Tag Archives: alliance

The other side of the fence

Maybe you’ve visited exhibitions, attended industry conferences. Ever wondered what it’s like to be an exhibitor?

My working life has seen me visit lots of exhibitions and attend a variety of conference sessions. This May, however, we were on the “other side of the fence” for the very first time. Our team was invited to co-exhibit at MedTec UK in London, by a company with whom we’re developing a partnership. They’re a great bunch to work with, so we leapt at the chance.

The two days at MedTec gave us the chance to learn more about how each other describes what we do, test different ways to say that to visitors and watch how potential clients responded. An early lesson on day one was that people engaged with usability when we talked about some of the strange things that “real users” do during testing as well as how products really benefit.

When conversations turned to quality and regulatory, a surprising number of visitors sounded visibly relieved at the idea of someone being around to guide them through the requirements and look after documentation.

The result of the lessons; we noticed that visitors moved from saying things like “oh, we don’t need that yet” or “we already have a leaflet” , to “I need to talk with you about CE marking” and “I could use some help“. Others asked for more details about how usability and quality support can be part of their device projects.

Day two, and we were in a groove. We were comfortable with working together and moving around the exhibition floor meeting new people, talking with exhibitors that looked interesting. We met up with a few people we’ve worked with before and were introduced to people that we will likely work with in the future. At one stand, it turned out that we’d worked on the same automated testing systems for a client, albeit a couple of years apart!

It was more tiring than I’d expected, standing up for two days, talking with lots of different people. The $64,000 question; would we do it again? We came away with lots of creative ideas to entertain and engage with visitors. So if we decide to jump over the fence again, it will be a lot of fun turning some of these ideas into reality.

4 steps to (device) heaven

After I wrote about the MDA’s approach to device development (here’s the post), several people emailed me to find out more. Perhaps, like them, you’re curious about it?

Feed your curiosity by reading this brief summary of the four steps; Define – Develop – Industrialise – Launch

Define

When it comes to medical device design getting it right is crucial. Unsafe and ineffective devices often result from informal development that did not establishment real design requirements or did not assess device performance adequately.

To combat this, follow a User Centred Design Process to understand the whole user experience before you start designing. Identify who your users are and how they are likely to use your product. This provides a solid basis on which a device development project can be built.

At this stage you need to capture the project activities in a plan. A plan that describes the process you are going to follow, taking care to ensure design activities (such as product design, risk and usability) and quality requirements (e.g. design reviews, design control procedures, supplier audits) are included.

Develop

Now, you refine concepts that will address the needs you’ve already identified. This iterative process irons out design flaws and risks to reveal the design which best meets the needs of both your users and your business.

You can choose from a variety of ways to do this, such as; creative techniques, brainstorming, visualisation, prototyping, testing and scenarios. Evaluate your design concepts’ feasibility from usability, risk and mechanical perspectives, feeding the results into the next design iteration. Subsequent testing of iterations ensures that you have successfully controlled the use-related hazards and that new risks have not been introduced.

Depending upon the device you’re developing, you may want to consider a clinical evaluation. This assesses and analyses clinical data concerning safety or performance of your device (or similar devices or therapies) and determines the need for clinical trials.

Take care to document changes as you go along; to device, instructions, labelling and user training, as their control is crucial to device quality.

Industrialise

You’ll now scale-up the product manufacturing and assembly processes in readiness for launch. This involves transfer of the design to manufacturing, handover of the design history to the production team, supporting scale-up activities such as supplier management and process design. A key factor in the success of this stage is the qualification and validation of both manufacturing and assembly of your product.

Launch

Preparing for a smooth launch of your product means having a clear strategy for compliance to international regulations. This will likely includes your activities to gain CE marking or conformity to associated international standards. Product launches are exciting and also resource hungry activities, so make sure you’re addressing supplier quality, manufacturing volume and expansion capabilities, and resolving of supply issues.

If you have identified the need for a clinical evaluation, launch preparation will include a risk benefit analysis and associated risk management report, both of which are required for releasing a medical device to market.

Next time…

You may be curious to find out what it was about Medical Device Development that recently got people nodding and smiling, before asking if they could have a copy?  My next post should satisfy your curiosity.  You might wish to be alerted when it’s published,  just sign up below (we will treat your email address with care, and won’t share it).

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Road testing the big picture

Get the right people together, in the right place, at the right time, with a shared idea and a similar outlook.

It’s amazing how quickly something can grow from that crucible.

It’s just 90 days since we were in the right place, at the right time, with three other groups who have a similar outlook.  Last week, the Medical Devices Alliance was born.  Less than ninety days to set up an alliance – perhaps that sounds quick.  It doesn’t stop there.

MDA press release photo We’ve put our heads together in the alliance, shared our knowledge of what works well, and what doesn’t, from the perspectives of quality, design, engineering, marketing, risk, suppliers, usability and clinical …

 

… the result could perhaps be described as Medical Device Development 2.0.  We think it’s a straightforward approach;

Define – Develop – Industrialise – Launch

How can you encapsulate the key steps of device development in this four stage eraser smallprocess?  I’ve been working (with help and feedback from our team) on an idea for an eye-catching, simple way of knitting together the key disciplines to see the whole picture. It’s an idea that draws upon something familiar.

In the past week, we’ve been on a brief road trip to share it with a select group of companies.  What we saw on the trip – people grasping the concept very quickly; nodding heads and smiling faces are common responses, before asking if they can have a copy.

Now to put the finishing touches to the picture and get it published, coming soon to this blog.

At the core of the MDA there’s Three Circles, University Hospital of North Staffordshire, Haughton Design and  Linki.  We’re working with 5 other organisations right now to iron out how they will fit in the mix.

Exciting times!