Monthly Archives: September 2016

Getting to grips with managing a medical technology project

With increasing pressures on healthcare businesses to get to market quicker, with lower development costs, managing your projects effectively has never been more important.

However, regulatory expectations folots of signpostsr medical technology development are continuously evolving.

There’s a natural tension between these two aims that is further complicated by the interactions and interdependencies of the major strands of product development.

Following a project management process that is focused on doing the right things, at the right times, ensures the balance is maintained, shortens your time to market and reduces development costs.

Perhaps you want to understand the crucial steps that need to be taken to ensure successful project completion? Then clear your diary for Tuesday 27th September 2016. We have collaborated with Medilink South West in delivering a one day seminar to outline the common pitfalls and how to avoid them, as well as providing implementable strategies to apply to existing and new projects.

“Great insight into the detail involved and how I can get started”

img_20150917_123707740-croppedThe day is will cover topics like:

  • Why projects fail
  • Why project management makes business sense
  • Project leadership and project management
  • Navigating the complexities of medical device development
  • Key strands of medical technology development:
    • Defining your project
    • Development
    • Industrialisation
    • Product Launch
  • Working with project management methodologies

“Very good, in depth project management tools”

extremely useful, very interesting and well structured.  My interest was held all day which given that it was an all day session is extremely difficult to do.”

At the end of our time together, you will have

  • Gained a thorough understanding of the latest principles of project management
  • Learned how to plan effectively, identifying and mitigating significant risks to your product’s development
  • Created a toolkit for adopting and implementing practical steps and measures at each stage of the process

“Workshops were very energetic and welcomed”

“I know now what we should be doing, and who to call for expert help”

Get started with resolving your project issues by clicking here to book your seat right now.

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.