Design Input
Business Requirements – It’s okay to be a little selfish when you’re designing your medical device. If there’s no regulatory requirement forbidding something, and it’s not going to create undue harm or duress, then go ahead and add it in.
Voice of the Customer – Go back to the beginning when you defined your user. Now’s the time to define that user’s needs. Does the user want the device to be handheld? Manual or digital? Would adding Bluetooth or WiFi help your user? Maybe your user needs a certain color, size, length, etc. Your research early on to define your user will play directly into defining their needs.
QA, RA, Engineering, Marketing – This is your core team. Input from each of these specialties will give you the best chance of designing a safe and effective device that meets both user needs and business needs.
State of the Art – What is the most current knowledge in the medical field that is associated most closely with your device? This includes standards, guidance documents, information relating to the medical condition for which the device manages, benchmark devices, and existing medical alternatives to using your device. Consideration of the State of the Art, while technically only an EU requirement, is imperative regardless of marketing geography to prevent outdated technology and knowledge from being used as a basis for the device design and development. Taking this extra step shows you want the best for your customers.
Risk Management/FMEA Initiation – At this point, your design input should include the development of your risk management file, including FMEAs and FTAs. Risk management will identify risks in your design inputs and help determine what risk reduction measures are required to mitigate those risks.
Design Output
Specifications (Design, Purchasing) – All that input you got from your specialists, the State of the Art, the customer combines into your design specifications. Requirements, features, functions, and behaviors should be defined via means that are both testable and measurable so that you ensure objectivity and repeatability. Once finalized, you can develop purchasing specifications for parts and tools to help you meet those requirements.
Drawings – Turn product specifications for your device into drawings to show finished parts and product views. These engineering drawings are your blueprints for final product.
Manufacturing Instructions – Define how you want the device put together. Manufacturing instructions allow for uniform production and processing of devices.
Software Development Plan – If your device incorporates the use of software, things can be a little bit tricky. Depending on the geography you sell in, your software may be considered a medical device as-is. Your software development plan will require its own verification and validation methods alongside overall device verification and validation.
Verification and Validation Plans – Verification confirms that you designed the device the right way (design output matches design input). Validation confirms you designed the right device (design output matches user needs). Both are necessary to ensure safety requirements and risk reduction measures identified in the risk management are affirmed.
Labeling Plan – Labeling is an essential means of conveying safety related information to your end users. A labeling plan defines how you are going to develop, verify, and validate all labeling (i.e. instructions for use/operators manuals, package labeling) and links each item directly to safety measures and regulatory requirements identified in the risk management as requiring additional user notification (warnings).
Post-Market Surveillance Plan – Like clinical evaluation, post-market surveillance is a commitment lasting the lifetime of the device. Develop a plan that defines how you plan to monitor your device after it’s been sold and at what level, depth, and frequency.