Month: June 2019

Leading the charge on battery-powered medical devices

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The e-skin market is expected to be worth $1,719 million by 2025. And much of this growth will be from devices designed for medical use.

There is one major issue, however, that could hamper its seemingly unstoppable growth. And that’s its power source.

It’s not just a problem for e-skin, but for all medical devices. As they become more flexible, thinner and smaller, the available space for the batteries that must power them shrinks and shrinks and shrinks.

What’s more:

  • They must be embedded in the device, rather than located in a battery compartment
  • They must be highly waterproof and protected from the effects of all other fluids
  • And often they must also allow the device to bend, expand and contract as flexibly as human skin

But the possible problems are even more complicated than this, as devices like pacemakers are not worn on the skin but must operate internally.

This means that, should they need recharging, invasive surgery – with all its risks and discomfort – is required to prolong their duration.

And, of course, as medical devices become functionally more powerful, they invariably consume more power.

The result: ever more demand on our already beleaguered batteries. And that’s increasingly a problem.

Is lithium-ion the solution?

Lithium-ion rechargeable batteries offer medical devices numerous advantages over non-rechargeable batteries. Their high energy-density chemistry can be custom manufactured to enable the miniaturisation of devices and their excellent cycle and calendar life can extend the lifespan of devices.

As such they are ideal for active implantable medical devices, such as pacemakers. Currently available systems have a lifespan of 9–25 years, compared to the typical 2–5 offered by non-rechargeable batteries.

Yet, high-profile hazards associated with the failure of these batteries – recently those of the Samsung Note 7 mobile hit the news – include excessive release of heat, electrolyte leakage causing toxic exposure and the malfunction of devices caused by battery capacity depletion.

Inevitably such risks have been addressed and mitigated but they have led to the search for alternative means for powering and charging medical devices.

Beyond the battery: AC/DC voltage induction

Of course, not all devices are powered by batteries.

Other medical devices run from the mains but even here it is vital that precautions are taken into consideration when designing each device.

It’s critical that the power supply is properly regulated and has reliable isolation to minimise the risk of electric shock. For electronic equipment to be approved for medical applications, it must meet IEC 60601 safety standards.

It must have effective and reliable isolation between the AC input and the power supply, its internal high voltage stages and its DC output. It also needs sufficient spacing between the conductors and the electronic components for proper isolation and doubled or reinforced insulation to meet leakage requirements.

Alternative power sources

Researchers from Dartmouth College, in collaboration with clinicians at the University of Texas, have recently created pacemaker “devices which will be self-charged by the energy harvested directly from the human body.”

 Although still undergoing advanced tests this approach could significantly extend the lifetime of implantable medical devices and remove the need for surgery to replace the batteries.

In essence, these devices use dual-cantilever structured thin films made of piezoelectric materials to convert kinetic energy into electrical energy that can be used to power the battery.

Elsewhere, other researchers – working with e-skin at Binghamton University – are looking close to successfully using human sweat to create electrical energy.

Commenting on his research, Seokheun Choi noted that ‘biochemical energy harvested from human sweat is the most suitable energy source for skin-contacting devices. Sweat is readily and constantly available in sufficient quantities, can be acquired non-invasively and contains a rich variety of chemical and biological entities that can produce electricity.’

Extending the battery: wireless charging

Wireless charging – due to the contactless nature of the technology – is ideal for implantable medical devices using batteries and also for the rapidly growing market for wearable monitoring devices.

In relation to implantable devices, rigorous testing is required to ensure that the device is not susceptible to unintended charging arising from nearby devices.

For all devices the charging circuit needs to be protected to guarantee that the cell cannot be charged beyond specifications, even if a third-party wireless charger is used by the patient.

Helping you to understand and build battery and power systems for the medical device market

We specialise in helping medical OEMs create devices that are built specifically for clinical validation.

Risk management, quality and accuracy are essential in the increasingly stringent regulatory requirements that apply to every step of a medical device’s life cycle. We embed checks, best practices, monitoring and recording into every stage.

Traceability is particularly important, using specified and verified components with fully defined finishes, battery types, temperature ranges, and so on.

The latest version of the requirements for a quality management system that meets the rigorous needs of the medical devices industry is ISO 13485:2016.

Our sales director, John Johnston, commented on successfully transitioning to the latest requirements:

‘It’s a huge privilege for us to be involved with some of the most pioneering medical projects in the world, something we take great pride in.

In order for us to deliver the very best for our customers, it’s vital that we take quality and processes extremely seriously. Standards such as the ISO 13485:2016 are an excellent mark of our commitment to quality, allowing us to credibly demonstrate our excellence in medical electronics manufacturing.’

And we’re here to help you overcome challenges as you design, prototype, test and deliver your products to market.

The electronic start-up’s shark fin dilemma – How your EMS can help you manage rapid growth effectively

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There has been a sea-change in electronic manufacturing markets.

And conditions are now ideal for disruptive start-ups looking to achieve volume at a pace never before possible.

The ponderous adoption that classified the sector until the mid-80s has been replaced by a vertiginous adoption model that graphically resembles a cliff rather than a slowly sloping mound.

These two adoption models are usually characterised as the ‘shark fin’ and the ‘whale’ model and are represented below.

shark fin graph

Image source

Innovative new products used to be adopted in small numbers by ‘innovators’ and ‘early adopters’, before gaining mass traction with the ‘early and late majority’.

The slower awareness of the ‘laggards’ helped extend the product’s life cycle. In recent years this has all changed.

The rise of disruptive start-ups in the electronics sector has benefitted from a tightly compressed adoption curve that features just two groups of consumers, usually referred to as ‘trial users’ and, rather prosaically, ‘everybody else’.

We’ll look briefly at why this compression has happened – and then we’ll explore what the potential for sudden, rapid growth of an electronic product’s market means for start-ups next.

Why the shark’s fin is making waves

Digital disruption lies behind the compressed adoption model that now characterises electronic products.

In essence, the proliferation of devices and the potential for information to disseminate through many (digital) channels rapidly is what has created a pattern for growth and product adoption that allows new products to rise rapidly from conception and gain high-speed traction.

  1. Customers become quickly aware of new products on the market through information available on the internet and social media.
  2. Digital marketing allows companies to achieve a lower cost of acquisition and a greater precision in targeting.
  3. Trends and new products spread rapidly and virally.
  4. But electronic products and platforms also become quickly obsolete.
  5. Continued competitive improvements in efficiency, price, performance or size, have led to a shorter cycle by which new versions and innovations replace products.
  6. Consumers are just as quick to replace products as they are to adopt them.
  7. To maintain market position, start-ups will need to launch other new, innovative products to create their shark fin growth again.

What shark fin growth means for electronic start-ups

The problem facing many ambitious start-ups looking to demonstrate rapid growth potential is that they struggle to marry great ideas, fantastic products, buy-in from investors and a surfeit of ambition with what is really needed to succeed at scale.

The missing ingredients are commonly the following: experience of volume manufacturing and finely-honed supply chain management expertise. Without these elements, the wheels can start to fall off even the most carefully planned rapid market penetration.

What’s more, it’s not something that can be bolted on at a later stage. Considerations such as Design for Manufacture (DfM) need to be factored into plans at the earliest time possible.

This is why, at Chemigraphic, our customer base is expanding almost as fast as that shark fin emerging from the choppy waters of rapid adoption. More and more start-ups are realising just how essential an EMS partner is in avoiding expensive redesign and re-engineering costs mounting up or obsolescence preventing those viral products flying off the ramp.

Let’s look at how early engagement with your EMS can help you manage rapid growth effectively.

Early engagement with your EMS partner

It is in the early engagement that you can ensure all those potentially costly creases are removed. And cost is not the only issue here: in a market that is rapidly changing being able to get your product to market as quickly as possible – and continue to supply it to meet vertiginous growth in demand – is essential. As is reducing risk- if the stakes are high, development costs need to be recouped and competitor products are emerging, you need a reliable partner committed to keeping you project on track and ahead of the market.

Yet, often start-ups underestimate the complexity of manufacturing. It is assumed that a product that works will work just as well when produced at scale. And is the “design package”, including all the drawings, circuit diagrams and specifications 100% complete? Has every specification been fully defined, quantified and made entirely clear? If not, the risk of unexpected misunderstandings and disruptions remain.

But this is rarely the case.

Unless your product is designed for manufacturing and for continuous volume production it runs many risks, including:

  • Low yield rate when production is scaled up to volume
  • Unforeseen problems in achieving fully compliant products on an assembly line
  • Unnecessary expenses caused by sub-optimal design
  • Non-sustainable supply chain failures that cause delays further down the lifecycle due to obsolescence

Mass production needs expert managing: it is within the complex interplay of software, electronic design, mechanic design, components, manufacturing efficiency, yield rate, major vendor support and testing that the perfect mix can be found.

And, without an EMS partner well-versed in understanding how to align the requirements, delays are almost inevitable.

A CNN investigation found the 84% of the top-funded tech and electronic Kickstarter projects ended up missing their promised launch date.

The critical point here is that your EMS partner must be there to offer more than manufacturing. They are there for design, smart sourcing, ensuring careful governance and management throughout the supply chain and making sure this all translates cost-effectively and efficiently into the volume manufacture of your product.

Without this shark fin projects will not sleekly emerge from the waters but appear thin, fragile and liable to snap at any point.

Call 01293 543 517 to speak to our team for advice about how to design, produce and fail-safe your next big thing for the electronic market. 

e-skin: the incredible backstory and promising future of med-tech’s latest and most innovative range of electronic devices

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What is e-skin?

e-skin technology is the culmination of over a decade of research and development. And it’s about to transform the medical device market. Many also suggest that, if that all-important price point can be met, it looks set to transform the consumer wearable market too.

e-skin is essentially a printed circuit board with sensors on a substrate that is thin, flexible, breathable and very comfortable to wear.

What challenges must e-skin overcome?

e-skin needs to be more than thin, flexible and comfortable, however. It must also be stretchable and contain self-healing electronics that can accurately mimic the functionalities of human skin, by responding to environmental factors like heat and pressure.

Many of the advances in e-skin development have come from designing materials for the substrate. Yet, at the same time, they also rely on advances in flexible electronics and tactile sensing. e-skin must have the ability to re-establish sensing functions, such as tactile sensing or electrical conductivity. And the challenges facing e-skin centre on the fragility of sensors, the recovery time of sensors, repeatability, overcoming mechanical strain and achieving long-term stability.

The research and results of several innovative examples means that that the tipping point has now been reached. The combination of flexible and stretchable mechanical properties with sensors and electronics that can self-heal is set to lead to exciting new possibilities, whose applications include soft robotics, prosthetics, artificial intelligence and health monitoring.

Speaking at the publication of his research into how human sweat could be used as a power source for e-skin, Seokheun Choi, associate professor of electrical and computer engineering at Binghamton University, said:

 ‘With the development of stretchable, biocompatible and self-healing electronic materials, significant research efforts are dedicated to the seamless and intimate integration of electronics with human skin, which will produce breakthroughs in human-machine interfaces, health monitoring, transdermal drug delivery and soft robotics.

As the emerging technologies of artificial intelligence and the internet of things are advancing at a rapid pace, e-skins will definitely be one of the ultimate forms of next-generation electronics.’ 

Changing healthcare and changing med-tech

It’s not just changes in tech that are driving the development of e-skin – there are considerable financial incentives too.

The latest market research suggests that the e-skin market will already be worth $464m in 2020. It is projected to grow 37.7% each year to reach $1,719m by 2025. The driving forces behind this growth are the wearable market, particularly for use in healthcare.

Healthcare needs such devices as it undergoes a number of changes itself. Affordable technology, wide-spread Wi-Fi, social media and a greater acceptance of sharing data are radically changing how healthcare providers engage with and monitor the wellbeing of patients.

Increasingly, patient care is primarily being administered in the home. Helping this trend is the increasing number of medical interactions being conducted online, enabled by devices that allow remote patient monitoring.

As a result, investment is moving from hospital devices and equipment and towards investment in innovative devices that can be used in the home for health monitoring.

And e-skin perfectly fits the bill.

Converging consumer and med-tech

Commentators have also noted that the historically distinct markets of regulated medical devices and consumer health wearables are starting to blend. Advances in one sector are being picked up on and developed by the other.

As a result, traditional consumer technology companies are moving deeper into the device space – and the latest upgrade to the Apple Watch, allowing for medical-grade quality monitoring available directly to consumers but also suitable for doctors to use in treatment and diagnosis, is just one case in point.

User-friendly and highly-accurate wearables

The beauty of e-skin is that it is incredibly user-friendly, indeed it is barely noticeable to those wearing it. Prior to e-skin technologies, medical wearables had hard, uncomfortable surfaces. To compensate for this, they were often loosely attached, thereby sacrificing data consistency and quality, or they were uncomfortable to wear, and unattractive to patients.

 e-skin technology will improve the monitoring of health and vital signs such as heart rhythm, respiratory rates, heart rate variability, ECG, temperature and more. It conforms to the natural shape of the human body and can be snugly placed at the most ideal location on the body based on the type of data to be monitored, which ensures accuracy.

How does e-skin relate to other electronic advances transforming med-tech?

Two of the other biggest technology trends that look set to transform med-tech are Augmented Reality (AR) and Virtual Reality (VR).

These are already helping with training clinicians through simulation, as well as in educating patients and helping with treatment.

Cool! VR pain relief, for examples, uses a virtual world of landscapes and changing seasons to distract a patient from the experience of intense pain. AR is also being used to gain efficiencies, for instance by superimposing a patient’s records and vital signs in real time as doctors make assessments.

Just one way that e-skin technology may merge with VR or AR is suggested by a newly developed e-skin that allows the wearer to manipulate virtual objects without actually touching them — such as typing on a keyboard or adjusting a dimmer.

From a study published in the journal Science Advances, it is suggested that such devices could one day be used in medical devices like prosthetics or in soft robots.

What’s next?

The potential for innovative electronic medical devices keeps on opening out.

The market is certainly ready for them.

The tech is certainly there.

e-skin looks set to be the latest tech that disrupts the sector.

‘In the coming years we see wearable technologies growing more in the healthcare industry and revolutionizing the way doctors engage with their patients. We also see wearable technologies enhancing the way parents and caretakers assist their sick loved ones.’
Lucia Nguyen, VivaLnk

The impact of VR/AR on electronic design

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Remember the Star Wars scene where the death star is 3D projected into the rebel’s central command? Or the hologram adverts popping up in Minority Report? Thanks to new technology, that’s no longer just sci-fi from a movie.

minority report AR

Before you panic – nobody has built a death star, and no one is getting arrested for ‘pre-crimes’ ala Minority Report!

Those holographic maps, and floating virtual control panels that operators appear to be able to touch and scroll through, are examples of what is now existing and viable technology.

Stepping into a virtual world provides endless opportunities to develop new products, so it’s little wonder new tech start-ups are racing to build incredible new devices that were previously only possible in sci-fi.

In fact, Augmented Reality (AR) and Virtual Reality (VR) developments are really starting to hit their stride, especially AR for action-oriented tasks and VR for training purposes.

Augmented reality vs. virtual reality – what’s the difference?

AR adds digital elements to a live view often by using the camera on a smartphone. VR implies a complete immersion experience that shuts out the physical world. AR allows users to interact with the real world with enhanced features and additions, and VR allows people to enter a world or scenario is completely removed from real-life surroundings.

AR on phone

In an education setting, for example, VR could allow students to ‘travel back in time’ to a historical period using VR technology. AR, on the other hand, can be used within training scenarios to show what a product, colour scheme or design style would look like if applied to the real-life space students are occupying.

In terms of industrial applications, AR systems are already in use in several sectors including aerospace, defence, and oil and gas. BAE, a multinational defence, security, and aerospace company, has created interactive work instructions that have enabled the company to train its staff 30-40% more efficiently. In addition, many oil and gas firms are using AR technology to simulate disasters for cost-effective training purposes.

Is VR and AR worth the hype?

In short – yes.

There are, frankly, endless possibilities to apply VR and AR tech within our world – from defence to cinema, manufacturing to marketing, and medical to flight simulation.

Real-world examples of virtual reality applications

VR is increasingly used to provide learners with a virtual environment where they can develop their skills without the real-world consequences of failing – or even dying. The military was a first-adopter and pioneer in VR development; the Virtual Battlespace Software Series (VBS) is the U.S. Army’s flagship training game and is also used by the UK Ministry of Defence and others.  

Nobody can hear you scream in space – so let’s practice it A LOT before we go up there. NASA has used VR technology for decades in their immersive VR to train astronauts while their feet are still firmly on the ground. From a specialised Virtual Reality Laboratory (VRL), trainee astronauts use real-time graphics and motion simulators and a tendon-activated robotic device on their hands to mimic the actual sensations of handling objects in space.

There are huge benefits for medicine too. VR can bring learning to life in a far more interactive manner than traditional training materials such as textbooks. Through VR, fledgling surgeons can experience complex surgeries without stepping into the operating room. On April 14, 2016, Shafi Ahmed was the first surgeon to broadcast an operation in virtual reality, allowing viewers to follow the surgery in real-time from the surgeon’s perspective.

Getting your 3D goggles at the cinema has become a normal experience. If we assume the technology will deliver everything promised, a future cinema could be just a space where people come together wearing VR headsets or some form of immersive device.

Augmented reality at work

Although adoption of AR has been tentative -not helped by the privacy issues and derisive comments made by those few people who wore Google Glass-  there’s been quiet but steady advances made in commercialised, industrial applications of the technology. AR is slowly but surely transforming the way companies design, manufacture, operate and service products. It’s clear that software developers, industrial products, automation, electronics and high-tech sectors are all moving quickly to capitalise on the AR opportunity. According to a Beecham Research report, the AR market is beginning to accelerate and could be worth around $800M by 2020.

There might even be X-ray specs

Smart glasses have received a tech makeover. Tech start-up, Magic Leap, has recently launched a new, futuristic pair of AR glasses.  Magic Leap One glasses are designed to enhance the world with digital objects and images while allowing you to interact with everything real that’s going on around you. Now on sale in the U.S. for $2,200, the headset combines natural light waves with synthetic lightfields to create an “unbelievably believable experience.”

Magic Leap One glasses

Source

It’s expected that more and more businesses will place smart glasses at the core of their Internet of Things (IoT) systems, as they look to make workers more productive and to streamline their back-end operations. For example, if an operator can look inside a device without opening the lid and act on the information being returned, it’s much faster and less expensive to maintain a system and diagnose faults.

VR, AR and now MR

The term Mixed Reality (MR) is one of the most recent developments, combining elements of both AR and VR and allowing real-world and digital objects to interact. If Microsoft’s HoloLens 2 system lives up to the marketing video, there’s an MR revolution on our doorstep, where virtual pop-up screens and immersive graphics are used to break down complex tasks into simple steps than an operator can follow. The Hololens 2 video is worth checking out here especially if you’re looking to perform a heart bypass or service a motorbike!

The impact of AR and VR technologies on design electronic design is two-fold – both in how products are designed and the types of products.

All three of these technologies (AR, VR and MR) could be used throughout the design stage of commercial manufacturing to streamline processes, test the designs and advise on component suitability or even obsolescence issues if plugged into big data. However, it may take time for electronic engineers to think of ways in which AR can provide tangible efficiency improvement. Many believe we are still waiting for better technology.

The electronic devices themselves will become more personal, more ergonomic – more humanised. They’ll be greater use of sensors, in-ear devices, micro near-eye displays, flexible and moulded electronics and ergonomic near-invisible hidden technology. We should expect these devices to become part of the fabric of our lives.

To see a real-life example of how we helped a start-up AR company to volume manufacture, take a look at our case study.