Early in my career, one of my mentors told me how product development goes - he said "you build 1, then you build 10, then you build 100, and so on."  The truth at the root of this philosophy is that you need a different approach as the order of magnitude of the build increases, and it's useful to think of development in this way.

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• Build 1 - you are staring at a blank sheet of paper, with some vague ideas about what you want to accomplish.  Few people can do this at all, and I've only met two people that I think do it very well.  A small team, with access to basic machine tools, will make a bunch of 1-off devices to try in simple models (think meat from the butcher, 3d printed anatomy scans, etc.)
   

• Build 10 - you identified one of the breadboards you built as having potential, so you build a bunch of them.  You have started drawings and/or solid models of the parts, so they all look pretty much alike, and you are ordering some of the parts, or having professional machinists make them.  You are testing them in more sophisticated models, silicone anatomy stand-ins, Syndaver, and likely your first animal lab.
   

• Build 100 - a design has finally passed your basic testing, the team has grown, and you enter design control.  Time to complete the design documentation (including process instructions), complete your risk management work, develop your V&V plan, and build to support formal testing.  
   

• Build 1,000 - you have completed DVT, and are starting clinical testing.  You are balancing the line, refining the workflow, refining the tolerances, validating to reduce inspections, putting visual standards into place, and locking down the initial production processes.
   

• Build 10,000 - you are building market share; time to automate, maybe offshore, to negotiate better component prices, to reduce scrap rate at each station, to refine your process, and aggressively reduce costs.

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What this model makes clear is that your team has to change as development progresses, and that's where bringing in consultants like JP Med Design can really help your process.