Technology: Planning, Protecting, & Documenting

IP Survey & Competitive Technology Review

A Technology Review is an exploration of the technology landscape as it relates to the innovation. By becoming fluent in the technologies that are being used to solve similar problems, the innovator is better prepared to evaluate the strengths and weaknesses of alternative solutions.

Awareness and objective evaluation of related technologies and applications early on allows the innovator to focus efforts on those that are novel. How have others approached this or similar problems? Is there room for innovation in this space?

To Be a Patentable Technology:

  • The idea must be novel, non-obvious and useful.
  • There must be ‘freedom to operate’ – not violate another active patent

This also requires performing a thorough search of prior literature on technology feasibility. There are a variety of associations and organizations which govern standards on different technologies. In doing so, you will become familiar with necessary standards or specifications this type of technology will need to meet in order to gain approval from these organizations

Quality Management Systems

QMS is a framework of business processes to support planning and execution of specific objectives of the company. QMS includes policies, processes and standard procedures to ensure development of safe, high-quality products and services that meet customer requirements. An important component of QMS is documentation of product development decisions.

  • General controls: Sec: 501 (adulteration), 502 (misbranding), 510 (registration), 516 (banned devices), 518 (notification and other remedies), 519 (records and reports), and 520 (general provisions)
  • Development Planning: designating activities & implementation responsibility.
  • Inputs: Ensure that the design requirements are appropriate and address the intended use of the device, including the needs of the user.
  • Outputs: Defines the design output in terms that allow an adequate evaluation of conformance to design input requirements.
  • Verification: Confirms that the design output meets the design input
  • Validation: Evidence that device specifications conform with user needs and intended use.
  • Transfer, changes and history – accurate record keeping; documenting decisions/changes

Documenting decisions throughout the product development pathway benefits everyone. Early discovery and market validation is vital to FDA regulatory application and proceedings. Some aspects of QMS apply to every product developer; the question is when to begin and how robust a QMS system needs to be. Medical device development and FDA approval require some level of QMS and will be dictated by the FDA and the Code of Federal Regulations (CFR).

Product Requirements

The Product Requirements Document (PRD) outlines the functional requirements that the technology must have to be successful. Unlike the market requirements which is a list of what the product should do, the product requirements determines how the market requirements will be realized. The PRD must be agreed upon and signed-off on by all internal stakeholders at release and when changes are made; this ensures that the development team is aware of changes in scope and helps to prevent ‘feature creep’. These requirements should reflect the needs of the user, as outlined in the market requirements document, and the capabilities and expectations of the company. As the technology solution matures, the PRD will become more complete and descriptive.

Manufacturing Transfer

Whether manufacturing will take place in-house or with an outside vendor or group of vendors there are a number of different paths a production plan can take. These paths are dependent on variables such as: product complexity, material & process selection, number of parts, assembly requirements, number of units ordered, quality assurance requirements, etc. The successful transfer to manufacturing will require that the innovator work closely with the internal development group or outside vendor(s) to ensure that there is excellent communication and that each party understands and agrees to their roles and responsibilities.

A complete manufacturing plan should be developed with all respective vendors. If there are components or subassemblies that may critically affect the company’s ability bring the technology to market, alternative vendors should be identified as a backup

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