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published on March 02, 2015 by
You are a drug/biologic developer and the time has come to select a delivery device (auto-injector, pump, etc.) that will be feasible for clinical trials and ideally commercialization. More than likely you are not interested in developing this device in house and you need to decide whether to develop a custom delivery device or leverage an existing “off-the-shelf” device. The points listed below serve as a guideline to facilitate the decision making process and to assist in selecting the best device for your specific needs.
Before you look at the device options and become consumed with the wide array of devices available to deliver your drug/biologic, spend some time to identify your specific needs. The reason for this initial step is that “off-the-shelf” devices are typically designed for a “nominal” set of features. By creating a preliminary set of patient needs and product characteristics one can better assess the device options available.
- User (Patient) Population Needs – What types of device features are important and why? How would you prioritize these features and which ones are willing to compromise on (if you can)? Ensure input from marketing, clinicians and end-users are well understood.
- Unique Product (Drug/Biologic) Characteristics – What therapeutic needs/elements are unique to your drug/biologic? For example: viscosity of drug/biologic, uncommon delivery rate (rapid or prolonged), frequency of use, etc.
Now that you have identified the critical patient and product needs use it as the framework for assessing your delivery device options. As you assess the options, it is in your best interest to dive as deep as possible into the details. Following are some key points to consider:
- Off-the-Shelf Device Options – Part 1: What existing devices are available to you and how closely do they align to the needs of your patient population? What is the “nominal” set of conditions the device was designed to accommodate? How much testing was conducted (i.e., number of lots and sample sizes)? Are significant modifications necessary to accommodate your specific needs? If so, what is the impact to the product development timeline and what is the projected impact on unit price? Can you get some samples to conduct a preliminary evaluation?
- Off-the-Shelf Device Options – Part 2: What level of quality documentation does the device firm have on hand and how much are they willing to provide to you? Is there a robust design risk assessment on the device? Remember as part of the new FDA combination product guidance document, you the manufacturer of the final product are responsible for ensuring a DHF exists on the device and that it is compatible with your product. Your goal is to understand early in the process how much documentation is available versus how much documentation you will need to generate. If you don’t have the expertise in house to assess the device company and their documentation, enlist the support of a third party to help you in the vetting and evaluation process.
- Custom Device - If there are unique elements to your specific therapy and nothing off-the-shelf is a good fit, a custom device might be a better option. But, while ideal, this may actually be more costly and risky. In assessing device design firms you will be looking for relevant device development experience, a firm that has a quality system (preferably certified), and a track record of developing devices that have successfully been cleared by the EU and/or US regulatory bodies. Keep in mind that the new combination product guidance issued by the FDA states that the drug/biologic and delivery device need to be developed via an integrated process. This integrated process is something that the device developer will typically not do on your behalf and will require oversight by the drug/biologic firm. Again, if you don’t have the expertise in this area, enlist the support of a third party expert.
Determining which pathway is right for you will be heavily dependent on your specific needs and having a clear understanding of these needs will facilitate a smoother selection process for your delivery device.
EdgeOne Medical and the leaders of their Combination Product Development Services Team have been supporting the device development component of Drug/Biologic and Device Combination Product Program for the past fifteen years. Services include Strategic Product Development, Project Management, Regulatory Strategy & Submission, Quality Systems, Remediation, Risk Management, and Device Product Testing.
