With the global spinal implant market forecast to grow up to
6
percent by 2022, companies are looking for better ways to improve patient
health while streamlining product development.
To meet this goal, two trends are emerging for spinal
implant designs. First, implantable devices continue to become smaller to meet minimally
invasive surgery demands. Second, companies are asking for validation of the
manufacturing process to minimize inspection time.
Trend #1: Increasing requests
for smaller devices
Minimally invasive surgery has been and will continue to be
a driving force behind the demand for smaller devices that maintain the best
performance possible.
Smaller devices can mean smaller incisions. For patients,
research shows that smaller incisions can improve healing time and decrease
operation time. For surgeons, less-invasive procedures often mean that more
procedures per day can be completed with better overall outcomes and fewer
complications.
In manufacturing, the technology to make these devices is
progressing alongside the need for smaller implants. New machine tools can cut
and grind smaller and smaller parts with dimensional accuracy to +/- .0001. This
wasn’t possible just a few years ago, but is now a critical capability in
building complex implants.
Trend #2: Validating
manufacturing processes to minimize inspection time
Data collection has always been important to medical device
manufacturing. But with a growing focus on validation and inspection time, more
companies are looking to their manufacturing teams for detailed data analysis
to minimize the time needed for these processes.
Validation ensures that a process is repeatable and reliable,
taking into account how individual parts are made and the tool path they
follow. When a process is validated, inspection time decreases because parts
can be inspected as a set instead of individually.
Device manufacturers are a key player in validation, and these
manufacturers are beginning to fully validate their processes to meet customer
needs. By pairing historical data with today’s statistical software, manufacturers
are able to ensure that a device’s design, and its development process, meet current
validation standards.
The relationship between manufacturer and medical device
company is critical to addressing these trends in data validation and
dimensions. By working closely together, each organization can improve a
device’s design and more quickly deliver the effective products patients need.
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