Device Development for Biosimilars: Human Factor Engineering for a Teriparatide Pen

ABSTRACT

Background

A thorough Human Factors Engineering (HFE) process was implemented to develop a new Teriparatide Pen for the treatment of osteoporosis. The pen provides a cost-effective treatment alternative to branded teriparatide pens. The HFE process ensured that the pen was safe and effective to use and fulfilled the regulatory requirements.

Research Design and Methods

The HFE process utilized a risk-based approach that included understanding the users and other use characteristics, preliminary analyses including a thorough risk assessment, a formative and two validation studies. The studies were carried out with intended users – patients, caregivers and healthcare professionals (HCPs) – in the form of simulated use assessments.

Results

The preliminary analyses supported the design of the pen’s user interface, including its Instructions for Use (IFU). The formative study helped to optimize the user interface. The validation study results were largely favorable but indicated a minor scope for improvement. The IFU was therefore further improved, and a bridging validation study assessed the revised IFU and found it to be effective in supporting the correct use of the pen.

Conclusions

The HFE process ensured and demonstrated that the Teriparatide Pen was safe and effective for its intended use.

KEYWORDS:

• Teriparatide pen
• dose accuracy
• human factors
• safety and effectiveness
• formative and validation

Abbreviations

EMA: European Medicines Agency; HCP: healthcare professional; HF: human factor; HFE: human factor engineering; IFU: instructions for use; PIL: patient information leaflet; RAC: risk assessment code; US FDA: United States Food and Drug Administration; uFMEA: use-related failure modes and effects analysis.

Acknowledgments

The authors thank Cambridge Consultants for planning and implementing the HF program of work including the studies, and all the participants who took part in HF studies. The authors thank Neil Hodson of Accord Healthcare (a subsidiary of Intas Pharmaceuticals Ltd.) for the support during the execution of the HF studies. The authors also thank the contributions of the Nemera team for the design and development activities and studies for the Teriparatide Pen.

Author contributions

R Patel and S Gupta were involved in planning the HFE program of work, including the design of the HF studies. S Gupta’s team at Cambridge Consultants was involved in the execution of the HFE program including the conduct, data collection and analysis of the HF studies. P Nair and S Khambhampaty provided inputs and specifications for the device development to Nemera. M Bhatnagar, P Nair and S Khambhampaty contributed to conceptualization, design, data collection and analysis of the dose accuracy and in-use stability studies. R Patel, P Nair and S Khambhampaty analyzed and interpreted the dose accuracy and in-use stability study data and results. All authors participated in the preparation and review of this manuscript. All authors reviewed and approved the final manuscript. Nemera team reviewed the manuscript for the device development part. Cambridge Consultants team primarily reviewed and approved the manuscript for the HFE part.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Declaration of Interests

R Patel, P Nair, M Bhatnagar and S Khambhampaty are employees of Intas Pharmaceuticals Ltd. S Gupta is an employee of Cambridge Consultants, Cambridge, UK. All the work and studies of Teriparatide Pen mentioned in this paper were sponsored by Intas Pharmaceuticals Ltd. Intas Pharmaceuticals Ltd. contracted Cambridge Consultants for the planning and execution of the HFE program of work described in this paper. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

All work carried out by Cambridge Consultants was funded by Intas Pharmaceuticals Ltd.