MaRS Library Step 5: Establish your healthcare product development plan
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 5 of the 10 steps to develop a healthcare product.
Before placing a drug, biologic or medical device on the market, a multi-phase procedure must be followed.
A typical drug or biologics product development lifecycle begins with a number of non-clinical studies, which are normally followed by three phases of clinical trials prior to applying for licensing approval. The U.S. Food and Drug Administration (FDA) offers an excellent graphical representation of a typical drug development process, entitled, “The New Drug Development Process: Steps from Test Tube to New Drug Application Review.”1
The product development pathway for a medical device is similar; however, the non-clinical and clinical programs are often less extensive than those of drugs and biologics, as these products are not intended to elicit a biological response (that is, a chemical or metabolic action).2 The
FDA offers an excellent graphical presentation of a typical medical device development process. Entitled “Figure 2,” it depicts “the medical device development pathway from discovery and ideation to product launch and post market monitoring” and notes that “the regulatory process affects a significant portion of the device development pathway and should accommodate the iterative, cyclical nature of device design and development.”3
Once a healthcare product has reached regulatory approval, a company may also conduct post-marketing studies (that is, Phase IV studies), such as market surveillance studies and/or post-approval studies, if desired by the company or requested by the regulatory agency.
Product development plan
Generally speaking, different healthcare products will follow a similar product development approach; however, the activities and requirements, as well as necessary time, costs and resources can vary considerably depending on the type and complexity of each product. This is particularly true for medical devices if comparing the submission requirements for a lower-risk device (for example, US 510(k) or Canadian class II medical device licence application) versus a higher-risk device (for example, US PMA [premarket approval] or Canadian class IV medical device licence application).
When establishing a product development plan, any design activities, studies required to demonstrate product quality, safety and efficacy/effectiveness, and other needs (for example, meeting with the agency, orphan drug designation application) as identified in the regulatory strategy document should be carefully mapped to each phase of the development lifecycle.
Once all the tasks are identified, the responsibilities for the completion of each task should be clearly defined, that is, “who” does “what” and by “when” and for “how much.” A development plan should be realistic and achievable.
If a company is working with third parties (for example, contract manufacturing organizations or contract research organizations) to complete each milestone, a dedicated individual should be designated as the contact person in order to identify, qualify and follow up on information such as protocol development, the conduct of the study, the generation of the study report and any amendments required during different phases of the tasks. Each major task (for example, the conduct of a biocompatibility study) should be broken down into subtasks (for example, protocol development, study conduct, report generation) to allow the creation of a realistic plan. Each subtask should then be further divided with regard to the authoring, review, updating, finalization and sign-off for each document.
Figure 1 is a simplified example of the tasks and subtasks required for conducting a biocompatibility study that forms part of the development plan.
Such a development plan should be established collaboratively with input from different functional groups, which generally include marketing, manufacturing, quality, non-clinical, data management, clinical, biostatistics, medical, research and development, legal and regulatory. Key milestones, critical paths and periodic reviews for “go and no-go” decisions should also be included in this plan. Revisit and update the plan periodically to monitor the progress of the product development, and ensure that management reviews and approves this document.
Did you know?
Gantt charts are commonly used for projects as they display the tasks, schedule, progress, responsibilities and milestones in one visual representation. A Gantt chart also allows you to spot any possible problems during your project timeline (by showing dependencies between tasks), which in turns allows you to correct the problem (for example, by allocating needed resources) before it occurs. More information, as well as chart templates, can be found at http://www.ganttchart.com.
Read the next step in the 10 steps to develop a healthcare product: Step 6: Execute your healthcare product development plan
Read the previous step: Step 4: Develop your regulatory strategy
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
- U.S. Food and Drug Administration. New Drug Development and Review Process. Retrieved August 15, 2012, from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm053131.htm.
- 2. U.S. Department of Health and Human Services. (1995, August 1). Statement Regarding the Demonstrations of Effectiveness of Human Drug Products and Devices. Docket No. 95N-0230. Retrieved September 26, 2012, from US Federal Register Online via the Government Printing Office: http://www.gpo.gov/fdsys/pkg/FR-1995-08-01/html/95-18877.htm.
- 3. U.S. Food and Drug Administration. (2011, February). Medical Device Innovation Initiative White Paper. Retrieved August 15, 2012, from http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/ucm242067.htm.