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

Ronak Patel1, Pravin Nair1, Meenal Bhatnagar1

  • 1Research and Development, Intas Pharmaceuticals Limited (Biopharma), Ahmedabad, India.

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Summary
This summary is machine-generated.

Human Factors Engineering ensured the new Teriparatide Pen for osteoporosis is safe and effective. This cost-effective treatment option underwent rigorous testing with patients, caregivers, and healthcare professionals.

Keywords:
Teriparatide pendose accuracyformative and validationhuman factorssafety and effectiveness

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Area of Science:

  • Medical Device Development
  • Human Factors Engineering
  • Osteoporosis Treatment

Background:

  • A new Teriparatide Pen was developed as a cost-effective alternative for osteoporosis treatment.
  • The development process incorporated a comprehensive Human Factors Engineering (HFE) approach.
  • The HFE process aimed to ensure user safety, efficacy, and regulatory compliance.

Purpose of the Study:

  • To detail the Human Factors Engineering process for the Teriparatide Pen.
  • To confirm the pen's safety and effectiveness for intended users.
  • To meet regulatory requirements for medical devices.

Main Methods:

  • A risk-based approach was employed, including user analysis and risk assessment.
  • Formative and validation studies were conducted with intended users (patients, caregivers, HCPs).
  • Simulated use assessments were performed throughout the HFE process.

Main Results:

  • Preliminary analyses informed the user interface and Instructions for Use (IFU) design.
  • Formative studies optimized the pen's user interface.
  • Validation studies indicated favorable results with minor improvements to the IFU, confirmed effective in a subsequent study.

Conclusions:

  • The Human Factors Engineering process successfully ensured the Teriparatide Pen's safety and effectiveness.
  • The developed Teriparatide Pen is suitable for its intended use in osteoporosis treatment.
  • The study demonstrates the value of HFE in medical device development.