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Electronics


problems in the heart, but also treating congestive heart failure.”


IMEs are equally finding a host of new applications beyond cardiac devices. Wound care, for instance, is highly resource-intensive, with around 6.5 million people in the US living with chronic wounds at any given time, resulting in an estimated annual expenditure of more than $25bn. Managing slow-healing wounds and associated complications is challenging, time-consuming and expensive, and traditional data collection approaches are often clumsy and inaccurate. Yet new hydrogel- based smart wound dressings are integrating drug delivery and sensing modules for blood pH and glucose, which could accelerate the treatment of cutaneous wounds.


In 20 years from now, might we see implantable pacemakers replaced by biological devices?


“I have been working in this field for 38 years, $112.5bn


The amount the market for implantable medical devices exceeded in


revenue in 2022. It is expected to grow at a CAGR of 9% between 2023 and 2032.


$271.5bn


The amount the market for implantable medical devices could be worth by 2032.


Global Market Insights 68


and the technological developments have been so spectacular I could never have guessed what the future would hold,” says Dr Kenneth Ellenbogen, president of the Heart Rhythm Society and a professor of cardiology at VCU School of Medicine in Richmond, Virginia. “Looking ahead 20 years from now, we might see biological pacemakers, not implantable devices, because there will be some kind of gene that restores heart function. “For now, there is tremendous development in the technology of placing devices without putting leads in their heart or batteries under the skin,” Ellenbogen continues. “When I started, defibrillators used patches on the heart, but now they can be transvenous or subcutaneous, and they used to last two years, but now can last 15 years because of improvement in battery systems.”


Recent clinical trials have demonstrated improvement in the safety and efficacy of cardiac IMEs, including complex stimulation systems, technical improvements in pacemakers, and subcutaneous implantable cardioverter defibrillators (S-ICDs). The mCRM System from Boston Scientific, which is the first modular cardiac rhythm management system and comprises an S-ICD system and a leadless pacemaker, has performed well in trials, with minimal complications and a high rate of communication success between components. Those results are significant because they indicate a potential upgrade pathway for patients currently using implanted S-ICDs – but who may develop a need for ATP or pacing.


“There is iterative development, then sometimes there is a big step up in technology, like the move from a defibrillator that has two wires to one with three wires,” is how Ellenbogen puts it. “The third can restore near normal cardiac mechanical function, which means we are not just treating electrical


The drive for personalised medicine, the development of new sensors and analytical devices – as well as advances in microtechnology and miniaturisation – all enable IMEs to support long- term medication delivery and organ stimulation. IMEs are equally revolutionising neurology, as deep brain stimulators improve treatment for conditions such as Parkinson’s disease and epilepsy. There are also likely to be huge strides forward in pain management using spinal cord stimulators.


Pushing the envelope Making IMEs smaller, more flexible, more biocompatible, and more robust has underpinned a tidal wave of innovation – yet implantable devices can still be rigid and bulky, particularly when it comes to power supply systems. Now, however, an intense focus on this problem


is leading to some promising breakthroughs, though the hard road to commercialisation and regulatory approval lie ahead. A key area for innovation involves harvesting energy from the body. Living organisms generate energy in many forms, including chemical energy from the reaction of organic molecules, and mechanical energy from muscle movement. This means internal energy-harvesting devices could hold the key to powering IMEs.


Nanogenerators (NGs) can convert mechanical energy into electrical energy through piezoelectric and triboelectric effects. That’s even as biofuel cells can generate energy from glucose oxidation. With this in mind, at any rate, it makes sense that a team in China recently unveiled a proof-of-concept design for an implantable battery that runs on the body’s oxygen supply. The system uses electrodes made of sodium-based alloy and nanoporous gold – encased in a porous polymer film – which chemically react with oxygen to produce an electrical current. Dr Yunlong Zhao, an associate professor at the Dyson School of Design Engineering at Imperial


Medical Device Developments / www.nsmedicaldevices.com


Arjan van de Logt/Shutterstock.com


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