Covering a wide range of products, from simple bandages to the most sophisticated life-supporting products, the medical devices sector plays a crucial role in the diagnosis, prevention, monitoring, and treatment of diseases and the improvement of the quality of life of people suffering from disabilities.
Over the coming years, medical technology innovations will fundamentally transform health care by providing new solutions incorporating medical devices that will revolutionise the way treatments are administered. Already medical technologies that would have been considered the stuff of science fiction just a couple of years ago are rapidly becoming the standard of care.
The pace of medical invention is accelerating, inspiring hope for better clinical outcomes with less invasive procedures and shorter recovery times. New innovations and developments suggest an unfolding pattern of "smart" technologies that integrate engineering and biological approaches, and that will provide better clinical interventions.
As these technologies advance, the critical path from promising new science and lab discoveries to applications that treat patients may present greater challenges for both innovative device manufacturers and for the Regulators.
Medical Device Sector in Ireland
Ireland has been extremely successful in developing an internationally renowned centre for medical technology, with over 140 companies currently developing and manufacturing medical devices. These companies employ approx 26,000 people and export medical products amounting to approximately €6 billion per annum, which represent 9% of Ireland’s total exports. A recent Government survey has shown that 80% of the companies in the sector are “innovation active.”
Fifteen of the world’s top 20 medical technologies (devices and diagnostics) companies are located in Ireland, including Abbott, Hospira, Medtronic, J&J, Baxter, Boston Scientific and Stryker.
More than 60 of the 140 medical technologies companies in Ireland are Irish owned. Internationally recognised Irish multinationals in the sector include Creganna, Trulife and Steripack. Products manufactured in Ireland include interventional products, diagnostics, medical equipment, dental, vision and hearing products and orthopaedic implants.
Many companies are now engaged in Research and Development (R&D) and business service operations. The Irish owned medical device segment is relatively small, but has demonstrated growth potential in recent years, as illustrated by companies such as Proxy Biomedical, Clearstream, Zerusa and Brivant. It is true to say that there is a broader range of companies within the medical technologies sector involved in R&D than is the case for the pharma or biotechnology sectors.
View a detailed description of the Medical Devices sector compiled by the Irish Medical Devices Association from the Ask the Experts panel above right.
The work
The Medical device sector is made up of a variety of occupations as follows:
The work in this sector can be viewed as arising from the following main functions:
Innovation:
Innovation - the ability to create something new or finding a better ways of doing something is at the heart of this sector. Traditionally, most medical device innovation comes from interaction between clinicians (medical specialists) and engineers. It is based on the sound application of existing mechanical or electronic engineering technologies – often mature technologies – to clinical problems.
The more fundamental innovations typically come from leading clinicians seeking to innovate in clinical practice, which may or may not be in the context of formal research activity. More incremental innovations may be initiated by clinicians, or by engineers seeking improved engineering solutions. Engineers still rely on the clinical insights of leading clinicians to validate their ideas. The main engineering disciplines for medical devices innovation are mechanical, electronic and biomedical. Biomedical engineering combines mechanical (sometimes electronic) engineering with biomedical sciences and biocompatible materials science.
The innovation process typically goes through a succession of prototypes, leading to the production of functioning prototypes that can be used in clinical trials. The prototypes are typically produced by highly skilled technicians.
With the increased use of biologically active substances in the medical device sector’s products, professionals with skills in both small molecule substances and the large molecule, and even cellular, products of biotechnology are required. This trend is making skills in biological sciences, chemistry and pharmacology increasingly important to innovation in medical devices, alongside the clinical and engineering skills that have traditionally dominated innovation.
Clinical Trials
In order to confirm their effectiveness and safety, medical devices undergo clinical trials before they are brought to market.
Clinical trials require skills in the following main areas:
- The clinicians (medical professionals) that have contributed to bringing a new medical device to the level of a trialable product have a critical role to play in clinical trials. They often carry out the first trials themselves, and their confidence in the device is important to recruiting other clinicians to take part later trial phases. They may also take a wider role in a clinical trial, for example in training other clinicians to use the device clinically.
- Skills in design and management of clinical trials are required to produce reliable evidence that meets regulatory requirements;
- The conduct of clinical trials is regulated, and regulatory affairs skills are required to ensure and demonstrate compliance; and
- Front line skills in conducting clinical trials are required.
Internationally, many clinical trials specialists come from nursing backgrounds, after taking further qualifications in the design, management and conduct of clinical trials.
Production
Biomechanical and Bioelectronic Devices
There is considerable diversity among medical devices production processes. While production of some medical devices products is heavily automated, many devices are assembled, tested and packaged manually. This diversity means that there are considerable variations in the mix of skills required between different medical devices production operations.
Key occupational areas involved in day-to-day operations include the following.
Manual Assembly Operatives – Manual assembly operatives account for a substantial share of medical devices production employment in Ireland. The main skills required are manual dexterity, the ability to conscientiously comply with formal working procedures, sufficient awareness to identify visible problems with components and assemblies, and the flexibility to move between assembling different products. They are typically qualified to Leaving Certificate level or equivalent, and may have taken a medical devices qualification at Level 5 in the National Framework of Qualifications.
Machine Operators (sometimes termed “technicians”, depending on the company and on their level of responsibility) – Machine operators operate machines, loading raw materials, watching for problems, and in many cases setting the machine up and undertaking basic troubleshooting and maintenance. Skill requirements are generally increasing over time, as operators take more responsibility in areas such as troubleshooting, maintenance and quality assurance. They are typically qualified to Leaving Certificate level or equivalent, and may have taken a medical devices qualification at Level 5 in the National Framework of Qualifications.
Technicians – Technicians working in production can have a wide variety of roles, in areas such as toolmaking, machine set-up, troubleshooting, maintenance, monitoring the operation of automated systems, and technical testing for quality assurance. They are typically qualified to around Level 6 (Craft Certificate or Higher Certificate) or Level 7 (Ordinary Bachelor Degree or (legacy qualification) National Diploma) in the National Framework of Qualifications, or have technical training or qualifications of some other sort. Some are qualified to a higher level.
Quality Control and Quality Assurance Staff – Depending on the level of automation, manual and visual inspection can play a major role in medical devices quality control. These roles are often filled by very experienced operatives and operators, typically with additional training in quality control, quality assurance and sometimes quality improvement.
Operations Managers and Supervisors – These roles are similar to those in other industries, except that they need strong skills relating to operating in a highly regulated environment.
A number of roles concerned with the design, improvement and management of production processes are also important in the sector, including the following:
Production Engineers/Industrial Engineers/Automation Engineers/High-level Technicians – These are engineering roles concerned primarily with bringing products into production, with optimising production processes, with keeping production processes in control, and with technical troubleshooting beyond the comfort zone of those concerned with day-to-day operations. They are mostly undertaken by people with Honours Bachelor or masters degrees in engineering disciplines such as production engineering, manufacturing engineering, mechatronic engineering or mechanical engineering. Highly skilled technicians, typically with qualifications around Level 7 in the National Framework of Qualifications also have a significant role in this.
Process Design Engineers – Process design engineers play a critical role where companies are designing automated production systems, particularly where the automation is end-to-end rather than in islands connected by manual operations. This is increasingly important as companies automate to increase efficiency and improve quality. They are distinguished from other engineering roles here because the core of these roles is about process design rather than incremental improvement, and because this has been identified as an area of skill that is particularly important to the future viability of the sector in Ireland or any other high cost location.
Validation Engineers – The medical devices sector employs significant numbers of validation engineers to validate the compliance of production processes with the specifications that have been approved by, or notified to, regulators. These typically have an Honours Bachelor Degree in a relevant engineering or science discipline. The role is traditionally paperwork intensive, but the increasing incidence of complex automated production systems is making it more technically challenging in many cases.
Regulatory Affairs – Regulatory affairs staff track compliance of operations with regulatory requirements, advise other staff on regulatory matters, report on compliance and manage relationships with regulatory authorities.
Bio-convergence Devices and Diagnostics
Where devices include significant biologically active components, companies employ scientists, science technicians and processing operatives with skills similar to those of the small molecule pharmaceutical or bio-pharmaceutical industries. They undertake roles parallel to those of engineers, technicians and machine operators in manufacturing biomechanical and bioelectronic devices. Qualifications of scientists are generally between primary degree and PhD level.
The term “technician” can cover a wide range of levels of skill and qualification, and can encompass process operative-type roles. Qualifications can range from a certificate at the equivalent of around Level 6 in the National Framework of Qualifications up to masters level (Level 9) for very highly skilled roles. The trend is for operative level workers to have specialist qualifications, whether obtained full-time in a training scheme or in college, or part-time after recruitment through certified training sourced by their employer.
In diagnostics, technicians are generally qualified to at least Level 6 in the National Framework of Qualifications in an appropriate discipline.
Where the biologically active material plays an significant active role in the product, it can be necessary for regulatory affairs staff to be expert in pharmaceutical regulation, as well as medical devices regulation.
Sales & Marketing
The main markets for most medical devices are with healthcare providers. The key players in achieving these steps are:
- The clinicians involved in the development of the product, and those who have been involved in clinical trials; and
- Healthcare economists, who have a leading role in establishing the benefits of a device quantitatively, and communicating these benefits to healthcare providers, health insurers and other reimbursement organisations.
- As the product is brought to market, the role of the sales organisation is central. Indeed, the economics of selling do much to shape the structure of medical device industries, favouring companies that focus on particular clinical specialisms, with broad portfolios of products targeted on those specialisms.
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