Drug Delivery
Devices that carry a dose to the patient, where the device and the formulation cannot be designed apart. Dose accuracy and material compatibility come first.
- Devices we have built here
- Drug aerosolisers, nano drug delivery, dermal patches.
What makes these devices hard
Dose accuracy
The delivered dose, not the set dose, is what has to be proven.
Drug and device together
Materials must not react with the drug or absorb it.
Combination route
Whether the product is regulated as a device, a drug or both shapes the whole plan.
Use by patients
Many are used at home, by people with no training.
Tell us these first
Useful in a first enquiry
- The drug, its form and the dose range
- Who gives it: the patient, a carer or a clinician
- Whether the drug is already approved, and who holds that approval
- The dose accuracy and dosing frequency you need, if known
- Any compatibility data for materials in contact with the drug
Dose accuracy depends on how the device is used
A dose measured on the bench by a trained operator is only the start. The claim has to hold across real use: held at an angle, used cold, with a step missed or a battery near empty. Standards such as ISO 11608 for needle-based injectors and ISO 20072 for aerosol devices test dose across set conditions, and usability work under IEC 62366-1 finds the use errors that change the dose.
The path for a device like yours
Questions about drug delivery devices
Is our product a device, a drug or a combination product?
That depends on which part achieves the main intended action and on how the drug and device are supplied. Each regulator decides it under its own rules. Raise it early, because the answer shapes the evidence plan. Read how routes differ in India, the US and the EU.
Which class will the device be?
The class follows the intended use and the classification rules, not the device type. Try the class and route tool.
Why does the drug path need its own testing?
Materials can absorb the drug, leach into it or react with it. Compatibility studies, often with the drug maker, show the delivered drug is unchanged. ISO 10993-1 covers the biological evaluation of materials that contact the patient.
Do our connectors need to meet a standard?
Where the device uses small-bore connectors for liquids or gases, the ISO 80369 series sets connector designs that reduce the risk of connecting to the wrong system.
Mechanism, materials and usability in one team
Our 41 engineers cover nine disciplines in one team, and we work with more than 100 clinician partners.
Standards that commonly apply
- ISO 11608Needle-based injection systems
- ISO 20072Aerosol drug delivery devices
- ISO 80369Small-bore connectors
- ISO 10993-1Biological evaluation of materials
The list for a given device, and the edition of each, is set in its regulatory plan.
Services that help here
Building a device in Drug Delivery?
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