Scalable Design: Strategies for Ensuring Your Device is Launch-Ready
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. So how do you make a journey into the unknown of R&D as predictable as a trip to the grocery store? Knowledge, experience, and – crucially – some creative project-thinking. Three things which TTP has in spades.
Scalability Insights
When 3M developed a novel hollow microneedle array for intradermal delivery of liquid drug formulations, the system showed promise. But achieving the required penetration from a microneedle was a challenge. Another issue was usability – this device wasn’t fitting in any obvious class, so how would users try to use it?
Identifying risks early in the product development process is crucial for ensuring smooth, surprise-free project outcomes when scaling drug delivery devices. Iain McDerment outlines the first-principles approach to the R&D process, applying rigorous modelling and experimentation to reduce risks – rapidly developing a highly reliable, safety-critical dose counter.
With every pipeline full of promising drugs comes a hurdle: sterilisation. Watch as David Cottenden, Senior Drug Delivery Consultant at TTP, shares his tips on sterilisation to help you scale up and bring to market your drug delivery device. Learn how to scale with confidence.
You’ve got a pipeline full of promising drugs that need a delivery device.
But there’s a hurdle to overcome – ensuring the device’s reliability when manufactured at scale.
Head of Respiratory Device Development, Svilen Savov sat down with us to share a few tips on reliability considerations when scaling a drug delivery device.
Making drug delivery to the eye more efficient is a major challenge in ophthalmology. This video explores how TTP helped Ripple Therapeutics design a sustained release implant to reduce the frequency of injections for patients.
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.
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
Let’s Talk about Scalable Design.
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.
