Presidential Address by Dr. John O'Dea ... - Engineers Ireland

Presidential Address by Dr. John O’Dea, Chartered Engineer, President of Engineers Ireland, BE MED MSc PhD Wednesday, 25th September 2013 Past-Presidents, Vice-Presidents, Director General, Guests, family members and fellow Engineers, it is a great honour to be here this evening to present my Presidential address. As I described on the evening of my appointment, a key focus of my year in office will be to give a greater degree of visibility to the issues facing the medical device industry both in Ireland and across the world, the role that engineers play each day in this industry, and to highlight how newly engineered technologies are changing the way medicine will be practiced. I have spent the past 23 years of my engineering career in the medical device industry, having originally commenced my career in the electronics industry. The medical device industry in Ireland is in strong health. This heavily manufacturingfocused industry employs close on 26,000 people and is close to reaching export levels of €7 billion. The industry employs a wide range of technicians and engineers working in a variety of manufacturing and design disciplines. Recognising the growth of the industry, the third level institutions have over the past number years developed specialist engineering degree, masters and PhD courses, targeted at supplying appropriate skills to the industry. However it should be emphasised that the majority of engineers working in this industry have graduated with degrees from traditional

engineering disciplines. There has been perhaps sometimes a misconception that a specialist bioengineering degree is a pre-requisite to work in this industry. This is far from the case. The diversity of the industry sees physicists, scientists, computer scientists and electronic engineers adding to the cadre of mechanical and biomedical engineers that populate the engineering ranks in medical device design and manufacturing. Not only do these work in the industry side, but also in supporting the significant technical infrastructure that sits within the hospital system. Indeed, we have recently seen a number of Civil Engineers successfully complete conversion courses, run through Engineers Ireland, resulting in a high percentage take up of jobs as Quality Engineers within the medical device industry. In summary, the industry is an open club for all engineering disciplines, not just those of a bio-origin. As we look forward it is clear that the number in the industry has remained stable over the past few years. Manufacturing jobs related to the introduction of new high technology devices are counterbalanced by off shoring of lower margin products. As we look to the future, one must look at where medical device technology is evolving to in order to ascertain where the jobs growth will come from. It is my fervent belief that in the coming decade we are going to transition from putting bits of metal and plastic in people to an era of regenerative medicine, where we help the body to regrow damaged tissues and organs. A recent presentation by Johnson and Johnson suggests that the regenerative medicine market will exceed $10bn by 2020. Underpinning this will be a range of new manufacturing technologies for genetically modifying and growing stem

cells, as well as the structures or scaffolds (yes scaffolds!) upon which those cells will be grown. These manufacturing technologies will be essential elements of the regenerative medicine toolkit. I would call on SFI, IDA and Enterprise Ireland to give focus to these areas of competence, in a manner similar to current nanotechnology manufacturing initiatives, which I believe will be of national import as we look to the next generation of job growth in this sector. With over 15 of the top 25 medical devices companies in the world having their European facilities in Ireland, we need to look to the segments of the future and the companies of the future that will represent these exciting new developments, to drive future employment growth. This will only be achieved through

the

country

having

the

demonstrated

manufacturing

competencies

underpinning these new segments. Indeed, a feature of this new reality will see far greater involvement of scientists interacting with engineers, since by their nature the product is more biologic and more chemical. In recent years there has been much discussion in Engineers Ireland on the route to membership for those from the cognate disciplines. Whereas much of this conversation heretofore was directed around computer scientists and software developers, the agenda will broaden to hose in the more traditional physical and biological sciences, particularly in the context of this industry.

Turning now to medical device design. Engineers play a key role in the betterment of health in translating clinical ideas into a functional reality. Most of the best medical device ideas come from practicing clinicians working with engineers. The life cycle moves from bedside to bench to bedside, and not simply from bench to bedside. In my career as an engineer in this industry, I have been privileged to work with some of the finest medical minds and some of the most outstanding medical innovators. It is interesting to hear how many of these innovators say they would like to have been engineers. Equally with the route to medical qualification in the US, it is not uncommon to encounter doctors whose primary degree is in engineering – what a priming to be a medical device innovator. A commonly held view would be that journey from bench to bedside takes around 7-10 years. This necessitates deep pockets, to cover not just the engineering design costs, but also significant costs associated with clinical trials and regulatory approvals.

There are some very exciting new technologies currently emerging that I thought I would take this opportunity to present this evening, just to give a flavour of what engineers are doing to improve the health and wellbeing of patients with various illnesses. Several of these are being worked on here in Ireland. It is my hope that we will get to hear from some of the pioneers in these areas at our Annual Conference in Sligo next year. These are just a selection of technologies, with perhaps a little subject matter bias in my own current areas of interest.

Fig. 1: TAVI – Transfemoral Aortic Valve Implantation One of the most exciting developments in recent years has been the introduction of transfemoral heart valves (commonly referred to as TAVI – Transfemoral Aortic Valve Implantation). Many will be familiar with the role of stents in opening clogged arteries and how open bypass surgery is now a lot less common because of this innovation from such companies as Medtronic, Boston Scientific, Guidant, J&J and Cook Medical. TAVI has taken this to the next stage of evolution, whereby an entire heart valve can now be inserted through the leg, much like a regular stent, and be deployed into the heart without opening the chest, as is normally required for a new heart valve. Such technologies will soon be in production in two companies in Galway - Medtronic and Boston Scientific. Initially the technology is being confined to the sickest of patients who otherwise would not be capable of tolerating open heart surgery. In the coming years, we will see the technology promulgating to less critically ill patients. Of note with this product is that it is spawning a number of other companies and technologies which offer supporting technologies. Two in Ireland - Apica and Vivasure - are engaged in

developing products to help doctors insert these valves into the body, and to close up the incision made when the large valve is introduced via the femoral artery or via a small incision in the chest. Initially pioneered by Edwards Lifesciences (AVT), this technology has cost this company alone over $1bn to bring to market. When one looks at the valve one can see that the prime engineering resources relate to mechanical engineering of the stent and the deployment device. This would be a good example of where engineers are designing structures, performing structural analysis, selecting materials. OK they are small structures, but nevertheless the skills required are already the well-oiled parts of any civil engineers toolkit. This is why I maintain that engineers contemplating entering his industry should not feel constrained by past career choices.

A second area of great interest in the medical device industry at present is Renal Denervation. Many people suffer from high blood pressure, and are on blood pressure medication (a $26bn market). However after time the body may stop reacting to the

medication and blood pressure stays worryingly high. Where to after that? By an amazing process of discovery, an engineer and clinician, Mark Gelfand and Howard Levin, at a company called Ardian, discovered that by burning some nerves in the kidney, blood pressure dropped by up to 30%. The sale of Ardian to Medtronics was one of the quickest and most profitable exits ever for a medical device startup (over $800m). As lead engineer Mark Gelfand commented in a recent interview, “out of the university, I started working in the pulp-and-paper industry, which is about as far from medicine as possible”. Am I over stressing the point?! Renal denervation i.e. deactivation of nerves in the kidney, is representative of an emerging trend, namely device substitution of a drug. It is very appealing to have a one-off minimally invasive procedure as a substitute to a life-long drug regimen, particularly for a younger patient. Given the prevalence of high blood pressure (who doesn’t know someone with high blood pressure), this is expected to be a major category in the medical devices area in the coming years, and indeed Medtronic in Galway are already playing a significant role in the rollout of the Ardian technology. Looking at the product one can see the roles played by software engineers, electronics engineers and mechanical engineers in bringing such a ‘medical solution’ to market.

Apart from potential cost savings attributable to a one-off procedure, the appeal is even greater when the drug has begun to fail.

It is interesting that these same inventors developed a technique known as aquapheresis (a Dracula for water!) which was developed through a company called CHF solutions (now part of Baxter). As with renal denervation, the inventors noted that many people who were having problems of fluid retention. They were taking drugs known as diuretics, (i.e. drugs to help you pee) to help them eliminate excess fluid. However many of these patients found that over time their body was no longer responding to the drug. They developed a concept, similar to dialysis, whereby water was extracted from the blood, and this was found to reduce the fluid overload in such patients. Again an interesting example of a medical device replacing the role of a drug. Again one can see the type of engineers involved – mechanical, electronics, software engineers and industrial designers.

Indeed an area close to my area of professional interest is surgery for chronic gastrointestinal reflux disease or GERD i.e. severe heartburn.

A number of companies are seeking to develop solutions for minimally invasive surgery for GERD e.g. companies such as Torax Medical or Endogastric Solutions. Again the objective is to replace a lifelong regimen of drugs, in this case so-called proton pump inhibitors (PPI) e.g. Nexium. Ironically, PPI’s were largely brought out to replace standard surgical techniques for dealing with GERD, so things are coming full circle i.e. from surgical solution to drug solution to engineered minimally invasive surgical solution. These devices tend to be designed by mechanical engineers. I have heard it said we need more engineers with experience in linkages and micro-motion to participate in the design of such equipment. It is probably true, as one area we have not been as active in is in surgery (other than orthopaedics), where a lot of engineers with such skills are employed. It is probably an opportunity for development.

Perhaps one of the most elaborate tools generated by engineers for surgery is the surgical robot. The concept was largely developed to allow for potential use in situations where an expert surgeon could perform surgery on patients a long distance away. However, nowadays the devices, as typified by the DaVinci surgical robot, are used to provide greater control in small areas within the body, to surgeons within the operating theatre itself. The robot is a phenomenal piece of engineering, though at over a million dollars each, many hospitals have trouble justifying the expense, particularly when the surgeon is right there in the hospital. There is constant innovation by engineers in the area of surgery, much of it directed at making the tools smaller to support making smaller incisions in the body to access internal organs.

We are now in an era where full abdominal surgery can be performed through the belly button.

Such “single port surgery” has continued to evolve to socalled natural orifice surgery, where no incision is made on the surface of the body. Endoscopy provides means for

the surgeon to access and visualize

within the

esophagus and stomach. By introducing an endoscope though the mouth, along with newly engineered tools, surgeons and gastroenterologists are now introducing new techniques to remove cancers within the wall of the esophagus by tunneling down inside the wall of the esophagus. Again these rely on engineers with good skills in linkages and micro-motion actuation.

Other interesting endoscopic techniques have

emerged.

For

instance

Boston

Scientific is introducing a new technology call bronchial thermoplasty, whereby a bronchoscope is introduced into the lungs, and the lining of the bronchial walls is burnt to reduce smooth muscle mass in the bronchii. This is again a nice example of devices potentially replacing drugs. It is still early days for this technology, but perhaps we could see the end of the inhaler?

Another nice example of a similar ablation technology is esophageal ablation for Barrett’s esophagus. This potentially pre-cancerous condition, largely arising from excess acid exposure in the lower esophagus, can now be treated by applying heat via electrodes to burn off the affected surfaces of the esophagus under endoscopic visualisation. Developed by Barrx, the technology is now owned and marketed by Covidien, another large medical device employer in Ireland.

Most of these devices have extensive involvement of software, electronic and mechanical engineering. So to electronic and software engineers, there is a huge diversity of engineering opportunities beyond the traditional IT sector. Technology does extend beyond the web!

A good example of devices/surgery replacing drugs is the area of diabetes. There has been great learning in relation to role gut hormones play in relation to weight loss and diabetes. Engineers have recently developed a duodenal sleeve liner which in

effect stops nutrients being absorbed in the duodenum. The effect of this is to cause less digested food to be presented further down the colon than would normally occur. This in turn leads to hypersecretion of hormones which in turn cause lowering of blood sugar. This so-called Endobarrier offers the first glimpse of a new era where engineered solutions may replace the need for diabetes drugs. Indeed it is now being found that many weight loss or bariatric, surgical procedures cause

such

altered

patterns

of

hormone

expression. The end result is that we are now entering an era where Type 2 diabetes may be curable by surgical intervention. In the next number of years we may be talking of going for curative “diabetes surgery”, something unthinkable ten year ago.

Early days but exciting ones and an area where engineers are designing devices to replace drugs.

Another area of strong interest in the medical device area is neuromodulation. We are all familiar with pacemakers and defibrillators, where electrical pulses may be applied to regularise heartbeat. However there is a growing class of applications where nerves are being stimulated with implanted devices to achieve different purposes.

One example that many will be familiar with is neurostimulation for reduction of pain, BMR in Galway being an example of one company producing such products.

Other applications include vagal nerve stimulation to reduce appetite in weight loss applications, stimulation of the sphincter between the stomach and the esophagus, to cause a reduction in reflux by toning up the sphincter muscles (Endostim), or pacing of the stomach to improve

transit of food (Medtronic). Stimulation of the brain is a new frontier. Whereas much has to be learned, engineers are now developing neural stimulation techniques for Parkinsons disease. Engineers in this latter area have specialist knowledge of signal processing. A new day is dawning in the fight against Parkinsons. Also early days but exciting ones and an area where engineers are designing devices to replace drugs.

Taken above, one can see that there is a rich vein of engineering innovation in the medical device sector. However a key challenge in the health system is cost. Whereas devices represent less than 6% of the cost of health care, new technologies are often seen as cost generators, and it can be difficult to get such technologies reimbursed by insurers. It was striking to hear one of the largest device manufacturers in the world recently announce a shift from selling devices to selling “solutions”. Having manufacturers offering business services to manage the whole episode of care, rather than simply selling devices is a profound paradigm shift. It is one that resonates with the health care providers, but not necessarily with most device providers. The healthcare system needs its own version of lean engineering.

In some sense, the cheapest care is best delivered outside the hospital environment. Connected health is a growing area of interest. Whereas on one level one can become enamoured by applying all sorts of sensors in the home environment, the reality is that most of us do not want to wear sensors as we go about our daily activities of life. Equally, there are not enough doctors with the time to be monitoring the output from a

variety of sensors spewing out reams of health information from their patients. There is, in my view, an excellent opportunity for Ireland, in becoming a leader in the management of such information. We have a unique constellation of IT and medical device companies co-located on this island. We have a strong reputation in customer support. The ideal scenario would involve organisations that monitor data and which flag to healthcare consumers when they need to visit their doctor. To use an engineering analogy, I feel the opportunity lies in ‘predictive maintenance’. Get the patient to their doctor before the condition worsens to a point where they may need hospital care. The healthcare system is overloaded. Ironically, some of the best technology from the healthcare system standpoint may be the technology that keeps patients away from doctors and hospitals, thereby freeing them up for those who truly need their care and facilities.

As we look to the future of novel medical device technologies, as previously mentioned, we are at the dawn of an era of regenerative medicine, or as it is sometimes

known,

tissue

engineering. We

have

recently seen the growth of a human trachea and bladder. We will, in the medium term, be growing organs from stems cells obtained from patients themselves. In terms of cell therapies, we have seen this seek the announcement of the first clinical cases of regenerative cell therapy for Parkinsons disease.

The scaffolds upon which we grow these cells, the bio-reactors that will be needed to be designed and operated to simulate the conditions (mechanical, temperature, chemical) to cause these stem cells to be appropriately differentiated, present design and manufacturing challenges that will keep engineers occupied for decades to come. We have a strong history of quality manufacturing in this country. Novel process engineering approaches will offer opportunities for manufacturing engineers. In particular the scaling of these processes will be crucial. As these are heavily automated processes making very high value product, the jobs they create will not be threatened by low labour cost countries. However we need to both leverage from, and develop beyond, our existing process engineering capabilities, and adopt to these new, more complicated, engineering and manufacturing challenges. These are manufacturing industries of the future that Ireland needs to gear up for, in order to protect its medical devices base. At the core is the competency of cell modification and cell manufacture. Significant progress in this respect has been made in this regard at the Regenerative Medicine Institute (REMEDI) in NUI Galway. It is just the beginning, and in my view needs to be nurtured, and developed further, to place Ireland at the centre and forefront of this new manufacturing industry.

Apart from the very strong multinational presence in the medical device sector in Ireland, it should be noted that over half the membership of the Irish Medical Devices Association is represented by SME companies. There is an exceptionally strong base of companies supplying into the multinational sector. This cluster of supply companies is also available to the growing number of end-user medical device startups which are now a growing part of the medical device landscape. To give a flavor of some of the companies in this area, the following are a few examples of medical device engineering companies developing products for the end user market place who are based in Ireland.

Apica Cardiovascular is developing a port to allow TAVI valves be placed into the heart through the wall of the heart (rather than transfemorally).

Aerogen has developed a word leading line of respiratory nebulizers.

Biancamed (now part of Resmed) developed non-contact breath rate monitoring technology.

BMR has a range of neurostimulation products for pain management and muscle rehabilitation.

Cappella is developing bifurcated stent technology for coronary disease.

Crospon has developed surgical imaging technology to improve the quality of GERD and other esophageal surgeries.

Mainstay Medical is developing a neuromodulation implant for pain management.

Marvao is developing access catheter technology to reduce infections for catheters that need to be in place for long periods of time.

Neuravi is developing tools for removal of clots in patients having a stroke.

Not disclosed illustration only.

Novate is developing a biodegradable vena cava filter to trap clots that may be generated during vascular surgery to prevent them reaching the brain.

Not disclosed illustration only.

Veryan is developing a biodegradable vena cava filter to stop clots formed after vascular surgery reaching the brain.

Vivasure is developing a transfemoral closure device for TAVI valves.

The above points to the rich diversity of startup activity in the medical device area. The majority of these companies have been founded by engineers. An overriding challenge is to keep such companies funded over a long development cycle of 7+ years (longer than most VC funding cycles). In 2012, there was €47m invested in start-up medical device companies, producing end-user products, based in Ireland.

As a regulated industry, the medical device industry has stood out from a viewpoint of there being no requirements on professional qualifications for those responsible for the release of product to the market. This is not the case in the pharmaceutical industry where this task is performed by a so-called ‘Qualified Person’. This is about to change with the new Medical Device Directive currently before the European Parliament. There will now be a requirement for a Qualified Person at each manufacturing facility, if the current draft of the Directive is passed. Engineers Ireland have been very active in relation to this aspect of the revised Directive having, in consultation with MEP’s and FEANI, proposed an amendment to the Directive which would, in effect, give presumed compliance with the requirements for a Qualified Person, to engineers holding a Chartered Engineer qualification (with relevant industrial experience). We are hopeful that the outcome of this proposed revision will be clear by the middle of 2014.

Whereas a lot of my talk up to now has focused on the manufacturing and design aspects of the medical device industry, another important engineering activity is focused within the hospital itself. Clinical Engineers are responsible for the selection and maintenance of a wide variety of medical equipment within the hospital system. They are a key interface between companies and clinicians during the clinical trial process for new devices.

To conclude on this topic, I hope that the above has given you all a good feel of what a dynamic industry the medical device represents. It is technology-laden and engineering driven. As an engineer one’s actions can have a direct effect on the health and wellbeing of many more patients than one could hope to meet in a lifetime as a medical doctor. As I hope you will have seen, the industry employs the full breath of engineering disciplines, and, I would add, thankfully maintains a more healthy engineering gender balance than some other industries. Equally as an industry we must not be complacent as regards the shifting sands, particularly as it relates to cost containment. We will need to be vigilant to the opportunities that the next generation of devices will present in terms of manufacturing job creation. These will necessitate investment in new skills, particularly in bio-processing. We are in the embryonic stages of the connected health revolution. Business models are as yet unclear, but clearly there are opportunities, particularly from a data management perspective, as this new segment within our industry evolves.

Moving on now to broader issues being addressed at Engineers Ireland, I would like to highlight some of the key agenda items for the 2013-2014 term. We have come through a number of tough years, and this has inevitably led to a drop in membership. However there would appear to be light at the end of the tunnel. 2013 will likely be the first year, within the past number of years, where membership may not drop. Hopefully we have hit a nadir, and with a return to wind in the sails of our economy we may see an uptick in

membership. Arresting the decline, if indeed a nadir has been reached, will be a notable accomplishment. Apart from last year’s excellent advertisement campaign, which we hope to repeat in the near future, the executive team, leveraging off improved IT infrastructure investment, have expended significant efforts in contacting members to renew their membership and the results are there to see. Greater efforts are being made to re-engage with our international members, and other engineers who have left our shores. Chartered Engineers in Ireland enjoy a tremendous degree of portability with their qualifications, by virtue of Engineers Ireland’s participation in a wide range of international mutual recognition agreements. Perhaps it is more unfortunate in the past number of years that this benefit of membership has had to be embraced. As an example of international outreach I look forward to signing an Agreement of Cooperation between Engineers Ireland and the American Society of Civil Engineers in Washington in November.

We are beginning to look more at the roles and titles of engineering technicians. We accept a closer look needs to be taken at why there is such a low level of membership of this very substantial group of engineering professionals, and this will become to be a particular agenda item of focus at Executive and Council meetings.

We are now in an era where the standard for registration as a Chartered Engineering has risen. Equally we, as an Institution, need to promote the title amongst those who issue contracts, or who employ engineering professionals. Much background work is

underway in this regard, led from the front, by our Director General. It is encouraging to note the increasing number of positions being advertised where CEng is a requirement.

Our membership will only grow if our children continue to see Engineering as an attractive career. We recognise that career decisions are made long before students enter third level education. As such, we need to grow beyond the already strong engagement Engineers Ireland enjoys with students in 3rd level institutions. The STEPS programme is therefore focussed on 2nd level students. On a personal level may I say that one cannot but be impressed by the sight of children as young as eight being educated in coding by volunteers in the Coder Dojo movement. I would urge our regions to interact and support the outstanding progress being made by the movement. Some dojos are now moving into teaching hardware design, and embedded programming skills to 14 year olds. This is fantastic to see, and we need to see what we can be doing to better engage with this activity at a local level. These are the breeding grounds of the technologists of the future. On another level, maths is such a crucial element of an engineer’s toolkit. It is a source of great pride to me to see our students packing this auditorium each Saturday, receiving free maths grinds from members of our Institution, a sight now also being witnessed weekly in Cork and Galway. I have earlier discussed the routes that are now open to scientists to become members of our institution. In that respect, this year will see ongoing activities related to accreditation of Computing Courses in colleges.

Of course education doesn’t stop after college. With the increased standards for CEng certification, will come a commitment to continuous professional development (CPD). It will consume significant resources at Engineers Ireland to put in place over the coming years a system which will track further education activities. This is another task that will be somewhat lightened by the recent years investment in IT. By 2017, CPD will be a mandatory element of maintaining CEng registration. It will not be long coming around!

Finally a word on our finances. Despite a drop in membership, and increased investments in IT infrastructure and promotion of the profession, we have managed to keep the books in good order. Indeed this year has seen a noted improvement in our finances. However we cannot be complacent, with the ever-pervasive risk of a double dip in economic circumstances. Last year a root and branch review was conducted of how we as an Institution are structured from a regional and divisional perspective. As with any organisation that has evolved over a long period of time, it is helpful to take a step back and assess why we are the way we are, and why we do things the way we do. The review, led by former President Martin Lowery was presented to Council earlier this year and feedback from the Regions and Divisions has been sought and is being collated. The actions arising from this review will underpin a number of activities over the coming months.

In conclusion, I look forward to working with Past President Michael Phillips, Vice Presidents Regina Moran and Bill Grimson, the Executive and Council and of course the first class executive team here at Clyde Road over the coming term. I thank you for your kind attention.