There is considerable diversity in medtech manufacturing and production processes. While production of some medical device products is heavily automated, many are assembled, tested and packaged manually. This diversity means that there are considerable variations in the mix of skills required between different medical technologies 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 medtech 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 medicaltech 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 lab science or technology qualification at Level 5 in the NFQ.
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 NFQ, 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 medtech 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, Industrial and 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 have qualifications around NFQ Level 7 and have a significant role in this sector.
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 medtech 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 NFQ Level 6 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 NFQ 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 technologies 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.