In short. A client building a rehabilitation chair, a type of mobility system, kept the mechanical design in house and gave us the entire electronics and firmware track. We built the control box, the control panel and a remote, developed the firmware under software safety Class B and produced the documentation for a 510(k) submission. In 16 weeks and 2,100 engineering hours, for $260,000, the client received five pre-production units and a complete design history file.

Device
Rehabilitation chair and mobility system
Split of work
Client: mechanics. OVA: electronics, firmware, documentation
Our scope
Two boards (control box and control panel), a remote, firmware under software safety Class B, 510(k) documentation package
Hours
2,100 in 16 weeks
Cost
$260,000 of engineering
Deliverables
Five pre-production units and a complete design history file

How the hours were spent

  1. Discovery about 280 hours

    Requirements, interfaces with the client’s mechanics, architecture, plan.

  2. First prototype about 720 hours

    Control box, control panel and remote, with firmware.

  3. Testing and iteration about 500 hours

    Bench tests and changes from the results.

  4. Compliance, project management and CTO engagement

    Standards work, documentation for the 510(k) package and the design history file.

Why the split worked

However, once you have a decent plan in the beginning, you can commit to the timeline. You can commit to the budget. So, the budget is firm. The timeline is firm.

Lisa Voronkova, CEO of OVA Solutions, on Global Medical Device Podcast

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Sources

Client names are not disclosed. Updated on October 9, 2026.