• Defined through user research, clinical requirements, technical requirements, and competitive benchmarking
• This helps identify the market, the appropriate clinical problem and technical and business requirements the device must meet

• Functional requirements specify what the device does, focusing on the operational capabilities of the device and processing of inputs and the resultant outputs.
• Performance requirements specify how much or how well the device must perform, addressing issues such as speed, strength, response times, accuracy, limits of operation, etc.
• User-device interaction requirements specify how a device is used and the overall experience a user has with the device
• Business/competitive benchmark requirements define the target costs and market size for the device

Continual iteration of ideas, concepts, and prototypes...

820.3(g) Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.

§ 820.3(y) Specification means any requirement with which a product, process, service, or other activity must conform.

• Participants are asked to describe the clinical problem from diagnosis through therapy in discrete steps. Their preferences, bias and opinions are captured and compared.
• Procedures are observed and detailed task analysis is generated highlighting the users manual, cognitive tasks as well as the environmental and contextual considerations.

• Specific tissue characteristics
• Surrounding anatomical structures

• Current diagnosis procedures
• Current standard of care

• Existing device/s, patent searches, usability preferences, costs, are explored and compared.
• In addition, comparative technologies are identified.
  (E.g. Pipeline camera for plumbing explorations = endoscope)

Define the characteristics of the device solution to the clinical problem.

• Prioritized based on critical elements e.g. clinical function, etc.
• Consider each research area and can be traced to their origin (clinical need, business need, user need, and/or technical need).

• 820.3(y) Specification means any requirement with which a product, process, service, or other activity must conform.
• § 820.3(z) Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.
• Process Validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
• Design Validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).
• § 820.3(aa) Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.

• Throughout the process experts are consulted with regards to the usability of a device.
• Prototypes are reviewed both in context (animal/cadaver labs) and through table discussions.

Our usability mantra –
“Make it harder for a user to do the wrong action and easier for them to do the right one!"

Following the developed set of design requirements each element is defined into target specifications and proposed tolerances.

• Concepts are developed from inspiration in ordinary household items to pure imagination
• Concepts are generated through sketches, computer models,3D models, and rapid prototyping
• These concepts are organized and chosen based on the set of design requirements that are developed
  • Pugh
  • Weighted Matrix
  • “Blink theory”

• Considering both the aesthetically pleasing ergonomically correct and that all components of the device fit, and it functions correctly, prototypes are developed from the most basic rudimentary proof of concept through functioning models.
• Techniques include: hand models, 3D powder print, SLA, and CNC mill.