Most medical robotics programs shouldn't start with a custom arm. Here's how to know when yours should.

Medical device companies don't come to Kinova to become robotics experts – they come so they don't have to. But at some point in a successful program, the standard arm stops being the accelerator and becomes the constraint. This white paper is about recognizing that moment, and what happens after it.

Should Your Next Arm Be Custom – Or Not Yet?

It's the wrong question to answer with a brochure. A custom mechanical arm is an investment in one very specific geometry and workflow, and it only pays off once you know that geometry and workflow are the right ones. Commit too early and you usually pay twice: once for the design, and again when the requirements shift.

So this white paper does something unusual for a vendor document: it makes the case for not going custom first, then sets out precisely what has to be true before it becomes the right call.

What You’ll Get

• A decision framework, not a pitch. A side-by-side comparison of going custom from day one versus starting on a standard medical-grade platform – across time to first integration, compliance groundwork, capital at risk, and principal failure mode.
• The four inflection-point signals. The concrete conditions that indicate a program is ready for a custom configuration – and the ones that indicate it isn't.
• What "custom" actually covers. A clear map of what is inherited from a proven actuator platform (safety architecture, diagnostic coverage, EtherCAT real-time control, cybersecurity hardening) versus what is genuinely bespoke (arm geometry, industrial design, wrist and tool interface, structural and thermal design).
• The division of responsibility. Who owns system-level requirements, who owns the arm's design and safety case, and how verification is executed against IEC 60601, ISO 14971 and IEC 62304.
• How an engagement actually runs. The program stages from design inputs to verification-ready hardware, and the documentation that accumulates alongside it – traceability, interface control documents, drawings, BOMs, design review reports.

Written for

• Medical device teams moving from a validated concept toward a productized platform
• VP Engineering and program leads weighing a second-generation architecture decision
• Regulatory and quality leads who need to know what evidence a robotics partner delivers, and in what form
• Founders and CTOs deciding where scarce engineering capital should go this year

If you're still answering does this concept work?, the white paper will tell you to stay on a standard platform – and explain why that's the faster path to your own answer.

"It's slower than picking a part off a shelf, by design. But it's also structured, transparent, and grounded in components with a track record – a very different risk profile than starting a robotic arm from a blank sheet of paper."

François Boucher, Vice President, Business Development