In order to help patients to safely administer drugs through improving the design of medical device, US based Becton, Dickinson Company (BD) has applied the principle of human factors engineering (HFE) for the development of diabetic pen needles and BD Physioject disposable auto-injector.
HFE is the process of designing equipment and devices that fit the human body. It involves a multidisciplinary approach with contributions from biomechanics, engineering, industrial design, economic theory, human performance graphic design, research and development, psychology, and clinical research. Testing of human factors validates the overall patient usability of the design system including safety, efficacy, usability, and risk.
Designed for use in the treatment of chronic diseases such as rheumatoid arthritis, multiple sclerosis, and osteoporosis, the BD Physioject disposable autoinjector is a single-use, disposable auto-injector that incorporates the 1-mL BD Hypak glass prefillable syringe to perform automatic injections in fixed doses. During the development of disposable auto-injector, multiple human factors studies were undertaken to evaluate all aspects of performance safety, efficiency, patient acceptance, and ease of use, including pain perception versus prefilled syringes.
Explains Murli Sundrani, business director, BD Medical-Pharmaceutical Systems, "Human factors (HF) is a body of knowledge about human abilities, human limitations, and other human characteristics that are relevant to device design. USA has implemented for several years and is increasing the pressure on manufacturers and pharmaceutical industry in the last 5 to 10 years. Europe is on its way to follow. However for risk evaluation and the validation of the 'Instruction of Use', it is mandatory in the US and Europe and some other countries."
HF input/engineering is used to improve and demonstrate/validate product usability, and requires a specialised skill set different to typical product engineering and market research. Regulatory bodies expect to see HF input, especially formative and summative study results. It is required regardless of scale of product change and should take place in simulated end-user environment. HF input is also a key part of risk-mitigation.
Murli further explains that in the development of self-administration devices, at BD, we are adopting human factors engineering (HFE) to address a wide variety of individualised aspects of device design and patient utilization, including task analysis and design; device evaluation and usability; patient acceptance, compliance, and concordance; anticipated training and education requirements; and systems resilience, adaptation, and failure.
Self-administered devices are becoming a very important drug delivery format around the world because of increasing chronic disease profiles. HFE, therefore, can play an important role in ensuring therapy compliance because of improved convenience and easy handling of drug delivery.
Echoing similar views, Dr Corinne Granger, vice president, medical affairs, BD Medical Pharmaceutical Systems, "Human factor testing is now integral in the development of drug delivery systems including disposable pens, auto-injectors and patch pumps. Through HFE, medical technology companies can design drug delivery devices that meet the physical and emotional needs of patients, healthcare providers, and other users-ensuring increased patient usability and therapeutic compliance.
"The testing of human factors provides a patient-focused approach to the development of new and innovative strategies to meet the needs of the pharmaceutical industry, and addresses recent regulatory guidance regarding device design," concludes Dr Granger.
Therefore, user friendly or safety engineered devices are being launched by pharma companies globally, which are believed to minimize accidents or injuries (like needle stick) and therefore reduced incidence of blood borne infections like HIV and Hepatitis B and Hepatitis C to a large extent.