Presidential Address by Dr. John O`Dea, Chartered Engineer

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.