Human factors testing has been vital to the success of the company’s BD Physioject Disposable Autoinjector.
Improving the administration and compliance of drug delivery is a common lifecycle strategy employed to enhance short- and long-term product adoption in the biotechnology and pharmaceutical industries. With increased competition in the industry and heightened regulatory requirements for end-user safety, significant advances in product improvements have been achieved in the injectable market, for both healthcare professionals and patients. Injection devices that facilitate preparation, ease administration, and ensure safety are increasingly prevalent in the marketplace.
|The BD Physioject Disposable Autoinjector offers users a 360° view of the drug injection process and features a one-touch injection button.
While self-injection devices use proven technologies that enable commercialization within one to three years, differentiating these systems in a competitive marketplace requires considerable insight into the disease state, market trends, and potential patient profile. Despite the operational burden associated with introducing a new self-injection device into the pharmaceutical market, many companies now use human factors engineering to retain or enhance market success.
The home healthcare market, for example, has become an area of increasing focus for the pharmaceutical industry, with growth in the United States of approximately 8% year over year and an annual market spend in excess of $2.6 billion in 2012.1 Interest in self-administration injection systems also continues to grow in outpatient care with the introduction of new injectable therapies for the treatment of diabetes, rheumatoid arthritis, infertility, multiple sclerosis, and many other diseases that affect large populations. Self-administration injection systems offer convenience by allowing patients to administer physician-prescribed medications in their preferred setting.
When selecting a system for drug delivery, it is imperative that the end user can use the system successfully. A patient-centric model can help maximize the opportunity for such success. The working philosophy of human factors engineering is now being used throughout the pharmaceutical industry through an interdisciplinary approach that evaluates patient dynamics and focuses on improving the safety, efficiency, and robustness of the delivery system. This approach examines where “a body of knowledge about human abilities, human limitations, and other human characteristics that are relevant to design” can be used when designing a drug-delivery system. 2
In response to increasing request for human factors studies in the approval of medical systems in the United States and EU, CDRH in 2011 issued a draft guidance on the consideration of human factors in medical device development and testing. The guidance provides recommendations for medical device design optimization through human factors analysis, testing, and validation. The intent is to improve the quality of the device user interface such that errors that occur during use of the device are either eliminated or reduced.3
As a result of the recent guidance, designers and manufacturers of medical devices are now accountable for assessing and mitigating user error. Coupled with IEC 62366:2007 and AAMI’s HE75, there are now clear guidelines to provide direction for applying best practices for human factors and usability engineering in product design, for assessing and controlling use error, and for developing the evidence needed to support regulatory review of the product.4, 5 In addition, these guidelines hold medical device developers and manufacturers accountable for considering user needs to ensure that design features are likely to lead to correct use of the device. Failure to consider human factors and usability can now result in costly delays caused either by designing a suboptimal product or by lengthening the process of obtaining regulatory approval to market the product.5
Traditionally, human factors engineering addresses individualized aspects of development for each self-injection device, including the following:
To achieve this, human factors scientists and engineers study the disease, patient, and desired outcome across multiple domains, including cognitive and organizational psychology, industrial and systems engineering, human performance, and economic theory—including formative usability testing that starts with the exploratory stage of the device and continues through all stages of conceptual design. Validation testing performed with real users is conducted as the final stage of the process.
FDA, however, recommends that validation testing be performed in a simulated user environment that challenges all key aspects of a product’s design and that reflects the level of product-use training end-users are likely to receive. To meet these standards, many pharmaceutical manufacturers and drug-delivery system companies will need to reposition product design and engineering platforms to focus more on the relationship between the patient and the delivery system.
There are, however, a number of limitations to the utility of human factors engineering in the development of medical devices, particularly self-injection devices. These are often directly related to the targeted patient profile, with many similar limitations to the overall clinical trial design and conduct. While field-based survey methods are extremely useful because they are conducted in the patients’ natural environment, there are various limitations including:
Becton, Dickinson, and Co. (BD) has more than 100 years of experience developing medical technologies to address healthcare problems and has established a patient-centric culture that flows through to the current product design approach. Our product development teams have realized that while home healthcare can offer patients new levels of treatment conveniences, there must be a greater focus on understanding the design and utility of the system and the human factors that influence its overall usability. BD proactively and independently designs studies to ensure the highest quality human factors research is a component of the final product our partners put into the hands of patients.
The goal of each product development team at BD is to develop drug-delivery systems that make it safer and easier for patients to take medication the right way every time. Considering the device-user interface, human factors engineering has become an integral part of medical device development and, consequently, for combination products, such as disposable pens, autoinjectors, and patch pumps. As a result, BD is now in the unique position to integrate new patient-focused characteristics to successfully prove the safety and efficacy of the systems released on the market.
In developing or modifying a self-injection system, the engineers at BD undertake extensive patient-focused research designed to uncover unmet patient needs¬—identifying human factors concerns that directly impact usability. A key part of this development process involves subjecting the device to several rounds of usability testing, putting the representative system into the hands of the target user.
The BD Physioject Disposable Autoinjector is a recent example of a commercialized self-injection drug-delivery device where human factors engineering played a key role in the product’s success. Designed for use in the treatment of chronic diseases such as rheumatoid arthritis, multiple sclerosis, and osteoporosis, the BD Physioject pen is a single-use, disposable autoinjector that incorporates a BD Hypak Glass Prefillable Syringe to perform fixed dose automatic injections.
To design the BD Physioject Disposable Autoinjector System , BD conducted multiple human factors studies and clinical studies to assess all aspects of performance safety, efficiency, patient acceptance, and ease of use, including pain perception compared with prefilled syringes.5 The studies provided essential insights regarding the overall user-product interface and highlighted that patients had a strong and positive response to both the product design and the user experience.
As a result of human factors testing, the BD Physioject Disposable Autoinjector System provides multiple features designed to aide in patient safety and ease of use, allowing the patient to control the start of the injection once the autoinjector is placed on the skin and the cap is removed. Specific design features included in the BD Physioject Disposable Autoinjector System include the following:
The BD Physioject Disposable Autoinjector System can also be customized to further meet patient-specific or disease-state-specific requirements.
As a result of the advances in patient adherence and compliance, as well as overall acceptability and effectiveness of autoinjection drug-delivery devices, drug-delivery system manufacturers now work in close partnership with pharmaceutical companies to maintain a high standard of product development through human factors testing. This partnership enables the design and execution of testing protocols that identify the widest possible range of issues that may affect the user experience at an earlier stage of drug development. When submitted to regulatory and health authorities as part of the overall approval process, data on human factors testing may facilitate product registration.
Although there are still logistical solutions to further address, human factors engineering provides a patient-centric model for the development of new and innovative strategies to meet the changing needs of the pharmaceutical industry. Medical technology companies can now design drug-delivery devices that meet the physical and emotional needs of the general population of care providers, patients, and other users—ensuring increased patient usability and therapeutic compliance. Human factors engineering plays a pivotal role in ensuring the patient remains central to the development process through usability, verification, and ongoing validation testing.
1. Declining Medicine Use and Costs: For Better or Worse? A Review of the Use of Medicines in the United States in 2012, [online] (Parsippany, NJ: IMS Institute for Healthcare Informatics, May 2013); available from Internet: http://static.correofarmaceutico.com/docs/2013/05/20/usareport.pdf.
2. A Chapanis, “To Communicate the Human Factors Message, You Have to Know What the Message Is and How to Communicate It,” Bulletin of the Human Factors Society 34 (1991): 1–4.
3. FDA, “Draft Guidance for Industry and Food and Drug Administration Staff —Applying Human Factors and Usability Engineering to Optimize Medical System Design” (Washington, DC: CDRH, Office of Device Evaluation, 2011).
4. IEC 2366:2007, “Medical Devices—Application of Usability Engineering to Medical Devices” (Geneva: International Electrotechnical Comission, 2007).
5. ANSI/AAMI HE75:2009, “Human Factors Engineering—Design of Medical Devices” (Arlington, VA: Association for the Advancement of Medical Instrumentation, 2009).
6. Supplement Approval—Rebif Rebidose, [online] (Washington, DC: FDA, 2012); available from Internet: www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103780Orig1s5121lt....
7. C Berteau et al. “Evaluation of Performance, Safety, Subject Acceptance, and Compliance of a Disposable Autoinjector for Subcutaneous Injections in Healthy Volunteers,” Patient Prefer Adherence 4 (2010): 379–388.
Raza Ahmed is worldwide director of medical affairs for the BD Medical – Pharmaceutical Systems at BD (Franklin Lakes, NJ). Reach him at Raza_Ahmed@bd.com.