table,row,low,high,unit,proposals,note
hours_by_path,"Idea or proof of concept to a demo or investor prototype (1 to 5 units, mostly off-the-shelf or printed parts)",80,700,estimated engineering hours,6,about 450 to 700 for the five medical and research demos; the low end is a simple consumer gadget
hours_by_path,One feasibility gate on the riskiest part (when one physics question decides the device),400,1000,estimated engineering hours,6,typically 400 to 560
hours_by_path,"Concept or proof of concept to 3 to 10 working prototypes, custom electronics, no DFM",1000,2500,estimated engineering hours,8,
hours_by_path,"Device on the market to a redesign (obsolete parts, new features)",1200,3000,estimated engineering hours,1,
hours_by_path,Existing prototype to pre-production units with a design history file,2100,3240,estimated engineering hours,2,
hours_by_path,Proof of concept to a production-ready or submission-ready design,3000,4000,estimated engineering hours,2,
hours_by_path,Idea or early prototype to a production-ready design or a pilot batch,4000,6000,estimated engineering hours,4,"one costlier route up to about 7,200"
hours_by_path,Large systems such as ventilators or glucose monitors,10000,30000,engineering hours,,published breakdown by Lisa Voronkova; not from the proposals
phases,"Discovery: requirements, architecture, risk list, plan for the next phase",100,336,estimated engineering hours,,median about 180; share: 5% to 15%
phases,"Feasibility gate, only when one physics risk decides the device",400,1000,estimated engineering hours,,typically 400 to 560; share: 10% to 30% when present
phases,"Design and first prototype: electronics, firmware, mechanics, first build",700,1600,estimated engineering hours,,share: 35% to 50%
phases,"Next prototype round: target form factor, fixes, bench and on-body tests",200,1000,estimated engineering hours,,per round; share: 15% to 25%
phases,Documentation and verification preparation (medical programs),400,1250,estimated engineering hours,,share: 15% to 31% of a Class II or sterile program
phases,"Design for manufacturing, transfer and pilot build",1000,2300,estimated engineering hours,,share: adds about 30% to 60% on top of the prototype work (2 proposals that priced it separately)
phases,Project management and coordination,,,,,"line item or spread over phases; share: 6% to 18%, usually 10% to 15%"
documentation_share,Class II wearable,15,15,percent of hours,1,about; testing and documentation line
documentation_share,"Class II powered system, IEC 62304 Class B",19,26,percent of hours,1,19 = documentation phase; 26 = all QA and documentation hours
documentation_share,Class II accessory set with full design history file,20,29,percent of hours,1,20 = documentation and V&V phase; 29 = all regulatory engineer hours
documentation_share,Sterile single-use device,31,31,percent of hours,1,about; includes test-method development and bench verification
documentation_share,Wellness demonstrators,0,0,percent of hours,2,no design controls or regulatory documentation
documentation_share,"Wellness product redesign, compliance preparation only",8,8,percent of hours,1,about
calls_start,Only an idea,30,30,percent of 70 sampled calls,,sample stratified by booking-form stage
calls_start,Proof of concept,24,24,percent of 70 sampled calls,,
calls_start,Existing prototype,36,36,percent of 70 sampled calls,,
calls_start,Device on the market,10,10,percent of 70 sampled calls,,
calls_goal,Working prototypes,61,61,percent of 70 sampled calls,,multiple answers
calls_goal,Design for manufacturing and production transfer,31,31,percent of 70 sampled calls,,
calls_goal,Clinical or pilot units,27,27,percent of 70 sampled calls,,
calls_goal,Discovery or feasibility first,26,26,percent of 70 sampled calls,,
calls_goal,Redesign or next generation,20,20,percent of 70 sampled calls,,
calls_goal,Regulatory documentation,16,16,percent of 70 sampled calls,,medical only
calls_type,Medical device,66,66,percent of 70 sampled calls,,
calls_type,Wellness or consumer health,27,27,percent of 70 sampled calls,,
calls_type,Non-medical hardware,7,7,percent of 70 sampled calls,,
calls_budget,Gave an amount on the booking form,10,10,count of 69 device prospects asked,,
calls_budget,Named a figure on the call,20,20,approximate count of 70 sampled calls,,roughly half of these were below the scope described