Our Discovery Workshop – How We Uncover Essential Project Criteria
Medical device companies can’t develop products without first understanding what their customers need. (In the same fashion, physicians can’t treat patients without first understanding their ailments.)
The diagnostic phase is critical. In fact, we won’t begin a major medical product design project without it. At MindFlow, we’ve developed an intensive Discovery Workshop as a foundational dialog with stakeholders that gives all of us a detailed view of the work ahead.
This isn’t a project kickoff; that comes later as we begin addressing the product itself. The Discovery Workshop allows us to dig into the business, market and product goals. Often, we uncover unseen opportunity that goes beyond the scope of the project we’ve been called in to discuss.
How Stakeholders Inform the Medical Device Design Process
Our Discovery Workshop begins with a pre-conversation questionnaire designed to jump-start participants’ thinking and gather baseline information. Either before or during the workshop itself, our team interviews stakeholders representing all the different disciplines within the client company. These one-on-one engagements reveal high-level insights from those who know the business best. We seek to identify what’s important to each individual so we’re conscious of those objectives throughout the project. These personal perspectives help inform larger project goals.
Depending on the complexity of the client’s need, the Discovery Workshop can run from one to two full days. It’s a commitment of time, of course, but we’ve learned that it’s essential to have the key stakeholders from different business groups — marketing, finance, R&D, sales, operations, etc. — there at the meetings to set the project off on solid footing. The meeting establishes consensus that helps avoid conflict as the project moves forward.
Designing a medical product may be a multi-year, multi-million-dollar effort; it would be irresponsible to begin without gathering input and buy-in.
Diagnosing Opportunity for Medical Device Manufacturers
We tailor the Discovery Workshop to our client’s unique situation, whether it’s a long established company or a startup, whether there are internal design and engineering functions or not. But we always incorporate six key areas of analysis:
User needs
Understanding and solving user needs is the foundation of medical device design. In addition, the FDA has certain expectations for the process a company should follow to document, solve, and validate that those needs have been met in the end. This category is typically where we find the most gaps or opportunities.
Business requirements
The bulk of our team’s role in the Discovery Workshop is listening then exploring with follow-up questions to bring clarity to the opportunity. The objective is to find alignment among stakeholders regarding the business goal, which underpins the scope of work that follows.
Technology and IP
At MindFlow, our work fundamentally connects technology to people. When a client comes to us with a technology solution or product for the medical field, we help them identify the market need and connect that product with real users.
During the Discovery Workshop, we’ll sit down with the engineering and design teams and dig deep into the product, review prototypes and discuss how they’ve thought about the product so far. We help companies really leverage their ideas — their IP — and align them with the real problems the product can solve for real users.
Throughout the project, this focus on aligning technology with users ensures that the resulting product has real-world significance and establishes a competitive edge.
Markets
Ultimately, the products we realize must compete with other offerings in the marketplace, so we have to understand what that marketplace looks like. Our discovery process evaluates the client’s competitors, their current products, the features and benefits that differentiate those products, and the visual brand language that defines those brands in the market.
This market analysis typically reveals opportunity — to create a new product or take a different design direction — one that no one else is taking.
Manufacturing
From the outset, it’s important to understand how the product will get made. Are we producing 100 units or 1 million? Where will production happen? What processes do we need to consider? Who are the vendors and suppliers likely to be involved, and what do we need to ask them before we get started?
This aspect of the Discovery Workshop prevents companies from spending R&D dollars on developing a product that’s too expensive or just not feasible to produce. We need to understand manufacturing realities before we start down the path of design.
Regulatory requirements
It’s one of the most critical questions in the development of any medical device: Will this meet FDA regulations?
Our team is certified in ISO 1345 Standards for medical devices, so we’re fluent in regulatory requirements. Our Discovery Workshop includes a basic audit of our client’s organization to help their teams understand what they need to deliver from a regulatory standpoint. We often hear from our clients our own quality management system gives them valuable reassurance that the products we advise on will meet regulatory standards.
Identifying Gaps and Opportunities
We have found that when we engage deeply with a client in these six categories at the beginning of a project, the Discovery Workshop doesn’t just provide a framework for a project. It reveals gaps that sometimes reshape the project’s direction.
As we prompt these conversations and conduct stakeholder interviews, we may discover that the team is missing an opportunity. One of our clients, for example, came to us with the concept for a device to treat a condition; our research and discovery process revealed that preventing the illness was a more lucrative business opportunity than treating it.
We understand: Business executives are busy people. Spending a day or more in a meeting is a big ask. But our Discovery Workshop forges a deep and productive relationship between our team and our client’s. Diving into development without first understanding the business, the market and the opportunity creates risk.
At the end of a Discovery Workshop recently, a new client — the VP of R&D for a medical device company — told us, “We’ve been working with the same design firm for the last 10 years, the firm you’re displacing right now. And I feel like your team has taken the time and gotten to know us better in the day and a half you’ve been here than they did in 10 years of us working with them.”
You can’t create great products without that kind of insight.
