Medical Technology Q&A

Rob Phillips, managing director of professional battery manufacturer Accutronics, has identified several key trends that are emerging in the MedTech sector, from rising energy densities to new innovations such as wireless charging. Below he offers his insights into these trends, where he predicts to see the most market growth in the next twelve months and where Accutronics fits into the industry.

Who are you and what do you do? 
I'm Rob Phillips, managing director of Accutronics Ltd. Accutronics is a successful independent battery business serving specialist OEM’s in the Medical Device market and similar sectors, specialising in developing and manufacturing high-performance smart battery & charger systems.
We have an excellent portfolio of demanding OEM customers, who enjoy a real competitive advantage from their long-term partnerships with us.

As well as the medical and healthcare sector, our smart batteries are used in defence and security, as well as industrial test and instrumentation sectors. From small credit-card sized batteries for use in wearable medical devices to intelligent power vaults for use in high-power, high-discharge environments in hospitals, we make them all.

Some of our technical achievements include class leading protection circuits that prevent batteries from over charging, over discharging and overheating, as well as algorithmic security that prevents fake batteries from being used in life-critical medical applications.


How would you sum up your company?
Accutronics enables forward-thinking MedTech companies to create and deliver the next generation of portable medical devices.

As a leading battery manufacturer, we're dedicated to helping overcome new challenges including the use of portable devices in extreme environments, as well as improved battery security aimed at eliminating counterfeits. To do this, we've brought together a passionate team of designers, engineers and market specialists to apply their expertise in creating the battery solutions of tomorrow.

Name a business achievement you are most proud of?
Having grown the company from a startup in 2009, during one of the worst recessions in history, Accutronics is now a first-choice partner for some of the world's leading MedTech OEMs. This is something we're really proud of.


What excites you about this industry?
The environment of constant innovation is enthralling. Knowing that all these efforts are aimed at improving people's lives and the quality of their health makes this a very rewarding industry to be in. On top of this, there are real opportunities open to smaller and medium-sized companies to play a significant role in this innovation.

We've identified several key trends in the MedTech sector: battery energy densities are rising, as more and more equipment is becoming mobile; security is a big concern, especially when it comes to counterfeit batteries; the demand for premium medical devices in the Asian MedTech sector is growing rapidly; new innovations such as fast and wireless charging are on the rise; and finally, the development of antimicrobial polymers and surfaces is providing an extra line of defence against superbugs.


Where do you predict industry growth will come from over the next 12 months?
The BRIC countries, Brazil, Russia, India and China, are widely recognised as being economies with the fastest growing infrastructure in areas such as health service assets, transportation and specifically portable medical devices, which will deliver increased flexibility and value to healthcare users. This is where we expect most of the growth to come from.


Which medical device do you wish you had invented and why?
The plastic syringe, as it's one of the most versatile products. It's more robust and lighter than glass. It's much cheaper to manufacture, there must have been millions manufactured already. Products like the plastic syringe offer a lot of scope for use in the field and are indispensable in places like Africa where the logistics of medical equipment can be very challenging.

Which is the right project methodology for you?

It seems nowadays that there is a rule, methodology and philosophy for everything. Many of these rules have been around for decades so it raises the obvious question, 'are the old methods still relevant in an age of rapid innovation and uncertainty?' This is especially pertinent for original equipment manufacturers (OEMs) where even a small advantage can mean the difference between success and failure. Here Prabhjit Singh, production manager at Accutronics looks at the top methodologies and evaluates how OEMs can choose the best one for them.

Developing a new product is not easy. The process of consultation, design, production, testing, logistics, integration and support can be challenging for even the best OEMs. This is made even more difficult in highly regulated industries such as the medical, security and defence markets. Here, products must not only meet stringent regulations, but also perform in extreme environments, where resistance to temperature fluctuations, humidity and vibration shock is critical.

When asked how he developed new products, the late CEO of Apple, Steve Jobs, famously quipped that, "it's really hard to design products by focus groups. A lot of times people don't know what they want until you show it to them." This very disruptive approach evidently worked for Apple and means that the company continues to produce some of the most desirable consumer products on the market.

Methodologies
So how does one go about choosing a methodology that offers the best of both worlds, a philosophy that is quick to adapt to change and yet is thorough enough to cater for quality control and planning? First we need to see what's available.

Project management methodologies can be broadly categorised into two areas, the first group are the traditional formal methods. The main systems include Prince2, Six Sigma, PMBOK (Product Management Body of Knowledge), TQM (Total Quality Management), QFD (Quality Function Deployment) and the Waterfall model. The second group has emerged from this and is known as lean. This includes lean, agile, JIT (Just in Time), TPS (Toyota Production System) and Kanban among others.

Suit up
To sum up, the formal methodologies all prescribe a holistic, start-to-finish, approach to process driven environments where quality of output must be maintained while reducing the variability of each output. Whether its business or manufacturing, formal methods are all about measurable, quantifiable, result oriented outcomes. This includes cost reduction, optimised time management and a deep understanding of inherent risks and benefits of each action.

While the formal methods are great for large scale, often multinational, projects, they can be difficult to administer. They are usually resource intensive, inflexible and bureaucratic in nature, making them difficult to roll out in smaller projects.

Going lean
At the other end of the spectrum we have the lean methodologies. Popularised by Japanese automotive manufacturers, lean, agile and just-in-time (JIT) systems are all about reducing a process down to its absolute core activities, improving efficiency and reducing wasted resources in the process. Ultimately, lean systems add value by reducing costs and improving delivery times, while maintaining quality.

However, it's not all plain sailing. One of the biggest criticisms of the lean methods is that the focus on optimising a single activity can often lead to OEMs losing sight of the bigger picture. This scope-creep can mean projects lose direction strategically. As well as this, inaccuracies in lean processes can quickly become magnified across the project and if not managed carefully, a lack of documentation can lead to traceability problems when things go wrong.

Choose your poison
So which is best? Well, in order to establish that, you need to consider three issues; external environment, internal setup and ability to adapt. Take Accutronics, for example. If you look at our external environment, you can see that we operate in many highly regulated, life-critical and extreme environments, designing and manufacturing batteries and chargers for medical and healthcare through to security and defence. For us it's important that we can demonstrate traceability, documentation and thoroughly tested products. At the same time we can only hope to achieve a competitive advantage if we understand the subtle and nuanced demands of our customers.

In the second and third stages, OEMs must ensure that physical resources, infrastructure and human expertise are leveraged in such a way that they can adapt to market changes quickly and smoothly. Whether it's a change in legislation, a new innovation in materials research or technological obsolescence, you must either adapt or die.

Plain sailing
Knowing and abiding by the rules is one thing, mastering them and using them for competitive advantage, is a whole new ball game. With a willingness to invest time and expertise, OEMs can hope to continuously build successful products and services time and time again.

Cyber hacking medical devices

A recent presentation of findings at US hacker conference DerbyCon demonstrated that medical cybercrime is on the rise.

Using a specially designed search engine called Shodan, hackers were able to identify vulnerable hospital networks along with all their connected devices including MRI machines, defibrillators and equipment in radiology and paediatric units.

Even though 68,000 medical systems have already been exposed, I expect this number will continue to rise. The growing trend in the medical technology (MedTech) industry for more portable and wearable medical devices that make up the Internet of Things (IoT) will render more devices vulnerable.

The problem here is that we have so far only been concerned with the cybersecurity and software based protection of our devices. For those OEMs who design, develop or manufacture their own hardware, it's vital to consider a more holistic, hardware based, approach.

The last thing you want is for your life-critical medical device to be compromised when it's needed most. Built-in algorithmic security, for example, can detect when a fake battery is used with a host medical device. 

Algorithmic security prevents attempts to use counterfeit or copycat batteries, of which there are millions in worldwide circulation that are easily available at the click of a button from grey market sources online. 

By ensuring that software and hardware works harmoniously to protect our medical devices, we can prioritise patient safety in the face of increasingly malicious cyber crime.

Whitepaper addresses medical battery technology

British battery manufacturer Accutronics is making available for download its latest whitepaper, which tackles the issues facing battery design, development and use in the medical and healthcare field. The intention is that it will help Original Equipment Manufacturers (OEMs) better understand the possibilities and limitations of rechargeable battery technology in designing products for the medical sector.

The paper is free to download and aims to inform its readers on three main areas of recent battery design interest. The first is a growing phenomenon dubbed the Apple expectation. It explores the convergence of consumer and professional medical devices and how fitness and health monitoring apps designed by large consumer electronics companies such as Apple and Samsung are impacting on the professional medical industry. 

The second topic looks at digital radiography (DR) and the increasing challenge to design batteries for modern DR applications that still use analogue equipment. This second piece looks at the latest innovations in digital film processing, the essential features of smart batteries, as well as the regulatory and compliance issues of designing, manufacturing and testing medical devices for worldwide distribution. 

Finally, the paper discusses the eHealth revolution, a trend that has witnessed an explosion in the use of smartphones, fitness bands and other wearable technology to monitor acute healthcare conditions in an increasingly ageing population. The piece goes on to look at high profile hospital trials of health apps to monitor patient health, as well as the cost savings the NHS can make from earlier cancer diagnosis.

“We have seen an increasing trend towards smaller, more portable battery solutions in all industries and especially in the medical field,” said Michele Windsor, marketing manager at Accutronics. “With this shift, there has been raised concern about reliable solutions for practitioners in hospitals and other areas where the need for reliable and long-lasting batteries is essential.

“We want to alleviate concerns about battery solutions and ensure that OEMs are informed about the choices they can make so they will not have to rely on inferior, consumer grade batteries.”

To download the new whitepaper for free go to http://bit.ly/HealthcareWP

Analogue infrastructure needn’t hold you back

Thanks to the digital revolution, technology in both our personal and professional lives is getting smaller and more powerful. For instance, new smart watches have more computing power than the Apollo moon landing space craft! The same applies to medical equipment; hospitals are replacing bulky analogue machines with more svelte, powerful devices. However, the march of digital technology through healthcare facilities is bound by the existing infrastructure, which was developed for analogue solutions, creating unique challenges for battery equipment.

At Accutronics we’re seeing an increase in demand from the medical sector for thinner batteries to be used in new or updated equipment. While advanced technology is a key driver for this, another reason is the fact that original equipment manufacturers (OEMs) have to design machines that fit into an analogue legacy system.

For instance, in new digital x-ray machines there is only 15mm of space for a battery – the space that was set aside for photographic slides in outdated apparatus. This is because hospitals need new devices to fit into the same space as the old ones. So, development of new technology is being shaped by the infrastructure that has been established for low-tech requirements.

In addition, hospital buildings themselves contribute to space saving needs. While there are modern hospital buildings in the UK, there are also those that were built as far back as the 1800s. Mobile devices and carts have to be designed with manoeuvrability around narrow corridors in mind. Therefore, the components inside modern devices are packed tightly together, leaving no room for large battery packs.

Retrofitting or retrospectively designing systems like this creates interesting challenges when it comes to providing a suitable battery to meet both size and power requirements. It’s frustrating enough when your smartphone battery can’t keep up with your usage, but in the healthcare field interrupted power supplies can cause serious problems.

This means that Accutronics often supplies batteries with very thin section walls, as little as 0.8mm, to allow as much space as possible for the cells. Currently, the size of a battery cell can’t be reduced by all that much without losing power, so in very tight spaces you end up having to compromise the capacity of the battery by using fewer cells.

The key to success is for OEMs to consider the battery earlier in the design process. That’s why Accutronics encourages early engagement for all of its clients. While our bespoke battery solutions can be tailored to almost any situation, the earlier in the design our teams can get involved, the easier it is to ensure optimum performance for requirements.

Accutronics works with its clients to create truly outstanding battery solutions, which provide tangible end user benefits such as low weight, minimal volume and ease of use. This is often achieved via our custom battery and charger design and manufacturing service, Accupro, which integrates seamlessly into OEM device development programmes. Some of our batteries even have more advanced control systems than the Apollo 11, which was about as complex as a modern toaster. It's just our way of staying ahead of the curve!

Batteries and medical device qualification

Rob Phillips, CEO of Accutronics, a leading independent battery design company servicing the medical sector, provides a brief overview of standards and design issues relevant to designing in batteries (and associated battery chargers) for medical devices.

 

It’s usually impractical for companies other than the largest to employ dedicated battery specialists internally. For many businesses, major battery (and associated charger) designs occur only every several years. Yet battery and the associated charger technology is a complex field that requires investment in continual reskilling in technology, as well as an understanding of multiple standards and legislation. Keeping internal battery specialists on-hand is often uneconomical and also, while Medtech designers generally know medical device standards, in my experience they don’t have the same knowledge of battery or charger standards.

 

However, whether you engage with a third party battery and charger specialist or not, project managers responsible for specifying the batteries in a medical device (and being able to charge them) will benefit from understanding the basics of the standards involved, and what some of the more common (and expensive) design issues are, so they can be avoided. Let's examine a few top line considerations:

 

Standards – the fundamentals

 

All electrical and electronic devices (including batteries and chargers) require certification that they have been tested against a recognised standard for safety when the product is subjected to abnormal or abusive operation conditions. Certification to these safety standards is not a guarantee that the product will continue to function after being subjected to these conditions, but that the product has been proven to not cause injury or damage to personnel or property.

Certification requires that the principal safety components (cells, fuses, enclosure materials etc.) have already been certified to their individual applicable standards. If not, then certification will be considerably more difficult, take longer to complete and incur considerable additional qualification testing.

The type of standard required depends on a variety of factors:

• Type of product
• Intended use of the product
• Market that the product is to be sold into (despite harmonised standards, many countries still only recognise their local standards)
• Timing of the product placement onto the market (standards are revised after a number of years to reflect product and market changes) 

A fundamental point is that the battery is tested to an appropriate standard for its relationship to the medical device, whereas the medical device is tested to an appropriate standard for its relationship to a patient. The battery is a “component” of the medical device.

For the same reason, a stand-alone battery charger is tested to an appropriate standard for the safe operation by all personnel as a management tool for the battery, and not tested as a management device of the patient.

Standards – Some specifics

Ultimately, an exhaustive discussion of standards related to qualifying batteries in medical devices could fill several very large tomes. For the layman, however, it’s enough to know roughly which standards might affect you. For anything more involved than this, you’ll probably need to seek advice.

 

The principle battery safety standard is IEC62133 “Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells”. Certain regions such as North America, principally recognise a similar standard; UL2054 “Household and Commercial Batteries”. Taiwan is introducing its own standard (CNS 15364) in 2014.

 

Although batteries are not classified as medical devices, it’s not unusual to adopt and test for specific elements contained of the Medical Device standard; such as drop-testing or EMC (Electromagnetic compatibility).

 

Lithium, Lithium-Ion, and Lithium-Polymer batteries are classified in “Class 9 – Miscellaneous dangerous goods.” They have the potential to generate a significant amount of heat or catch fire if damaged, improperly packaged or cared for, than do other battery chemistries. In order to be transported, they must be certified to separate transportation safety test standards, and against the requirements of Section 38.3 of the United Nations document ST-SG-AC10-11, “Recommendations on the Transport of Dangerous Goods – Manual of Tests and Criteria”.

 

Battery chargers are tested primarily to IEC60950-1 “Information technology equipment – Safety” (and equivalent UL60950-1). As with batteries there are a few geographic differences: again, Taiwan is introducing its own IT safety standard, CNS 14336-1 in 2014.

 

The Medical Electrical Equipment standard IEC60601 / UL60601, (also EN60601 in the UK), is a suite of separate tests, each with their own set of documents targeting a specific aspect of a medical device, such as direct patient intervention, something a battery or charger on their own, will never encounter.

 

We work with each customer to establish the most appropriate certification body, applicable standard(s) and additional testing suitable for the intended use and the intended geographic market(s). Customers sometimes ask for unnecessarily high certification standards (which carry a highly elevated test cost premium) and it has not been unknown for obsolete standards to be requested when that standard has been absorbed and refined into a much newer revision.

 

We recommend that customers contact us early within the development with their requirements for each product, so that we can establish what is needed, at that time, for that product, for their chosen marketplace and application.

 

Underspecified / over specified

 

One of the other most common problems battery consultancies see when designing in to medical devices is over specifying and under specifying.

 

The early warning signs that you, as a designer of the medical device, may have over specified your battery will be either commercial or physical. Either you will end up surprised by the cost of the battery required to meet your specified device runtime, or just how large or heavy the battery needs to be to meet the brief. Generally the negative effects are down to cost. The latest lightweight battery technology, with highly accurate fuel gauging and advanced protection systems, all have a cost attached to them.

 

We were once required to deliver a battery to a customer that was able to operate from -30°C to +70°C. Although this gave them a superior product to their competition, it drove their costs up significantly. Competitors could offer a battery at a fraction of the price that worked across 80% of the range, and which was ‘good enough’. If you create a product that can do everything for everybody, you may sell nothing to anyone, because you will be overpriced.

 

In battery design under specifying, on the other hand, tends to manifest itself in short runtimes or short battery lifetimes. Device developers will produce an initial ‘power budget’ outlining how much power each part of the system, (screen, processor, etc.) will use. Problems most commonly arise when additional components or software are added to the device design that increase the necessary power budget, or when the marketing department insists on a smaller battery, (to fit a certain form factor or increase mobility).

Under specifying on battery lifetime is worth a special mention: You need to consider what the total battery life and chargeability of your device is going to be, not just how much it charges initially, but how consistently it will charge. Even medical customers focus unduly on ‘out of the box’ performance and high initial capacities, as if they were buying a mobile phone rather than a high-end medical device. No-one wants to replace the batteries on a medical device that cost tens of thousands of pounds to purchase. But high initial capacity and long life rarely go hand-in-hand. Sometimes it pays to consider lowering initial performance in return for long-term battery lifetime benefits.

 

Other common issues

It’s also important for designers not to back themselves into a corner when it comes to cell selection. This is another reasonably common issue.

Before 1995 there were a small number of nickel cadmium and nickel metal hydride cell types, manufactured to IEC standard dimensions. Life was easier back then. Now there are literally hundreds of cell sizes and shapes, and you’re by no means guaranteed that a particular cell will be available in the same dimensions in another five years’ time.

In costly medical devices with operational life cycles of many years it’s important to select cells available from multiple manufacturers, and allow space inside cases for alternative cells if required.

Similarly, it can cause problems down the line if you do not opt for a chemistry-independent charging system. These so-called ‘smart’ charging systems allow batteries to request their own specific charging profile. This is useful if higher-capacity batteries or batteries with different charging profiles become available later.

Lastly, it’s frequently worth trying to keep your battery rating below 100Wh, where possible. Lithium-Ion batteries rated at over 100Wh are subject to quite particular transport restrictions. If you can’t keep battery energy beneath this threshold in your design, consider the use of multiple batteries where each battery is rated at under 100Wh.
 

Charging forward 

A surprising number of companies underestimate the extent of the ramifications of battery choices for rest of their device design. Batteries are often seen as one of the ‘simpler’ parts of a design, and by many as a ‘commodity’ part. But getting it wrong, or failing to meet key standards, can lead companies to having to rework their entire product design.

For all these reasons designers need to ensure they work with battery experts that take a holistic view of product design, and can provide expert advice with regards to both the relevant standards and the wider effect battery considerations will have on your product design as a whole. Getting the specification nailed down accurately at the start of the project is key, as is ensuring that you’ve guarded your supply chain and support provision for the lifetime of your medical device.
 

Going for growth - New chairman to accelerate business development

International battery manufacturer Accutronics has appointed Steve Lamb as its new chairman. The addition to the management team will allow the company's managing director, Rob Phillips, to focus his efforts on new business development.

The new chairman will have a general management focus, working alongside managing director Rob Phillips, operations director Mike Allen and financial director Debbie Hodgetts. Prior to joining the Accutronics board of directors, Lamb built up a highly credible reputation as MD, CEO and chairman of a number of other companies, and brings with him an extensive amount of knowledge and expertise.

Lamb began his career in manufacturing before moving into the IT sector with the advent of 3D CAD/CAM systems in the early 1980s. His previous senior roles and directorships have included positions at software development business ECS, GADC Networks and on the International Executive Committee of listed European firm GFI Informatique.

"Our primary objective in appointing Steve is to bring a new dimension to our new business work," explained Accutronics managing director Rob Phillips.

"Among his responsibilities, Steve will chair the monthly management board-meetings, and once Steve is on board I’ll have more time to focus on sales and marketing."

Accutronics specialises in developing smart batteries which offer improved functionality and performance and features such as charge control, accurate fuel gauging and device communication.

The company targets specific product application market sectors, including medical and healthcare, defence and security, industrial and portable electronics markets worldwide.

The independent battery design, development and manufacturing expert currently exports its products to over 30 countries across Europe, North America, Africa and the Middle East.

"The original equipment manufacturers (OEMs) we work with as customer are chosen to match our capabilities as a potential strategic supplier," continued Phillips. "With the support of Steve and the rest of the management team we can strike a better balance between managing the company and growing the business. Our aim is to successfully enter new markets and expand our customer base."