Medical device startups/founders and enterprise partners have unique strengths and goals, which are often reflected in the way they work with CDMO (Contract Development and Manufacturing Organizations) partners. In this blog StarFish Medical engineers, project managers, quality/regulatory professionals, and senior managers share differences between startups/founders and enterprise partners and how we support and empower both organization types.

TL;DR

• Startups and enterprise partners approach CDMO projects with different expectations
• Startups value speed, iteration, and flexibility; enterprise teams focus on risk reduction and process
• Deliverables must align with capital events for startups or budget adherence for enterprise
• CDMOs must adapt communication, QMS integration, and launch support for each type
• StarFish supports both models through tailored processes, data insights, and team alignment

Relationships

Startups/founders tend to have few key people, and their lines of communication are very straightforward, simple, and open to outside team members.

Enterprise partner relationships and communication are more complex. Making sure that the right team members are talking to the right people, and updates are communicated to the management structure is a bigger challenge in a large company.

Solution: Allocate time and energy to understand relationships inside an enterprise partner and how finance, marketing, and product management team decisions are made.

Finances

Startups/founders must raise money incrementally, so they’ve got to justify new financing requests to their investors through milestones and proven performance. There’s a parallel within an enterprise partner’s corporate setting where they must justify corporate capital incrementally. But how they go about making that justification is quite a different process.

Solution: We develop our deliverables to their unique milestones. For startups/founders, these are often linked to capital raising events, whereas enterprise partners tend to use milestones that demonstrate adherence to budgets. They’re cousins, but not quite the same. It’s very important to understand the difference.

Program directors specialize in understanding a specific client type and their project milestones. They make sure the right team is assembled and focused on startups/founders or enterprise partners and understand which deliverables will achieve their client’s unique capital needs.

Innovation and IP Creation

Startups/founders are often more focused in innovation and IP creation, whereas enterprise partners are often more interested in flawless execution. The person that works on innovation and IP is not necessarily one who excels in managing flawless execution through a commercial release. They’re different kinds of people and make a different type of team.

Solution: We adapt and reduce risk for enterprise partners by allocating more effort to scheduling and planning. Many startups/founders are willing to accept more risks to focus on innovation.

Startups/founders usually do not look too far in advance. Often, we know what’s going to happen in the next four weeks instead of the next four years. We adapt as we learn and try not to put too much effort into long-term planning.

Risk Tolerance

For many startups/founders, the market is not known, whereas understanding the market is a risk that Enterprise Partners want to knock off before diving in too deeply.

Startups/founders generally want to take risks, whether they are technical, schedule, budget, prototypes, or regulatory. They often feel the iterative process is more efficient. This equates to more fast failures for more learning. It is a less linear process and when things go great that works out nicely. They usually look at overall checks and balances and feel the best way to get where they want to get is to take risks.

Solution: That works fine with our values and company culture.

Enterprise partners are often the opposite. They would rather build in buffers and want to be able to commit and get things done per their plan. Generally, they’re looking for predictability with confidence and consistency in delivery.

Solution: That also works fine with our values and company culture. We measure timelines, budgets, quality, and client satisfaction which we review at all monthly all-hands meetings. These metrics impact profit sharing, social activities and personal performance bonuses at all levels.

Product Development Cycle Experience

There’s often a difference in the sophistication and understanding of a product development cycle. Enterprise partners have usually executed Product Development Cycles many times in many different scenarios. Startups/founders may not know what they’re getting into unless they’re led by a serial entrepreneur. They often don’t have as sophisticated of a corporate oversight in terms of how a project should be run.

Enterprise partners usually have existing internal and external resources but are challenged with bandwidth. Startups/founders are less likely to have internal or external resources, or the resources are limited.

Solution: We integrate with enterprise partners and are flexible about the division of labor and who does what. We provide startups/founders withwhatever they need or help them find and qualify external resources. With enterprise partners we often strategize and consult with their internal experts and execute day-to-day activities ourselves.

Enterprise partners tend to have a lot more program inertia and their program milestones are often already set in place. Startups/founders are more flexible; they look for opportunities in innovation. They can more easily pivot on a dime. That helps communication. Someone who wears multiple hats and has authority to make decisions is generally faster than a project manager that requires approvals from finance, product managers, et cetera. There is less willingness to be flexible on the go when innovation opportunities come up.

Solution: We guide and support both startups/founders and enterprise partners’ unique needs and process preferences throughout this process, so everyone understands the purpose and value of CDMO actions.

Quality Management System

Regardless of which QMS is used, one party will need training on the chosen QMS, That expectation should be understood and established from the outset.

Often startups/founders know they need a quality management system (QMS), but they don’t know what they need.

Solution: We advise them on that and how to structure it in a way that works for them.

Enterprise partners quite often have their own QMS.

Solution: We integrate with enterprise partners and build a strategy for determining which QMS to use and when. Alignment is required on both sides, and we use both methods very successfully.

Launch Strategies

The launch strategy is usually vastly different. Startups/founders are more likely to exit pre-launch, or launch a product that may sell incrementally, learn from the market, and then change or update it. Perhaps they sell 10 units in the first month, but their long-range target is to sell 10,000 units a month when they’ve ramped up. On the other hand, for enterprise partners, the launch day must go well.

Leveraging CDMO Experience

For over 25 years StarFish Medical has worked with startups/founders and enterprise partners developing and manufacturing hundreds of medical device projects. We keep a historical snapshot of every project we’ve ever done. Our database summarizes Statements of Work (SOW)s, lessons learned, and project cost data that can be used to estimate costs in today’s dollars. It provides insights from hundreds of projects that we use and leverage for both startups/founders and enterprise partners.

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