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.