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.


Capture hazards as per ISO14971
Eliminate risks through design
Avoid risk by design where possible


Determine modular split by function
Specify objectives for analysis or tests
Establish specific goals for integration


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

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.

Read the full case study here

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.

Read the case study here

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.

Read the case study here

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.

David Cottenden
Senior Consultant, Drug Delivery
James Howarth
Senior Consultant, Drug Delivery
Svilen Savov
Senior Consultant, Drug Delivery

Get in touch with our team

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