Innovations in Healthcare Conference 2015!

Monday 13th July sees Sheffield's Innovations in Healthcare Conference open a week long series of events that demonstrate the importance of health technologies and medical devices in Sheffield and the local region.  Innovations in Healthcare is again themed very much on making the University's significant research expertise and capacity even more accessible to the medical devices and related health technologies industry.  We have also extended this theme to include consideration of careers and employment, a natural extension from research collaboration.  These are all important subjects, related of course to the region's and indeed the UK's ability to innovate and remain at the forefront of a significant global industry.  However, the speaker I am most excited about will not be talking about the University or even our industrial partnerships, but she will instead tell us something of her life has been enhanced by healthcare technologies (as well as I'm sure sharing some of the limitations of what we in the academic community consider to be state-of-the-art!).
Claire Lomas is becoming increasingly well known as an adventurer who pushes the boundaries of what is meant to be achievable after a serious spinal injury.  Claire lost the use of her legs after a riding accident in 2007, yet in 2012 she donned a robotic exoskeleton and walked full London Marathon...in 17 days.  I like many tuned in to watch her cross the finish line, a moving and inspirational moment that coincidentally brought medical robotics into the public eye.  My recollection is that the London Marathon organisers refused to award her a medal for being too slow, although I note that most online sources say little about this and instead focus on the large number of runners who sent her their own medals in recognition of her accomplishment.  In the context of our Innovations in Healthcare Conference, Claire is significant because she reminds our community that research and its translation into real products and devices is intended primarily to help real people live full, pain free, and - sometimes - very exciting lives.  While doing this at the same time our research base and competitive manufacturing industry create and sustain many thousands of jobs, employment that reaches into an incredibly diverse supply chain and ultimately into UK society.  The diversity of our supply chains should not be underestimated, ranging from raw materials to quality assurance, intellectual property law, regulatory affairs, and of course clinical placement and use by real patients. Innovations in Healthcare will open a very full week that will see every aspect of medical devices and healthcare technologies covered.  Do check our many websites and news items, it might not be too late to make a last minute visit and be inspired!

https://www.eventbrite.co.uk/e/innovations-in-healthcare-conference-2015-tickets-16081967598

http://www.eventbrite.com/e/visible-difference-an-interdisciplinary-symposium-tickets-17095841121

Final thoughts on REF2014 and UK Dental Schools

There has been relatively little critical analysis of the data from REF2014 compared to previous exercises.  While the reasons for this lack of interest remain unclear, it may be in part because individual Units of Assessment (UoAs) were so large as to make subject or institutional comparisons relatively meaningless.  The situation was made more complex by the different strategies adopted by institutions (and indeed different strategies developed by individual teams within institutions).  There have been very few criticisms of the large and often unusual combinations of subjects in different UoAs, either from the individual institutions, the wider academic community, or the media. It could therefore be assumed that the situation is generally approved or at least tolerated.  Inevitably though different research groups seek to compare their performance against peers, especially where critical analysis provides insight into best practice in terms of quality or impact.  The aim of this brief review is to determine how different institutions with Dental Schools performed in REF2014, and consider whether a more detailed and useful analysis could be performed on the basis of the data available.

The UK has 18 institutions with a Dental School or similar academic unit delivering dental education (see Table 1). Not all of these institutions made a return to UoA3, and even where they did it was not always possible to be certain that the institutional return included any staff active in dental research.  What is clear though is that the University of Liverpool, the University of Edinburgh, and the University of Aberdeen did not appear in the list of institutions that returned to UoA3, so in the event that dental and related research was submitted it would have been to a different UoA.  The remaining 15 institutions were listed in the UoA3 documentation available on the HEFCE website (http://www.ref.ac.uk/). 

Table 1:  UK academic institutions with a Dental School or related departmental activity alongside data from REF2014 for UoA3.  Note that this is the total number of staff submitted to UoA3 for each institution, the specific number of Dental School staff submitted to REF2014 is not known.

The summary data for UoA3 shows that 83 institutions made 94 submissions in total (as a number of institutions made multiple or joint submissions).  While this situation makes comparison more challenging, of the universities listed in Table 1 only four made multiple returns to UoA3 (Queens Belfast, Kings College London, Sheffield, and University College London).   The results of REF2014 were analysed by a number of independent parties including the Times Higher Education Supplement (THES), Research Fortnight, The Guardian, and a number of professional blogging sites such as Wonkhe (who utilised additional data made available by Exeter Consulting Ltd.).  Further data on staffing levels was made available after the release of the REF results by HESA, and this shed more light on differences between institutions. While few sources agreed on their detailed analyses, there appears to a be general consensus that (1) the data generated was probably less meaningful than REF2008, (2) the main winners of the exercise were the “golden triangle” institutions (especially large universities in London), and (3) of course the majority of individual institutions were able to generate “good news” headlines for their websites and press releases.  

Research Professional usefully combined the separate submissions made by individual institutions to UoA3 to produce a simplified institutional ranking i.e. each institution only appeared once in its league tables. This data was available on their secure website for subscribers at the time of writing, see (https://www.researchprofessional.com/media/pdf/UoA03_Allied_Health.pdf).  They weighted the data to create a number of useful metrics including Quality Index (a weighting based on the funding allocation, where 4* research is awarded 75% and 3* 25%), Power (how the Quality Index compares to the top performing University in terms of numbers of staff submitted) and Market Share (an estimate of the proportion of actual funding the institution will receive based on REF performance).  This data can be applied to produce league tables for institutions returned to UoA3 where it might be reasonably assumed that dental school staff contributed to the data.  Ranked by number of staff submitted to UoA3, Sheffield was one of the major contributors.  Again it is impossible to know how many dental staff were part of the overall figures (and even where a UoA3 return was named “dentistry”, this was misleading as it typically included staff from other health professions such as nursing or communication science).  By combining knowledge of the affiliation of UK Dental School with this combined REF data, it is possible to produce the institutional rankings given in Figure 1 below.

It may be argued that REF2014 was relatively unhelpful if one wanted to determine differences between specific subjects or departments as well as institutions (and therefore this was most likely the intention of those who were most closely involved in planning and execution).  Extending this argument, the only real beneficiaries were the “golden triangle” including the large London institutions, and it might also be concluded that they in some way disproportionately influenced the planning with this objective in mind.  It is therefore surprising how little public criticism there has been of REF2014 to date, with the few critical comments appearing to focus on the usual arguments i.e. how wasteful (in terms of time and resources) the whole exercise is, and how unhelpful the REF is as a tool to inspire and motivate academics to produce great research and scholarship.  That said, while my personal view is that there has been relatively little in depth or critical analysis of REF2014 compared to previous exercises, it should be acknowledged that a number of very good articles and blogs do stand out.  For example, the Times Higher Education Supplement has reflected some of the wider frustrations in the academic community, and John O’Leary produced a very insightful blog for Wonkhe (http://www.wonkhe.com/blogs/rankings-data-tables-and-spin/).  It would be wise for academics to promote ongoing discussion towards a fairer and more insightful analysis if this activity is going to be repeated in 2020, if the community remains silent we will undoubtedly see something that closely resembles the unremarkable REF2014.

With respect to the relative position of UK Dental Schools, at first sight it may appear impossible to compare performances using the results of REF2014.   Relatively few of the institutions returned in UoA had a dental school, some institutions chose not to return to this UoA, and others split their return across two or three submissions. Even where a split return was termed “dentistry”, an unknown proportion of the actual staff and subjects concerned would have been drawn from outside of the dental schools.  That said, almost all institutions and indeed dental schools have found some pieces of processed data to include on their web sites to demonstrate success in REF2014, but it is widely acknowledged this is related far more to marketing than any meaningful measure of difference.  Rankings of UoA3 based on power rating, then corrected for proportion of eligible staff returned, would provide useful comparisons but currently this is not possible (and it is unlikely to become possible in the future).  If it is essential that Dental Schools are compared, then this can only realistically be performed at the level of combined entries to UoA3 under power rating.  Sheffield lies 3^rd among institutions with a Dental School on the basis of both quality and power, in many ways a very satisfactory result. Ultimately though it is the financial benefits of a strong REF performance that matters most, and any artificial ranking will be less relevant in the absence of a cash reward.  The information that has emerged thus far suggests that this REF and subsequent adjustment of the national funding formula has been an exercise to further concentrate investment in London, Oxford and Cambridge at the expense of the N8, and northern Dental Schools could therefore suffer the ill effects of a badly executed REF for several years to come.  There now needs to be some response from the academic community who understand the value of an exercise performed well, and this includes the majority of UK Dental Schools who wish to maintain their important, distinctive and clinically relevant research for the benefit of the UK, including our industry and ultimately our patients.

Additional notes and data:  Research Professional also ranked institutional submissions to UoA3 by their Quality Index (Figure 2).  Differences in Quality Index were not as great as those seen in Figure 1 (above), with the greater discrimination by Power in part due to the number of institutional staff returned to this unit of assessment.  The different institutional policies are apparent here, for example KCL made a large return and benefitted in the Power Rating ranking (Figure 1), whereas Cardiff made a smaller return with a greater focus on quality, therefore coming 2nd in the Quality Index but falling to 5th in Power (it has been argued that as Cardiff are separately funded to the other UK institutions they were more interested in external perceptions of quality rather than the final HEFCE financial calculation).

What to say at Sheffield University's Industry Day?

On 6th March, I will have* the privilege of welcoming over 300 business delegates from across the whole medical devices and health technologies supply chain to the University of Sheffield.  Specifically, I have 15 minutes to introduce the day and explain why every year we set aside one day for this key sector.  This is of course not a difficult task in the sense that the drivers for innovation are well known, and they connect all of us whether we work at the laboratory bench, in a law firm specialising in patents, in a manufacturing industry in production or marketing, or indeed in a hospital.  These drivers include the ageing population, increased patient expectation, new scientific discoveries, regulatory pressure, free market competition, clinical advances, and wider government policies.  It is relatively easy for a professor in the field to construct a stimulating welcome speech based on this sort of material, coupled to examples of academic-industrial collaboration benefiting both parties, and ending with an enthusiastic invitation to delegates to talk to the University about their company's research needs to discover what we can do to help.  It might be that this is exactly the talk I will give, hopefully offering insights that will be new to at least some of the audience, but nevertheless a relatively safe presentation.

I have, however, just opened a picture taken last year of my elderly grandmother sitting next to my eight year old daughter, and I feel that this image is challenging me to raise some deeper challenges as a part of my welcome speech.  The image of my daughter reminds me that our generation have a special responsibility to create prosperity and jobs in the future, and high value manufacturing as found in the medical devices and health technology sector is exactly the kind of industry that can perform this service for the UK and Europe.  I have come to believe that responsible job creation is one of the most important things people in senior positions do - or should seek to do - whether in industry, or in universities, or within other parts of the supply chain.  Younger people have suffered disproportionally in this recession, and as we emerge it is important we create opportunities for them to flourish. I was fortunate to open a small meeting where a number of new health technology companies that had been started by young graduates presented on their work and business growth.  They were still small companies, but in only a few years had grown from one or two people to half a dozen.  What really struck me though was the energy, optimism and determination of these young entrepreneurs, and I was left with a reminder of what young people can achieve if they are given opportunities.  The task for those with power and influence is to provide those opportunities.

My gran is of course at the other end of the age spectrum, and she is now suffering from several of the problems that we associate with old age including dementia and failed hip replacements.  These past few months have seen her moved from care home to city hospital and then on to a small hospital, she is almost certainly at a point in life where she is unlikely to "get better" and the best she can hope for is to be made as safe and comfortable as possible.  Many people have experienced, or will inevitably experience, parents and grandparents ageing to the point where they are robbed of good life quality.  Seeing my gran, I feel strongly that she was previously denied interventions that could have prolonged the life of her infected hip replacement.  She was not denied these on account of her age or NICE guidelines or clinical incompetence, she was actually denied a potentially efficacious intervention by the regulatory environment.  As a result of my research I know that there are very many technologies that could be employed to eliminate or reduce the severity of a device associated infection, but the regulatory burden associated with drug-device combinations or silver-containing products is so high that it is simply not economic for companies to invest in taking these products to market.  I have though formed the view that the elderly need access to more potent health technologies than other patient groups, and even if the associated risks are greater I think this is a risk worth taking.  My gran's life expectancy is shorter than mine, she is not going to have children, her risk of cancer is low, and her innate capacity for self-repair is non-existent - by definition the types of medical device and health technology she needs are different to a younger patient, and the risks are different too.  Yet the current regulatory environment does not even try to discriminate between the needs of different patient groups, or indeed the different risks they face.  I think these are the types of questions that academic groups should have the courage to ask, and the whole health technology community should invest resources in making a more detailed argument to government and regulators.  I feel that my gran and thousands of elderly patients deserve interventions that will give them not only a long life but a good life.  More selfishly, when I am old I want the clinicians treating me to have access to products that meet my specific needs, ideally products born from UK intellectual property and made by our manufacturing industry.

I do not know yet though if I will tackle this more complex and controversial subject in my opening, ask me in the comments section below.





*Or by the time most of you read this, "will have had".

PIP Breast Implants: Who is responsible?

The manufacture of breast implants using a non-medical grade silicone is a saga that runs on and on, not only for the victims who received PIP devices but also for the companies in the supply chain, the surgeons, the regulators and (of course) the lawyers who are arguably the only beneficiaries of this disaster.  Today a French court appears to have determined that a German "Notified Body" (a legal entity who is considered competent to recommend whether or not a CE mark should be awarded) shares some of the blame for this disaster.  You will need to note here that a CE mark is necessary to place a medical device on the open market in Europe.  It is not a "safety certificate", it is simply a mark of compliance with European law (albeit European law that was implemented as a risk reduction measure).

For the lay person, this is a very confusing subject, and the BBC have tried hard but probably failed to make this story easier to follow (see: BBC story on the recent legal case.).  Why is this story so confusing, and why then is it so difficult to determine precisely who is to blame?  To answer these questions, you have to find the answers to a number of other related questions that are being scrutinised by lawyers and regulators throughout Europe.  These include (1) Was the PIP breast impact actually a medical device or instead a mad-made component to be used in a purely cosmetic and non-medical procedure, (2) Were the regulators to blame for not having strong enough definitions to answer question 1, (3) Was the "Notified Body" to blame for incorrectly recommending the award of a CE mark on the basis of their inspection (if indeed this is what they did, and as an appeal has been launched we need to be careful not to assume), and even (4) Were the private clinics, hospitals and surgeons to blame for not wondering why these French implants were cheaper than the majority of devices on the market.  These are all important questions, but given the legal result reported today, I want to comment mainly on number (3), was the "Notified Body" TUV Rheinland really responsible?

As a Notified Body, this company had the job of checking the documentation regarding design and specification for a medical device, as well as the quality of the manufacturing environment (including quality assurance processes).  The nearest analogy that a lay person might understand - at least in the UK - is the garage that checks the safety of your car before awarding an MOT certificate.  If you were to use low quality brake components - perhaps purchased off eBay - that did not work properly, you would expect a diligent mechanic to detect this and your vehicle would fail the MOT.  If the mechanic did not test the breaks, and you were awarded an MOT shortly before killing a pedestrian because you failed to stop at a crossing, it could be construed that the mechanic and his/her employer were in some way responsible.  My view though is that the vehicle owner who fitted the "dodgy" components is really responsible, and all the more so if they deliberately fitted the parts knowing they were sub-standard. 

In the case of the PIP breast implants though, I expect that TUV Rheinland will claim that the French manufacturer deliberately lied in their documentation and hid the malpractice from them.  In this case, it is as if you re-fitted high quality brake components for the purposes of passing your MOT, but then took them off immediately after obtaining your certificate.  It would be very unfair to hold the garage responsible if you then caused an accident, but this appears to be the decision of the French court. Of course this comes to whether or not the German Notified Body did its job properly, and also what the law says about responsibility in this case.  Perhaps at appeal we will find out.

The only other comment worth making is on my first question, are PIP breast implants medical devices?  This is very important, because in this context only medical devices need CE marks.  The fact that the manufacturer applied for a CE mark suggested that - at least in some cases - they expected the device to be used in a medical procedure (for example, in a breast reconstruction following mastectomy).  However, if the device was for purely cosmetic enhancement of breast shape and size, this was arguably a purely cosmetic procedure and it is probably the case that the medical devices directives would not apply.  Now the average person might think the same quality and manufacturing standards should apply, but the fact is that they do not (at least not in any legal sense), and a short visit to eBay shows that people may be surprisingly relaxed when it comes to the purchase of so-called cosmetic materials such as powerful tooth bleaches from Hong Kong, "Botox effect gels", and home made cosmetics, none of which come with any safety or quality checks.  If the manufacturer used medical grade silicone for the implants to be used in medical procedures, and a lower grade filler only for cosmetic implants, then he may yet deflect the full force of justice.

I have written another article on this subject that questions the role of the purchaser in this debacle (usually a private clinic, but also NHS hospitals), and even ponders whether or not clinicians should today take a keener interest in the provenance of the medical devices that they use?  All of these questions and more are difficult to answer, the only certainty for now being that lawyers will be reaping the benefits of this uncertainty for many years to come.


 

Ethics Abandoned: What do shameful practices among some military medical personnel have to do with innovation?

This week saw the release of a long-awaited report on doctors in the US military, and it concluded that some had been complicit in the torture of detained suspects.  This report makes interesting and at times depressing reading, but it should be noted that these are a tiny tiny minority of healthcare professionals, and this is certainly not an indictment of modern medicine as a whole.  You can read more here, with a link to the report itself at the bottom of the post: http://www.theguardian.com/world/2013/nov/04/cia-doctors-torture-suspected-terrorists-9-11

While this failure to adhere to ethical codes and professional standards was probably a greater problem in the USA, the UK profession has not been immune (the best example being Derek Keilloh, struck off for his complicity in seeking to cover up the fatal injuries of Baha Mousa received while detained by the British Army).  There is much written on these emotive subjects, and those who are interested can find plenty to digest and debate elsewhere.  This did, however, make me think more broadly.  The interesting questions here then are do professional standards and ethical codes for doctors and dentists matter in the world of health technology innovation, and if they can be eroded in a military setting could they also be undermined when working with businesses or even universities? 

In my dealings with healthcare professionals, I am always impressed by the strong emphasis of what is in the best interests of the patient above all other considerations.  This strong moral foundation is not new, it can be traced back to (among others) Hippocrates and the oath that is still taken by many physicians today (including in the UK and USA).  Clinicians and their professional bodies take a dim view of colleagues who fall short of these high standards, and thankfully the available evidence shows that very few doctors do transgress.  That said, this tiny minority includes a number of clinicians who were perhaps overly influenced by commercial factors, or who at least paid insufficient attention to the of the medical devices they were using.  One example was the use of poor quality PIP breast implants by countless surgeons, where the major determinant of implant selection appeared to have been (low) price.  This may not be a fair example, it is unlikely that the surgeons themselves were involved in procurement, but I have argued in a previous article (The PIP breast implant scandal: lessons for dental implantology Faculty Dental Journal volume 3 pages 68 to 72) that perhaps surgeons should concern themselves more with the quality of medical devices being purchased by their hospitals, and if purchasing decisions are made solely on the basis of the lowest price then quality will fall and ultimately patients will suffer (if you disagree, just think about the contents of Tesco's value lasagne).  Of course this is not wilful disregard for professional standards or even dishonesty, and where new health technology innovations go wrong it is very unlikely that deliberate clinical malpractice is to blame.  What the behaviour of a few US military doctors, Derek Keilloh, and some surgeons associated with the PIP scandal, tells us is that working environment and prevailing culture can have a subtle but sometimes very negative impact on personal and professional ethics.  Society would be wise to consider this risk when we place medical professionals in places where their training may not have prepared them fully for the new environment.

If this subject attracts some interest and comments, then I would be happy to follow up with some more detailed analysis of medical device disasters, ancient and modern, and we can look at the roles of the professional and the industry.  For now though, I remain very confident that the vast majority of clinicians engaged in the development and evaluation of new healthcare technologies do so because that are motivated by the highest values of the caring professions, and therefore what is in the best interest of the patient.

Link to the IMAP report: http://www.imapny.org/medicine_as_a_profession/interrogationtorture-and-dual-loyalty

The Witty Report: Are SMEs more important than large companies to exploit innovation in health technology?

This is the 3rd of my blogs on the Witty Report, and I want to visit the complex issue of where and how precisely does healthtech innovation happen, and are SMEs really more important than large multinationals?  OK, to be this is not exactly what Sir Andrew says, but he does emphasise the role of SMEs in innovation, and says relatively little about large companies and whether or not universities should continue to focus their attention on multinationals.

I agree with the Witty Report that compelling evidence suggests that innovation now takes place mainly in SMEs.  I have experience of collaborating with innovative SMEs, and I have witnessed at first-hand how academic support can be instrumental in growth and job creation.  While I am therefore a convert to argument that significant benefits will come from improving opportunities for SMEs and universities to work together, it is probably the case that not all academic staff share this view.  The reasons are complex, but one contributory factor is the relative small scale (and perhaps a lack of kudos) associated with working in partnership with a very small SME compared to a global multinational.  Much thought needs to be given to communicating the value of working with SMEs, and the development of incentives and instruments to drive this collaboration.  Indeed, the Witty Report makes a number of recommendations that - if implemented - could change the collaboration landscape in the UK and make a real difference to our economy.

But is it only SMEs that are important in health technology and medical devices innovation?  Obviously not, and again especially in these sectors. Large multinationals (and indeed the largest SMEs) are still very important drivers of innovation, but this is increasingly because of their role in maximising the impact of de-risked innovative technologies developed by SMEs, and by providing greater opportunities for economic growth on the basis of their exploitation. Larger companies have the maturity, expertise, and infrastructure (including specialist knowledge of regulatory affairs, market needs, reimbursement, marketing, and distribution networks) necessary to respond quickly to opportunities created by SMEs.   The supply chains in health technology and medical devices are sophisticated, and the expertise embedded in UK-based multinationals is a critical determinant of our ability to exploit innovation, generating prosperity as well as providing more general socio-economic benefits.  Perhaps even more importantly, large companies are frequently “cash rich” and/or have access to sizeable capital that is necessary to scale up innovation, even those innovations that have already been de-risked by SMEs. 

I will now be taking a short break from blogging, and hopefully people will have time then to digest and comment on my thoughts stimulated by Sir Andrew Witty's Report.  More in the week beginning 4th November. Don't forget you can read the Witty Report for free: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/249720/bis-13-1241-encouraging-a-british-invention-revolution-andrew-witty-review-R1.pdf

The Witty Report: A Role for Large Companies?

After 24 hours, I still believe that the Witty report is welcome and timely, focussing on the opportunities for growth that would be generated if the academic power of UK universities were even more effectively coupled to innovation and wealth creation in the private sector. The report is very perceptive, recognising I think all of the key issues including the “granularity” of business and academic activities, the special role of SMEs in driving innovation, and the challenges faced by government in determining the best strategies for effective deployment of precious resources to maximise benefits for the UK.  These challenges are significant, for example the relative immaturity of the LEPs, but they are not insurmountable and many of these new challenges have arisen precisely because of steady progress over the past decade.

One area of debate raised by Witty is the potential value of sectoral (and specifically regional sectoral) strengths that are mapped against available academic expertise, i.e. is it a good thing to invest tax payers money where University expertise is co-located with an innovative industrial base?  The easy answer is "yes", but I think Sir Andrew is correct to caution against this being seen as the only factor that should determine funding (not least because the greatest added value is often found with wider national or even international partnerships).  Does this mean that I think city regions and larger geographical clusters are a distraction?  No, I and Sir Andrew I think agree that regional strengths are often very important determinants of future growth potential.  One example of this is the tendency of established companies (and their supply chains) to gradually embed skills and knowledge in a region.  

My long experience of working with industry in the medical devices and health technologies sector, and the additional experience of coordinating an S&T mission to Texas and Minnesota to investigate the impact of converging technologies on medical devices, together confirm for me the value of geographical clusters.  In brief, one key reason for their importance is the creation of a regional community who populate all parts of the supply chain and who frequently interact for mutual benefit (the creation of LEP sectoral groups being a logical evolutionary step).  For example, in Minnesota I frequently met entrepreneurs and employees of local companies who had originally worked for - and been professionally developed by - Medtronic.  The same is true in Yorkshire, where many talented people in the medical devices and health technologies sector either work for or used to work for our large companies (such as Smith & Nephew and J&J Depuy Synthes).  Despite recent structural changes in many of our larger companies, their impact on the region remains significant, and the value of the experienced staff they generate should not be understated.  This is particularly true in the medical devices and health technology sector, where the supply chains are sophisticated and the regulatory environment is complex (and rarely fixed). I will say more about this tomorrow, and consider whether or not the Witty Report has underestimated the value of large companies versus SMEs in driving innovation and growth.