Product Design & Development

Concept Development for Medical Devices

Turning vision into a viable medical device takes more than technical skill — it requires clear alignment around user needs, product-market fit, and regulatory expectations. We work closely with your team to define the product from every angle, ensuring that what we design is not only innovative, but feasible, fundable, and built for commercial success.

User- and Patient-Centric Medical Device Design

Getting this stage right can make or break your device’s success. At StarFish, we take a deeply user- and patient-centric approach — ensuring that every design decision is grounded in real-world needs, clinical workflows, and regulatory expectations.

Our team helps you move beyond concepts and assumptions to create precise, manufacturable designs that support safety, usability, and commercial viability. We bring the technical depth, cross-functional insight, and rigorous design controls to help you de-risk this critical stage — so you can advance with clarity and confidence.

Rapid Prototyping for Medical Device Development

Each prototype is a critical learning tool — not just a box to check. In MedTech, small oversights can become costly delays or regulatory barriers later. We help you move quickly and intelligently through iterations, combining rapid prototyping with rigorous testing and risk management.

Our goal is to help you uncover and resolve potential issues early, validate key assumptions, and refine usability — all while keeping development aligned with your regulatory path and market strategy.

Verification, Validation, and Clinical Prototypes

Verification and validation is where your device must prove itself — to regulators, to clinicians, to investors. We understand how pivotal this stage is to your overall success.

Our team brings deep experience in developing clinical-grade prototypes and managing the complex documentation and testing required for submission and trial readiness. We help ensure your device not only meets regulatory standards, but performs reliably in the hands of real users and patients.

Regulatory Strategy for Medical Devices

Regulatory strategy isn’t just about compliance — it’s about enabling progress. Missteps can stall your timeline, burn investor trust, and derail commercial plans. That’s why we embed QA/RA expertise into every stage of development, not just at the end.

We work as an extension of your team to align design decisions, risk management, and documentation with your regulatory pathway — helping you move forward faster and with fewer surprises.

Technology Transfer and Manufacturing Scale-Up

Scaling from prototype to production is where many devices stumble. Maintaining design integrity, managing supplier complexity, and meeting regulatory requirements at volume is not trivial.

We guide you through this high-risk transition with a clear focus on quality, consistency, and risk reduction. Our expertise in technology transfer helps protect your investment and prepare your device for successful launch and sustainable production.

Medical Device Program Management

Complex MedTech programs involve many moving parts, stakeholders, and risks — and poor coordination can quickly derail progress. We provide dedicated, experienced project and program management to keep everything aligned — timelines, technical progress, regulatory strategy, and business goals.

Our approach helps ensure momentum, transparency, and accountability across the entire team — so you can drive the program forward with confidence.