POC Demonstration Expectations
Will “Proof-of-Concept” requirements be the same for all observers?
The requirements for demonstration of product feasibility vary greatly, and will be affected by the combination of the selected commercialization path and the background and experience of the observers. You may also be attempting to demonstrate a great deal more than proof-of-concept. Regardless, the following information and suggestions are provided to encourage a realistic inventor mindset in the development of prototypes, and in the ensuing interactions with potential partners in the commercialization process — especially for those inventions destined for medical application.
Because all commercialization options will require financial decision-making by other individuals, such as investors, partners, or licensees...
Anything you can do to reduce their perception of risk is valuable. If you have investigated and incorporated prospective customer needs in your design of product features, that’s a great start.
Your investment in thorough customer “needs” research will provide the guidance for avoidance of “near misses” in features design, but will also help you determine just how much prototype development should be necessary to demonstrate proof-of-concept to a range of interested parties ─ on the first attempt!
Industry Licensee vs Startup Investor
If you have determined that out-licensing to an established company is the appropriate path for commercialization of your technology, you should attempt to learn something about the organization you may be targeting as the licensee and future developer of the product.
Profiling Companies as Potential Technology Licensees
If you have accurately assessed the needs of the potential licensee’s customer base, then you should be able to expect support from the company’s marketing representatives (once you get access to them). However, university faculty and students typically get their first exposure to industry through scientists or engineers representing a particular company’s R&D organization.
You may be approached by an industry representative who has followed the research in your field, or who may be responding to an abstract of your new invention that is being marketed by your tech transfer organization…
The perspective of a visiting corporate scientist or engineer (evaluating your technology and prototype) may be influenced to some extent by whether or not they would remain directly involved in the development of the technology post-licensing.
A pattern of behavior is not necessarily associated with either situation, but it would be an advantage in answering questions if you knew the perspective of the company representative.
Proof-of-concept can be established to the satisfaction of industry representatives with prototypes of varying degrees of sophistication, as long as you actually demonstrate the feasibility of the most important product features.
Sometimes achieving this milestone may be more demanding, for example if the product concept involves multiple engineering disciplines (mechanical, electrical, fluidics, software), and therefore requires some level of systems integration to demonstrate feasibility.
NOTE: It may be even more difficult to satisfy such observers when key materials utilized in the prototype are either unknown to industry experts, or are known to be ill-suited for performance, or unacceptable with respect to cost or manufacturability. It’s not unusual for university researchers to be forced into such a prototyping scenario due to lack of access to (or funding for) more appropriate materials.
Some industry diligence on your part may expose such an issue, and provide time to prepare for the challenge, possibly with data to defend your prototype as being representative of the envisioned product.
If you are contemplating the formation of a startup and are attempting to attract investment capital based upon an early-stage prototype…
You may also face a challenging POC demonstration requirement, but for different reasons. If the device invention is to be applied in an area where the inventor team has no prior experience, investors, in an effort to reduce their risk may want to see a level of prototype demonstration that could go well beyond proof-of-concept.
To a certain extent, therefore, what an observer needs to see as proof of concept is similar to one’s perception of “beauty”. It’s … ” in the eyes of the beholder”.
Will you need external engineering “validation” of your prototype goals?
As discussed earlier in this section, it’s important to learn as early as possible if there are serious manufacturing limitations associated with your design, or problems related to the large-scale availability and/or cost associated with any materials or components of your prototype.
Therefore, in addition to user input regarding product features, it could be of value to have input from an industry-experienced development engineer or manufacturing expert regarding these potential issues in advance of your POC demonstrations to industry or investor representatives.
However, you should carefully consider where you might solicit such industry input (possibly a contract manufacturer?) without jeopardizing your commercial opportunity. And, of course, you would only initiate such discussions after patent filings have been made. A confidentiality agreement may also be appropriate.
For additional information more specific to the prototyping and demonstration of feasibility for medical devices, visit Medical Device Prototypes.