It is easy for those of us involved in medical device development to have a technology-centric view about creating new and innovative products for use in the ICU. The ICU is, after all, a technology-rich environment and the huge advances in critical care over the last 40 years have mostly been enabled by technologies of various and varied sorts. However the critical care world is changing and I suspect it will impact the innovation landscape. Some of the trends that I’ve seen include:

Money isn’t in endless supply so new products can’t necessarily be adopted just because they improve care. New products will need to demonstrate improved care AND cost saving. An improvement in care alone may not be good enough.

Infection control is a massive issue and our arsenal of antibiotics and antimicrobials is diminishing. However, the biggest improvements in infection control haven’t come from sexy technologies but from people-centric improvements in practice.

Usability is becoming more important for regulators and notified bodies. Whilst the clinical staff who work in the ICU are relatively well trained, they are under tremendous pressure and have a huge number of products to interact with. Therefore getting design right can have a huge impact on adoption and outcomes.

I think we need to be mindful not to always reach for the ‘clever technology’ cupboard for our next generation of products. Technologies of many and various kinds will continue to have a huge role to play but we must focus on delivering products which clinicians find easy to use, fit with established workflow, save time or money, improve outcomes, and create a strong affinity between our customers and our products.

In the field of robotics technology, there have been many advances over the last couple of decades, with successful application in various industries such as automotive manufacture. According to the International Federation of Robotics there are over 17 million robots in use worldwide, and the number of robots doubles approximately every 2.5 years.

However, until now the advances in medical robots has not been as pronounced … but times are changing!

As the healthcare providers push for lower costs and better clinical outcomes than existing techniques, I believe we can expect to see some exciting developments in the next 10 years. The advantages offered by robots include higher diagnostic efficacy, fewer errors, less complications, and reduced hospitalization time and cost.

Few medical robots will look like C-3PO, the Terminator or the Daleks, but some have a passing resemblance to R2-D2 or Wall-E. Here is a brief outlook on some of the medical fields that robots are being used in:

• Surgical Robots – One of the more advanced areas is surgical robotics, in which a robot performs surgery under the control of a surgeon. Systems such as Magellan and Sensei X from Hansen Medical, and da Vinci from Intuitive Surgical all enable minimally invasive surgeries through improved visualisation, dexterity and precision. The use of much smaller incisions often means quicker healing, and lower risks of infection and other complications.

• Maintaining Organs – When donated organs are retrieved, they have previously needed to be packed in ice and rushed to the transplant hospital. Systems like the OrganOx Metra – the normothermic organ perfusion system designed and developed by Team – enable the preservation of organs for much longer time periods, and objective viability assessment prior to transplantation. These systems will help to increase the number and quality of organs for transplant.

• Cognitive Therapy – From Japan, we have Paro, a therapeutic seal robot. Studies have found that interacting with Paro was found to improve the brain function of elderly patients with cognition disorders, and so improve the quality of their lives and decrease the need for long term care.

• Aging Populations – As many nations deal with the challenges associated with aging populations, robots will be of great assistance to the elderly and the healthcare systems. Some will help to remind users to take their medicine, some will help to open doors, and some like RIBA will help lift those who are not able to sit, walk or stand themselves.

• Drug Dispensing – Intravenous drug delivery is the most powerful route to administer drugs but when things go wrong, it has the most devastating consequences. Solutions such as IntelliFill i.v.from Baxa are designed to automate the intravenous drug preparation process, and can fill infusion bags and syringes more quickly than people. They typically use barcode scanning, vision systems, and weight confirmation steps to identify final products and to reduce medication errors, and they reduce staff exposure to highly aggressive therapies.In any medium or large hospital, the pharmacy can expect to fill and dispense over 5,000 prescriptions every day, handling over 700 different medications. This is both time consuming and mundane, and human operators do make mistakes. Robots are ideal for tasks like this, and the ScriptPro 200 and ROBOT-Rx have both been used to great effect – to the extent that as of 2009, the ROBOT-Rx had given out more than 45 million doses without any mistakes.

• Sample Storage – Biobanks of varying sizes have been designed, developed and installed which enable the safe storage of biological samples in sub-zero conditions. The Polar system from TAP Biosystems is a network of robotic armature apparatus and temperature components that stores and retrieves up to 10 million perishable samples, at temperatures of -80°C. By using a robot to do the work of sample retrieval, humans won’t have to suit up and enter the extreme cold environment and work time will be quickened.

Developing medical robots is a complex, expensive and long process, however, the need – whether that is reducing the cost, eliminating mistakes or opening up new opportunities – is there and the technology exists. A solid understanding of the clinical environment is essential if the technology is to be harnessed to meet the user needs, but the possibilities are endless.

On the 26th of May 2012 I will be attempting to ascend the stairs of New York’s Empire State Building whilst carrying 125kg in weight for various charities (so far I’ve raised over £300,000 through corporate supporters and personal donations). I’ve been in training for a year and I’ve picked up a number of injuries in this time, although very few of them caused by the training itself. As a ‘warm up’ I climbed the BT Tower in London for the charity Sport Relief in March (raising £18,000 in the process).

Standing at the top of the 177 metre tall BT Tower I looked across the skyline at the high rise buildings and monuments that make London such a fantastic city and considered the enormity of what I had just achieved. A sense of pride came over me as I was greeted by my support team and friends who deemed jumping on me an appropriate way to congratulate someone who had just carried 150kg up 34 flights of stairs in under an hour.

It was all too easy to get carried away with the moment. Whilst this was a pretty amazing achievement, a world record and thousands of pounds for charity, I had to figuratively keep my feet on the ground amid the adulation and remember in the grand scheme of things this was merely a training exercise for the main event. In May I’d be taking on the 86 flights of stairs to the observation deck of the empire state building in New York City in an attempt to break a world record I’d arrogantly scoffed at one evening almost a year ago to the day. No amount of training could prepare me for the sinking feeling I had in my stomach that was telling me this wouldn’t even be the halfway point.

“Crikey that was a lot of stairs” wheezed the lady from the Guinness World Records office who had been following me up the BT Tower to make sure nothing untoward was going on.

“How do you think I feel?!” was my muttered response.

www.justgiving.com/Mark-Shepherd

When a clinician tells you they want a specific device to satisfy an unmet clinical need – how do we know whether that specific solution is actually what they want and isn’t just what the clinician thinks they want because they aren’t aware of an alternative?

I attended a recent conference entitled ‘Clinical Needs and Sensing Solutions – Meet the Clinicians’ in which a number of clinicians presented their ‘bucket lists’ of unmet clinical needs which they believe could be satisfied by sensing solutions. I have no doubt that the problems mentioned are real clinical needs, but as a medical device developer what do you do? Develop the product the clinician can tell you they want now, or try and dig deeper into the bigger picture in order to develop the product they might not even know they want yet? The two approaches could result in two very different products developed – and only one could be the ‘right’ product.

Let’s take for example a problem highlighted at the conference by an orthopaedic surgeon, with diagnosing compartment syndrome. Groups of muscles in the arms and legs are separated from each other by fascia, which create confined ‘compartments’ and which contain the muscles tissue, nerves and blood vessels. Following a trauma or crush injury, the tissue inside the fascia can swell, but the fascia itself does not, leading to an increase in pressure within the compartment and causing ‘compartment syndrome’. If this pressure goes above a threshold, blood flow to the compartment will be blocked. This can lead to permanent injury to the muscle and nerves and if the pressure lasts long enough, the muscles may die and the limb may need to be amputated. The problem highlighted by the orthopaedic surgeon was that in order to diagnose compartment syndrome, the patient must have an invasive pressure sensor inserted into the muscles in an OR and under anaesthesia. Therefore, his unmet need was for a non-invasive pressure sensor to replace his current invasive method. I am certain that a non-invasive pressure sensor would be a good solution, however, without digging any deeper into the problem how do we know whether a non-invasive pressure sensor is the ‘right’ solution? For example, what’s driving his request and what’s his overall goal? Is it to reduce costly OR time? Is it to minimize the need for anaesthesia? Is it to minimize pain to the patient? Is it to reduce the number of amputations that occur due to compartment syndrome? We also might want to know more about the trade-offs and what’s important to the clinician. Who are the other stakeholders involved? What’s the context of use for the product? Therefore, depending on the clinician’s goals, and a number of other factors, there could be many product solutions to the problem which don’t necessarily involve a non-invasive pressure sensor.

From a human factors perspective, this is a very interesting area. It is very important to ensure that a product is usable from a safety and design perspective, but if it’s not the right product in the first place will it be a success? I believe it’s really important to have clinical input right the way through the product development process; from early investigative work at the start to define the product opportunities and then continuing with regular touch points throughout concept generation to ensure that the ‘right’ product ends up in detailed development where the more safety critical aspects of usability can then be assessed.

So – what they say they want and what they really want – are these the same thing?

The news today that the UK government is set to launch a ‘national challenge on dementia’ and double funding for research to £66m is encouraging but ultimately a small drop in the ocean.

This often neglected illness is thought to affect around 800,000 people within the UK at an estimated annual cost of £23bn to society (Alzheimer’s Research UK). These figures, while high, can never capture the personal cost to the friends and families of patients who often bear much of this burden in silence.

The Design Council and Department of Health are currently looking at ways in which good design can improve the lives of patients are carers suffering with this disease. Partnering charities with design consultancies, they aim to create products and services to make both patients and carers lives easier, better planned and ultimately more enjoyable. The proposed solutions are wide-ranging and innovative but fail to tackle one of the biggest challenges surrounding cognitive decline in the UK – early diagnosis.

Prime Minister David Cameron was quoted as saying that “the level of diagnosis, understanding and awareness of dementia is shockingly low. It is as though we as a country have been in collective denial”.

The 2004 Facing Dementia Survey gathered data from various groups across six European countries and found that the time taken to diagnose Alzheimer’s, after symptoms were first noticed, was considerably longer in the UK (32 months) than in France (24), Spain (18), Italy (14) and Germany (10). In fact the UK ranks in the bottom third of all European countries when it comes to diagnosing the condition. A 2007 National Audit Office report found that only 58% of GP’s questioned felt confident in their ability to make a diagnosis of dementia. This highlights a worrying trend; in 2004 the number was 64% when asked the same question.

Ultimately diagnosis is the gateway for care. Without it no drug or non-drug based treatment can be given, no well-designed products or services can be accessed, and the effective forward planning and interventions with the ability to extend and enhance lives cannot be put into place.

This is a growing problem; globally there is a new case of dementia every seven seconds. This morning’s announcement of additional funding, coupled with an initiative from the Design Council are welcome steps in the right direction. However, until we can address the challenge posed by effective early diagnosis, the benefits offered by these potentially life-changing services and products will be limited.

Living well with dementia (courtesy of Design Council UK):

The new verification standard for inhalers, BS EN ISO20072:2010 was published a few years ago and is beginning to find its way into device verification plans and activities. Here at Team, we have been involved in helping several clients to interpret the new standard and translate it into an agreed set of verification tests and assessments.

Naturally, all new standards have a ‘bedding in’ period, where the industry discovers what the requirements mean in practice. This standard contains a new aspect which is leading to greater uncertainty than some, though many other aspects of the standard are thankfully clear.

The BS EN ISO20072:2010 standard fits with the apparent trend in pushing responsibility for defining, as well as managing, risk to the device developers. In pushing this aspect even further, this standard now states that the developer needs to establish a “device functionality profile” (DFP) that “consist[s] of identified critical functions and design features, test methodology, tolerance limits and acceptance criteria”. This is intentionally separate from drug delivery performance, which is explicitly excluded from all but a final “system verification test”.

This ‘DFP’ allows the standard to be applicable to the different types of inhaler and might, at first, appear to be a subset of the requirements -those that are critical to function. In addition, the standard states that this DFP should also be “based on the outcome of the risk assessment” and, hence, it should be assumed that some risk mitigations (from FMEAs etc.) will also be used. It is good to see the specification of requirements for device performance taking into account the nature of the medication – and the risk of not delivering it successfully – but the way in which this is incorporated is open to interpretation.

Therefore, the standard effectively asks the developer to create a statement that, if the device does everything listed in the DFP, within acceptable limits, the device ’works’. This is inevitably open to significant differences in opinion about how much is incorporated into the DFP as well as being largely dependent on the organisation’s general attitude to risk. There is also some ambiguity as to what the DFP ‘looks like’, and whether or not it is the set of requirements for the device or the summed description of what performance profile the device actually achieves.

It will be interesting to see how the regulatory agencies react to these initial interpretations of the term DFP, and whether the trend is towards large sections of the requirements and large numbers of mitigations being included…or the reverse. It does, at least, force the developers to keep questioning what it is that defines how their device actually works, outside of drug delivery performance.

I’m currently preparing my presentation on EEDDs (electronically enabled delivery devices) for next week’s Management Forum Injectable Drug Delivery conference in London (21 & 22 March 2012). And during the course of my preparation a colleague kindly provided me with some headline figures from a report from Cutting Edge Intelligence on patient adherence. I won’t quote all of the figures in this blog post (you’ll have to come and listen to me present at the conference) but they are striking.

In particular, the overall annual cost (to the payers, patients and pharma companies) in the US alone of non-compliance is estimated at $180bn. Now think what this could be on a global scale…

Compliance and adherence is the hot issue at the moment. It has been the big issue since 2009 when ANSI/AAMI HE75:2009 was published and with these figures it will continue to be one of the big issues impacting on medical device design. As insurance companies and healthcare providers realise that this lack of compliance is costing them money they will quite rightly push back on the industry to demand that something is done about it. Although technology and device design can’t solve the problem, turning user understanding and empathy into good design and safe/simple interfaces can play an important part (alongside better IFUs, patient support, device training, etc, etc).

This need to improve compliance is one of the trends behind the introduction of electronics in drug delivery devices. Not just injector pens, pumps and autoinjectors, but also all other delivery routes. Electronics aren’t the silver bullet and they aren’t appropriate in all cases but in my presentation I highlight a few opportunities where they could have a positive impact on improving usability and compliance (as well as anti-counterfeiting).

Hopefully I’ll see you next week. But if you can’t make it and would like to know more about my presentation I’d be delighted to hear from you.

Sir Paul Nurse, leading geneticist and Nobel laureate, spoke of his passion for science when he gave the recent Richard Dimbleby lecture on the BBC.

Sir Paul said: “The UK has a great advantage with a very strong life science research base, a unified health service and an active pharmaceutical industry. If all three work together we can carry out research which will not only improve our health services but help our economy. It is time to turn the NHS into a health care producer as well as a healthcare provider.”

He mentioned the need for greater collaboration between publicly funded research and private companies to help turn ‘discovery research’ into effective applications.

Sir Paul iterated many times how [good] science will help and drive the economy, and promote economic sustainability. But that a cultural shift is needed to recognise this crucial role that science will play and not just be seen as a drain on resources by the public, politicians and the Treasury.

From the science and discovery comes the engineering and manufacturing. Despite years of decline, the UK government believes that manufacturing will help get the country out of recession and boost economic growth. But while the government is keen to financially support the banking sector it seems reluctant to invest significantly in bolstering science and manufacturing in this country.

I think we need to get on Sir Paul’s bandwagon and get government and society to accept the importance of science in our culture and its ability to improve our economy and support sustainability.

The Government’s decision to completely re-assess and re-energise teaching of computer science in schools is a very welcome decision. They’ve identified that spending time teaching kids how to use Word and Power Point is pointless and dull, and they’re going to shift the emphasis to writing computer code instead.

Two giants from my very geeky childhood are behind this initiative: Ian Livingstone and David Braben both important entrepreneurs in the area of videogames. I grew up in the era where every school had a lab of BBC Micros (if you’re under 30, ask your dad) and the kids were actively encouraged to learn to program. Maybe a lot of this didn’t go far beyond getting a line of obscenities to scroll down a computer screen but firing kids’ imaginations with control of ‘robotic’ peripherals and data gathering was hugely powerful. The kids who really engaged with this grew up to power the UK’s dominant position in the videogame and computer modelling industry.

A lot of junior schools now have teachers with no real grasp of coding or any other form of engineering and so if we’re going to keep this momentum moving in all our technical disciplines it’s going to be up to us, in industry, to help. I’m a school governor in my spare time as I’m anxious to give back to the education system that gave so much to me and I’d encourage all the engineers and technologists reading this to give some time to their local schools to turn this initiative into a revolution and help a new generation of geeks make their impact on the world.

The role of mass media in influencing the way technology is created is in the spotlight again. The Royal Society of Chemistry has recently bemoaned the influence of negative film stereotypes on the nuclear power industry and a new X prize has been announced for the first creator of a Start Trek style medical ‘Tricorder’.

But do films and television inspire inventive people? Do they even inspire children to want to become inventors, engineers or designers? Or do they merely reflect what the wider population understands about what creators of new technology do? In contrast, people are bombarded by glamorous lawyers and doctors in the media every day.

I attended a talk by Sir Christopher Frayling a few years ago in which the way inventors are perceived through media was examined. The slightly pithy “From Brunel to Wallace and Grommit” belied the important shift in perception from technology creators as saviours to sinister agents or, possibly, ineffectual objects of humour. This obviously mimics the public perception of technology as a whole, but affects the way our industry is perceived…as a beneficial solver of problems, or as a creator of unexpected, or intentional woe.

As much as mass media can damage the reputation of technology, I have never met an engineer or designer that wasn’t affected and inspired in their youth by characters or situations in films and television. Maybe we shouldn’t be too disheartened by the role of mass media in technology. I would suspect that doctors bemoan Dr House’s portrayal and, let’s face it, scientists have it far worse.

I, for one, hope the poorly researched science fiction and news reporting filled with hyperbole continue to inspire young people to choose a profession that can improve people’s lives and be truly rewarding.

I was sad as I left the old Central Saint Martins college building at Southampton Row for the last time (after attending the alumni party shortly before the closure of the site last year). I guess mainly driven by nostalgia of happy days back in the early nineties when I spent three years there studying Product Design. But also driven by a feeling that maybe it wasn’t ‘right’ to move from a building with such history that saw so many influential designers and artists pass through it, to what I was concerned may be just another generic new facility in a cheaper part of town. One of the strongest memories I have of the old building was the feeling of pride I felt the first day I walked through the heavy old wooden doors and climbed the staircase with its brass handrail and marble steps polished by years of hurrying students late for lectures. Pride that I was studying at such an established institution, no doubt evoked by the architecture and history which surrounded me. ‘How could this possibly be emulated in a new building?’

The inspiring spiral staircase

On Tuesday evening I was invited to the new site in Kings Cross which I can sum-up in one word ….WOW!.

From the ‘super cool’ airstream caravan café, to the exposed brickwork and wooden joists of the old 19th century Warehouse and transit sheds. It manages to retain a sense of history and nostalgia helped by the inclusion of a few curiosities around the place that I remember from Southampton Row, like the old shop front signage in the reception area and the fact that they’ve retained the name of the Letherby gallery.

‘Huge’ open spaces intersected with modern glass and concrete detailing bring it into the 21st century and make it a more usable space, but what I believe is more important is the fact that so many creative talents are thrown together under one roof. Sir William Letherby had this same vision when he created the former Central School of Art building in 1896, 100 years later when I studied there we were still free to roam between the various studios mixing with jewellery and ceramic designers, print makers and stained-glass designers. Benefiting from the experience and approaches of each discipline and the creative sparks that it encouraged. The school as a whole though had become more fragmented, since its merger with Saint Martins in 1989 and was spread across several sites.The whole college is now housed in the same facility and therefore students can truly benefit from the eclecticism of all the different subjects.

At Team we have a similar approach. In our 13th century barn just outside Cambridge, industrial designers, mechanical, electronics and software engineers and human factors specialists are mixed up in the open-plan environment which encourages open communication and collaboration. We have the ability to put people in project or discipline focused groups when needed, but we firmly believe that mixing disciplines encourages creativity and helps remove barriers that could otherwise develop. To have the ability as a designer to lean across your desk and ask an experienced analytical engineer whether a 20mm diameter aluminium tube can carry the weight of a person or what the battery life will be if we use a colour touchscreen rather than an LED display can save days of work and open up a new opportunities that might have not otherwise been pursued. Similarly I’m sure mixing fashion designers and fine artists, with graphic and industrial designers will lead to new ideas and approaches in design process and will help Central Saint Martins retain its reputation as one of the world’s finest educational institutions for art and design.

The world of design has changed dramatically in the fifteen years since I graduated, with opportunities created by advances in computer software and rapid prototyping technologies, a world of design research information now available at our fingertips in the form of the internet and new challenges introduced with a move from local manufacture to off-shore. The role design plays in our world will continue to develop and it’s important that design education moves with it, to best prepare the next generation of thinkers for the changing needs of our society. This new building, I believe, is a sign that even some of the oldest establishments are ready to embrace change and I look forward to seeing what it brings.

BCC research claims that the global pulmonary drug delivery market will be worth a staggering $44 billion by 2016. They estimate that the global market for pMDIs will double over the next four years to almost $30 billion, with a similar rise for DPIs – reaching $13.4 billion by 2016.

Whilst anyone involved in the design and developments of inhaler products will clearly stand to benefit from this huge CAGR of over 14%, the question that comes to mind is, “What is causing such significant market growth?”

Much can be attributed to the unfortunate rise in asthma and COPD resulting from rapid industrial expansion in BRIC countries – however, a recent report (April 2011) by Frost & Sullivan estimates that the total number of US citizens with asthma or COPD is likely to rise to almost 44 million by 2016 – 4 million more than in 2009. Even in the Western world, respiratory disease is an increasing problem.

There is also substantial research currently underway to deliver drugs via the pulmonary route for therapies beyond asthma and COPD – for example; break-through cancer pain, migraine relief, diabetes and vaccination. This offers exciting opportunities to develop devices that must work for inexperienced users. Usability will be paramount to the success of such inhaler products – their market will not be well-practiced individuals who routinely inhale twice daily. Additionally, many of these new formulations are unlikely to be carrier-based, due to the high dosage requirements. Devices that deliver drug-only formulations are technically challenging, and rely upon different underlying aerosol science to classical carrier-based formulations.

So it appears that we have busy times ahead… The challenge is to develop inhaler technologies which can deliver sometimes large quantities of respirable particles in a controlled and efficient manner, and that do not require the extensive effort of developing ‘engineered’ formulations in order to work effectively.

Jonathan Ive has been made KBE in the New Year Honours list. This is fantastic news for three reasons.

Firstly, it’s great to see a British Designer at the heart of the massive success of Apple…and he is at the heart of it. British design is a globally respected skill and a heritage we should be proud of.

Secondly, it’s great to see product design given publicity in this way. The design industry is a forgotten part of the “creative industries”, which creates a huge amount of wealth for the UK economy.

Thirdly, and personally the most important, Jonathan Ive is a designer that truly values the creative power that is found in team work. He is passionate about the user, the experience, the technology and the magic of modern production. At a talk I attended in 2010, he spent most of the time conveying his awe of how the iPhone is made.

Perhaps the scariest point ‘Sir Jonathan’ made at his talk was that the growth of touch screen devices was effectively leading to the withdrawal of industrial design. The iPhone (for example) is all interface. Therefore, the product disappears and the experience is dominated by the graphics.

It will be a while before medical devices have to worry about third party applications on their screens, but it will be worth watching the new paradigm that the design industry is learning to engage with.

A couple of Jonathan Ive videos worth watching on youtube:

Jonathan Ive talks about the magic of production

Jonathan Ive talks about the importance of instinctive interface

In December, it was announced by the Technology Strategy Board that the Cell Therapy Catapult (formerly known as the Cell Therapy Technology and Innovation Centre) will be based in London, and will draw upon the nationwide expertise from hubs and universities such as Cambridge, Edinburgh, Loughborough, Newcastle and UCL.

The Catapult will receive £50 million pounds from the TSB over the next five years, with the intention of similar amounts coming from industry, and through competitive grant funds. This is great news for the cell therapy and regenerative medicine sector in the UK, and should enable British scientists and industry to develop radical treatments for degenerative diseases which can then be commercialised, in turn boosting the economy.

As the direction and operational vision of the Catapult is shaped and defined, Team consider it imperative the it considers not only the science but also the science can be successfully translated and commercialised, which means that there must be due consideration of how the therapeutic product will be manufactured, inspected, shipped and delivered into the patient.

In recent issues of GEN, we have highlighted that there is recognition internationally amongst stakeholders in the cell therapy and regenerative medicine sector that the commercialisation of novel therapeutic interventions requires expedient development in order for them to be provided by healthcare system and providers, within the existing infrastructure. For us, this means agreement on standards and developing approaches for reducing the total cost of goods, and we firmly believe that this can be best achieved through collaborative effort – and the Catapult can help to drive this forward.

The TSB’s plan to establish a minimum of six Catapults by summer 2013 is provided in its strategy document, Technology and Innovation Centres Strategy & Implementation plan, published in May 2011. This builds on previous reports created by Herman Hauser (The Current and Future Role of Technology & Innovation Centres in the UK) and James Dyson (Ingenious Britain).

Drug Delivery to the Lungs (DDL) goes from strength to strength – now in its 22nd year hosting almost 500 delegates at the EICC in Edinburgh, having long since outgrown its origins in the Church House in Westminster, London.

DDL has always had a strong focus on the technical side of respiratory drug delivery – with numerous poster presentations pushing the collective knowledge of the underlying science. And it continues to do so, with a wide variety of presentations covering everything from patient needs, formulation, device engineering and the physics of aerosolising fine powders.

Professor Peter Barnes from Imperial College London presented the opening DDL lecture with a though-provoking talk in which he called for the development of new COPD drugs with a smaller MMAD (Mass Median Aerodynamic Diameter) in order to target the deep lung.  The rest of day one centred around ‘Disease states beyond Asthma and COPD’, and included presentations on the treatment of lung cancer, migraine relief and tuberculosis from device and pharma companies, and academic research groups.

Vectura sponsored the evening drinks reception and entertainment, which encouraged visitors to the main exhibition hall, where they could eat, drink and network, and enter various competitions to win Kindles, iPads and numerous bottles of single malt.  For the first time this year, the DDL organising committee ran a quiz with an iPad as the main prize – many of the answers required knowledge only available in the exhibition hall – a cunning plan that certainly seemed to do the trick!

Our own stand was very busy, with many people up for the challenge of inspiratory ‘weight lifting’, using our purposely designed Inhalator apparatus – with two Kindles on offer as prizes to the man and woman with the highest inspiratory muscle strength.  Frank Koppenhagen of Teva held the lead at the end of the first day, with a staggering lift of 5.77 kg, which was all of the weights we had available at the time!

Day two began with several presentations on ‘optimising inhalers’, including some thought-provoking science about the underlying physics of deagglomeration / aerosolisation by James Tibbatts (Concept Flow).  This led onto a new format with presentations given from device ‘champions’ representing the patient, pMDIs, nebulisers and DPIs, followed by half an hour of questioning from the audience.  I was invited to be the DPI champion and presented its case. You can download a PDF of my slides here or you can view them below via SlideShare. The afternoon hosted poster presentations from candidates for the Pat Burnell New Investigator Award, which was won by Eva Littringer (Research Center of Pharmaceutical Engineering) for her research into the effect of carrier shape and roughness on fine particle fraction.

Despite hurricane force winds during Thursday, attendees arrived bright and early on Friday for the final sessions – the physio chemical properties of drugs, and ‘What on Earth’ – in which the audience enjoyed learning about Liquidia Technologies’ process for printing inhalable particles – precisely controlling their size and shape.  Frank duly defended his title on the Inhalator, fending off efforts from Douglas Bradshaw (TTP), Mark Hammond (Melbourn Scientific) and David Morton (Monash University).  He was still able to comfortably raise 6.27 kg (we found some more weights) – demonstrating a whopping 30+ Joules of inspiratory energy.  Eva Littringer, who won the Pat Burnell award the previous day, topped the ladies’ leaderboard, with a lift of 4.27 kg, half a kilo more than her closest competitor, Georgina Fradley (3M).  Both Frank and Eva took home the latest Kindle eReaders.

Another year and another fantastic event – our thanks go to the organising committee and the attendees who published, presented and came along to make it all happen.

Just in case you missed it, November has been unofficially renamed as Movember and all over the world men have been raising awareness of, and raising money for, men’s health (in particular testicular and prostate cancer). As a bit of fun a group of 14 of us at Team decided to join in.

So on November 1st we arrived at Team HQ all clean-shaven and excited at the prospect of emulating Tom Selleck, Freddie Mercury or even Hercule Poirot. What followed was 30 days of competition, complaining and itching but finally we made it. Some had previous top-lip experience and some were blessed with good facial hair genes but we all had a good laugh (at ourselves and each other) along the way.

At the time of writing we’ve collectively raised £1739 for a number of cancer charities and hopefully done our bit for men’s health. If you would like to donate you still can, just click here.

Below you will find a Flickr album of the results:

Amidst all the drug-centric conferences which make up the majority of the opportunities to share knowledge and experience with competitors and clients, it’s always encouraging to find an equal level of enthusiasm for the industry at the smaller, niche conferences.

On Tuesday 29th November I attended Medelec, the only event of its type in the UK and certainly matching the description of a ‘niche’ conference. It’s no secret that the Medical Device and Systems market is growing rapidly, and personal experience has recently shown a clear increase in interest from clients in using electronics to add value or utility to a product. In its first year, Medelec has made a credible stab at addressing this sizeable opportunity.

First, the downside. Inevitably, when a conference deliberately strips itself of the comfort of big-pharma, there’s a practical limit to the size of the event. In this case, 120 delegates took the event close to the limit.

And the upside? By choosing the Menzies Hotel just North of Cambridge (UK) as the venue, UMR (the organisers) have cleverly limited their exposure whilst at the same time attracting a reputable speakers list and an interested audience. It was certainly encouraging to find a full house from the first presentation through until the late afternoon, and there was even the luxury of two parallel presentation tracks during the core hours from 11am.

The presentations ranged from the instructional – Julian Day from Green Hills Software on mitigating risks with IEC62304 (No really, this is interesting stuff, just pop me an email if you don’t believe me) – to the inspirational; Dr Jon Hayes’s presentation on getting a fertility monitor on the market with minimal time or money, for Cambridge Temperature Concepts.

In between these extremes were solid technical presentations from Bitwise, Adacore, Intel, MLelectronics and Wind River (although the parallel track meant I was only able to catch up on the first and last of these by networking over lunch), and a small but interesting exhibition hall featuring stands from these same speakers and a small band of related software tool vendors.

Yes, the rooms were slightly small, and the sound system struggled at times to overcome the overworked air conditioning, but overall this was a productive day and a creditable first attempt to approach the industry from a different angle. It will be interesting to see how the event develops in future years.

Last week Team attended the 2011 PDA Universe of Prefilled Syringes and Injection Devices event in Basel. This is recognised as the premier event focussed on parenteral delivery and this year a record number of 620 delegates from around the world came to network, renew friendships, get industry updates and learn about new products and technologies. Team had a stand (or booth if you are from the US) and were pleased to welcome many of our existing clients and partners together with a large number of new faces. I was privileged to be a member of the scientific planning committee and to deliver a keynote address at the opening plenary session.

The main theme of the conference was intended to be device usability – and this certainly was a major interest for many participants. However two other topics were high on the agenda, both during discussions around the show and in many of the presentations; these were the use of cyclic polyolefin primary containers instead of glass and the delivery of high volume, high viscosity doses.  A number of presentations (mine included) mentioned the rise of the COC and COP prefilled syringes now being offered by several manufacturers and also the proliferation of patch pumps/bolus delivery devices.

All in all a very lively and interesting conference, which stimulated a lot of very useful and thought-provoking discussion. We look forward to the 2012 PDA Universe of Prefilled Syringes and Injection Devices event in Las Vegas.

You can see the slides from my keynote presentation below:

In my second article for GEN magazine on regenerative medicine I’ve focused on cost of goods. Without complete devices or systems that are designed and manufactured with cost and manufacturability in mind, the scientists behind some truly ground-breaking regenerative therapies or interventions may never see their creations reach the market or obtain the investment they need to develop it further.

We’ve always argued the case for considering device design from the outset, not once the science is finalised as the therapy and the enabling device need to co-exist. In my article I’ve focused on why this is so important, especially in the embryonic RegenMed sector. You can download a copy of my article here.

Alternatively you can read it via SlideShare below.

Colin Mathews and I kicked off the recent World Pre-filled Syringes Summit in Washington DC with a three hour interactive workshop with the title ‘The Process and pitfalls when developing an Autoinjector’. We had hoped for plenty of participation and certainly got it – a very constructive and open discussion with some fascinating perspectives and experiences.

This was the first injected therapy event by organisers Hanson – Wade.   There were about 65 attendees from across the industry; big pharma / biopharma, established speciality Pharma, generic pharma / biopharma and venture funded early-stage companies plus from the device / CMO / manufacturing side, major device and component suppliers and companies providing fill / finish and test equipment. And then there were a handful of service providers and consultants – including Team!

The title ‘Pre-filled syringes’ could sound rather narrow but this is not really the fault of the organisers – it has become a label applied by the industry as a whole to describe any and all of the issues assocColin Mathews and I kicked off the recent World Pre-filled Syringes Summit in Washington DC with a three hour interactive workshop with the title ‘The Process and pitfalls when developing an Autoinjector’. We had hoped for plenty of participation and certainly got it – a very constructive and open discussion with some fascinating perspectives and experiences.iated with self-administered injections. Just a few years ago, self–injection meant patients coming to terms with using a vial and syringe.  Changing the primary packaging format to a glass bodied pre-fillable syringe simplifies therapy for the patient but also introduces new issues for the manufacturer, a wide range of which were covered this week.

Some attendees were already using pre-filled syringes or about to do so, but for many the focus was the autoinjector – the logical evolution to further improve usability.  Experiences ranged from having marketed autoinjectors through current implementers to others involved in developing alternative, completely different injection systems.  Irrespective of delegate background, there was real openness, and a willingness to share ideas and swap experiences which was genuinely refreshing. In a shift from typical historic practice, there was notable and widespread acknowledgement that as the interface between the drug and the patient, the delivery system must be considered from the outset alongside development of the therapy, drug or formulation.

If you are interested in learning more about our workshop or the process of developing an autoinjector, then please get in touch.

On 29th September 2011 just over 200 delegates gathered at UCL London to hear presentations from four of the UK’s leading stem cell companies.  Organised by the LRMN and OBN the event was an evening showcasing some of the best UK cell therapy and regenerative medicine companies.  The presentations were held in the rather splendid tiered Gustave Tuck Lecture Theatre followed by the opportunity to meet the speakers and delegates over light refreshments.

There were two common themes coming through the presentations: firstly, that stem cell technology is likely to significantly benefit patients (including horses!) over and above current therapies; and secondly, that the venture capital community sees such investments as high risk opportunities and alternatives such as Angel funding or grants were often needed.  According to Michael Hunt, CEO of ReNeuron, “It is not the technology that keeps me awake at night – it is the funding – the fear of the business failing before it has had the opportunity to prove the beneficial effects in man.”

For Greg Sando, CEO of Cell Medica, “funding is a challenge – big pharma has not yet woken up to cell therapies – VC’s are focussed on simple business model with a 5 year exit (sell-on) strategy – VC’s are not interested in revenues which is tough for cell therapeutic companies”.  There was no talk of delivery devices as this is not currently seen as a priority given the funding situation. There were no clear strategies on busess models although all of the companies seemed to want to build viable businesses with revenues rather than sell-out early.  In summary, there is huge promise from this sector but it may be some time before these pioneering companies achieve both clinical and business success.

Yesterday, Team headed up to the futuristic-looking Lowry Centre in Salford Quays for Regener8’s annual conference, entitled Delivery of Regenerative Technologies on a Commercial Scale.  Great venue, but the bottlenecks at the lift highlighted man’s eternal struggle against using the stairs…particularly to the 4th floor conference room. The event kicked off with an update from John Fisher on Regener8’s achievements over the past year, focusing upon the organisation’s success in bridging the innovation gap between early stage university research and industry-led product development.  There were a number of key themes running throughout the conference, particularly the need to develop enabling technologies to support translational regenerative medicine studies, and the reliance upon truly broad and multidisciplinary collaborations spanning material sciences, mechanical engineering, molecular and cell biology, in order to progress the science and establish clinical proof of concept.

One of the standout presentations for us was a keynote talk by David Haddow, Operations Director at Sheffield-based Altrika.  A material sciences company, Altrika is utilising novel acrylic acid polymers to culture autologous and allogeneic skin cells in such a way as they can be delivered to the wound bed in a biologically active state with greater efficiency and less waste product as compared with existing tissue engineering approaches.  Altrika’s approach to wound care management highlighted the potential to significantly reduce the number of clinical visits for patients with burns and diabetic ulcers, resulting in overall reduction in cost of treatment.

One observation from the day’s talks: the reliance upon non-dilutive, central funding sources rather than venture backed funding to progress UK-based RM product development programmes.  The financing of the RM sector was picked up by Cathy Prescott at Biolatris, who highlighted the need to align risks, drivers and incentives for each of the major stakeholder groups and presented a novel approach to funding RM therapies, based on significant loss of economic productivity caused by the typically chronic conditions which RM aims to treat, rather than healthcare costs alone.

David Williams highlighted downstream requirements such as manufacturing, transportation and physical delivery of the final therapy should be considered early in the process to ensure product development success.

It was a good day in terms of the quality of talk and networking.  However, it would have been good to see better representation from the pharmaceutical industry, where we know there is growing R&D interest in regenerative medicine interventions.

A risk-based approach to design for manufacture and assembly allows the manufacturer to have greater control over each stage in the production process, which brings with it the assurance that a process will yield its expected return.

Every designer,manufacturer and assembler – no matter the product or sector – wants certainty. Clearly, manufacturers want assurance that the product they have invested time, energy and money into conceiving and designing is going to make it through manufacturing and assembling to market,without added costs or last minute delays. Once the product reaches the market, they want a lean, reliable and safe production process without problems.They are not gamblers and they don’t like risks, especially in the healthcare and life science industries…

You can read more about this risk-based approach in the article that was recently published by PMPS. Click here to download a PDF version, or alternatively, read it below:

I was recently invited by GEN magazine to contribute two articles to their magazine on regenerative medicine, and in particular how these innovative therapies and interventions could go ‘mainstream’. From our perspective as engineers and medical device developers there are two particular themes that need to be overcome: standards and the cost of goods. In the first of my articles I’ve focused on the development, introduction and adoption of industry standards, which you can read  below or download a PDF copy here.

 

 

Last night two colleagues and I attended the OBN (Oxfordshire Bioscience Network) Annual Awards at the lovely Pembroke College. We were sponsoring the Best Emerging Medtech Company category which was won by OxTexs, a manufacturer of anisotropic self-inflating tissue expanders for use in reconstructive plastic surgery and restorative dentistry.

So, well done to OxTexs on their award and well done to the OBN for another successful event.

I was recently invited by On Drug Delivery to write an article that provided an analysis of the advanced injection devices landscape including historical perspectives, observations on current and recently developed devices, and likely future trends.

You can download a copy of my article here in PDF format or alternatively, you can read it below:

 

 

 

In June (2011) I was invited by QNX and ARM to present at a joint conference they were running on designing safety-critical medical devices. The event was held at ARM’s office in Cambridge, UK.

Below you will find a copy of my presentation.