Commercialisation

The process by which a new product or service is brought to market. Commercialization is broken into phases, from the initial introduction of the product through to mass production and adoption. It takes into account the regulation, production, distribution, marketing, sales and customer support required to achieve commercial success. As a strategy, commercialization requires the development of a marketing plan, determination of how the product will be supplied to the market and anticipate barriers to success.

Freedom to operate

As the number of patents filed on an annual basis continues to increase, the process of analysing freedom to operate for new technology, becomes more complicated to achieve. The first step is to conduct a freedom-to-operate search, as such products (and their patents) may be vulnerable to infringement suits, potentially resulting in costly litigation procedures and/or forcing a withdrawal of the product from the market.

Intellectual Property

A categorical description for the set of intangibles owned and legally protected by a company or inventor from outside use or implementation without consent. Intellectual property can consist of patents, trade secrets, copyrights and trademarks, or simply ideas. The concept of intellectual property relates to the fact that certain products of human intellect should be afforded the same protective rights that apply to physical property.

Licensing

A licence is permission to do something that would, without permission, infringe intellectual property rights. It is different to an assignment, which is a transfer of ownership of the IP.

Market validation

Before spending much money developing an innovation a fundamental question must be asked. Is there a need in the market for this product or service? Based on the competitive situation and market characteristics, what return could be expected from the innovation and does this make development viable?

Patent searching should be conducted to determine not only freedom to operate, but also to determine competitor technology trends and to identify any possible R&D savings.

Prototyping

Engineering a prototype is the first tnagible embodiment of the conceptual design. It is likely the product of several iterations of the design process.

Risk Assessment

The identification of design, use and process risks; an assessment of the risks frequency of occurrence and the severity of their outcomes; a review of the steps taken to mitigate those risks, Developing medical devices, that expose users to potential safety concerns will require a clinical risk-benefit analysis.

Value Proposition

A business or marketing statement that summarizes why a consumer should buy a product or service. This statement should convince a potential consumer that one particular product or service will add more value or better solve a problem than other similar offerings.

International regulation

CE Mark is the regulatory approval that enables a company to sell its device in European countries. Obtaining the CE Mark means that the company is compliant with the European medical device directive that applies to the device.

510(k) clearance/ PMA approval are the regulatory routes that enable a medical device company to begin selling in the US.

510(k) clearance is the route the FDA applies the least amount of controls, making it the shortest and least demanding pathway. The core determination is proving the device is substantially equivalent to an existing device that has been cleared previously.

PMA approval is the process intended for high-risk devices. The most rigorous process, subject to the strictest controls and requires significant clinical data for hundreds of patients over a prolonged period.