From idea to market: how to structure your product development process

At Pilotfish, we’ve spent 25 years guiding innovators through this complexity, not just designing beautiful devices, but delivering working, compliant, and manufacturable products. Whether you’re in a startup pushing for your first pilot or a corporate team developing a next-gen device, a structured product development process is what turns momentum into outcomes.

Here are the five essential stages we follow, and why each one matters more than you might think.

1. Scope before you build: aligning vision, risk, and opportunity

Most product failures don’t happen because the engineering wasn’t good enough. They happen because early assumptions go unchallenged, the user story is vague, or teams aren’t aligned around risk.

That’s why scoping is so critical. Before any sketch or schematic is made, we work with your team to ask:

• What problem are we solving, and for whom?
• What does success look like, technically, commercially, and experientially?
• What are the knowns, and where are the gaps?

The output isn’t a glossy concept. It’s a Product Definition Document (PDD) and a high-level product architecture, clear, aligned, and realistic. It becomes the reference point for everyone, from designers to compliance leads.

At this stage, we begin embedding validation and verification checkpoints, ensuring that your assumptions and early decisions are grounded in real-world feasibility. Learn more about how we integrate V&V into every phase in our blog: Building it Right, Building the Right Thing

"Scoping is where we align vision with feasibility, and ambition with structure."

2. Concept design: turning ideas into human-centered experiences

Design isn’t about guesswork or aesthetics, it’s about translating your product’s purpose into a form that people can trust, understand, and use.

During this phase, we develop:

• UX flows and wireframes grounded in real use scenarios
• Human factors insights based on regulatory expectations
• Industrial design directions with clear CMF (color, material, finish)
• Quick Proofs of Concept (PoCs) to test high-risk ideas early

This is where experience starts to take shape, not just for users, but also for the internal team. Stakeholders begin to see and feel what they’re building toward. The design becomes a tool for alignment and decision-making.

"The best design phase gives everyone the same mental image of the future product."

3. Engineering: making it real and ready

Once your concept is clear, engineering begins. This is where many projects either gain speed or grind to a halt. At Pilotfish, our approach to engineering is integrated and anticipatory. That means:

• Mechanical and electronic development happen in sync
• Firmware prototyping informs real-time decisions
• EVT (Engineering Verification Test) samples are built with an eye on DFM (Design for Manufacturing)

Every decision in this phase affects cost, scale, and compliance. That’s why our engineering teams are deeply involved in risk analysis and testing strategy, not just CAD and code.

"If it can’t be built reliably, it’s not ready."

4. Tooling & trial production: testing for the real world

Even the smartest design needs to prove itself in production. This stage is about validating that your product can be made reliably, repeatedly, and to spec.

What we focus on:

• Tooling design (including fast and soft tooling for small batches)
• Golden sample development
• Design Verification Testing (DVT)
• Pilot production with SIPs (Standard Inspection Procedures)

This is where technical validation meets operational reality. We’re testing not just the product, but the supply chain, the documentation, and the inspection process.

"Pilot production isn't just about yield, it's about trust."

4.5 Compliance & commercial readiness: more than just a working device

A compliant product isn’t something you add on at the end. It’s built in from the start. We ensure that your development process is ready for:

• ISO 13485, MDR, FDA, CE and other certifications
• Risk documentation and usability validation
• Design history files and traceable decision-making

But technical compliance is only part of market readiness. You also need:

• Commercial positioning
• Scalable documentation
• Trusted partners

That’s why we co-founded MedTech Unleashed, a collaboration platform bringing together regulatory, design, engineering, and go-to-market experts to accelerate innovation and increase commercial success in MedTech.

"Safe, sustainable, and commercial go hand in hand."

5. Manufacturing & market launch: transferring with confidence

The final step isn’t just a handover. It’s a managed transfer to manufacturing.

With in-house production capabilities in Taipei, we ensure:

• Faster and smoother transition from pilot to production
• Developer-supervised tooling and QA
• Golden sample approval and line validation

You’re not left navigating suppliers on your own. Our engineers remain involved, translating every decision into factory-ready outcomes.

When it’s time to scale, Pilotfish combines in-house production capabilities with a trusted network of suppliers to manufacture devices of any complexity at industrial volumes. We deliver consistent, high-quality results through rigorous quality control, certification support, and full-service packaging and logistics.

Pilotfish Taipei is ISO 9001:2015 (Quality Management System) certified by SGS, a unique achievement in the creative product development space. This certification reflects our commitment to continuous improvement and our ability to deliver repeatable, reliable, and compliant solutions for complex product development challenges.

"We don’t hand off. We hand over, together."

From vision to volume

No two innovations are alike. But structure, collaboration, and end-to-end execution are what make them real.

At Pilotfish, our Fast-to-Product framework adapts to your stage, market, and ambition. Whether you're prototyping your first wearable or scaling a certified medical device, we help you build what's next, faster, smarter, and always ready for what comes after.

Ready to get started?🔗 Explore Fast-to-Product

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