Introduction to Medical Devices

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RefME is a platform I have talked about before as a useful piece of kit for managing your referencing. RefME has been purchased by another reference manager which has both free and premium (pay to use) versions called Cite this for me. RefME will shut down in due course so it might be worth considering moving to another manager. Cite this for me is a very simple to use reference manager but there are quite a few programs out there which offer both free and premium versions. A list of my top reference managers can be found below:

Zotero has chrome plugins to assist reference capture.

January 2017 Exam Timetables are now available here:

As an update to a previous post on this please note there is a newer and more often updated free desktop publishing software known as Libreoffice. Not everyone has or can afford Microsoft Office but there are plenty of free packages out there that do much the same as Microsoft office and are similarly easy to use. You can get a free office suite of programs from many companies and organisations but one of my favourites is Libre Office. Select the version open office for your system here:

Medicines manufactured by the pharma sector cost significant amounts of money to go from discovery to market. This can mean that many medicines when they launch are beyond the ability of most people to afford them. In most cases the largest purchaser of pharmaceuticals are countries. Countries buy the drugs for their own national formularies. In an ideal world everyone would get the drugs they need to treat their illnesses. This unfortunately is not the case. Countries have limited budgets with which to buy essential medicines. Pharmacoeconomics is the study of the value of one drug or drug therapy over another. In Ireland the NCPE (National Centre for Pharmacoeconomic Evaluation) takes on the task of deciding which drugs should be made available freely from the state. Their mission is:

…to facilitate healthcare decisions on the reimbursement of technologies, by applying clinical and scientific evidence in a systematic framework, in order to maximise population wellness. The NCPE assess evidence for comparative effectiveness and cost-effectiveness of technologies for use by patients in Ireland. This is done through assessment of evidence submitted by manufacturers and independent systematic review. The NCPE also undertake research to inform national guidelines for health technology assessment.


The EMA (European Medicines Agency) which is the EU regulator of the pharmaceutical, bio-pharmaceutical and medical device sector currently has its head offices for all of Europe in London. Following the vote on Brexit, and once the UK follows through on leaving the EU, the EMA will have to fine a new home for it’s HQ in a European country. Ireland may be well placed to become home to the new HQ due to the size of the sector in the country. We’ll have to watch and wait for now.

In 2013 it was agreed by European Pharmaceutical Associations that a new policy around disclosure of payments was to be implemented by member Associations. The IPHA (Irish Pharmaceutical and Healthcare Association) who are a member of the EFPIA set up a website to document all payments made from Pharmaceutical companies in Ireland to Irish healthcare professionals. The code is voluntary unlike the open payments system in the US which came in under the sunshine act. The first data disclosed related to 2015 and was published in a central industry report on the IPHA website on 30th June 2016. As the code is voluntary, Irish healthcare professionals can refuse to be listed and currently according to the IPHA about 55% of them are partaking in the voluntary code. You can find more details at the links below:

Transfer of Value

An explanation of the code

Search the database




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Not everyone has or can afford Microsoft Office but there are plenty of free packages out there that do much the same as microsoft office and are similarly easy to use. You can get a free office suite of programs from many companies and organisations but one of my favourites is Open Office. Select the version open office for your system here:

Please note this applies primarily to my own lectures and exams.


The following video goes though general gowning and grade “A” pharmaceutical fill suite. The video also goes through proper gloving procedure.

Cleanrooms are essentially controlled environments in which manufacturing can take place. They are designed to control the levels present of contamination, be it physical (dust), biological (micro-organisms) or chemical (cleaning agents/solutions) present within the defined area. After gowning you enter through an airlock. Each zone prior to the cleanroom itself is designed to reduce the level/risk of contamination within the room. The images below show the type of simple layout of a cleanroom and the filters (known as HEPA or High Efficiency Particulate Air filter) used in cleanrooms to reduce contamination from the air both inside (through cycling of the air within the room) and outside (air being brought into the room is cleaned).

cleanroom_layout HEPA filter

A Quality Management System (QMS) is a structure that leads to the implementation of quality within an organisation. The figure below summarises the structures within a QMS.




In the USA the FDA regulates medical device manufacture and as part of this process classifies medical devices into one of three categories.

Class I: Most Class I devices and a few Class II devices are exempt from the premarket notification [510(k)]. They have only general controls and a few class I devices are even exempt from GMP requirements with the exception of complaint files and general record keeping requirements. Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments.

Class II: These devices can have General Controls and Special Controls. Devices in class II held to a higher level of assurance than Class I devices, and are designed to perform as indicated without causing injury or harm to patient or user. Examples of Class II devices include powered wheelchairs, infusion pumps, surgical drapes and an implantable radiofrequency transponder system for patient identification and health information.

Class III: This class of devices requires General Controls and Premarket Approval. They are generally the highest risk devices and are therefore subject to the highest level of regulatory control. Examples of Class III devices that currently require a premarket notification include: implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, and dental implants.


Courtesy and Wikipedia

The video at the link below (courtesy Stanford University) is a short 3 min clip explaining the key differences between 510K medical device premarket notification and full premarket approval. The image below also outlines some of the other differences between the two as well.


Courtesy CDG Whitepapers

The IMDA (Irish Medical Device Manufacturers Association) is the representative body for many of the medical device manufacturers operating in Ireland today.

Some key Irish Medtech facts/ figures:

  • There are currently 250 medical technology companies in Ireland, exporting €7.9bn worth of product annually and employing 25,000 people – the highest number of people working in the industry in any country in Europe, per head of population.
  • Exports of medical devices and diagnostics products now represent 8.5% of Ireland’s total merchandise exports; and growth prospects for the industry globally remain good.
  • Many of the world’s top medical technology companies have invested significantly in Ireland and a number of exciting, research-based, indigenous companies are emerging and competing internationally.
  • 50% of the companies in the sector are indigenous (ref Enterprise Ireland)
  • The Irish government has identified the medical technology sector as one of the key drivers of industrial growth for the future and provides a wide range of supports to encourage and foster this growth.
  • The medical technology industry in Ireland is changing from being prominently manufacturing to being more complex and driven by R&D. It now involves intensive collaboration between a broad range of partners, including research institutions, clinicians, manufacturing companies and government agencies.

The video below is a short overview of the industry in Ireland