Healthcare product development (that is, the development of a drug, biologic or medical device) is a long and complex process. It is critical to know the general product development lifecycle from the proof-of-concept (POC) stage to the licensing stage so that your development process can follow the correct path. Knowing which pitfalls to avoid will speed your time to market.
The healthcare product development process involves 10 key steps, as shown in Figure 1. Further details and links to related in-depth articles are below.
Step 1: Properly classify your healthcare product (that is, as a drug, a biologic, a medical device or a combination product) so that you know which regulatory path to take. If in doubt, contact the appropriate regulatory body to confirm the product type and how your product is regulated.
Step 2: Identify the claim of your healthcare product so that you know what types of studies to conduct to support the claim and your product label. For instance, changing your claim may change the medical device classification which can lead to different regulatory oversight requirements (for example, class II versus class III device―meaning a 510(k) submission versus a Premarket Approval [PMA] submission in the US).
Step 3: Determine your healthcare market. This will guide you to the requirements that are specific to each jurisdiction. It is important to identify jurisdiction-specific requirements upfront so that they can be included early in the product development plan.
Step 4: Develop your regulatory strategy by identifying the specific regulatory requirements as well as the possible pathway(s) to take. A thorough understanding of these requirements will guide the development of your regulatory strategy.
Step 5: Establish a healthcare product development plan so that the product requirements can be translated into actions―that is, who does what and by when and for how much. Such plan should be established collaboratively with input from different functional groups. It should include key milestones, critical paths and periodic reviews for “go and no-go” decisions and be updated periodically.
Step 6: Execute the product development plan. It is subject-matter experts who possess knowledge of the investigational product who must carry out (and be responsible for) the corresponding manufacturing, quality, regulatory, non-clinical and clinical programs, as well as any coordination with third parties.
Step 7: Execute the clinical plan. If a clinical program is required in support of the licensing application, these studies should be conducted according to good clinical practices (GCP) and country-specific requirements, such as ethics approvals and/or necessary regulatory approvals for conducting the clinical trial(s). Often, it helps to have a pre-submission meeting with the regulatory agency prior to submitting a clinical trial application in order to address specific issues (for example, the design of the clinical trial and the study end point[s]).
Step 8: Collect your data for regulatory submission. Once the data from the product design and the manufacturing, quality, non-clinical and clinical programs are available, these data and reports should be collected for inclusion in the regulatory submission.
Step 9: Collate your regulatory submission according to applicable regulatory requirements specific to your type of submission. Ensure the completeness of the submission and anticipate the resources needed to address questions from the agency during the submission review. For an innovative healthcare product, it is often recommended to have a pre-submission meeting with your agency prior to submitting the licensing application.
Step 10: Ensure post-marketing compliance. Make sure to fulfill all necessary post-marketing obligations.
For more details on healthcare product development, please click on the hyperlinks provided to access the in-depth articles on each of these 10 steps.
The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional.
Published: October 17, 2012