I’m once again involved in writing two Horizon 2020 proposals. One of them is for the “SME-instrument” where a single SME can apply
The SME-instrument offers support for the commercialisation of innovations that are fairly close to market. A phase-1 project is a feasibility study, where the EC will give a lump sum of EUR 50k to conduct a (commercial) feasibility study and come up with a detailed business plan. In phase-2 this business plan can be further developed through prototyping, operational validation etc. An SME does not have to do a phase-1 project but can directly apply for phase-2 if they have a detailed business plan. In phase-2, 70% of the eligible cost are funded by the EC—which is a pretty good deal.
I’ve just had a first assessment visit by CQS (Certified Quality Systems), the certifying organisation I’m working with. That left me with a pretty positive feeling that I’ll be able to achieve certification within two months.
CQS’s Allan Baskerville is a big fan of using flowcharts. I also found that making them is very illustrative, as it forces you to think about the key activities and decision points in your processes. Allan’s most used phrase in our conversation was “is there appropriate evidence to support that …”. In a fair number of cases I could say “yes” to that.
The first thing I needed to do was to define the scope of the certification. In my case “product realisation” includes design and development but excludes series manufacturing.
If I make prototypes or models they are not stand-alone products, but secondary to the engineering documentation I’m delivering. This means that those clauses in the standard dealing with production issues—and for medical devices there are quite a few—are not applicable.
Earlier this evening I attended a Cambridge Network event where Jaideep Prabhu—co-author of the book “Jugaad Innovation” and professor at the Judge Business School—gave a talk about innovation practices in developing economies.
Compared to their counterparts in the affluent West, Indian innovators seem to be more:
- Frugal. They need to do more with less resources
- Flexible. High uncertainty means they need to change their plans more often
- Inclusive. Targeted at reaching consumers and partners outside the established economy
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.