Healthcare product development is complex. It is critical to know the general product development lifecycle so that you can follow the correct path. Knowing which pitfalls to avoid will speed your time to market. This article outlines step 6 of the 10 steps to develop a healthcare product.
After your healthcare product development plan is established and approved by senior management, it is ready for execution. By this stage, specific regulatory requirements should have been identified in the regulatory strategy document. Such requirements may concern quality, safety and efficacy, or may be specific to a particular product or disease. Subject-matter experts who possess knowledge of the investigational product are responsible for carrying out the corresponding manufacturing, non-clinical and clinical programs, including any coordination of activities with third parties.
Many factors, including regulatory requirements, product characteristics, the proposed claim and/or product label and the study duration should be incorporated into the study design so that appropriate data can be generated to support product approval or clearance.
The execution of each manufacturing, non-clinical or clinical program should be in accordance with applicable regional Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) to ensure the integrity of the data being collected. Although the details of the development plan vary from product to product, the general activities will include the following:
Manufacturing programs are carried out to ensure and demonstrate the quality of a product and to establish controls for both drug substance(s) and drug product(s). Information on the following is normally required in support of product registration:1
In a non-clinical program, safety and preliminary efficacy are obtained to demonstrate product safety. These studies may include:
Information on clinical programs for drug and biologics as well as medical devices is provided in a separate article. For more details, please see Execute your clinical plan.
Manufacturers should establish and maintain product development plans that describe the design and development activities and that define the responsibilities for the completion of the design (that is, what must be done and by whom). Although the activities can vary considerably depending on the type and complexity of the medical device being tested, one of the general approaches is to follow the design controls requirements. The design control elements of ISO 13485 and of Title 21, Section 820.30 of the US Code of Federal Regulations (CFR) are quite similar and are presented below:3,4,5
|ISO 134857.3 Design and developmentii||21 CFR820.30 Design Controls|
For more information, please see the article Medical device regulations, classification and submissions.
iThis may not be required if the drug or biologic is intended for short-term use.
iiThe requirements for design transfer and design history files in the US Code of Federal Regulations, Title 21, 820.30 are addressed under ISO 13485 in sections 4.2.4 Records and 7.3.1 Design & development.
Read the next step in the 10 steps to develop a healthcare product: Step 7: Execute your clinical plan
Read the previous step: Step 5: Establish your healthcare product development plan
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