Medical Device Manufacturing Landscape
Have a potential client that we may do research for. Am trying to get a feel for whether or not we can actually find them the right respondent types. They are looking to speak with key decision makers of medical device manufacturers, specifically looking to speak to them about the following:
- identifying pain points, fears, uncertainties, and potential points of confusion that they can address through marketing communications
- establishing the audiences that have the most interest in and need for the client's services - what motivates them, where do they get information, etc.
- questions/concerns that manufacturers have about entering the chinese market and work with the cfda
- general unmet needs or medical device manufacturers as it pertains to better grasping standards set for class ii or iii devices by the cfda, fda, or ema.
If there is anyone that feels they might be the right person to speak with for this study, or know what title(s) we should be targeting at the manufacturers, please send me a message.
Targeting key decision makers that actually work for a medical device manufacturer
thank you!!+undefined Other Responses
Wound Care Medical Device
Subject -- wound care medical device 510k / pma
we are looking for expert who has done a wound care 510k or pma submission this year or last year. We are looking for a long term engagement. We do not need help writing the submission, but we only need advise on deciding what claims we can make or not make, what type of concerns fda has expressed in the recent submissions, and will the product be subject to a 510k or a pma submission.
Please do let us know your hourly rate.
jasmine+13 Other Responses
Hello, i'm looking for a consultant to assist with an fda 510k submission for a:
class ii ophthalmic medical device
if you have expertise in this area, please let me know. Thank you.+24 Other Responses
Medical Device Prototype
Looking to design and manufacture a proof of concept alpha prototype for a medical device work with compressed air and abrasive powder for a dentalooking for subject matter expert (individual, team, or company) who can design, develop and build an alpha-prototype a device for dental surgical procedure based on our ip. The device utilizes abrasive powder under pressure in a focused controlled pattern to perform the invasive procedure in oral cavity.
The rfp will include the design and alpha prototype, manufacture of 1) a handheld operative hand piece or “working head” and 2) a controlled “pneumatic power control unit” which would include compressed air and vacuum source, abrasive powder distribution reservoir, rinse system (reservoir and pump), pressure/vacuum gauges analog or digital, regulators, control valves, control panel, fittings/tubing, electrical wiring and chassis.
Required expertise includes but not limited to
• cad design through solidworks or similar software to prepare a 3d design of the assembly and components/subassembly prints for manufacturing
• mechanical engineering, r&d, and product development experience preferably in the medical device industry.
• innovative strategist and problem solver who can develop customized, effective solutions to meet needs in challenging user requirements and mitigate procedural risk through design.
• ability to coordinates manufacturing/assembly, and testing to achieve client’s objectives on time, within budget, and to specification.
• fluidic designs: such as micro-fluidics, valves, manifolds, pumps-(e.G. Precision aspirate/dispense, diaphragm, solenoid, syringe, piston) reaction and mixing chambers, flow-cells, aspirate/dispense probes, fittings, tubing, flow calculations.
• pneumatic design: pneumatic power modules, motion/transfer devices, valves, manifolds, fittings, tubing, compressed air calculationsl procedure. Need a consulting firm who can develop a cad design, perform engineering analysis, prepare specifications of the design and source manufacturing of the alpha prototype and test the device for expected performance+16 Other Responses