Med-Tech Innovation Product development


To hand the design to another, late stage, team raises the possibility of losing the intent and integrity of the original design.


Its familiarity with assembly processes including ultrasonic welding, vision systems, vibratory feed issues, picking or holding orientation is important. Awareness of generic production processes and design for high cavitation tooling with its broader tolerance requirements is essential.


IP generation – it’s property after all A CDO with integrity recognises that the client is paying for its time and will acknowledge that IP generated from the brief, and the client’s expressed needs and existing technology belongs to the client, even when the IP is not used in the product being developed. For ongoing trust and good relations the author believes this should be offered to the client. This can pay dividends to the CDO because development of that IP is often best placed back with the originators as the experts in the concept. More often, the core value of IP lies in the quality of the question, and perhaps less so in the answer, but that is the subject of a different article.


Change and data control – Production data must be the same wherever it is Change happens therefore controls must be in place. Because it is happening initially not in your office but somewhere else, you need to know it is traceable. To enable unambiguous communication, the components must be understood, numbered, named and the features within them named and understood/ justified and logged. Dimensions should have serial numbers. This also helps with communications with maths modellers.


Changes should be logged as to who called for them, the reason for the change, what has changed, the implications of the change, who undertook them, who needs to know about them and/or authorise them, where the old version is stored, and whether the change is exploration or production.


At some point your company will want to bring MEDTECH ITL quarter 55 x 180_MEDTECH 55 x 180 23/08/2013 13:24 Page 1


the project in house and clarity of the design and the decision-making that created it is vital. A long track record of appropriate development


Medica 2013 Stand H20, Hall 3 Dusseldorf


20-23 November From Design to Manufacture and


everything in between We transform ground-breaking ideas into commercial reality. Our experience is in medical, diagnostic, analytical, precision electromech and laboratory instruments. We quickly grasp new concepts, develop cost-effective solutions, satisfy clients’ visions and meet market needs.


We provide the skills and expertise from consultancy and design to global manufacturing – all from a single source.


Concept & Design • Prototype • Quality Manufacture www.itl.co.uk


sales@itl.co.uk Tel: +44 (0)1233 638383 www.med-techinnovation.com Bringing Your Instruments to Life September/October 2013 ¦ 19


at your chosen CDO is enhanced by a low turnover of personnel. With the appropriately, protracted development of devices Warwick Design finds that sometimes its client’s staff turnover means that the history of design decisions lies with us because original key client personnel have moved on. That is why we recommend (although it slightly slows down the origination of the product design) leaving a trail of logged decision making, so that newcomers to the project (be they your staff or the CDO’s) do not try to reinvent the product because of a lack of knowledge of its evolution and the sound logic behind it.


And, of course, your chosen CDO should be able to demonstrate complete on and off site backup systems to avoid potential losses.


Designing down risk All companies and the regulatory bodies want a perfectly safe delivery, but in reality nothing is perfect so it comes down to risk judgement and minimisation. Neither of these is as absolute as perfection, therefore, unpleasant as it sounds, budgets play a part in determining safety. But what a good developer can do is to recognise potential risk scenarios, long before even the first failure mode and effects analysis, and design them out. You want the CDO to be a member of your team and with the same goals of a successful, safe and effective device. It has a different business model – shorter term financial gains – but it should want to be the first company you turn to for your next device. So while you want the best out of them they should be looking to give you the best for long term return business opportunites. Get to know the CDO and how it has operated in the past, does it have its own products in the same sector as you, what are the implications of that?


Andrew Gibbs is Design Manager at Warwick Design Consultants, the company has been designing and developing drug delivery devices, and their test and production equipment under contract to major pharmaceutical companies for twenty years. 12 Waterloo Park, Bidford on Avon B50 4JG, UK, tel. +44 (0)1789 490 591, email: wdc@ warwickdesign.com, www.warwickdesign.com


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50