Step 4: Develop your regulatory strategy

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 4 of the 10 steps to develop a healthcare product.

Once the product classification, claim and healthcare market(s) for a drug, biologic or medical device are identified, it is time to collect all relevant information associated with your product. Information on drug, biologic and medical device development can be easily obtained from websites (such as this one), professional organizations, books, journals and conferences, and, of course, formal academic training. Direction is readily available, ranging from legislation to regulations to guidance documents to the latest information on science, technology and approved therapies.

Customize your strategy

Gathering information is an important step in preparing a regulatory strategy document. The knowledge you compile on regulations, competing products, therapeutic markets or clinical practices must be filtered, interpreted, connected and adapted to your healthcare product and to your organization. Knowing the regulations and content of relevant guidance documents, the disease or conditions being investigated and the approved therapies and their basis of approvals provides the foundation for your regulatory strategy. 1

Additionally, to successfully navigate the complex regulatory system, recognize and respect factors such as development timelines, budgets, resources and available expertise.

A well-planned regulatory strategy document should be balanced, realistic and achievable to support the organization’s mission and vision. The document should not only outline which path to take, but also include the rationale of why a specific path is selected or recommended. It should be user-friendly as it will need to be communicated to the team (for example, company executives, investors, scientists, engineers, the project manager, and investigators) who provide the financing or carry out the development activities.


Consider a road trip as an analogy, with your plan being to travel from point A to points B and C (but not necessarily in that order). You have options such as avoiding tolls or choosing highway driving. Depending on traffic and road conditions, it may be better to go to point C before point B. You would be wise to base these decisions on costs, time, traffic situations and the conditions at the final destinations.

Similarly, if you are planning to bring a product to countries X and Y, factors such as  budget, timelines, regulatory requirements in different jurisdictions (for example, device classification or registration requirements, especially the need for a clinical study) and market conditions (for example, established distribution channels, support of key opinion leaders, competitors) may affect your decision.

The same principles apply to a product with multiple indications. A device classification may change due to any risk associated with different intended uses. For example, in the US, a human chronic gonadotropin (HCG) test system used for the detection of early pregnancy is categorized as class II, but it changes to class III if the product is intended to aid in the diagnosis, prognosis, management or treatment of tumours or carcinomas.2 And a medicinal product may be targeted for a general or an orphan population, which can lead to different regulatory pathways.

All these options should be reviewed against the organization’s circumstances before finalizing the strategy. A company may wish to start with a simpler pathway, such as a 510(k), and gain regulatory experience prior to pursuing a more challenging but more desired indication (for example, a premarket approval [PMA]).

Lastly, make sure to periodically review and update the regulatory strategy document to address any changes in regulations, markets, and study results that arise from product development.

Key elements of a regulatory strategy document

A strategy document is a concise summary and analysis of data collected. The key elements include the following:

  • Date and version number
  • Product/project code and product name
  • Product information (for example, background information, product type, product design, marketing history)
  • Proposed claim or indication
  • Identification of different submission phases (for example, pre-submission meeting, clinical trial applications, other types of applications [such as an orphan drug designation], licensing applications, post-marketing requirements) and their corresponding submission types and agency review timeframes.
  • Specific requirements to develop the healthcare product and support each of the submission phases, including the data requirements to support the safety, efficacy/effectiveness and quality of your healthcare product and its intended use, which may include links to relevant guidance documents and standards
  • Summary
  • Conclusion, options or recommendations (for example, if multiple pathways are identified, explain the pros and cons of each so that management can make an informed decision).

Read the next step in the 10 steps to develop a healthcare product: Step 5: Establish your product development plan

Read the previous step: Step 3: Determine your healthcare market


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


  1. Manuts, D.S. (2008). Chapter 11. The practice of regulatory affairs. In Pisano, D.J. & Mantus, D.S. (Eds.), FDA regulatory affairs: A guide for prescription drugs, medical devices, and biologics (2nd ed., pp.109-23). New York: Informa Healthcare.
  2. United States Code. (2012, April 1). Title 21, Section 862.1155, Human chorionic gonadotropin (HCG) test system. Retrieved August 16, 2012, from