We generally divide medical device product development in 3 main pieces: Discovery, Development, and Commercialization. I’ll address each of these in separate blogs. Let’s start with Discovery.
At the highest level, Discovery is about:
- Solving the customer’s problem
- Ensuring there is a market
- Establishing technical feasibility
- Identifying project risks
1. Solving the 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, such as observational techniques and customer and/or clinician panels. During panel studies, early staged prototypes are an effective and efficient way to understand and solve the customer’s problem. Design teams also need to collect and integrate usability and human factors feedback from early concepts into their design options.
2. Ensuring there is a Market
During Discovery, the organization must clearly understand market potential, price points, margins needed, payer requirements, and user requirements. This must also align with the company’s strategies, portfolios, and roadmaps.
Today’s payers may not be the actual users of the product. However, 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, as an optional requirement, is an effective way to ensure that product costs are considered in the overall design process.
3. Establishing Technical Feasibility
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 early staged prototypes.
There is some confusion regarding whether medical device companies can use early staged prototypes. Examples of how prototypes should be used during discovery are shown below.
- To gain a better understanding of user needs or preferences
- To assess new technology, design options, or technical feasibility before transitioning to design controls
- To discern human factors or usability needs important to the solution
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.
4. Identifying Project Risks
All projects have risks, which need to be identified and managed as part of the project. These risks are separate from the user risks that must be addressed per ISO 14971. During Discovery, the cross-functional team should identify and document any known or anticipated risks or uncertainties. Project risks most often fall under market or technical risks, but may include many other categories such as production, suppliers, regulatory, etc.
The project risks should then be evaluated and prioritized. We recommend that your project team address the most important uncertainties early in the project. Download our infographic on how addressing an uncertainty early saved a project team more than 6 months on a project.
Strategy 2 Market developed a process called Exploratory PD (ExPD) that helps project teams identify, evaluate, prioritize, and track uncertainties and risks throughout a project. To learn more, please go to www.exploratorypd.com.
The key outputs of Discovery are customer needs, product requirements (design inputs), commercial feasibility, and demonstrated technical feasibility. Medical device organizations often choose to enter design controls once Discovery is complete. Future posts in this 3-part series will cover Development and Commercialization.