Gloved hand with syringe

ISO 13485: My journey to certification – prologue

I like to think I deliver a quality service. My deliverables do the job, I have little overheads, and my clients are happy.

I never felt the need to get a quality certification and deal with the associated paperwork. But I’m now discussing another medical device development project from concept through to CE-marking and production, and my client is new to the medical device arena. They do not (yet) have their own medical device quality certification, so I see this as a good opportunity to pursue ISO 13485 certification of the Panchromos Quality Management System (QMS). To get external validation that Panchromos can compete with the big consultancies in this field.

Horizon2020 logo

Horizon 2020 success!

I have just been informed that a Horizon 2020 proposal I co-wrote has been positively evaluated.

The proposal I co-wrote earlier this year was one of only two proposals evaluated positively to receive funding from the 20 that were submitted for the FoF-4 call. It deals with how the ubiquitous ITC infrastructure and data-gathering that is part of the Factories-of-the-Future (Industry 4.0) concept can be utilised to improve the attractiveness of factories as a place of work for the well-trained employees the manufacturing sector needs.

Flashforge Creator X

3D-printer joins stable of workshop tools

I’ve just installed a Flashforge Creator X 3D-printer for plastic rapid prototyping.

The Creator X is—like many other 3D-printers—a Makerbot Replicator 2 clone (in itself modelled on the RepRap open-source printer).

Carbon fibre chassis Alfa Romeo 4C

Designer materials: modelling novel composites

The Horizon 2020 proposal I’ve been writing—submitted earlier this week—deals with improved numerical simulation tools for the behaviour of complex, composite materials.

Think about carbon-fibre reinforced car bodies, aircraft wings, or surf boards. The performance of composite parts not only depends on the constituent materials, but to a large extend on fibre/matrix structure and material interactions at the molecular scale (e.g. fibre/matrix adhesion).

I’m giving a talk at Medtec UK on May 15th

I’ll be giving a talk on Thursday May 15th at the Medtec UK conference held at London Olympia. It’s titled “Specifications suck: Why too much focus on essential requirements leads to mediocre products”. Well, the organisers did say they wanted a catchy title…

The gist of my talk is that stating design objectives as pass/fail requirements does not capture the relationship between design parameters or design choices on the one hand, and the utility or value of the designed product on the other hand.

I’m also chairing stream A on the Thursday so I will be around in Olympia all day.

EMC testing

Does my product need a CE-mark?

Probably. By applying the CE-mark to a product, the manufacturer or importer indicates that the product meets all applicable EU regulations—mainly on end-user health and safety, but also on energy and material efficiency.

Many categories of products require CE-marking before they can be placed on the market: These include medical devices, electrical and electronic equipment, machinery, toys, pressure equipment and many others. They specifically exclude food, pharmaceuticals and chemicals. The European Commission (EC) has published the “blue guide”, which offers excellent if very wordy guidance.

production worker measuring part

Industry 4.0: Factories of the Future

As in previous years I am again working with Bax & Willems Consulting Venturing of Barcelona (a company founded by my brother Laszlo), co-writing two proposals for calls from the Horizon 2020 EU innovation programme. This initiative is a successor to the FP7 framework programmes of the past few years with a somewhat changed approach.

Cubli self-balancing cube

Cubli: one cool cube

Swiss researchers have created Cubli, a cube that can jump up, balance on its corner, and walk about.

Cubli is a small robotic cube with 15cm sides, incorporating flywheels rotating around 3 perpendicular axes. By spinning a flywheel at high speed and suddenly braking Cubli can jump up, and by tightly controlling the speed of the three wheels can balance on a side or on a corner.

Bad Piggies

Start 2014 with some construction challenges…

From the makers of Angry Birds: bring out your inner mad inventor in the Bad Piggies game—it reminds me of the 90’s game TIM (The Incredible Machine).

Charles Leadbeater at PraxisUnico 2013

The frugal future

Last week I attended the PraxisUnico 2013 annual conference of technology transfer professionals in Nottingham.

The first keynote speaker was Charles Leadbeater, who presented his views on the post-consumerist “frugal future”. His core assumption is that the common consumer-society innovation model of creating more/better/faster products has run out of steam, and that this has lead to the economic downturn we’re facing today.

Page 2 of 3123