Medical Device Sterilization
I would like to learn more about e-beam sterilization - both for medical devices and pharmaceuticals. I am interested primarily in how customers choose a) their sterilization method/modality and b) which provider to use. Beyond that i am interested in the likelihood that device manufacturers would switch to e-beam if it is clear that i) their device(s) is(are) compatible and ii) they could save 20%+ on sterilization costs while iii) saving time and, consequently, inventory and working capital. I am interested in how much sterilization expertise typically resides within the device manufacturers and to what extent they rely on the sterilization provider for that expertise through the validation process. I am also interested in why e-beam has not captured more market share to-date versus gamma and eto.+18 Other Responses
Medical Device Sterilization
I am looking for a medical device sterilization expert to assist with a new product development effort.
- help select most appropriate sterilization methods
- define sterile product manufacturing requirements
- define sterilization validation plan
- assist with setting up manufacturing processes and procedures.+7 Other Responses
Medical Devices Product Launch
I am looking for an expert to support the launch of a new product in europe in 3q 2012. The competitive candidate will have demonstrated expertise in international trade, customs, supply chain, logistics, distribution and insurance for class ii & iii fda/ema medical devices.+8 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