Tag Archives: quality

Three ways to smooth your path for device development

Medical Device Development routemap v5.0 narrow viewSpring of 2013 still seems recent, so I was surprised to realise that the route map for medical device development will shortly be 3 years old. If it were a child in the UK, we would be able to get 15 hours free childcare a week from this September.

Children learn and grow at an alarming rate, especially when you’re looking back over what seems like a very short time and realise that the baby you remember holding in your arms “yesterday” is now a teenager.

The route map too is growing up fast. It’s being used across the world, from Australia, through Asia to Europe and on to North America. Users have fed back great experiences. Uses ranging from a desktop aide mémoire, a teaching aid, through to a planning and design review tool!

There comes a time when a child learns new skills, and naturally integrates them into their daily lives and toolkit.

We’re proud to announce the launch of the route map for medical device development 5.0 today. Numerous user suggestions have been incorporated in this new version, along with two new tracks; Intellectual Property and Market Research.

The route map continues to help you in three ways, it;

  1. Describes the journey you’ll embark upon, from a device idea through to launch.
  2. Sets out the main activities for each of 9 disciplines, through four stages of product development.
  3. Identifies the points where there are major interactions between disciplines.

And here it is…

Click to open a pdf version you can download

Click to open a pdf version you can download

You may already see how this picture will be helpful, whether you’re working in medical devices, combination products, pharmaceuticals, aerospace, defence, electronics…..

Send me your thoughts on how you can use the route map, because having a straightforward, independent view is always valuable.

Is herding cats easier than Design Controls?

With increasing pressures on healthcare businesses to get to market quicker and pressure to lower development costs, managing your design controls activities effectively has never been more important. However, regulatory expectations for medical technology development are continuously evolving. IMG_20150917_121626071There’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 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.

This may all sound difficult to balance, managing to cope with these strands going off in sometimes wildly different directions.  If you’ve ever even thought about herding cats, you’ll appreciate the challenges involved.  However, in the latest of our programme of professional development training courses, in collaboration with Medilink West Midlands, we had the pleasure of focusing on how to manage control these strands,.Getting to grips with Design Controls

“Excellent, interactive aspect of the course was a brilliant idea”



Our goal was to provide attendees with an understanding of the crucial steps that need to be taken to ensure successful project completion. We outlined common pitfalls and how to avoid them as well as providing strategies to apply to existing and new projects.
Typical of the training events we deliver, the day was intensive and action packed, no time for delegates to switch off!

“Excellent, very well paced, good practical sessions”

Talking issues through
As usual, there were several full immersion workshops, interspersed with “classroom” sessions, as you can see from these photos. Delegates experienced first hand the key stages of defining and managing a project though to completion.

Delegates left the event full of enthusiasm and keen to implement what they’d learned.

“I wish we’d looked at this course 18 months ago”

They left better equipped for their next (or current) device project and perhaps more capable at herding cats too.

All of our professional development sessions can be run in-house and tailored to fit your specific needs. Some of our recent sessions include project management, medical device development, design controls, Human Factors and risk management.

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

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.