtech, revolution that will benefit both the economy and patients.

From monitoring patients to increasing diagnostics, the medical field stands to benefit from a digital transformation that will change the way patients interact with doctors, nurses and other practitioners.

“The medtech space is booming, and we’re working with the innovation team within the HSE,” said Peter Rose, founder of software developers TEKenable.

TEKenable works in areas such as the Internet of Things (IoT) and Artificial Intelligence (AI), which are essential for medical technology: think of connected devices that report patient statistics and help doctors establish diagnoses. One of the company’s activities in this area is to ensure that devices and software are compliant – an obviously important factor in healthcare.

“We have a good, solid offering in IoT. If you think about the things you need in medical technology, you need IoT, you need the software, and they need to be properly compliant with European medical devices. and the US FDA. [Food and Drug Administration] regulations on anything approaching diagnostics,” Rose said.

Indeed, any device or software used outside of a test bench must be certified, and for good reason: if the devices do not diagnose patients, the information provided influences the diagnosis.

“If the system tells you that the patient has an 89% probability of X, then you have already influenced the diagnosis. Now the clinician is looking for reasons why they have it, not working from a clean slate,” he said.

Increase decision making

Although much has been said in recent years about the potential of machine diagnostics, the reality is that today technologies such as artificial intelligence are there to augment professional decision-making, not to replace. Indeed, IBM’s Watson Health project was recently sold to a private equity group. Nevertheless, the field is gaining in importance.

“These kind of recommendations come from AI, especially deep learning,” Rose said.

The key is that inferences made by an AI should be presented in terms of probability rather than fact. Rose said this was crucial because RNs cannot be allowed to direct doctors.

“If you had a COPD patient who has a high respiratory rate, you know. But you also have more complex issues like asthma, so what boost should this AI give the doctor? How you represent this information is extremely important,” he said.

As a result, compliance with the ISO 13485 medical device standard is a challenge for AI, Rose said.

“You have to be able to prove that it works indisputably, and with AI you can’t do that,” he said.

A medical device manufacturer turned to TEKenable to specifically address this issue.

“A start-up accompanied us because we understood it. You might give a percentage or a sliding scale, or sometimes you would note the presence of specific indicators,” he said.

“How do you create machine learning models that know what is normal for a patient? You end up with a machine learning model with each patient.

Rose said TEKenable operates across the medical technology space and therefore can provide services to a range of customers.

“We have full end-to-end partnerships with electronics manufacturers, so we don’t just implement the IoT sensors, but we design them, connect them, feed them data to the cloud, run analytics on them. , and run AI and deep learning models on it. It’s pretty unique,” he said.

Indeed, TEKenable has a long-standing partnership with the IoT team at Arrow Electronics, and is also partnering with Vodafone on connectivity globally, including 5G networking, and the future looks very promising announcement. The long-promised low-latency, fast, and lag-free connectivity is finally poised to offer exciting possibilities in telemedicine and robotics, including remote surgery where a specialist surgeon can act remotely.

Currently, however, Rose said one of the main benefits of medical technology is to reduce health care costs for individuals and society by reducing waste. Since the cost of health care is continuously rising, this will be widely welcomed.

“The health service has a limited budget and unlimited demand. All they can do is optimize their spending and that means treating people outside of hospital as much as possible,” he said.

Patients benefit too, and not just their pockets, because continuously monitoring patient stats frees up the ability to call for help when needed.

Rose said in-home community monitoring can call for intervention before it becomes a major problem, and clinic time can be used for people who need intervention. As a result, resources are not used caring for healthy people and so those in need can access the care they need.

“It’s optimizing health care, it’s optimizing quality of life and it’s optimizing spending efficiency. This is the essence of medical technology, IoT and AI,” he said.

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