Bio Break: Why the Design History File (DHF) Matters in MedTech

Resources

Bio Break: Why the Design History File (DHF) Matters in Medtech

Topic: Bio Break

When developing a medical device, documentation isn’t just a regulatory checkbox, it’s a fundamental tool for ensuring safety, traceability, and successful market entry. At the center of this documentation is an important file, the Design History File (DHF).

In this episode of Bio Break, Nick and Joris break down what a DHF is, why it’s required, and how it plays a vital role throughout the development lifecycle. A DHF includes all design documents created during development, such as product requirements, risk assessments, and verification reports. It’s the formal record that regulatory bodies like the FDA review to ensure a device was designed according to sound engineering practices and quality system procedures within the Design History File framework.

The conversation dives into why clients sometimes view DHFs as a burden, especially in the early stages of innovation where rapid iteration is key. To address this, StarFish Medical takes a two-phase approach. Initially, they prioritize flexibility and creative ideation. Small teams use light tools to explore feasibility, test concepts, and gain confidence before formal documentation begins. At this stage, they start gathering elements crucial to a comprehensive Design History File.

This approach helps teams avoid premature overhead while still aligning with regulatory expectations. It also ensures that once a device is ready for submission, the documentation is accurate, thorough, and aligned with the product’s risk profile and intended use, ultimately contributing to a successful completion of the Design History File.

Whether you’re a startup innovator or part of a large MedTech team, this episode offers a clear explanation of how design documentation supports both development and regulatory success, without derailing early creativity, and highlights the importance of the Design History File.

Split image showing two close-up views of a human eye. On the left, the eye is seen through thick black-framed glasses, indicating impaired vision. On the right, the same eye is enhanced with a futuristic digital overlay of concentric circles and interface elements, suggesting advanced vision restoration technology. A red curved arrow points from left to right, implying improvement. Bold text at the top reads "Restoring Vision?"

Ariana and Mark explore how accommodative intraocular lens technology may one day restore natural vision for people who require cataract surgery or suffer from presbyopia. As Mark shares, traditional bifocals are not ideal, and new lens solutions may offer better outcomes.

A hand holds an iPhone on the left side of the image, with a red curved arrow pointing to a sleek, futuristic medical device shaped like a handheld drill on the right. Above the arrow, a black box with white bold text reads, “Make it like Apple?”.

Learn more about StarFish Medical.

Cupping therapy on a person's back with six transparent suction cups applied to the skin. A bold text reads 'This is the future!' with a large red arrow pointing toward the cups. The background is minimal and white.

Nick and Nigel explore a surprising approach to injection pain reduction using suction technology. What started as an unusual product order at StarFish Medical led to important insights on improving patient comfort during injections.