At the highest level, Discovery is solving the 1) customer’s problem, ensuring there is a 2) market for that solution, 3) establishing technical feasibility, and 4) project risk to implement the solution.
Solution to Customer’s Problem
Products that solve a customer’s problem require a true understanding of the users and their environment. We have found that some team members want to jump in and provide a solution before understanding the real customer need. Definition of the user(s) and use environment, including differences from country to country, is crucial. For example, a medical device used by a surgeon in a hospital in the United States may be used in an office procedure by a physician (non-surgeon) in Europe. Within the surgical environment, users may include the surgeon, surgical nurse, and the cleaning/processing group for reusable devices. A device developed without this understanding may provide only a partial solution.
To understand and solve the customer’s problem, medical-device companies use various methods. Examples include observational techniques and customer and/or clinician panels. During panel studies, early prototyping (sometimes referred to as pretotyping) is an effective and efficient way to understand and solve the customer’s problem. Design teams also need to integrate and collect usability and human factors feedback from early concepts.
During Discovery, the organization must clearly understand market potential, price points, margins needed, payer requirements, and user requirements.
Today’s payers may not be the actual users of the product. Integrating payers’ expectations into the product improves the product’s chance of commercial success. Product reimbursement considerations include questions such as these: Does the product fit within an existing category? What is needed in order to justify premium reimbursement (for example, a new category or code plus health economics evidence to support it)? How do the requirements change in different countries? Answers to all of these questions become inputs into the market feasibility analysis.
To meet price point and margins, sellers must produce the product at a cost that meets business needs. Adding those cost requirements to the design inputs is an effective way to ensure that cost requirements are considered in the overall design process.
Once the organization understands how to solve the customer problem, it must determine whether the technology for solving the problem exists. Expertise may be internal or external. Depending on the company’s strategy, some work may be needed to demonstrate feasibility before entering design controls. This point in product development is appropriate for using prototypes or pretotypes.
There is some confusion regarding whether medical device companies can actually use prototyping early in the process. It depends on how the prototype is used:
- For better understanding user needs or preferences, it is appropriate to prototype early in the process. Prototypes may also be used to understand new technology design options or technical feasibility before transitioning to design controls.
- Later in the project and under design controls, prototypes have a different objective. They enable the product development team to make design choices, obtain feedback from user groups, and study product or subsystem performance, including usability.
All projects have risk, and the biggest project uncertainties should be identified by the cross-functional team early in the process and resolved throughout the process. These risks are separate from the user risks that must be addressed per ISO 14971. Those risks most often fall under market or technical risks, but may include many other categories.
The key outputs of Discovery are customer needs, product requirements (design inputs), commercial feasibility, and demonstrated technical feasibility.
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