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Cutting Instrument Solutions is a program that assists those in the orthopedic industry with developing, prototyping and manufacturing orthopedic cutting instruments. Orchid is leveraging its extensive expertise with cutting instruments to help companies reduce time to market on the items that may not necessarily be core to what they do on a daily basis.
What is the rpm of the power reamers?
Do you have the ability to test cutting effectiveness of different drill designs?
Have you seen laser marking affect corrosion resistance during multiple autoclave cycles with 440A?
Have you had complaints about paint flaking off? Is your paint able to withstand all cleaning/sterilization processes out there?
What do TPS and AO mean?
Why is a passive layer important on a drill?
Can you provide prototype drills in two weeks?
Do drill coatings (gold and chrome) have any negative effects on the drill performance?
Do you have a wide variety of different surface patterns available on your broaches?
Are your prototypes representative of the final article, i.e. could it be used for example in a cadaver lab?
Are trocar tips, or pyramid shaped tip drills effective for bone drill?
Are there other features that can be added to the tip area to increase effectiveness of heat build-up and drill start-up?
Do you deliver models of the drills after we submit the survey? What is the deliverable? How is an OEM supposed to create an internal print for manufacturing?
Does e-polishing influence the sharpness of a drill. If yes how much?
Are your prototypes made from DMLS or machined from stock?
Which flute parameters do you need to inspect to ensure that cutting efficiency is consistent lot to lot?
What type of passivation (citric/nitric) is recommended post laser mark on chrome coated surfaces?
How do you define multi-use?
Is passivation necessary if the instrument is electropolished?
Would there be any reason to passivate an instrument prior to chroming?
Are the "prototypes" manufactured under full QS controls?
Q: What is the rpm of the power reamers?
A: RPM is specific to the hand piece used by the surgeon. The most common max RPM for hand pieces I've seen in action is 1500 but it is variable speed based on the surgeon's preference.
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Q: Do you have the ability to test cutting effectiveness of different drill designs?
A: We do have the ability to test cutting effectiveness on certain types of drills. Currently the two test methods we use are customer specific and proprietary to their product. [ top ]
Q: Have you seen laser marking affect corrosion resistance during multiple autoclave cycles with 440A
A: With any steel with iron as an element, the potential for corrosion exists. If the substrate is prepared properly (ie, EP or some form of passivation) to ASTM A967 there should not be a problem. Once the passive layer is disturbed, or removed, through an abrasive wheel or media blast finish, or laser etch, then that passive layer must be restored with a secondary passivation per ASTM A967. If these processes are validated and monitored, there should not be any issue.
We have seen where a hospital may autoclave an instrument, and corrosion results. With further investigation, we have found that if the technician did not autoclave correctly, then undesirable results occur. For example, if tap water was used instead of distilled water, the minerals in the tap water will cause the corrosion to begin. Deionized water is also not recommended, just distilled water.
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Q: Have you had complaints about paint flaking off? Is your paint able to withstand all cleaning/sterilization processes out there?
A: No issues normal sterilization
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Q: What do TPS and AO mean?
A: TPS is a registered trade mark of Stryker Instruments and stands for Total Performance System. AO is the abbreviation for Arbeitsgemeinschaft für Osteosynthesefragen, an organization formed to conduct research in bone healing, with particular reference to the influence of the mechanical environment of the fracture upon its healing pattern. Along with a group of surgeons, who first met together in March 1958 at Chur, this embryonic AO took a number of initiatives. They basically study the healing of bone, mainly in regards to internal fixation (plates/screws/rods...). [ top ]
Q: Why is a passive layer important on a drill?
A: Stainless Steel naturally has a passive layer to prevent corrosion, when machined this layer is removed. Having a passivation step after final machining or laser etching reestablishes this passive layer, helping to prevent corrosion. [ top ]
Q: Can you provide prototype drills in two weeks?
A: It is our goal to be as responsive as possible, which is what this program is all about. Orchid has set up a special manufacturing cell focused on supporting the needs of this initiative. [ top ]
Q: Do drill coatings (gold and chrome) have any negative effects on the drill performance?
A: We've never experienced any negative effects or had any negative feedback regarding Gold (TiN) or Chrome PVD coatings. [ top ]
Q: Do you have a wide variety of different surface patterns available on your broaches?
A: Broaches can be manufactured with a wide variety of patterns, diamond patters are the most popular. Patterns are determined by the customer’s application. [ top ]
Q: Are your prototypes representative of the final article, i.e. could it be used for example in a cadaver lab?
A: Yes. Prototypes are manufactured in the appropriate material using appropriate processes and can be used in a pre-clinical setting. [ top ]
Q: Are trocar tips, or pyramid shaped tip drills effective for bone drill?
A: Yes, the trocar tips are effective in bone drills; the trocar tip helps when drills must be located precisely and physically tapped in prior to drilling. [ top ]
Q: Are there other features that can be added to the tip area to increase effectiveness of heat build-up and drill start-up?
A: Yes, reducing the web thickness and split pointing will reduce heat and help the drill start on center. [ top ]
Q: Do you deliver models of the drills after we submit the survey? What is the deliverable? How is an OEM supposed to create an internal print for manufacturing?
A: We will deliver what is required by the customer. We can deliver native 3D models, native detail drawings, and/or pdf drawings. We work in SolidWorks, Pro Engineer and Unigraphic Solutions. [ top ]
Q: Does e-polishing influence the sharpness of a drill. If yes how much?
A: Yes, if done incorrectly the drills sharpness could be reduced depending on how hard the parts are electropolished. Done correctly, drills receive a brilliant bright finish and the sharpness is not affected. [ top ]
Q: Are your prototypes made from DMLS or machined from stock?
A: Prototypes are made from stock material usually. [ top ]
Q: Which flute parameters do you need to inspect to ensure that cutting efficiency is consistent lot to lot?
A: The flute should have the clearance diameter, margin, land width and helix inspected. Points should have the point angle, primary and secondary angles as well as web inspected. [ top ]
Q: What type of passivation (citric/nitric) is recommended post laser mark on chrome coated surfaces?
A: Typically nitric passivation or electropolishing would be done before chrome coating and laser mark, and then citric would follow. [ top ]
Q: How do you define multi-use?
A: We define multi-use when a cutting instrument is used for more than one application or procedure. [ top ]
Q: Is passivation necessary if the instrument is electropolished?
A: Only if product is etched after electropolishing. [ top ]
Q: Would there be any reason to passivate an instrument prior to chroming?
A: Passivation or electropolishing aren't necessary but do ensure a clean surface before coating. [ top ]
Q: Are the "prototypes" manufactured under full QS controls?
A: Yes. In order to speed the process, blanks may be made at Orchid Design in CT and sent to Orchid Unique in MI to be ground. Both facilities are ISO 13485 for manufacturing with full material certification(s) and inspection provided. Also, if a feasibility prototype is requested that is not lot controlled, we can provide that as well. [ top ]
Contact us at CIS@orchid-orthopedics.com or (517) 694-2300 for more information.
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