Healthcare IT product development need not necessarily be a long and complex process. However, It is critical to know the general product development lifecycle from the proof-of-concept (POC) stage to the licensing stage so that your development process can follow the correct path. Knowing which pitfalls to avoid will speed your time to market.
While product development companies dealing with non-fatal illnesses are not as closely scrutinized, those that deal with adverse and deadly diseases such as cancer and tuberculosis have to be extra careful. For instance, product development companies that offer products that fail have to deal with a strong market backlash.
In this context, this article summarizes why information technology product development is vital in the health sector and more importantly what needs to be kept in mind while at ground zero.
Identify Worthy Ideas, Innovations, and Inventions
It’s important to have an understanding of the differences between creativity, invention, and innovation. Creativity is the ability to come up with new ideas or concepts. It has nothing to do with value or monetizing the idea. Innovation is the process where value is created in the form of a new solution to a problem and occurs when a need is identified and a product is developed to meet that need. Innovators use existing technology in new ways.
Invention, on the other hand, involves a filed patent. It results in a better mousetrap and new way of doing something, and is an improvement or new idea that must be proven to be different and often superior. Paramount to moving the idea, innovation, or invention toward success is remembering that it will not be worth much if nobody wants to buy it. Identifying consumer wants and needs, and subsequently developing the product or service to meet them, is an initial step that must be completed before moving onto other steps in the process.
Patent Research, Intellectual Property, and Patent Product Development
This includes researching existing and/or potential competition, as well as patent defense mitigation. The protection of intellectual property (IP) is essential to your project. In return, it stimulates medical advances, economic growth, and the introduction of new medical devices. You will be better positioned for compensation for your contribution to the field when the necessary and cautionary steps are taken to secure the concept.
Unless you are a knowledgeable patent attorney that is able to complete these tasks, it is advisable to find one to advise and help legally and properly bring the concept to fruition. A reputable project developer will have worked with competent patent attorneys and can suggest one if so desired
Create asset growth through identification, development, and execution of innovative technology-based products via business plans and strategies, and then continually monitor progress.
FDA Registration, Regulatory, and Compliance in Product Development
This segment of the process will end your project quickly if you do not dot all of your i’s and cross all of your t’s. It is ongoing throughout your device development and is an intricate part of every step you take. The first item the FDA looks for in a submission is how the product was developed. Did the developer follow a formal Design Control Process and do they have evidence of compliance with the process? Generally, design controls for medical devices are part of a broader Quality Management System (QMS) for the developing company.
Design for Manufacturability
Some of the many additional considerations in this development stage include the enterprise license, reproduction, territory, term, termination rights, fees, warranty and disclaimer, infringement indemnity, limitation of liability, assignability, and miscellaneous contract provisions. It’s a significant number of considerations to juggle so think expert, and then secure one.
At Santeware, we’re passionate about creating breakthrough and custom products. We thrive on first-of-a-kind design and engineering challenges. And we love the multi-disciplinary connections between product strategy, creative design, and ambitious engineering.