When developing prototype medical devices, ensuring safety and functionality should be the top priorities for students. There are several important steps students can take to address these critical factors.
Testing, Testing, Testing – Extensive testing is crucial to evaluate a prototype device and refine any issues before human use. Students should create test plans and conduct tests in various simulated-use scenarios to identify potential problems. All components and systems should be rigorously tested to establish they work as intended and will not fail in a way that endangers a user. Regular testing throughout the development process allows issues to be found and addressed early.
Address Biocompatibility – Students must prove all materials used in the device that may contact tissues, fluids or other biomaterials are biocompatible and will not introduce toxicity or other harmful risks. This involves material selection, surface testing and interaction testing under simulated biological conditions over time. Any material of unknown biocompatibility should not be used.
Establish Design Controls – To ensure consistent and repeatable safety and performance, students should follow design control processes. This includes clearly defining design inputs and specifications upfront based on intended use and risks, using a phased design and development approach with gate reviews at each stage, conducting a hazard analysis, implementing validatable manufacturing and quality systems and more. Formal design controls provide oversight and management of risks.
Consider Human Factors – How users will interact with and respond to the device must be carefully evaluated. Usability testing involving intended users should be done to identify any human factors issues early such as unintuitive controls, sizing concerns or potential for user error. The design should incorporate reliable user interfaces and foolproof designs to prevent accidental harm. Instructions for use must be fully validated for comprehensibility as well.
Follow Risk Management Processes – A risk management process pursuant to international medical device safety standards should be implemented. This includes identifying and analyzing all reasonably foreseeable hazards and estimating/evaluating associated risks, then controlling these risks by priority through design changes, additional testing, warnings or other means. Residual risks must be reduced to acceptable levels before human exposure.
Conduct Animal or Initial Human Testing – Depending on the class of device and risks, it may be appropriate for students to conduct limited animal or initial human testing of the prototype under an approved Institutional Animal Care and Use Committee or Institutional Review Board protocol. This allows further evaluation of safety and performance in more realistic biological conditions before broader human clinical research. Strict protocols minimize risks.
Validate Sterility and Cleaning – For devices requiring sterilization or cleaning prior to reuse, students must fully validate appropriate sterilization/cleaning methods and equipment under worst case soil and bioburden conditions. Sterility assurance levels and cleaning efficacy must be established through processing validation as well as product shelf life testing as needed. Cross-contamination risks are unacceptable for medical devices.
Address Manufacturability – To ensure consistent safety and performance once scaled up, prototypes should incorporate design features suitable for manufacturing as well as be conceptually manufacturable through anticipated processes. Students should evaluate manufacturability factors and eliminate any unfeasible components or assembly steps identified. Production quality systems such as process validation help assure manufacturing results in an acceptably safe product.
Document All Activities – Throughout development, students must retain documentation on all activities demonstrating due diligence to address safety and functionality concerns. This includes detailed test plans and reports, risk analyses, design reviews, validations, changemanagement records and other essential documents. Complete records serve to prove care and analytical protocols were followed in line with regulations, standards and best practices.
By systematically addressing these factors, students can give their medical device prototypes the best chances of proving safety and functionality while also gaining valuable experience with disciplines required in medical technology product development. With thorough processes and documentation, they minimize risks in line with prevailing standards of care for developing medical devices.