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.

Execution of manufacturing, non-clinical and clinical programs

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:

  • Identification of requirements for each manufacturing, quality, non-clinical or clinical program
  • Information gathering
  • Study design (for example, study plan or protocol, statistical analysis plan)
  • Implementation of the study according to the plan and recording of changes to the plan (for example, notes to file, deviations, protocol amendments)
  • Study completion
  • Data analysis
  • Report generation

Product development plan for drugs and biologics as well as for medical devices are presented below.

Drugs and biologics

Manufacturing program

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

  • Manufacturing activities (that is, who does what and how), so as to safeguard the consistent production of quality drug substance(s) and drug product(s). This information should cover areas such as the identification of in-process control steps, critical processes and parameters; contamination minimization; and validation activities. Each facility involved (for example, fabrication, testing, packaging, storage) should comply with regional Good Manufacturing Practice (GMP) requirements
  • Product characterization and formulation development
  • Control activities for drug substance(s), drug product(s) and excipients, including details for defining the appropriate release specifications, identifying related substances or impurities and establishing validated analytical procedures
  • Reference standards
  • Container closure systems, which are appropriate to protect the drug substance and drug product from environmental conditions involving factors such as humidity, light, temperature and shipping. Materials used in packaging should be compatible with the product and should not interact with the drug substance and drug product or leach materials into the product
  • The stability program, which establishes the shelf-life, storage conditions and any in-use shelf-life for the drug substance and drug product

Non-clinical program2

In a non-clinical program, safety and preliminary efficacy are obtained to demonstrate product safety. These studies may include:

  • Pharmacology
  • Toxicological kinetic and pharmacokinetics
  • Pharmaceutical safety
  • Toxicity
  • Genotoxicity
  • Carcinogenicityi
  • Reproductive toxicity
  • Immunotoxicity
  • Photosafety
  • Any other studies specific to your product

Clinical program

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.

Medical devices

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
  • 7.3.1 Design and development planning
  • 7.3.2 Design and development inputs
  • 7.3.3 Design and development outputs
  • 7.3.4 Design and development review
  • 7.3.5 Design and development verification
  • 7.3.6 Design and development validation
  • 7.3.7 Control of design and development changes
  • Design and development planning
  • Design input
  • Design output
  • Design review
  • Design verification
  • Design validation
  • Design transfer
  • Design changes
  • Design history file

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.
The 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


  1. International Conference on Harmonisation. (2002, September 12.) ICH M4Q(R1). The Common Technical Document For The Registration Of Pharmaceuticals For Human Use: Quality – M4Q(R1): Quality Overall Summary Of Module 2 Module 3: Quality. Retrieved August 16, 2012, from
  2. International Conference on Harmonisation. Safety guidelines. Retrieved August 16, 2012, from
  3. United States Code. (2012, April 1.) Title 21, Section 820.30, Design Controls. Retrieved August 16, 2012, from
  4. ISO 13485:2003. Medical devices – Quality management systems – Requirements for regulatory purposes.
  5. Tobin, J.J. & Walsh, G. (2008). Chapter 9. Medical devices. In Medical product regulatory affairs. Pharmaceuticals, diagnostics, medical devices. Weinheim: Wiley-VCH Verlag GmbH & Co. KGaA.