Med-Tech Innovation Product development
planning and execution, the readiness of the device, its assembly and the filling line converges with readiness of the formulation.
For a very new concept in delivery it would be more prudent to work with just the CDO to create the product in the early days until there is something to talk around. When mutual trust and confidence are established in the working relationship it is beneficial to both parties to establish end of month invoicing against the work that has been performed. This may take a little longer to set up initially, but it enables the project to follow all the twists and turns of opportunity and problems without having to continually rewrite and approve new programmes and contracts.
A good CDO will be able to provide you with a broad range of skill sets, which can minimise the number of subcontractors required and keep the design intent on course, reduce duplicated effort and build a solid foundation for the product long after its contract with you is complete.
Proof of concept – getting stakeholders on board It can be difficult to get commitment from an investor, internal or external, or customer without a working prototype. Your device developer therefore develops proof of concept demonstrators that are the building blocks for a new device. All projects start as words then progress to a PowerPoint presentation. At some point, and the sooner the better, you need to be able to demonstrate that the product is technically viable and that it is feasible to produce something like the required level of performance relatively quickly.
The objective of the proof of concept stage is to be able to demonstrate a working system and a credible path forward to a production product. A good start are computer generated graphics visualisation techniques such as User Interface mock-ups and photo realistic rendering of an enclosure design to help investors and potential clients understand what a product may look like, but there is nothing like seeing a “device” working. Sometimes bench rigs of off-the-shelf products can be used to form the new system. On other occasions custom designed hardware and embedded software will be required. Simple systems may only demonstrate basic operation and that is often sufficient. Alternatively, performance of the proof of concept systems may need to be tested rigorously against the specification of the final product so that stakeholders can be convinced that the proposal works. This service coming from your device developer and an understanding of the operational challenges can seamlessly transfer into the technology and know-how for the production of the device rather than having to brief a new company. A developer should provide good looking devices;
these provide more efficacious treatment. If the design of the internal working parts progresses expertly, the ultimate package will be kept in mind 100% of the time. This means that major changes will not be necessary when the external skin of the device is needed, indeed it may well be simultaneously developed.
18 ¦ September/October 2013
From the end user’s perspective positive comments on the look of the device can, indeed should, include the following: • “Looks cool.” The disease being treated is never welcome, but at least the device looks good or is inconspicuous.
• “I don’t mind using it when I am out.” An attractive product increases compliance because it is more likely to be used in company or public situations and is not just an ugly reminder of the medical condition.
• “It looks like it will work.” Good design inspires confidence. As confidence increases so does the efficacy of the treatment by an increase in the inherent placebo component of all treatments.
• “They have gone to the effort of making a nice product for me.” An attractive looking product inspires a feeling of being cared about, looked after even, by the manufacturer.
• ”I can continue a normal life.” Smaller, within limits of human factors, is usually better, partially for ease of portability and therefore compliance, but also a small device can provide the impression: “small device – small disease problem.”
Building in design for metrology – lifelong measurement The components are created in CAD with the control dimensions used as drivers for the features, this will assist with the design of robust dimensioning and methods of measurement.
This means variations to the controls to bring the moulded/machined product into tolerance can be made with the minimum of changes to the model and lessening of the chances of unforeseen, or worse still, unnoticed changes happening to the model and drawing. Involvement of the metrologist in the design stage of
new projects makes this possible and makes the first-off inspection report (FOIR) and initial sample inspection report (ISIR) quicker and easier and without data changes.
Stuctured CAD – solid foundation for the life of the product By crafting the CAD model so that feature types are logically grouped in sensible order allows quick analysis of the model by suppressing all non-functional features such as moulding drafts and edge radii. This requires highly disciplined designers. This approach enables easier changes to be made by
your staff at some point in the future, with reduced risk of unintended changes and with a much-lessened chance of the CAD model “falling over” or crashing, causing hours or even days of rebuilding. If this simple regimen continues to be pursued by downstream editors there is much greater opportunity for others to understand the model and in their turn edit it appropriately.
Production design Your CDO needs to know about design for manufacture.
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GlaxoSmithKline’s intranasal delivery device
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