During 2015 we dipped our toe in the water, posting thoughts and tips both on our website and LinkedIn Pulse. At the close of the year, the results are in and one thing the top posts have in common is the sharing of difficulties and practical ways to overcome them.
You may be thinking that you’d like to re-read some or all posts, or that you missed them first time round. Simply click the post title to read the first few paragraphs. Then, if you’d like to read the whole post, click on the link at the bottom.
And the winners, ranked by the number of readers, are…
#5: Zen and the art of Design Controls
There are days when I think “is it me?” Especially when it comes to appreciating Quality Systems. I confess I do like logic and I even get a buzz when I see a logical progression in project deliverables, moving from A to B to C and so on. It’s wonderful, having links and traceability.
I must make it clear I have never been part of a Quality Department. I have been involved in medical device development for many years and lived through, what I now think of as the unenlightened times (although immensely fun), when we defined our own ways of working, prior to the introduction of Design Controls and ISO 13485; having standards and guidance is now quite comforting for me. This probably explains why I find it distressing when I come across people who do their level best to ignore or get round the logical order laid out in Design Controls.
I struggle to grasp why it is faster to go from A to C and then back to B and then try to jump to D. Worse yet are those who think they can start at C and miss out… (click to read more) [/reveal]
#4: The Designer Friendly Usability Specification
Getting your head around ISO 62366:2008 can, at the least, be tricky, perhaps even frustrating. The standard mentions many documents and requirements for a medical device Human Factors programme.
Take the Usability Specification as an example. It’s meant to provide testable requirements for usability verification and for usability of the primary operating functions. On top of these, it is also expected to include criteria for determining the adequacy of risk controls that have achieved by the usability engineering process.
With me so far?
Once you’ve deciphered these requirements for your Usability Specification, you’re next asked to;
- Add in inputs from a range of other documents (Application Specification, The Primary Operating Functions, Hazards and Hazardous Situations relating to Usability),
- Include any foreseeable use errors associated with … (click to read more)[/reveal]
#3: If you don’t have time to do it right …
“…when will you have time to do it over?”
Most of us will agree that there is an ever increasing pressure to deliver immediate results from our projects. As organisations in many sectors tighten their belts, there is an expectation of doing more with less, in shorter time. But, in the rush to get on with doing, are we throwing out the baby along with the bath water? Are project time-lines and costs actually increasing as a result of skipping over or rushing through the scoping or planning activities?
There are many pressures on projects within the modern organisation. Some of these are cultural, such as the belief that “productivity = doing something”.
Can we kick back against this pressure, to identify or check that we are “doing the right something”? (click to read more) [/reveal]
#2: Is your product development missing these key activities?
With the much anticipated and long overdue update to ISO 13485 moving out to the end of the year and probably into 2016, it looks like medical device companies can breathe easy for a little while longer, before beginning the revamp of their Quality Management System.
Is it time to relax though?
Before you relax too much, consider that people often miss out chunks of the current version of the standard, or focus on its content; forgetting about hot topics that are not currently well defined. Their absence in development projects gives me a headache on a regular basis. Headaches that are cured when we resolve things like;
- Traceability from the initial requirements through to what has been validated and is (hopefully) about to be manufactured for the market. Often traceability is done … (click to read more) [/reveal]
#1: Correct these 9 deficiencies to avoid becoming regulatory inspection road-kill
It’s not unusual to be thinking about how regulators will see your product development and where they may find holes.
The closer you get to submission of your newly developed device or combination product, the larger this probably looms in your mind.
It can be useful to see what the recurring issues uncovered during inspections are, but you could easily spend days sifting through inspection trend information available online, without understanding what it actually means for you and what should you be doing now to avoid being part of the deficiencies statistics for 2015.
Top observations found during inspections of both pharmaceutical and medical device manufacturers are reported each year by the US regulatory agency… (click to read more)[/reveal]
What were your top reads of 2015?
Drop us a line to share your favourites.