Medical Device Development - How to Define Requirements

One of the most important steps in medical device development is defining the requirements of your medical product early on to prevent costly revisions later and delayed time to market. Taking total product life cycle into consideration from the very start is key to success.CAD-mechanical-engineer-491274-edited.jpg

Consider the following when preparing your medical Product Requirements Document (PRD):

  1. Features and functions supporting user needs and intended use: What’s required for the user to interface with the machine? Determine and document any aspect of the system configuration and sub-system configurations, including disposables and cartridges that the user will interact with to ensure that the device’s intended use is met.
  2. Performance requirements and characteristics: What are the device’s intended capabilities? Establish the product features and its processes, including process handling, sample processing, throughput, reliability, temperature and humidity, power, fluid ingress, sound and calibration.
  3. Usability and application support: Document all of the user interface requirementsTPLC Download Now, with exception handling included, modes of operation, usability requirements and levels of access.
  4. Safety, regulatory requirements and standards: What are the potential safety hazards of your device and how will the design prevent them? What are the FDA regulations you’re required to meet? Decide how your device will comply with ISO, RoHS, IEC and other regulations, and document that in your PRD. Consider the materials needed to adequately clean the device while complying with environmental and safety standards.
  5. Product and data security: How will your system retain log files and generate reports? Determine how long that information will be retained and how it can be accessed.
  6. Physical characteristics and exterior design: Document the minimum and maximum size dimensions, and weight of the instrument. Will an operator need to move a module? Make sure your weight requirements reflect that.
  7. Product configurations and external interfaces: What else does the instrument need to interface with and what’s required to make that possible?
  8. Packaging and shipping: What needs to be included with the packaging? Also, document any shipping conditions that need to be met to protect the integrity of the instrument.
  9. Service and installation: What is required to service the instrument? Include spacing requirements that allow hands or instruments necessary access to the internal components and note how servicing will be logged. Are special tools required for installation and how m
    any service users will installation require? Also, document how often the instrument should receive maintenance and how long that should take. 
  10. Sourcing and manufacturing: Specify the quality procedures and methods you require of manufacturers or suppliers.
  11. Labeling and product documentation: Note which languages the labels need to be, and indicate what user documentation will be included with the instrument and how the language will be determined.

Thoroughly define the requirements of your medical device before designand manufacturing begins to ensure that all customer requirements are covered and intended use of the product is defined. Incorporating all of the above considerations in the PRD prepares your medical device for defining system requirements and positions the instrument for FDA approval from the beginning to ensure the best outcome for your medical device and your customers.

Download the total product lifecycle chart to learn more about KMC's approach.  


Topics: medical product definition, medical device development, define medical device requirements, medical PRD