MedTech & Biochemical Engineering

Ireland has been extremely successful in developing an internationally renowned centre for medical technology, with over 250 companies currently developing and manufacturing medical devices here. One hundred of these companies are indigenous and 17 of the top 25 global medical technologies (devices and diagnostics) companies are located in Ireland. Nine of the top 10 global medtech companies have a base here, including Abbott, Hospira, Medtronic, J&J, Baxter, Boston Scientific and Stryker Ireland, Cook Medical, Merit Medical, Technopath Manufacturing, Arc Royal, Nypro Healthcare, Pro-Tek, Res Med, Bellurgan, Delcath Systems Inc., and Diaceutics Dundalk.

Over half of the medical technologies companies located 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.



Medtech companies export medical products amounting to approximately €6 billion per annum, which represents 9% of Ireland’s total exports. A recent Government survey has shown that 80% of the companies in the sector are “innovation active”. Despite the economic climate of recent years, the Irish Medtech sector has continued to do well.

The latest Census results show that the medtech sector registered the highest employment growth across the manufacturing sector, increasing by 10% to 24,305. IBEC's most recent sector sentiment and investment survey showed that confidence in the future is high and two thirds of medical technology companies expect turnover to increase going forward. Nearly 1,500 jobs and €200 million in investment has been publicly announced over the past two-years.

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.

The MedTech sector utilises a variety of occupations: 



The main markets for most medical technologies are with healthcare providers. 

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A number of roles concerned with the design, improvement and management of production processes are also important in the sector, including the following:

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.

Technicians

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.

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• Clinicians (medical professionals) that have contributed to bringing a new medical device to the level of a trialable product often carry out the first trials themselves, and their confidence in a device is important to recruiting other clinicians to take part in 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;

• 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.

In 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. Billions of patients worldwide depend on medical technology, at home, in nursing homes and in hospital.

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.

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; 
• 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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