Tag Archives: real life stories

Making a difference to medical device users for 10 years

10-years-banner

This week (28th November – 4th December) marks our 10th anniversary at Three Circles.

Over those ten years we have grown, changed and added to our capabilities and knowledge base.  Initially established as a project management consultancy, we quickly expanded to support may aspects of medical device and combination product development, from; human factors, quality management, risk management, regulatory compliance; complemented by lectures and training in those areas.

Throughout our first ten years we have always strived to make a positive difference, both for our clients with the products they develop and launch, and for their end users. Our aims are to help make devices and processes more usable for users, and to help and support the development teams we work with.

We are proud of our team, their expertise and professionalism; they are the foundation for the strong relationships we build with our clients and our network of partners. We now look forward to the new challenges the next ten years will bring.

Here’s a taster of what we have helped clients achieve:

10 years suppporting better healthcare

 

Normal service has been resumed!

It’s finally happened! It's the law - blue flashing light

Despite following recommended security practices, we’ve been the subject of a website hack, posting some bizarre items to our blog feed over the past day or so.

Please accept our apologies for any concern recent postings may have caused.  We have removed the suspect articles.

Normal service has been resumed.  Coming later this week, celebrating our 10th birthday….

The Cupboard of Shame

Many people like to be able to present a clean, well-ordered home when they are expecting visitors. Some even prefer to have their home “inspection ready” most, or all, of the time.

skeleton-closet_smallerThis goes for our work environment too, especially if these visitors are about to audit us. So it’s common during preparation for audits to tidy-up and clear out any junk or items that have accumulated for a variety of reasons. There’s nothing wrong with tidying up and audits are often a good prompt to do those annoying jobs that we have been putting off. Jobs like finding out how to dispose of some nasty chemical or how to recycle a load of plastic parts. However, as with tidying your home there can be a reluctance to throw some things away, even when you know you should, because at some point they may become useful or someone may ask for them.

A while ago, our team was supporting a client’s regulatory audit. The whole site was looking pretty good; tatty old labels and signs had been updated, benches were clean and everything was labeled to within an inch of its life, everything was looking spick and span. The site was ready.

On the first day of the audit the inspector asked to be shown around the site. The site tour included laboratories, manufacturing and packaging areas, the waste disposal area and the warehouse. The site tour was going well, people were looking happy and were able to answer the inspector’s questions satisfactorily. All was fine, until the “cupboard of shame” was discovered lurking at the back of the warehouse. Now of course the cupboard wasn’t really called that at the time, but thanks to the back-room team, the name stuck. The cupboard looked harmless enough, it was padlocked closed and was very small in size. However, when the inspector asked about the contents, signals started to be given off that something may be wrong. There was a lot of shuffling of feet and sidelong glances and it took a while to find someone who had a key.

Danger, Will Robinson!The padlock was unlocked, released and the cupboard doors swung open to reveal the contents; lots of “odds and sods” items, the stuff that really could have been disposed of long ago.

There were several boxes of a product from another site, no longer in production and years past its expiry date. There were end of reel labels and ”spare” plastic bottles, device components, plastic bags. A lot of the stuff had been kept just in case it may be useful, one day.

Now, the people who knew about the “cupboard of shame” weren’t doing anything malicious and genuinely had good intentions, they had even padlocked the door to restrict access. But none of that prevented the inspector’s discovery appearing as an observation in the final audit report.

red-light_smallerYou can bet that their “cupboard of shame” no longer exists after that unfortunate series of events.

Do you tidy up for every visit, or do you prefer to be “inspection ready” all the time?

Whichever your preference, what’s hidden in your “cupboard of shame”? You may welcome a fresh pair of hands helping to sort it out.

What A Difference A Medical Device Can Make

This week, a guest post…

John Lennon famously said, “Life is what happens while you are busy making other plans”. And so it did. I had planned a week of developing ideas, gathering data for a project, business meetings and so. Then life struck. With a bladder that felt like the size of a football I was rushed to the local Medical Centre where a urinary catheter was inserted to my great relief! Everything was put on hold. However, as an engineer with an interest in equipment that help people manage or recover from an illness the situation was one I had explore further during my recuperation.

The purpose of a medical device is to “diagnose, prevent, or treat a disease or other conditions, and does not achieve its purposes through chemical action within or on the body.” They can range from disposable gloves through to Robotic Surgeons. The market for medical devices is projected to be a market worth $398 bn globally by 2017. The urinary catheter market is estimated to be worth $2.37 bn by 2020. Big business !

The urinary catheter has been around for 3500 years. The earliest ones consisted of bronze tubes, reeds, straws and curled-up palm leaves ( ouch ! ). The device has evolved throughout the centuries to the one that I am using with all of its parts made from soft plastic. There must be many design challenges and off the top of my head they would include: minmise infection, no leakage, minimal pain during installation and extraction, ease of use. The actual list I am sure will be significantly longer.

It is interesting how the world changes for the user of a medical device. In my case, public toilets were key points of reference when out shopping. I developed a mental map of where and when the toilets were open. Of course planning is critical to cover all eventualities when out and about especially when drinking too much !

Using the catheter requires some basic plumbing skills that most of us who connect garden hose pipes can easily master. The valves used on the bags are an example of keeping it simple with an intuitive way of switching it off and on. Also, for my own interest, I started to gather data on how much I was drinking and volumes when emptying my bag ( inputs and outputs in engineering terminology ), which produced a fascinating insight into how my body was working. Given the problem that the catheter is managing – emptying urine from my body – and the constraints of everyday use, the one I used worked well.

One final point. The District Nurses gave me great practical advice based on their experience of helping other people managing their catheters. For any medical device designer getting feedback from the people who are using it is an invaluable source of information for revisions to the design. In general, the users of medical devices can very often find better solutions to the problems of using it even if it involves Duct Tape !

Next time I am sitting in the waiting room of my medical centre, probably listening to some John Lennon classics, I will be reflecting on the many people, over the centuries, who developed the urinary catheter and how the current version saved me from torturous pain !

Big thanks to the Doctors, Nurse Practitioners, District Nurses, and the people in the Dispensary for their professionalism and kindness during my urinary problem.

You can read this and other posts on a range of topics on David’s blog;  http://dtinblack.github.io