Human Factors Considerations for Platform Drug Delivery Devices & Leveraging IFU Templates
Human Factors Considerations for Platform Drug Delivery Devices & Leveraging IFU Templates
What Are Platform Drug Delivery Devices (“Platform Devices”)?
There is an abundance of research, documentation, and advice on the best practices for development and design of medical devices and products. Companies producing combination products that require a drug delivery device consider many factors when selecting or developing the delivery device, including cost, time to market, product performance and scalability across products. Many companies strive for the ‘gold standard’ when developing combination products, which is to design a drug delivery device and associated instructions materials (e.g. Instructions For Use, user manual, etc.) that can be used across a variety of products for different intended uses and users. This is often referred to as a platform drug delivery device (referred to as “platform device”), where the same delivery device is used across multiple products to administer medication, and the associated instructional materials are based on a template leveraging the defined critical use-related steps for platform device operation. In the example below, the combination products use the same platform drug delivery device for the administration of different drugs for different intended uses.
What Are Potential Benefits Of Leveraging Platform Devices?
The primary benefit of using a platform device strategy is that companies do not necessarily have to reinvent the wheel each time a new drug product is developed that requires the same delivery mechanism as existing products, as long as the platform device has been rigorously tested and demonstrated to be well-designed, safe, and effective for end users. In these cases, a platform device can potentially be used to reduce the costs and burdens associated with developing a completely novel drug delivery device for each new product. Therefore, considering an appropriate generalized platform device may be worth the initial time, effort, and resources to streamline product development in the future.
Whether a company is looking to design one product with multiple sizes for simultaneous rollout or aiming to advance a family of products over several years, companies should always consider human factors implications associated with using a platform device. Designing a platform device for broad use may enable human factors data to be leveraged across products in some cases, which can help streamline human factors validation of new products. The development of the platform concept is not unique to medical devices. From motor vehicles to software development, maintaining a consistent user interface that has been demonstrated to be safe and effective for end users can be a reliable method to reduce safety risks for end users and enhance the user experience.
Why Should Companies Consider Human Factors In Platform Device Decisions?
Although it often seems like a no-brainer to leverage an existing platform device across multiple products, companies should always incorporate human factors analyses into this decision. It is important to note that each new product that utilizes a platform device may be associated with different end users and use-related risk profiles, even though the operational sequence for using the platform device remains the same. Just because a platform device has worked well for some user groups does not mean that it will automatically work just as well for all user groups. Therefore, consider the following for each new product:
Identify Intended Users
Who are the intended users? Are they different from the users of other products using the platform device? For example, some products may be intended for lay users, while other products may be intended for use by healthcare professionals (HCPs) only. Defining intended users is critical, as each unique user group may have different characteristics, limitations, backgrounds, and experience that could impact use of the platform device.
What are the characteristics of the intended users, and how might these impact use of the platform device? For example, if a company identifies a new indication for a platform inhaler device that includes patients with severely reduced lung capacity, will those users be able to effectively inhale a full dose of medication? Or is a different inhaler design required that reduces the inspiratory force required needed to achieve a full dose of medication, given the physical limitations of the intended users?
Is the platform device appropriate for the end users? Sometimes companies have use-related post-market data for a product that was built upon a platform device that suggest the product is extremely well designed and safe. However, as outlined in the example above with the inhaler, not all platform devices will be appropriate for all user populations. Identifying the appropriateness for user groups early can prevent costly mistakes.
Assess Specific Use-related Risk Profiles
What are the critical use-related tasks specific to each drug product? Due to drug, indication, and end users, task criticality may not be identical for every product using a platform device. Companies should identify risks associated with each specific drug product and not assume that the risk profiles associated with using a platform drug delivery device will be the same across all products. For example, a critical task for one product may not be a critical task for another product, even though both use the same platform device.
Are there any new or different critical use-related risks? Companies can perform a gap analysis to determine whether the new product poses any additional risks beyond the risks identified for other products using the platform device. For example, “Product A” is currently on the market and contains a drug that can be fully administered through subcutaneous injection in 5 seconds. The manufacturer has developed “Product B” for a different indication, using the platform auto-injector. The use-steps are essentially the same, except the drug viscosity for “Product B” extends the amount of time a user must hold the injection to administer a full dose to 15 seconds. Can the users of “Product B” safely and effectively use the platform device for this new product?
If using a platform device across a family of products, can intended users differentiate between medications if the delivery device looks the same? This is an important question for companies to consider because selecting an incorrect product could lead to the wrong drug delivered.
How Can Companies Successfully Leverage Instructional Material Templates For Platform Devices?
When manufacturers think about using a platform device, they often want to create instructional materials that are consistent across products whenever possible. Sometimes, manufacturers create instructional material templates for the platform device that include all relevant use-related steps, formatting and areas that can be updated with any product-specific content as necessary for individual products. Leveraging an instructional material template can certainly be beneficial, but there are several things that manufacturers should keep in mind to help ensure the outcome will be as successful as possible.
Based on Agilis’ experience working in platform device and instructional materials development, we recommend companies keep the following 6 tips in mind when making decisions about incorporating an instructional materials template strategy for platform devices:
Final Thoughts
In some cases, companies can benefit from implementing a platform device strategy across a family of products or across similar products. If executed effectively, using platforms across devices or products can streamline development and enhance user experience for end users. However, remember that one size does not necessarily fit all! Human factors analyses should be always applied to new products to determine the potential use-related risks associated with product use and to ensure safety and effectiveness for all current and potential intended users. If you have questions about your platform device initiative and how human factors analyses and instructional design can be applied to optimize your product, contact Agilis to discuss your needs!
About the Author:
Lauren Jensen, PhD
Dr. Lauren Jensen, PhD, is a Biomedical Engineer and Human Factors Consultant with Agilis Consulting Group, LLC. Lauren is experienced in applying human factors principles to the design, evaluation and validation of medical devices and products. Prior to joining Agilis Consulting Group, Lauren worked in the startup space in Austin, TX engineering wearable medical products, and competed as a top ten finalist for the NASA iTech Cycle III for innovative technologies. During her PhD at Tulane University School of Medicine, Lauren developed and validated a therapeutic wearable to reduce surgeon tremor and fatigue in the OR.