Monthly Archives: February 2015

This might just save your life, in an inspection!

Last time, I covered the top 9 deficiency areas that regulatory agencies in the EU and US encounter when inspecting medical device, combination product and drug product manufacturers.  There were many similarities between the gaps found across these three disciplines.

It seems only natural to then share a way of pro-actively attacking these gaps, so here it is….

Our inspection lifeboatAround the middle of last year, we were asked by a client to help them prepare for pre-approval inspection for their new medical device.

Like them, you may have developed a medical device or combination product, and particularly if you’re getting ready for pre-approval inspection or routine audit, you may want to know more about the areas that could be investigated.  As with many things in our industry, the FDA take the lead in describing the scope and content of their Quality System Inspection Technique (QSIT for short).

In brief, the QSIT approach describes four areas that investigators can cover during an inspection (they typically cover at least 2 of them); Continue reading

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, the FDA. Traditionally these data are reported as separate datasets in both the media and trade press. However, it can be very useful to see what’s happening on the other side of the fence. Some may say the view over the fence is critical for those developing a combination product. After all, these devices must comply with the requirements of both the Quality System Regulation and Good Manufacturing Practice.

The picture in Europe is less easy to determine, as inspection trends aren’t routinely published. That aside, the most recent data published by MHRA indicates very similar themes to those experienced by FDA.

There are actually common themes across both drug and device inspection deficiencies (links to the full lists of FDA observations and MHRA inspection deficiencies are at the bottom of this post). The good news is that getting it right for one field will cover a lot of what’s problematic in the other.

Common areas of concern for the agencies included; Continue reading

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?

Time to breathe easy?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 late on in development and unsurprisingly, holes are found in the design and testing. Sometimes it’s that critical or frequently used functions were overlooked in test design, other times that testing crept to include parameters or functions that weren’t part of the device design.
  • Test results during development that can be held up to scrutiny (i.e. the equipment was qualified and the method validated). Quick and dirty tests are often called for by design engineers, and certainly have a place in concept development. Saying its “just for development” or the data is “for information only” may seem fine at the time, but as soon as you try to use the data to support a decision… or, I hesitate to say it, transfer a test method from supplier to manufacturer, what then? This seems particularly prevalent where computers, software and spreadsheets are brought into the mix.

Continue reading

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 Tortoise and Hareyet are those who think they can start at C and miss out A & B, until they reach stage F. I have experienced this in various guises and I don’t think I have ever seen a project delivered anywhere close to the original time lines when run like this, usually missing the mark by several years.

Hind sight is a wonderful thing and yes I have on occasion been known to fall back on it, having been carried along with the fast track idea. However, when it comes to building up a sound development package, skipping through stages invariably comes back to bite you if you choose to miss bits out.

Filling documentation gaps that should have been produced much earlier in a project is always fun.

No, I am lying, it really isn’t.

If you have ever had to do this you’ll know that you find out why your project hasn’t gone as swimmingly as you had hoped it would (back to that pesky hindsight thing). Here are three real life examples:

  • Producing the User Requirement Specification for a product when the product design is already decided and having the realisation that the wrong (unjustifiable) features have been added or that critical features are missing from the design is always a hoot.
  • Completing a design FMEA and dreaming up a raft of new and impossible to execute tests after all of the Verification testing has finished.
  • Finally a personal favourite, conducting usability studies with no idea; who the target audience is, what their requirements are or how the device is intended to work.

There has been much in the press lately about the brilliance of 3D printing and undeniably it is fantastic what can be achieved. But there is a flip side; 3D printing has made the possibility to jump around Design Control stages even easier. Designers can now generate what looks like a finished product before anyone else has even had the chance to think about what the problem is that the development team are trying to solve.

It is all too easy to focus on refining or “optimising” this nearly finished product. Contrast this with concepts presented as block models, sketches or simulations. There’s an inherent understanding that much work lies ahead to turn the best concept into a fully fledged, marketable device.

Design Controls CascadeThere are many graphics out there that try to explain Design Controls. The one thing they have in common is that; to get a good output you need a good input, to get a good input you need a good understanding of the problem you are solving.  For me following the flow of Design Controls takes away a lot of development pain and anguish of trying to guess what comes next.

Design Controls is basically a logical progression built from the years of knowledge of other people who have already suffered in development limbo and have found a clear, signposted way through.

“Begin with the end in mind”
Stephen Covey

Look out for our post later this month that may help you think about the point of each stage in Design Controls, enabling you to get the most out of each stage of development.