How to Conduct a Technology & Intellectual Property Review for Medical Devices
Table of Contents
- How to Conduct a Technology Review
- Literature Searches
- IP Rights & Mitigating Potential IP Challenges
- IP for Universities: Technology Transfer Offices
- The Patenting Process
How to Conduct a Technology Review for a Medical Device
A Technology Review often begins with early assessment of the technology solution, which entails confirming that the technology is feasible and has not already been developed. This preliminary work informs the following Simbex evaluation activities, and is required in order to conduct a thorough Need and Opportunity Analysis.
Two aspects of technology review are of critical importance: assessment of Intellectual Property for freedom to operate (FTO) in the technology space and identification of relevant regulations. An overview of the Evaluation Strategy steps is provided below in Table 1: For each of the evaluation steps, Simbex helps identify the tests, what tools are necessary, and what outcomes must be measured:
The Question: What is the question I need to answer to evaluate the technology at this stage of development?
The Test/Procedure: What test can be devised to answer the question? How would the test be structured? What tools, skills and facilities will be needed? Who would conduct the test? What is the target population? Where will the test be conducted?
Prototype Needed: The evaluation steps go hand-in-hand with technology development steps. In planning evaluation activities, the innovator will need to consider timing of technology development milestones.
Outcomes: What outcomes will be measured and how? How will success or failure be determined? The feedback will provide an early opportunity for the team to ‘pivot’, i.e., make changes to the product before development begins.
|Evaluation Strategy||Potential Approaches||Necessary Version of Product||Outcome|
|Validate Societal Problem||Literature search and synthesis||None||Go/no-go decision|
|Validate the Customer Need||One-on-one interviews with customers||None||Go/no-go decision, initial market requirements|
|Validate Concept||Focus groups, interviews with customers||Concept||Revised market requirements|
|Validate Solution||Focus groups, interviews, surveys||Rough mockup, Beta-prototype, Pre-production model||Yes/No Answer, Revised market requirements, Revised product requirements|
|Validate the Business Model||One-on-one interviews with customers||None||Draft business model and list of outcomes required|
|Component Testing||Feasibility, safety, and usability testing in laboratory or ideal setting||Pre-production model||Study reports, documentation of properties & function|
|Safety and Usability Testing||Feasibility, safety, and usability testing in laboratory or ideal setting||Pre-production model||Study reports, documentation of confirming safety and usability|
|Clinical/Comparative Effectiveness Research||Clinical research||Final production model||Evidence of effectiveness in real-world settings|
Table 1: Overview of the evaluation steps to be conducted for product development.
Validating the Societal Need
While Customer Discovery interviews will reveal customers’ needs and problems, it is also important for the innovator to understand the issues surrounding their technology concept from the perspective of researchers via scientific literature as well as provider, policy and advocacy groups. Communicating what is known about the problem and what priorities have been established at the community or societal level serves as a powerful advantage in the journey toward commercialization. A Literature Search is the main method employed at this stage. Regarding Technology Review, the objectives are to determine whether there is freedom to operate and confirm that your technology does not defy the laws of nature.
|Evaluation Strategy||The Questions||The Procedure||The Outcome|
|Validate Societal Problem||Literature search and synthesis||Literature search and synthesis||Yes or no answer; A written summary of the specific evidence about prevalence, incidence, individual or societal impact, research or clinical priorities, guidelines or standards. Appropriate for the Significance section of grant application or an Executive Summary|
Conducting Literature Searches for New Medical Devices
Where to start? First consider the tools: databases are sources of material (e.g. Medline, CINAHL, etc.) and the search engines that help you find the material (e.g. Google Scholar, PubMed, Ovid, CINAHL). Important information can also be accessed from national organizations, which may involve searching websites. If the topic is a major national priority, start by searching within websites of major organizations, for example, a center within the National Institutes of Health or a relevant foundation. If it is a clinical issue, look for clinical practice guidelines that cover the topic.
There are a wide range of databases and sources the innovator may use to best to search for answers. PubMed, Ovid, and Google Scholar will be useful if attempting to find research articles. There are many resources for learning how to search the medical/rehabilitation literature, and a few good ones are provided below. If you have access to a librarian, by all means engage help of the experts! Here are a few basics to start in the direction of an informal search.
Write questions down in complete sentences. For example, “How many older people fall?” or “How often do older adults fall?” Identify the main concepts involved in the question, for example, older adults, falls/falling, balance, prevalence, etc. Search those terms or look for major subject headings that relate to those terms.
Literature Search Resources:
IP Rights & Mitigating Potential IP Challenges
Intellectual property is an idea, invention, or process that derives from the work of the mind or intellect. Intellectual property (IP) protection comes in several forms: patents, trademarks, or copyrights. A patent prevents others from copying or selling an idea, or incorporating it into their product and claiming it as their own. To be patentable an innovation must be novel, non-obvious and useful compared to what has previously been described, shown or made (i.e., the prior art). Under U.S. patent law, patents can be obtained for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”
Freedom to Operate (FTO) means that a product or service does not infringe on any intellectual property from another party. Thus, is it important to begin a product development endeavor with a search of the existing patents for the components of and processes for that product, while keeping meticulous records. The patent landscape is a dynamic one with new patents being issued and older patents expiring or being abandoned therefore the innovator should monitor the patent landscape throughout product development.
A different approach to researching is used to determine patentability. FTO analysis begins with reviewing patent prior art by searching the US Patent Office, internet, trade publications, scientific literature, as described in the Technology Review Module.
The US Patent Office offers free tools to help navigate the IP landscape. Google Patents also offers a simple way to enter search terms that describe a technology.
IP for Universities: Technology Transfer Offices
Innovators associated with a hospital or university will have engaged in an agreement regarding ownership of the intellectual property for a new invention. In general, a university can choose to claim ownership of a portion of an invention developed by a faculty member. Technology Transfer Offices (TTOs) help manage intellectual property strategy by assisting with writing, filing and prosecuting patent applications and paying the associated costs. A faculty member who wants to sell or license their technology needs to be proactive with developing a business strategy and reaching out to potential licensing partners. The range of support that TTOs provide varies widely, but overall they focus more on managing IP than on product development and commercialization.
The Patenting Process
Submitting a provisional patent application begins a 12-month time period starting on the US patent filing date that allows the innovator to use “Patent Pending” on a product and begin commercial promotion if desired.
One reason to file a provisional patent application is if there is a planned public disclosure such as; abstracts, posters, papers, discussions, grant proposals, etc. For the provisional application, it is important that the innovation is thoroughly described.
If there is no planned public disclosure is there a reason to file a patent now? One reason to hold off from filing a provisional patent is if commercializing or licensing within one year does not seem possible. Since filing begins the 12-month clock, holding off until commercialization is in sight may be desirable so that the utility patent application will describe the most advanced iteration of the product.
It is important to note that navigating the intellectual property landscape, determining Freedom to Operate and submitting a patent application are quite often complex endeavors that have wide-ranging strategic consequences. Educating oneself as much as possible and seeking legal counsel are always wise when considering patent protection.
Standards and Guidance Documents
- International Organization for Standardization (ISO)
- Federal Communications Commission (FCC)
- Association for the Advancement of Medical Instrumentation (AAMI)
- American National Standards Institute (ANSI)
- American Society of Mechanical Engineers (ASME)
- American Heart Association
- American Academy of Neurology
- FDA Guidance Documents