Pharmaceutical Devices and Human Factors
COMBINATION PRODUCT: ‘a product comprised of any combination of a drug and a device, a biological product and a device, a drug and a biological product, or a drug, device, and a biological product’ Code of Federal Regulations 21, 3.2(e)
Oral medications such as tablets and syrups have a simple delivery mechanism; they are swallowed. But once you integrate your drug with a device, you have created a combination product.
Both elements, the drug and device, are regulated components. They work in tandem to deliver the intended therapeutic effect to the patient.
The role of human factors then becomes critical to ensuring the safe and effective use of a combination product. For example it is well documented that patients have difficulty mastering the correct technique for inhalers.
And with the current trend for more specialised, expensive and targeted drugs at lower doses and for more severe conditions, it is vital to ensure that users can safely deliver the right dose at the right time in the right way.
Experienced, trusted and innovative
- Experienced with inhalers, injection systems and infusion pumps
- Working to FDA standards, ANSI/AAMI/IEC 62366 and HE75
- Validation studies for drug delivery devices in USA and Europe
- Work for some of the world’s largest pharmaceutical companies
- Performing studies on time and in budget
- We have built up an extensive network of recruiters
Testing walk through video based at the Medical Device Usability Cambridge Head Office.
The approach we take to testing combination products is no different in principle to that for medical devices. However, there are some important differences.
- The human factors testing programme will need to be planned alongside the clinical trials programme to ensure that you end up with a product that has a satisfactory clinical and human factors dossier for the intended ‘go-to-market’ product.
- With combination products, the user is increasingly a non-expert; they may be elderly, in poor health, living at home and expected to use your product to self-medicate without the help of a healthcare professional.
- Your human factors dossier may be reviewed by a regulator with expert clinical knowledge but limited human factors experience; therefore it is vital that you produce clear and comprehensive HF data in a familiar format to aid expert review.
- Given the long lead times in developing pharmaceutical products, you need confidence that your HF provider can get the testing right first time; repeating HF studies because of methodological errors is time-consuming and expensive.
MDU have built up a comprehensive experience of human factors evaluations over nearly 20 years; we work on inhalers, injection systems, infusion pumps, diagnostic devices, sprays and drug dispensing systems. The process follows FDA guidance, and the key steps we take are:
- Define the intended device users, uses and use environments
- Describe all elements of the user interface, including instructions, packaging and peripheral items
- Research the known use problems with similar devices, or earlier versions of your device
- Define how the clinical hazards of the drug components have been characterised, and how use-related risk has been defined
- Perform analytical approaches to understanding use-related risk, including formative evaluations, expert reviews, heurist analyses and focus groups
- Feed data back into your risk assessments
- Perform simulated use testing to verify and validate that the user interface for your combination product enables users to use your device safely and effectively
- Write the human factors report, describing the residual use-related risks and associated clinical benefits for your product