Presentation
Using Human Factors Methods to Influence Device Component Selection in the Manual Delivery of High-Viscosity, High-Volume Drugs
DescriptionIn recent years, the industry has seen an increase in the development of higher concentration, and thus higher viscosity, medication. This increase is primarily due to the rise of biologics which are inherently viscous, or the desire for a slower and more sustained release of medication, which more viscous drugs allow.
Such viscous drugs may not only result in improved therapeutic outcomes for patients, but also less frequent dosing regimens. This benefit can improve patient compliance with a given regimen, reduce healthcare costs, and reduce the burden on clinicians to administer the medication and on the environment in the production and disposal of medical devices.
Despite various advantages, delivering injectable viscous drugs can present issues for both patients and healthcare professionals, a significant factor being that the device and/or user must apply a high, sustained force to inject the viscous solution through a small needle. A high deliverable volume further compounds the issue.
For high viscosity and high volume drugs administered subcutaneously, autoinjectors or infusion pumps may be the typical administration routes of choice to improve the patient and user experience. However, there are situations in which manual delivery of these drugs using a syringe is either desirable, necessary, or both, for example, due to the need to use a longer needle for intramuscular injections or the reduced development burden of a syringe compared to an autoinjector.
When device components are selected for manually injected high viscosity and high volume drugs, a balance of various factors must be struck; for example, a lower gauged needle will result in an easier and quicker delivery but will likely mean increased pain when inserting the needle into the body and a poorer patient perception of the experience. Conversely, a higher gauge needle is likely to be more tolerable for the patient and easier for the clinician to insert but will make for a longer injection time with a higher force required. Other aspects such as needle length and syringe size can also have an impact.
Conducting benchtop tests and literature reviews may provide an initial indication of the expected withdrawal and injection forces with various syringe components and the degree to which users may be able to use a device. However, these activities alone cannot replicate the user interaction with a device during preparation and administration of an injection and the subjective experience of using a device to deliver or receive a highly viscous drug. Therefore, the role that human factors can play in helping to select the most appropriate device components should not be underestimated.
Recognizing the importance of human factors, Gilead has supplemented its laboratory testing with human factors activities throughout the development of pre-filled syringes and syringe-and-vial kits for the delivery of highly viscous and high volume drugs; this ensures that the capabilities and limitations of the user as well as the broader user and patient experience are considered during the selection of device components and development of instructional material.
Gilead has therefore commissioned several human factors activities during the early stages of its device development processes to assess both the physical capabilities of users to complete use tasks (for example, removing the rigid needle shield using bespoke instrumented test devices or exploring the time taken to withdraw drug from a vial and then inject), as well as users’ and patients’ subjective experience and priorities when injecting or receiving highly viscous and high-volume drugs.
This application of human factors principles not only ensures that devices can be used safely and effectively by their intended users, but it also aims to enhance the user and patient experience of using such devices. Furthermore, it economises the development process by eliminating certain components from consideration before expensive validation assessments or clinical trials have taken place.
This presentation will describe Gilead’s recent approach and key learnings when integrating human factors methodologies into the selection of device components, assisted by Team Consulting.
Such viscous drugs may not only result in improved therapeutic outcomes for patients, but also less frequent dosing regimens. This benefit can improve patient compliance with a given regimen, reduce healthcare costs, and reduce the burden on clinicians to administer the medication and on the environment in the production and disposal of medical devices.
Despite various advantages, delivering injectable viscous drugs can present issues for both patients and healthcare professionals, a significant factor being that the device and/or user must apply a high, sustained force to inject the viscous solution through a small needle. A high deliverable volume further compounds the issue.
For high viscosity and high volume drugs administered subcutaneously, autoinjectors or infusion pumps may be the typical administration routes of choice to improve the patient and user experience. However, there are situations in which manual delivery of these drugs using a syringe is either desirable, necessary, or both, for example, due to the need to use a longer needle for intramuscular injections or the reduced development burden of a syringe compared to an autoinjector.
When device components are selected for manually injected high viscosity and high volume drugs, a balance of various factors must be struck; for example, a lower gauged needle will result in an easier and quicker delivery but will likely mean increased pain when inserting the needle into the body and a poorer patient perception of the experience. Conversely, a higher gauge needle is likely to be more tolerable for the patient and easier for the clinician to insert but will make for a longer injection time with a higher force required. Other aspects such as needle length and syringe size can also have an impact.
Conducting benchtop tests and literature reviews may provide an initial indication of the expected withdrawal and injection forces with various syringe components and the degree to which users may be able to use a device. However, these activities alone cannot replicate the user interaction with a device during preparation and administration of an injection and the subjective experience of using a device to deliver or receive a highly viscous drug. Therefore, the role that human factors can play in helping to select the most appropriate device components should not be underestimated.
Recognizing the importance of human factors, Gilead has supplemented its laboratory testing with human factors activities throughout the development of pre-filled syringes and syringe-and-vial kits for the delivery of highly viscous and high volume drugs; this ensures that the capabilities and limitations of the user as well as the broader user and patient experience are considered during the selection of device components and development of instructional material.
Gilead has therefore commissioned several human factors activities during the early stages of its device development processes to assess both the physical capabilities of users to complete use tasks (for example, removing the rigid needle shield using bespoke instrumented test devices or exploring the time taken to withdraw drug from a vial and then inject), as well as users’ and patients’ subjective experience and priorities when injecting or receiving highly viscous and high-volume drugs.
This application of human factors principles not only ensures that devices can be used safely and effectively by their intended users, but it also aims to enhance the user and patient experience of using such devices. Furthermore, it economises the development process by eliminating certain components from consideration before expensive validation assessments or clinical trials have taken place.
This presentation will describe Gilead’s recent approach and key learnings when integrating human factors methodologies into the selection of device components, assisted by Team Consulting.
Event Type
Oral Presentations
TimeTuesday, April 11:52pm - 2:15pm EDT
LocationHarbour A/B
Medical and Drug Delivery Devices (MDD)