The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices conference was held in Palm Springs, CA, October 18-19, 2022. In attendance were some of the world’s largest providers in this combination space which included innovators, pharmaceutical companies, suppliers of injectable devices and contracted service providers. The conference speakers presented on a variety of topics including bridging the gap between clinical and commercial devices, the design considerations for advancing technologies, and understanding human factors as well as the use ecosystem for successful development, delivery, and product lifecycle management. One theme wove a thread through every presentation I attended. Timing is key!
A consistent theme in this conference was that there is a perception (based in reality) that the device constituent lags in the development of combination products. Several speakers noted that the development time of even well-known platforms for intended use can take years. A novel device may take as many as seven years. There is an inconsistency in the time to development, clinical trial, and market launch between the drug and device constituents that is frequently overlooked. In some cases, the device is an afterthought, only given consideration mere months before intended application filing.
Several factors impact the time necessary to fully develop the design of the device constituent. These include the complexity of the device (for example, is it a connected product with a software interface), the novelty of the device and the availability of predicate devices upon which to base your device choice and design, where you can leverage market data, and the maturity of your organization in the device space.
Significantly complex products such as smart pens or on-body devices which rely on software for patient feedback and/or drug delivery require complex design. Software consideration, including cybersecurity, maintenance of code and patient interface scan significantly delay development where current in-house expertise is lacking in a traditional Pharma firm.
Where a device is novel and there is very little market experience and no predicate devices, the development time can be even more lengthy. User experience is lacking, thus extensive time must be provided to ensure that the device user needs, and design needs are clearly understood. Prototype human factors studies are both critical and also time consuming.
Finally, the maturity of the organization can further delay time to market. Where an organization is new in the combination space, there is often a knowledge gap between pharmaceutical manufacturing and medical device manufacturing. This frequently leads to a delay in considering the device component, with resultant misconceptions about regulatory and compliance requirements. Frequently, inexperienced organizations do not understand or appreciate the amount of work necessary to develop a combination product even when using a well-established platform provider or an “off-the-shelf” device, both of which have marketing authorization holder responsibilities surrounding design.
Timing is critical and can lead to delays in filing and delays to market when it is discovered very late in the process that the device design work did not start at the initial product concept. Delayed filing and delays to market can adversely impact financial projections and impair a young company’s ability to finish the job in getting the product in the hands of the patient.
Start early, and, if you do not know what early is, then work with a business partner who can help ensure that you have all the systems in place to begin a combination product project, including the necessary quality system to govern it before the project starts. Establish a project plan which requires the device constituent to be considered at the time the finished product concept is presented. Allow for the extended time that device development requires and put that into the project plan which runs in parallel to, or in concert with the drug development. And most of all learn what you don’t know to ensure you start right and end right.
If you are new in this space or just want to learn more about combination product design, manufacturing, quality systems or regulatory pathways reach out to Lachman Consultant Services, Inc. at LCS@LachmanConsultants.com to discuss how we can partner with you for success.