News

In the very near future

The surgeon in Karachi monitored the 3D images of the patient’s brain. The patient lay anesthetised in the operating theatre of King’s College hospital.

Clutching what appeared to be a gaming control, the renowned neurologist began to manoeuvre a sophisticated robotic ‘arm’ situated 5,000 miles away in King’s.

The remote-controlled catheter moved precisely through the patient’s brain. An error of a few hundred microns could result in irreversible brain damage – but with unerring accuracy the payload was delivered exactly where it was needed.

The anticancer drug would set to work almost immediately having been injected directly into the brain tumour.

We’re not quite there yet – but we’re not far away

Information technology and medical technology are the things that will be very different 20 years from now than they are today.
(Bill Gates)

The EU-funded EDEN2020 is developing an enhanced delivery ecosystem for neurosurgery that is based on the existing Programmable Bevel-tip Needle (PBN), a flexible needle that can advance through the brain with remarkably little tissue damage.

And, in 2017, Professor Shailesh Shrikhande in Mumbai and Hitesh Patel in London collaborated in avatar form on bowel cancer surgery.

Here’s where we are

Motors and motion control electronics in home care medical devices must be almost fail-safe, especially for consumers. This level of performance is expected from components that are ever smaller.
(Leslie Langnau, Managing Editor for Design World)

It’s clear that motion control is already changing medical procedures and has the capacity to transform them.

It is estimated that by 2022, the motion control market will be worth $22.84 billion. And that robotics will form the next wave of motion systems – predicted to be worth $23.9 billion by itself in 2022.

The sectors driving this growth are manufacturing, logistics and the medical industry.

The medical industry has specific requirements for robotics and motion control applications, especially the ability to achieve precise control. The use of motion systems in medicine includes bionic prosthetics, wheelchairs that can traverse stairs and rough terrain, air pumps for respiratory needs, transplanted mechanical valves and microsurgery instruments.

What does medical motion control mean for electronic manufacturers?  

• Design for Manufacture and simulation are more important than ever

Due to the growing demand for smaller, more powerful devices with increased power densities, effective thermal management has become crucial in the development of medical electronics, wearables, and IoT designs. With the help of simulation, electronics designers and engineers are able to improve the reliability and efficiency of their products, innovate new solutions and ensure that they are complying with the necessary safety regulations.
(Bill Wong, Technology Editor, Electronic Design)

In order to avoid unpleasant and unexpected surprises, employing manufacturing experts early in the design phase is essential. Increasingly for complex, precise motion control devices simulation is used, enabling the testing of a wide variety of options.

Simulation begins in the design phase, using techniques like finite-element modelling to better understand performance. With a detailed digital model – including the masses that will be moved or rotated – elements such as the motors and gearboxes can be sized for optimal performance, minimal footprint and maximum cost-effectiveness. 

Yet, simulation can be highly useful throughout upgrades and designs of new platforms. Software tools allow OEMs to explore exactly how a controller behaves as part of a larger system – not just how it moves but also how it works in use (known as the human-machine interface). 

And simulations can also be useful even when the motion controller is in the field. It allows hundreds of variations to be tested and analysed much more quickly than a ‘live’’ test – and without causing downtime or wear to the physical machine.

• Smaller and smaller products

The medical industry is fuelled by motion control systems
(Carlos Gonzalez, Machine Design)

All devices are trending toward being smaller, more compact, easier to carry and store. Yet motion control devices for the medical market are often designed for precise applications where size really is at a premium.

Miniature ball screws, motorized linear actuators, motorized lead screws, and linear bearings are increasingly being chosen for use in smaller-scale applications.

In addition, electromechanical actuators can now replace the pumps, compressors, delivery systems, and other space-consuming technology essential for hydraulic and pneumatic actuation while internal electronics increasingly eliminate complex wiring, connecting to power sources and communications networks with just a few wires. 

• Personalisation and prototyping

‘One of the main areas of benefit the decentralised, smart manufacturing model offers is the ability to efficiently individualise products with high quality results — something that will be critical to success in the patient-specific devices market.’
(Francisco Almada Lobo,  CEO, Critical Manufacturing)

Particularly in the medical market, demand for faster delivery of more personalized equipment is on the increase. Effective prototyping is important to many solutions because designers typically must try various component options before settling on the one that best suits the application.

Again, this is where advanced modelling technology, such as 3-D metal-based printers and simulation software, give designers more flexibility and greater speed.

Automation also plays a key role in personalising or customising products.  Automated processes allow your EMS partner to easily switch from high-speed and high-volume production to agile systems that can seamlessly alter manufacturing product types without the need to stop the line.

Many emerging production technologies, from computerized-numerical-control (CNC) cutting to 3-D printing, bypass the need for tool changes, also make it possible to produce batches of one.

Customisation – and increasingly personalisation – of patient-specific devices will require high quality, high mix production that is perfectly suited to the application of IoT tech, machine learning and automation.

• And, lest we forget, the IoT

The Internet of Things (IoT) has opened up a world of possibilities in medicine: when connected to the internet, ordinary medical devices can collect invaluable additional data, give extra insight into symptoms and trends, enable remote care, and generally give patients more control over their lives and treatment. (econsultancy)

We’ve discussed how the IoT is already enabling smarter medical electronic device by providing a pathway for the efficient production of increasingly complex products, while capturing and analysing data flows to assist with regulatory compliance and process improvement manufacturing.

Yet the future of medical motor control devices will inevitably be greatly enhanced and furthered by the application of IoT capabilities.

Prosthetics can collect and relay data helping patients and doctors monitor performance, other devices can send warnings if components are under-performing and – as we have seen – IoT combined with VR or AR opens up, quite literally a world of possibilities.

Innovation rests on experience

A structured design approach can heighten the hit rate in the fuzzy front end of innovation processes.
(Jens Martin Skibsted, member of the Forum for Young Global Leaders)

As medical motor control electronic devices innovate to serve new, more complex purposes – and often in highly miniaturised forms – the ability to partner with an EMS that can design for manufacture, simulate, prototype, customise, mitigate supply chain risk and adhere to strict regulatory standards is essential.

“We now find ourselves at the gateway of a revolution in transport technology, the likes of which has not been seen since the invention of the combustion engine. These technological advances will create a new way of planning and managing our transport.”
Steve Yianni, Transport Systems Catapult

Digital technology and innovative electronic devices are transforming our railway network. And it’s about time.

Britain’s railway network is the most congested anywhere in Europe and it just gets busier and busier. In the last 20 years the number of people travelling by train has doubled, and the rail network has hit capacity.

But rail passenger numbers are forecast to increase by another 40 per cent by 2040 – representing more than a billion extra journeys on an already crowded network.

Network Rail has admitted that simply supplementing the existing network is neither cost-effective, practical, nor likely to provide a solution. It has stated that ‘we will never be able to build enough tracks and platforms to meet this capacity challenge in the traditional way. To grow future capacity we are investing in digital signalling as part of our Digital Railway programme’.

Let’s take a look at how this will work, what it replaces and how innovative electronic manufacturing processes are rising to the challenge of enabling this transformation.

Digital: the new diesel

“Not since the railway transformed from steam to diesel in the 1960s has a technological breakthrough held such promise to vastly improve our railway for the benefit of the millions of people and businesses who rely on it every day.

This commitment to adopt and roll-out new digital technology, for both trains and track, will deliver faster, more frequent services for passengers and businesses alike, giving our economy a massive boost.”
Mark Carne, Network Rail Chief Executive

Digital is very much a proven technology solution for rail. Its adoption has already been tested as a cost-effective way of boosting capacity on the existing London Underground network and is now in place on the London Bridge Thameslink route and on Crossrail.

By using IoT devices and connectivity to manage the network with greater precision and efficiency, allowing more trains to run on existing tracks and placing safety and reliability at the centre of the rail service. It also reduces overcrowding, cuts delays and drives down operational costs.

In essence, the ambitious Digital Railway programme will deploy digital in-cab signalling, connected driver advisory systems, sensors to track trains and automated train control technology.

By using connected technology to replace train command, control and signalling systems that were designed in a pre-digital age, significant improvements can be realised.

The stop-start traffic light and semaphore signalling system mainly used at present is a Victorian legacy. And it’s about to receive a long overdue radical digital overhaul.

Innovative electronic manufacturing

While digital may be the disruptive enabler here, electronic devices and sensors lie at the heart of this project.

• From the driver control screens in cabs, to the passenger information systems in carriages
• From the signalling stations trackside, to the sensors in tracks
• From the automated train, to the networks handling the data

There are some lessons we can learn from the existing technology.

Signalling system failure, for instance, is often caused by a component fault. A complete system is made up of many thousands of individual components and duplication is not always possible thanks to the increased risk of obsolescence due to the system’s age.

It is clear that electronic devices manufactured for the Digital Railway must be developed with a firm eye on the supply chain that is deployed to source its components.

Failures of signalling equipment are also frequently caused by the environment in which they must operate. These can include risks from flooding, lightning strikes, high impact jolts (if located as part of the interlocked system of points), external power supply failure and extreme heat.

Rigorous testing of all devices must account for the environments they will be used in and the forces they will be susceptible to.

But, on the whole, there isn’t much the traditional technology can teach us – the addition of new, innovative digital solutions and capabilities requires radically different designs.

Each of these devices – and each component within them – must be able to operate in safety-critical situations. Again, supply chain considerations, power supply factors and the ability to design, build and rigorously test complex assemblies is critical to the Digital Railway project’s success.

Overcoming the electronics challenge at the heart of rail’s digital transformation

Rail companies and manufacturers need to work with partners who have a track record of delivering high-reliability and safety-critical electronic devices for the challenging environment the rail network operates in.

A partner that can offer design support, supply chain management, rigorous testing and are dedicated to robust manufacturing process governance is vital when tackling this type of digital transformation.

With several, highly relevant electronic rail products already manufactured for clients – including trackside signalling technology, control-room monitoring equipment, communication technology and safety devices. It’s time to meet the challenge and seize the opportunities that rail’s digital future will present to the industry.

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.

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.

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.