Navigating Tough Decisions & Multi-Generational Planning in Medical Device Development

Additional Contributors: Joe Gordon, Tony DiBella and Andrew Kenoian

How to Achieve Your Medical Device Development Milestones (and Future Goals) Within Timeline and Budget

At a Glance 

The Challenge: Medical device teams face fixed constraints of time and money while navigating opposing priorities: craving full features with limited budgets, speed to market but also ultimate performance, cost reduction or staying competitive against competitors. 

The Solution: Multi-generational planning  

Multi-generational planning means defining a unique minimum viable product (MVPs) for each milestone, not just the final product. This approach transforms trade-offs into strategic decisions by: 

• Aligning business drivers and priorities upfront 

• Defining distinct milestones (not goals) with specific MVPs 

• Making conscious feature trade-offs based on long-term vision including market opportunities 

• Drawing the straightest possible development line through subsequent phases 

Key Insight: Development with only one product version in mind risks costly redesigns, missed market windows, and competitive disadvantages. Strategic planning preserves tomorrow's options while meeting today's milestones. 

The Reality of Fixed Resources in Medical Device Development 

There's only so much time and money you have to reach each milestone. So how do you make the tough decisions to make the most out of it? Start with a multi-generational plan because it transforms a complex network of design parameters and opposing priorities from sources of conflict into strategic decisions with clear rationale. 

Start with Business Drivers to Navigate Opposing Needs 

Every medical device development program has opposing priorities that require prioritization and navigation. Teams want a fully featured product, but the vast majority of budgets and timelines make this impossible (and often unnecessary) to achieve. They want speed to market while maintaining ultimate performance. They need to reduce development costs while building competitive advantages to maintain their market share. The way to navigate these opposing priorities is to compile context and potential impact to guide strategic decisions. 

Business drivers provide this context. It is best practice to outline business drivers like complexity, ease of use, performance or competitive advantage, with cross-functional teams. This surfaces questions to help navigate the trade-offs and ensure alignment prior to execution and to ensure development is efficiently executed to aligned priorities as well. Without this clarity, teams often find themselves talking past each other, with the engineer thinking about the prototype while the marketing lead envisions the year-two commercial product. 

Consider a handheld device with a digital interface as an application of this principle. It's easy to get caught up in wanting multiple features due to all the technology that exists today, but each addition could introduce the following consequences: 

1. Development time and cost will increase. Each new function introduces dependencies that can slow down the entire development timeline. More features often mean higher material costs, longer manufacturing times, and more expensive testing protocols. 

2. The additions are not driven by an actual user need and become a wasted effort.  Will they aid in ease-of-use or will they add risks to the workflow? If the latter, then additional features will be required to mitigate and add into the device complexity. Cost per test and number of use steps have direct implications for adoptability and development timelines.  

These aren't just technical specifications; they're business trade-offs with direct implications for development activities. 

Applying Business Drivers to Medical Device Development: When, How, and What That Means for Your MVP 

When to execute the business drivers exercise? 

At the beginning of each phase of development. Development phases are initiated by completion of one milestone and moving onto the next. Reassessing business drivers at each phase is critical to ensure priorities are consistent with the current “state of affairs” in light of new knowledge generated, shifts in funding or shifts in the competitive landscape. This also gives cross-functional teams an opportunity to re-align the priorities at hand for the upcoming milestone.  

How to scope the business drivers exercise? 

Clearly define your milestone. There is a critical distinction between goals and milestones in medical device development. Commercialization and market adoption levels are goals. Design freeze, successful design verification and validation testing, preclinical studies, and regulatory submissions, are milestones. Aligning the business drivers to the next development milestone will clarify priorities and support efficiency in direction and activity for the executing team.  

How the business drivers translate to product development scoping.  

As medical device design and development progresses, the design takes shape then evolves as the engineers determine new technology opportunities, usability features, or collect input for robust requirement rationales. These aspects should be captured in the requirements traced back up to the user needs per design control best practices. There will always be aspects that are not essential for device performance to meet the user needs but are more “nice to have” for competitive advantage, increased performance accuracy, or data collection. To best assess the tradeoffs of including these aspects or not, it’s best to capture them in a multi-generational plan that outlines technical features included in the current product being developed (commonly the minimally viable product or “MVP”) vs. future iterations. Capturing the additional features in this way helps ensure the teams are aligned to the current development priorities and builds a roadmap for future product generations.  

Making Smart Trade-offs in Medical Device Development Through Feature Breakdown  

Multi-generational planning and defining the MVP for each milestone is another tactic to help maintain alignment to priorities per the milestone and aid in navigating trade-offs. For instance, the MVP for an early phase design feasibility demonstration will not be the same as the MVP for initial engineering verification to ensure the design is ready for official design verification. Utilizing this approach creates what we call a "parking lot" for valuable but non-critical features, maintaining focus on milestone essentials to achieve the primary goals while also preparing for future capabilities and success. 

Example 1: Data Collection for Future AI 

Including the capability to collect and store clinical or other high value data in the current generation of the device in development, even though you'll do nothing with it initially, might seem like unnecessary complexity. But when you anticipate that a next generation of the device will need AI-driven features or software to stay competitive, that early investment becomes strategic. You can't go back in time and say, "I wish I'd been collecting that data so I could implement AI or submit for expanded indication."  

Example 2: Bluetooth Capability Decision 

Choosing a processor with Bluetooth capability might increase device cost (maybe $1.20 versus $1.00 per unit). But when a future generation of the product will need a companion app to stay competitive, you're simply turning something on rather than redesigning the entire board or making complex considerations for power management, security and the like. You've reduced friction and made that subsequent improvement dramatically easier. That $0.20 difference today can save months of design changes, significant costs, manufacturing and supply chain changes, and additional regulatory deliverables. 

Example 3: Physical Design Evolution 

These decisions represent adding complexity strategically, not removing it. If you're building a prototype with 8020 aluminum and sheet metal but know you'll eventually have custom molded panels, you start putting in the bosses for those panels now. You may not use them until that later milestone, but you've anticipated the future need. When you get there, you have a framework to build upon rather than starting over. 

Why Multi-Generational Planning Drives Success 

Multi-generational planning isn't about predicting the future; it's about making today's decisions in ways that preserve tomorrow's options. When you develop with only one version of a product in mind, you're missing opportunities and potentially risking success entirely. 

This disciplined approach helps you understand which technical debt you're pushing downstream and whether that's acceptable or not. You can reduce required rigor and refinement at a particular milestone to meet a business goal, but you're making that choice consciously. Your early prototype doesn't need the look and feel of a commercial product if it's only for generating functional data. That's a valid trade-off. But you should anticipate that, for a user study, you'll need usability features included and plan your MVP accordingly. 

Our engineers’ strengths as generalists across multiple device types and therapy areas, rather than narrow specialists, helps identify these cross-functional dynamic risks. We've seen decisions that seem optimal from an engineering perspective create regulatory nightmares or market silos, or cost-saving measures in generation one triple development costs in generation two. This strategic approach with long term visibility and alignment ensures smooth development with a plan for future successes. 

Frequently Asked Questions 

Q: How do you prioritize features with limited budget in medical device development?  

A: Start by establishing clear business drivers, then define your milestones and goals. Maintain a multi-generational product plan to support a defined MVP for each milestone, placing non-critical features in a "parking lot" for future generations. This approach will transform opposing needs into strategic decisions and support future success. 

Q: What's the difference between milestones and goals in medical device development?  

A: Goals are endpoints like commercialization and adoption at certain levels. Milestones are specific achievements along the way: design freeze, preclinical studies, design validation, or regulatory submission(s) for approval. Defining an MVP makes achieving each milestone within timeline and budget more likely. 

Q: When should you include future capabilities in current medical device design?  

A: Include future capabilities when the cost of adding them later would have substantial design changes required and financial impact. Examples include data collection infrastructure for future AI, Bluetooth capability for eventual companion apps, or structural mounting points for future components. 

Q: How do you balance speed to market with long-term product success?  

A: Multi-generational planning allows you to right-size development for immediate milestones to align to business priorities while preserving future options and technology opportunities. Consciously choose which technical debt to accept, ensuring today's speed doesn't compromise tomorrow's competitiveness. 

The Bottom Line 

Don't let perfection get in the way of progress. With fixed time and budget constraints, success comes from disciplined prioritization informed by aligned business priorities and focused milestones, not from trying to do everything at once. 

Development with only one product version in mind means you're not just missing opportunities. You're potentially setting yourself up for costly redesigns, missed market windows, and competitive disadvantages. A well-crafted multi-generational plan transforms difficult trade-off decisions from sources of paralysis into strategic choices with clear rationale. 

Let's map your business drivers, milestones, and multi-generational plan so you can reach your goals faster, on budget, and ready for what's next.