In the medical device industry, minimally invasive and robotic surgical markets are seeing changes when it comes to the manufacturing and materials of its devices. This year at MD&M West, we noticed a few topics that were top of mind for most of our booth visitors.
Material Selection
The challenges of robotic assisted surgical devices, from the material selection to design requirements
Material selection for medical devices is always important and even more so when devices are being manufactured at the sub one-millimeter microcomponent size.
The complexities of automating and miniaturizing surgical instruments are numerous, but one complexity that stands out is the material used to create these devices.
Traditional medical devices would typically use stainless steel; however at the microcomponent size, traditional stainless steels might not hold up, so unique alloys are often necessary to meet the demand these microcomponents are subjected to.
Examples of more suitable materials could be titanium, nitronic 60, 17-4 - all alloys traditionally designed for aerospace to be used in the very demanding environment of the hot section of an aircraft engine.
These alloys can stand both the demand of being used at the sub-one millimeter level and the rigorous sterilization process required between each medical procedure. Both actions would tax many other materials such as traditional stainless steel.
Ultimately, these devices are being asked to perform the same actions a surgeon would perform in a traditional open surgery, but at a minimally invasive level while being automated. This is a big ask and the material used to create them needs to be able to meet that demand without failure each time.
Tolerance Stack at the sub 1mm size
The challenges of creating a manufacturing process that will develop components to meet the required tolerance stack for robotic assisted surgical devices at a sub one-millimeter size
Another hot topic we saw this year was surrounding the tolerance stack microcomponents are required to meet for the non-invasive and robotic surgical markets.
Any surgical component would be required to have very tight tolerances and this is amplified even further when these components are scaled down to a sub-one millimeter size.
Instruments need to be able to cut and suture through both soft and hard tissues and perform flawlessly during the length of a procedure, while meeting the required number of procedures before an instrument needs to be replaced.
Talking through these items in the design process is typically, for all intents and purposes, easy - yes, what is being asked for is usually possible. However, actually manufacturing the sub components and final devices in a way that ensures performance often proves to be much more difficult; this is where Schivo can make possible happen.
How Schivo is adapting
Recent acquisitions of Supreme Screw and APN
Schivo has years of experience and knowledge behind us, and with our recent company acquisitions, we have increased that expertise exponentially.
Acquiring Supreme Screw Products allowed Schvio to inherit their knowledge and expertise which focused on manufacturing parts traditionally made on a complex machine and creating those same parts on a Swiss machine that only requires one setup.
This allows for more automation, thus decreasing the man power needed and ultimately providing easy scalability, enhanced reliability, and potential cost reduction without sacrificing quality.
In fact, with this method, quality can be easier to manage and guarantee - by only touching the part one time, the risk of operator error is significantly reduced.
This process allows Schivo to be much more cost competitive on very hard to manufacture, complex parts; also allows manufacturing to scale easily - once the process is locked down on one machine, it is easy to scale through copy and paste.
The acquisition of APN took the above benefits and elevated them; APN’s expertise allows the necessary operator intervention (as is seen across all manufacturing) to be driven by data, rather than human decisions.
Data driven decisions predictively and proactively determine what changes need to be made to the process to reduce human error.
The operators are only there to make changes told to them by the data, which allows for increased quality - in fact, quality is built into the process as the forethought, not something done after the fact.
All of this allows Schivo to be on the cutting edge of medical device manufacturing. At Schivo, we make possible happen. If you have a question for our team of experts, please reach out.
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