Presentation
When is Enough, Enough? How Many Times Do We Have to Demonstrate a Commercially Available Platform Device is Safe for the Public?
DescriptionThe development of a novel drug delivery device is a time-consuming and expensive process, so it’s no mystery why many pharmaceutical companies choose to utilize proven off-the-shelf platform devices: it can be a less risky way to bring important medicines to market faster. We all know and love these devices – the Ypsomed YpsoMate autoinjector, the SHL Molly autoinjector, the BD UltraSafe prefilled syringe, the Aptar Unidose nasal sprayer, and so on. Platform devices like these allow pharmaceutical companies to make their medicines available to patients in a quicker, more cost-effective manner. And as they become more prevalent in the marketplace, intended users learn to use them quicker as well.
These platform device manufacturers spend years developing a reliable device family that meets various cost targets while performing all the required activities to gain clearance from regulatory authorities. This, as it should, often has included human factors engineering (HFE) activities such as use-related risk analyses and human factors validation tests, to make sure those devices support safe and effective use. However, once paired with a drug product, the pharmaceutical company is required to complete all the activities required to bring that combination product to market, which oftentimes involves repeating these HFE activities partially or in their entirety.
Now, there is no denying that HFE plays a critical role in the development of combination products, even if they use a commercially available platform device as the delivery vehicle. After all, we all have the same goal: the user interface for a final finished combination product supports safe and effective use, so everyday people like you and me can be sure we give medicine correctly to those we love. But as a discipline, we owe it to ourselves to ask, “When is enough, enough?” Do we really need to have hundreds of validation tests on a platform device that has been FDA-cleared and commercialized for years? How many times do we have to demonstrate that various populations can safely and effectively use these platforms, in various use environments? And what happens if your validation test, for example, shows less than optimal results with root causes due to the device design? Will FDA consider all commercially available products using that device be subject to things like recalls then? Of course not.
We contend that our discipline has a responsibility to be least burdensome when it comes to HFE testing especially in light of the agency’s own reviews available at Drugs@FDA and their emphasis of following a least burdensome path in their recent guidance on use-related risk analysis. To that end, we intend to present several currently marketed combination products that use platform devices that used strategies to meet HFE requirements, some with and some without human factors testing; all of which found these platform devices with other drug products support safe and effective use.
These platform device manufacturers spend years developing a reliable device family that meets various cost targets while performing all the required activities to gain clearance from regulatory authorities. This, as it should, often has included human factors engineering (HFE) activities such as use-related risk analyses and human factors validation tests, to make sure those devices support safe and effective use. However, once paired with a drug product, the pharmaceutical company is required to complete all the activities required to bring that combination product to market, which oftentimes involves repeating these HFE activities partially or in their entirety.
Now, there is no denying that HFE plays a critical role in the development of combination products, even if they use a commercially available platform device as the delivery vehicle. After all, we all have the same goal: the user interface for a final finished combination product supports safe and effective use, so everyday people like you and me can be sure we give medicine correctly to those we love. But as a discipline, we owe it to ourselves to ask, “When is enough, enough?” Do we really need to have hundreds of validation tests on a platform device that has been FDA-cleared and commercialized for years? How many times do we have to demonstrate that various populations can safely and effectively use these platforms, in various use environments? And what happens if your validation test, for example, shows less than optimal results with root causes due to the device design? Will FDA consider all commercially available products using that device be subject to things like recalls then? Of course not.
We contend that our discipline has a responsibility to be least burdensome when it comes to HFE testing especially in light of the agency’s own reviews available at Drugs@FDA and their emphasis of following a least burdensome path in their recent guidance on use-related risk analysis. To that end, we intend to present several currently marketed combination products that use platform devices that used strategies to meet HFE requirements, some with and some without human factors testing; all of which found these platform devices with other drug products support safe and effective use.
Event Type
Oral Presentations
TimeMonday, March 3111:30am - 12:00pm EDT
LocationHarbour A/B
Medical and Drug Delivery Devices (MDD)