Phase Zero is a design strategy that helps medical device companies be resource-efficient with new product opportunities. Here’s how.

When it comes to medical devices, most companies start with a formal product development process. These frameworks typically consist of a sequence of phases intended to move an opportunity from requirements to qualified samples off a production line; usually with four or five stage gates along the way. Engaging in such a process organizes and gives attention to all aspects of the product, iteratively testing and improving the design to ensure function, safety, and compliance with market regulation.

Although these processes and the activities contained within them are critical to creating a medical device, market success must be based on work done before beginning the product development process. Work that refines the inputs along several key dimensions is often what an organization needs to reduce the risks associated with the product launch. They should consider focused efforts built on developing confidence in the following pillars: 

• Vision and Value

• Technical Feasibility

• Business Strategy  

In the early days of an opportunity, medical device organizations should consider their level of confidence in each of these aspects. If there are serious doubts about any of these key aspects of vision, function or business viability, it should trigger a “Phase Zero” effort.

Phase Zero is a step that allows the development team to focus on the topic of concern, reducing the risk of a showstopper and increasing confidence in the project.

In short, if something is keeping you up at night, it might be time to enact a Phase Zero.

Fill Your Reservoirs

Phase Zero is both an exploration of a specific risk element and a focused risk reduction effort. While it may seem that adding a step will slow development, when properly employed, it makes the formal product development process far more efficient. The development team will have confidence that their inputs lead to a viable product. Such pre-work helps avoid development pitfalls, such as allowing extraneous use scenarios that can lead to requirement conflict, or letting presumptive solutions backfire late in the program. And because Phase Zero is focused on early-stage feasibility, the design control burden can often be reduced or removed entirely unlike the formal product development phases.

If we think about our confidence in vision and value, function, and business strategy, like reservoirs, Phase Zero works to fill the lowest tank. Keep in mind, each aspect should be investigated individually—it’s ok to engage in multiple Phase Zero stages. This narrowing of focus helps each Phase Zero effort have clear goals that allow a small team to enforce structure and self-manage their Phase Zero activities. Although Phase Zero activities can last a few months or even a few years, the process can yield high-value information, and ensure that the product is launched with significantly reduced risks.

When successful, a Phase Zero process improves the confidence an organization has in a product’s value, its functionality, and how it fits in the business’s overall goals.

Vision and Value

Ensuring vision and value involves acquiring a deep understanding of users to generate a validated product vision and story. Activities in this phase would include user research and market research. This step will often take a look at the users’ needs and preferences to make a better product. It can also include looking at competitors on the market. The activities in vision and value are pretty well understood and have a long history of providing the background for a successful product launch. Design houses often excel at activities that help hone vision and value.

Technical Functionality

Assessing technical functionality includes creating and demonstrating new technical capabilities and features. It should involve specific steps to assess the technology and feasibility, through the testing of prototypes and other activities. Check for cost and performance, reliability, and robustness in this stage. Early prototyping is critical to establish technical functionality. Again, design houses can often fill in any organizational gaps to perform these steps. 

Business Strategy

Business strategy can encompass a range of ideas that might be involved in supporting the product commercialization approach and business planning. These can include the business growth model, the market fit, the IP landscape, the regulatory and reimbursement, and the decision-making process. Because the business strategy involves varied categories and sometimes significant work in each category, the business strategy deserves a deep dive. It might also require help from varying experts. Start-ups, in particular, may need to spend a significant level of energy and resources on ensuring their business strategies are sound.

The Three Pillars of Opportunity Success

It can be tempting for development organizations, particularly start-ups, to focus on their comfort zone, e.g., strengths of their technology. Phase Zero is intended to ensure medical device firms apply consideration to three pillars of opportunity success: vision and value, function, and business strategy. Weakness in any one of these areas could prevent market success.

Spending time and resources on the uncomfortable parts of the Phase Zero processes can ultimately save time and money by making the product development framework more efficient. Companies can gain efficiency because the preparation ultimately saves time and money.

Phase Zero activities can help an organization reduce the risks of failure in future development. It increases the likelihood of a product launch’s success.

When companies look at vision and value, technical feasibility, and business strategy, they should assess where products are weak, where the risk is the greatest. Phase Zero strategies can help fill those reservoirs with confidence.