Engineers Ireland president Dr John O’Dea has urged Science Foundation Ireland (SFI), IDA Ireland and Enterprise Ireland to invest in the development of manufacturing technologies for genetically modifying and growing stems cells, as well as the structures or scaffolds upon which those cells will be grown.
Speaking at his presidential address, which took place last Wednesday in Engineers Ireland HQ, O’Dea said these manufacturing technologies were essential elements of “the regenerative medicine toolkit”. “I call on SFI, IDA Ireland and Enterprise Ireland to give focus to these areas of competence, in a manner similar to current nanotechnology manufacturing initiatives, which are vital to the next phase of job growth in this sector.”
The medical device industry employs almost 26,000 people in Ireland and is close to reaching export levels of €7 billion. Third-level institutions have developed specialist engineering degrees, masters and PhD courses, targeted at supplying appropriate skills to the industry.
“There has been perhaps sometimes a misconception that a specialist bioengineering degree is a pre-requisite to work in this industry. However, the majority of engineers working in this industry have graduated with degrees from traditional engineering disciplines,” said O’Dea. “Physicists, scientists, computer scientists and electronic engineers work with the mechanical and biomedical engineers that populate the engineering ranks in medical device design and manufacturing.”
He noted that a number of civil engineers have successfully completed conversion courses, run through Engineers Ireland, resulting in a high percentage take-up of jobs within the industry. “It’s an open club for all engineering disciplines, not just those of a bio origin,” he added.
The numbers employed in the industry have remained stable over the past few years. Manufacturing jobs related to the introduction of new, high-technology devices are counterbalanced by offshoring of lower margin products. According to the Engineers Ireland president, Ireland must plan for the future to ascertain from where jobs growth will come.
“We’re going to transition from putting bits of metal and plastic in people to an era of regenerative medicine, where we help the body regrow damaged tissues and organs,” O’Dea continued. “Johnson & Johnson research suggests that the regenerative medicine market will exceed $10 billion by 2020. Underpinning this will be a range of new manufacturing technologies for genetically modifying and growing stems cells, as well as the structures or scaffolds upon which those cells will be grown. Future employment growth will only be achieved if we can demonstrate the manufacturing competencies underpinning these new segments.”
A feature of this new reality will see more scientists interacting with engineers, since the product is “more biologic and more chemical”, according to O’Dea. “Whereas there has been much discussion about the route to membership from cognate disciplines such as computer scientists and software developers, the agenda will broaden to those in more traditional physical and biological sciences.”
MEDICAL DEVICE DESIGN
[caption id="attachment_7992" align="alignright" width="532"] TAVI in action[/caption]
Most of the best medical device ideas come from practising clinicians working with engineers, O’Dea continued. He outlined some emerging technologies, demonstrating what engineers are doing to improve patient the health – several of which are being worked on in Ireland.
“An exciting development has been transfemoral aortic valve implantation, or TAVI. Many will be familiar with the role of stents in opening clogged arteries, and how open bypass surgery is now less common because of this innovation from such companies as Medtronic, Boston Scientific, Guidant, J&J and Cook Medical.
“TAVI takes this to the next stage, 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 Medtronic and Boston Scientific,” O’Dea explained.
A number of other companies are offering supporting technologies around this product. 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 a small chest incision. “Initially pioneered by Edwards Lifesciences (AVT), when one looks at the valve, the prime engineering resources relate to mechanical engineering of the stent and deployment device. This would be a good example of engineers designing structures, performing structural analysis and selecting materials.”
Renal denervation is also developing apace. Many people are on hypertension medication but, after time, the body may stop reacting to the drug. O’Dea explained how an engineer and clinician, Mark Gelfand and Howard Levin of Ardian, discovered that by burning some nerves in the kidney, blood pressure dropped by up to 30 per cent. The sale of Ardian to Medtronics was one of the quickest and most profitable exits ever for a medical-device start-up (over $800 million).
Renal denervation is representative of an emerging trend – a one-off minimally invasive procedure to insert a device, as a substitute to a life-long drug regimen. Apart from potential cost savings attributable to a one-off procedure, the appeal is even greater when the drug has begun to fail. Given the prevalence of hypertension, this is expected to be a major category in the medical devices area in the coming years.
[caption id="attachment_7994" align="alignright" width="732"] Renal denervation[/caption]
“The same inventors developed a technique known as aquapheresis, which was developed through a company called CHF solutions, now part of Baxter,” said O’Dea. “They noted that many patients taking diuretics to help eliminate excess, over time, no longer responded to the drugs. They developed a concept whereby water was extracted from the blood, and this reduced the fluid overload in such patients. Again, one can see the type of engineers involved – mechanical, electronics and software engineers and industrial designers.”
A number of companies are seeking to develop solutions for minimally invasive surgery for gastro-oesophageal reflux disease, such as Torax Medical and Endogastric Solutions. “We need more engineers with experience in linkages and micro-motion to participate in the design of such equipment, as one area in which we haven’t been as active is surgery (other than orthopaedics), where a lot of engineers with such skills are employed. It’s probably an opportunity for development.
“Most of these devices have extensive involvement of software, electronic and mechanical engineering. So to electronic and software engineers, there’s a huge diversity of engineering opportunities beyond the traditional IT sector.”
Devices/surgery replacing drugs can also be seen in diabetes, in response to a greater understanding of the role gut hormones play in weight loss and insulin production. Engineers have recently developed a duodenal sleeve liner, which 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 leads to hypersecretion of hormones that cause lowering of blood sugar.
“This ‘endobarrier' offers the first glimpse of a new era where engineered solutions may replace the need for diabetes drugs,” O’Dea explained. “It has been found that many weight loss, or bariatric, surgical procedures cause such altered patterns of hormone expression. The end result is that type 2 diabetes may be curable by surgical intervention. In a few years, we might be talking about curative ‘diabetes surgery’ – something unthinkable a decade ago.”
COST OF NEW TECHNOLOGIES
[caption id="attachment_7996" align="alignright" width="540"] Endobarrier - a duodenal sleeve[/caption]
O’Dea acknowledged that a key challenge in the health system is cost. Whereas devices represent less than 6 per cent of the cost of healthcare, new technologies are seen as cost generators and it can be difficult to get them reimbursed by insurers.
“It was striking to hear a large device manufacturer recently announce a shift from selling devices to selling ‘solutions’,” he said. “Having manufacturers offering business services to manage the whole episode of care, rather than simply selling devices, is a paradigm shift. It resonates with the healthcare providers, but not necessarily with device providers. The health system needs its own version of lean engineering.”
[caption id="attachment_8001" align="alignright" width="682"] Duodenal sleeve before insertion[/caption]
The Engineers Ireland president explained how the cheapest care is best delivered outside the hospital and that ‘connected health’ is a growing area. “Whereas on one level, one can become enamoured by applying all sorts of sensors in the home environment, the reality is that most people don’t want to wear sensors every day. Equally, there aren’t enough doctors to monitor the output from all of these sensors. There’s an excellent opportunity for Ireland to become a leader in managing such information.”
Ireland, he said, has a “unique constellation” of IT and medical device companies, as well as a strong reputation in customer support. The ideal scenario would involve organisations that monitor data and flag to consumers when they need to visit their doctor. “The opportunity lies in ‘predictive maintenance’ – some of the best technology may be that which keeps patients away from doctors and hospitals.”
O’Dea said the world is on the brink of the era of regenerative medicine, or tissue engineering. We have recently seen the bioengineered growth of a human trachea and bladder. In the medium term, organs will be grown from stems cells obtained from patients themselves. In terms of cell therapies, we have seen the first clinical cases of regenerative cell therapy for Parkinson’s.
“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,” he explained.
[caption id="attachment_7998" align="alignright" width="472"] The first engineered human trachea[/caption]
“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 won’t be threatened by countries with low labour costs. 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.”
MANUFACTURING OF THE FUTURE
Ireland must “gear up” for these manufacturing industries of the future in order to protect its medical devices base – and at the core is the competency of cell modification and cell manufacture, he said. “Significant progress has been made in this regard at the Regenerative Medicine Institute in NUI Galway. It needs to be nurtured and developed further, to place Ireland at the forefront of this new manufacturing industry.”
The majority of Irish medical-device companies have been founded by engineers. The challenge is to keep such companies funded over a long development cycle of seven years-plus (longer than most VC funding cycles). In 2012, there was €47 million invested in start-up medical device companies, producing end-user products, based in Ireland.
As a regulated industry, however, there have been no requirements regarding professional qualifications for those responsible for releasing products to market. This is to change with the new Medical Device Directive currently before the European Parliament. If passed, a ‘qualified person’ will be required at each manufacturing facility.
“Engineers Ireland has, in consultation with MEPs and FEANI, proposed an amendment to the Directive that 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’re hopeful that the outcome of this proposed revision will be clear by mid-2014.
“As an industry, we 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 bioprocessing,” O’Dea concluded. “We’re 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.”
Dr John O’Dea has 23 years' experience in the medical device industry and is CEO of Irish medical device company Crospon. He previously co-founded Caradyne, an Irish respiratory medical device company in 1998, which was selling products in 30 countries prior to its acquisition by Respironics Inc in 2004. Prior to founding Crospon, O'Dea served as general manager of Respironics Ireland. In the past 25 years, he has held R&D management positions in Nellcor Puritan Bennett and engineering positions in Digital Equipment Inc and in Dataproducts Inc.
O'Dea is a named author on eight issued US patent families and is chairman of the Irish Medical Devices Association. He holds bachelor and masters degrees in mechanical engineering and a PhD in electronics engineering, all from University College Dublin and an MSc in clinical research from NUI Galway. O'Dea is currently adjunct professor at the School of Engineering and Informatics at NUI Galway where he is chair of the External Advisory Board for the Irish Regenerative Medicine Institute.