Bio Break: How much does it cost to develop a medical device?

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Bio Break: How much does it cost to develop a medical device?

What are the real costs of developing a medical device? In this episode of Bio Break, Nick and Joris dive into one of the most frequently asked questions they hear from clients: How much does it cost to develop a medical device?

When companies approach a product development firm like StarFish Medical, they usually bring a set of expectations around cost, timeline, and quality — what Nick calls the “holy trinity” of client expectations. But aligning these expectations with reality can be a challenge, especially for startups or first-time medical device entrepreneurs.

Nick and Joris explore what drives the cost of medical device development, from simple devices like tongue depressors to complex systems like MRI machines. They highlight that costs vary widely depending on the device type, how mature the technology is, and whether there are existing components to leverage.

For example, when a client already has a validated lab-developed test (LDT) and wants to turn it into a product like an ELISA kit or a lateral flow assay, the development cost can be relatively modest — potentially a few hundred thousand dollars. In contrast, developing entirely new technology — where the scientific principles haven’t been proven and significant technical uncertainties remain — requires larger teams and longer timelines, driving costs into the millions.

Joris also points out that leveraging off-the-shelf components and reusing existing technologies can help reduce costs, but when you’re inventing something truly novel, the cost of technical innovation quickly adds up.

Finally, they remind viewers that clinical trials, regulatory approvals, and manufacturing scale-up will introduce additional costs beyond early prototyping and design.

How much does it cost to develop a medical device?

A laboratory or engineering workstation featuring a high-precision stereo microscope mounted on an articulated arm, positioned beside two computer monitors displaying 3D CAD models or imaging of a complex mechanical or biomedical device. The workspace also includes a keyboard, mouse, and a metallic container, all situated on a clean white desk in a dimly lit, modern lab environment.

In a sophisticated world of ever increasing complexity, we need our tools to evolve alongside us and assist in complex decision making, allowing us to understand the consequences of choices ahead. Computational Modelling and Simulation (CM&S) is emerging as an essential tool in building evidence for medical device development.

Three engineers are assembling or troubleshooting a large industrial or medical device prototype in a workshop. One person is seated in a wheelchair, another is standing behind the structure, and a third is kneeling on top of the machine for internal access. The workspace includes tools, laptops, electronic parts, and a large diagram of the device on the wall.

I routinely engage in the development of prototype medical devices. These prototypes typically incorporate at least one printed circuit board (PCB) installed within a plastic or metal enclosure, featuring numerous connections to external components through various connectors.

A laptop on a wooden desk displays a digital document icon on its screen. Beside it, bold text reads "Design History Files Explained," highlighting the topic of regulatory documentation in medical device development.

Nick and Joris break down what a DHF is, why it’s required, and how it plays a vital role throughout the development lifecycle.

Two colorful paper boats—one red and one yellow—float on a blue background with illustrated white waves beneath them. Bold text reads "From Idea to Impact," symbolizing innovation and progress in medical device development.

Nick Allan and Joris van der Heijden revisit one of StarFish Medical’s most successful Pathfinder journeys, showcasing how a bold research concept evolved into a fully realized clinical diagnostic device.