Opportunity realised through crisis

18 November 2022

Industry 4.0 has been the source of much excitement across medical device engineering during the past decade – but the pandemic might have finally been the spark the field needed to really soar. Not that the path ahead is straightforward, with insiders forced to face a number of manufacturing and security challenges. Andrea Valentino speaks to Dr Vladimir Popov at Tel Aviv University to learn about his revolutionary work on 3D printing, how the resulting implants can transform the fortunes of patients and manufacturers alike – and what it all says about the broader difficulties and opportunities of Industry 4.0 in the medical devices field.

Beloved of think tankers and Davos graduates the world over, the term Industry 4.0 (I4.0) has been milling around the public consciousness for years. Broadly meaning the ways in which automation and digitalisation could transform global manufacturing over the next century, it was first popularised by the World Economic Forum back in 2015. Two years later, it was firmly entrenched in the wonkish imagination and now is practically inescapable even in the mainstream. To give one example, data from Google Trends reveals that the phrase ‘Industry 4.0’ is now nine times as popular as it was seven years ago, with countries as disparate as Malaysia and Zimbabwe curious about the term.

Yet, if I4.0 is dominant in a rhetorical sense, its march from academic conferences to factory gates has been less secure. Nowhere is that arguably truer than the field of medical device development. You can certainly find articles linking the two sectors all over the internet. But experts continue to fear that a sphere as subtle as medical equipment may struggle to adapt to the radical potential of digitalisation and AI. Among other things, insiders worry about the difficulty of training staff in new technology, as well as that of exploding traditional corporate cultures. Security is another challenge; after all, if a computer starts making personalised implants, that sensitive data is at risk of being stolen.

But though I4.0 may have traditionally struggled to make its mark on medical devices, the generational emergency of Covid-19 could be the turning point it needed. Nor is this particularly hard to appreciate. Buoyed by unprecedented pressure in demand – to say nothing of the tumult of lockdown – scientists and corporates across the planet have begun embracing all I4.0 has to offer. It goes without saying that this trend could have revolutionary consequences for manufacturers and consumers alike, offering cost savings for the former and specialised treatments for the latter. Even so, the same old challenges persist, posing significant problems for anyone planning on embracing I4.0 in earnest.

“Radical growth”

Few experts are better placed to reflect on the risks and opportunities of I4.0 than Dr Vladimir Popov. The main or contributing author of over 40 academic papers, he is currently engineer of the Biomaterials and Corrosion Lab at Tel Aviv University, as well as manager at the institution’s 3D-printing TAU+ R&D Centre. This dedication doesn’t take long to understand. For as Popov says, I4.0 “is all about the personalisation of healthcare, the development of medicine on demand and increasing the effectiveness of diagnosis and consulting services”. As Popov adds, meanwhile, the technologies that make up I4.0, including machine learning and deep learning, not only make manufacturing faster and more efficient – they also help sharpen treatments for patients. Rather than relying on mass-produced devices, or workshopping solutions on an ad hoc basis, AI can instead compute the experiences of thousands before offering specialised manufacturing solutions.

All this goes a long way towards explaining the dramatic growth of I4.0 over the last few years. Though detailed statistics are scarce, a January report by Israel Advanced Technology Industries found that 60% of leading venture capital groups plan to boost investment in health technology over the next year. Nor is this timescale accidental. As Popov explains, he saw a “radical growth of interest in I4.0 for medicine” during the Covid crisis, suggesting that the drama of the pandemic – from lockdowns to social distancing – forced the profession to adapt. At the same time, Popov emphasises that there’s been similar interest in the manufacturing space – not least when it comes to 3D printing, his own area of focus.

In fact, 3D printing is as good a place as any to start appreciating all I4.0 can offer the medical manufacturing space. Giving factories the ability to design specialised structures cheaply, 3D printing has the potential to transform everything from orthopaedic implants, through to dental restorations like crowns, as well as prosthetic arms or legs. That’s echoed by other areas of research too. It’s particularly clear in terms of data analysis, where manufacturers can use AI and machine learning to track device parts or understand where things are going wrong. Relying so much on computers, moreover, offers a number of happy side effects – notably around sustainability. Remove paper from the supply chain, after all, and you help the planet even as efficiency explodes.

“[I4.0] is all about the personalisation of healthcare, the development of medicine on demand and increasing the effectiveness of diagnosis and consulting services.”

Out on a limb

Of course, talking about the power of I4.0 in theory is all well and good, but what does this process actually look like in practice? Once again, Popov’s experiences offer something of an answer. With his colleagues in Israel, he uses 3D printing to develop titanium alloy implants for patients. These implants cover a range of medical conditions – from strengthening bones damaged by cancer to fighting bone tumours – but are unified by their clever use of technology. In particular, that involves so-called electron beam melting machines, which essentially zap materials together using a combination of diffusion and heat transfer processes. That’s shadowed by work across Israel, where a colleague of Popov has exploited technology to create an entire 3D-printed heart – albeit one too small to use in people.

What’s clear, at any rate, is that all these achievements require careful planning and close partnerships between departments. Popov, for his part, says his research involves working with printing engineers, materials scientists and medical professionals. The process starts in the hospital, where surgeons use CT scans to understand what kind of implant a patient needs. From there, they team up with engineers to determine which part of the bone can be saved and which will need to be replaced. Once the implant is built, it can be sterilised and installed, though Popov stresses that “observing the tissue and bone ingrowth into the implant” will continue for some time after.

Examine I4.0 more generally, meanwhile, and you get the sense that other projects are reliant on similarly intimate relationships. DePuy Synthes, for instance, is a major American orthopaedics company that recently invested €36m to promote collaboration. Elsewhere, international bodies like the European Advanced Manufacturing Support Centre, are encouraging academic partnerships across borders.

“Nowadays, in healthcare, the terms ‘Hospital 4.0’ and ‘Medicine 4.0’ are gaining popularity by highlighting a new era in medicine and healthcare-assisted spheres.”

Hacked off

Challenging as they may be to set up, these partnerships are clearly worthwhile. To take Popov as an example, he says that using 3D printing, and rapidly crafting personalised devices, can drastically reduce the lead time of surgery, especially important when fighting cancer and other malignant illnesses. There’s also money to be saved. According to Popov, every extra hour spent in the operating theatre costs literally thousands of euros. But by preparing personalised devices in advance, doctors can get the procedure done much faster. It goes without saying, meanwhile, that I4.0 can also offer savings in the data department too. There aren’t detailed statistics on medical devices specifically, but work by PwC found that gathering information effectively, then using AI or machine learning to understand where manufacturing tweaks could be made, or else where humans could be cut from the production line, could ultimately save firms $421bn.

The risks of evolution

Between the advantages it can offer patients and manufacturers, it’s tempting to imagine that I4.0 is here to stay. But if he clearly has confidence in new technology, Popov is the first to concede that streamline manufacturing isn’t easy. In his own field, he notes that educating medical professionals about the potential of 3D printing is one area of difficulty, as is developing alloys that can safely be inserted into fragile human bodies. More broadly, many insiders worry about the cybersecurity dangers of integrating digitalisation into the manufacturing process. Think about it like this: to 3D print a personalised device, you need to plug patient details into a computer first. And the moment you do that, hackers become a worry. Nor is this merely a theoretical danger. According to work by Deloitte, to give but one example, the UK government found that almost half of businesses reported having cybersecurity breaches or attacks in the year to summer 2020, a situation that’s bound to get worse as digitalisation rises.

Even so, Popov is ultimately confident about the potential of I4.0 over the longer term. “Nowadays, in healthcare, the terms ‘Hospital 4.0’ and ‘Medicine 4.0’ are gaining popularity by highlighting a new era in medicine and healthcare-assisted spheres,” he says. “Now, business strategy and administration need to be customer-oriented through new relationships provided by the Internet of Things.

It is also noteworthy that AI, big data analytics and robotics will [be integrated into] the very fibre of everyday life, especially in safety-critical applications.” Popov is equally excited about specific developments in the medical manufacturing space. If 3D printing is already proving its worth, he’s similarly curious about microscopic sensors that could offer detailed information on internal organs, as well as digital tools that can help researchers understand the microstructures of new materials. It seems clear, at any rate, that I4.0 is finally coming of age. Given half a decade has passed since the term gained popularity, it’s probably about time.

A 3D-printed implant designed to reconnect a broken clavicular bone.

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