Scalable Design: A guide to making sure your device is ready for product launch
Designing for scalability
There are few things as expensive to develop as new drugs. On-patent time is all too short, and every day they spend on the market is worth millions. With time that precious, delivery devices need to be ready for the drug product – not stuck in pre-production while stubborn automation issues refuse to be solved.
What everyone wants is an utterly predictable process from design through scale-up to full-scale production. The drug and the delivery device themselves can be full of exciting potential, but when it comes to the development process, that’s the last thing anyone wants. For good product realisation, it’s time for a large dose of boring…
So how do you make a journey into the unknown of R&D as boring as a trip to the grocery store? Knowledge, experience, and – crucially – some creative project-thinking. Three things which TTP has in spades. So here is TTP’s short introduction to successful, scalable, product design, the boring way.
Our approach – Smooth scaling by early, sustained risk focus.
Build fundamental design understanding before detailed development.
Hazards
Capture hazards as per ISO14971
Eliminate risks through design
Avoid risk by design where possible
Modularity
Determine modular split by function
Specify objectives for analysis or tests
Establish specific goals for integration
Characterisation
Establish operating window for modules
Characterise failure at extremes
Investigate failures during integration
Detailed Design
Statistical modelling of system function
Verify modelling through testing
ISO14638 and robust design
CMO Transfer
Clear assembly step specifications
Assembly assessed for functional risk
Debug guided by deep understanding
Scalability Insights
Our track record in scalable design
Discover how clients have been able to count on us to develop scalable medical devices, both in end-to-end medical device developments and through design review prior to transfer to manufacture.
Designing a dose counter for manufacture at scale
Symbicort is AstraZeneca’s world-leading therapy millions of people with asthma rely on every day. We used probabilistic design methods to develop and generate the manufacturing specification for the dose counter, which needs to be as reliable as the inhaler itself.
Evaluating concepts for confidence in scalability
Ripple Therapeutics approached TTP to de-risk several device concepts for drug injection into the eye. TTP evaluated feasibility through a series of trials that were designed to give Ripple Therapeutics confidence and inform medical device development underway at the company.
3M’s hollow microneedle: commercial-ready
We worked with 3M to develop their hollow microstructured transdermal system (hMTS) into a device for convenient self-administration of liquid drug formulations. By providing reliable intradermal drug delivery, this offers the possibility of faster drug action and improved bioavailability over existing subcutaneous delivery methods.
Device development team
To find out more about our capabilities in medical device development, visit our Drug Delivery page or find our more about our “BuildSpace” facility.
