I really enjoyed living in Galway during my cooperative work experience, so I kept an eye on the papers & internet for suitable roles there. Creganna had recently set up their Design Services department & advertised a position for design services engineer. I applied for the job & had 2 interviews. I was successful & moved to Galway just before Christmas in 2004. I started working in Creganna the following January & really enjoy working here.
Describe a typical day?
The good thing about working in Creganna is that the job has a lot of variety to it. Unlike working in a R&D department of a large company, Creganna provides the service of device design to many different companies. Hence you could be working on a device for a cardiovascular application, like a stent delivery system one day & on a biomedical cement delivery device the next.
A project is usually kicked off with brainstorming sessions, which may involve 8 – 10 engineer discussing a possible device design & subsequently coming up with possible solutions. We will then try to construct prototypes in the lab. The next step involves testing these devices in conditions which simulate those experienced during application. Some projects may require additional research, for example, we often travel to NUIG hospital to view various procedures. This enables us to understand the conditions the device will be exposed to during surgery & the requirements of the surgeon.
Once a prototype has been refined & there is confidence in its performance against a defined set of specifications, animal trials will be carried out, which is a very important step. During these trials we can test the device to the extreme & ensure that once it is used in patients it will perform as expected & not cause any injury to the patient or physician.
What are the main tasks and responsibilities?
As a design engineer you will oversee the application of your knowledge through the design cycle.
Observations made during hospital visits, historical experience with other devices & the experience from the other design engineers are all feed into the design of new & improved products.
As the medical device industry is constrained by a lot regulatory requirements, testing of any ideas makes up a large part of the job.
Another aspect of the job involves regular communication with various vendors to ensure the timely delivery of components for the assembly of prototypes. As it is such a competitive industry, timelines are extremely important. Therefore as businesses want to be first to market with their new products, management of the project to specific timelines, together with the quality of the product is all part of the design engineers responsibility.
What are the main challenges?
Device design & the application of new materials: As the majority of products we work with have to be delivered to the body non-invasively the main challenge is to find materials & components that are small enough to provide the necessary requirements.
For example, the application of Nitinol (NiTi), a shape memory metal, to stents in the 1990’s. NiTi is commercially used in spectacles & can withstand very high stresses & stains. Stents are small metal structures used to open vessels in the body which may have become blocked. The stent can be reduced in outer diameter & is attached to a delivery device. Once in the body it is enlarged, sometimes by the inflation of a balloon which pushes the stent against the wall of the vessel it needs to dilate.
Other challenges include the management of projects & ensuring timelines are hit on schedule.
Some of the new materials we get to use.
Observing animal trials & seeing our devices being used.
Observing procedures at the hospital & getting feedback from surgeons.
The coolest thing of all however is to hear that the device has worked & the quality of life of many patients has improved.
What's not so cool?
Because we work in such a regulated industry there is a lot of paperwork required. This involves validation of the design & all the various processes used to make the product. This represents the uncool aspect of the job but is extremely important as it reduces the potential that a patient will be injured or die as a result of a poor design.
What particular skills do you bring to your workplace?
Being able to visualize something before it becomes a physical entity is very valuable.
Good attention to detail & to be good with your hands.
Understanding medical device regulations & testing requirements.
Types of materials that can be used in the medical device industry.