Friday, November 18, 2016

Critical feature confirmation: The next big thing in medical device design. Link to MD+DI Article

Ongoing design revisions during development can put stress on a medical device’s go-to-market timeline.

Narrowing the list of critical features in a design is one of the best ways to keep a project on track and on time.

Critical feature confirmation (CFC) is a leading-edge method to figure out which device features are critical and which aren’t. It uses designed experiments to test product and design requirements against key design inputs. The test results indicate which features are critical.

The CFC process helps companies alleviate pain points in getting a product to market in three important ways:

Accelerating reviews: Design and product development review processes now focus only on the few things that matter – features confirmed by the CFC process. This quickens reviews to ensure projects are delivered on time and on budget.

Simplifying the quality control process: Test method development targets only confirmed critical features. This also helps reduce the amount of data that needs to be collected throughout development.

Improving regulatory review: Clean, objective data answers what-if questions, and is better documented for regulatory bodies to review during submissions.

To learn more details about critical feature confirmation and how to apply it for your device, click here  for a link to MD+DI.

Monday, November 14, 2016

Two key trends driving today’s spinal implant device manufacturing.

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.