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.

Tuesday, October 4, 2016

Three best practices to convey design intent for medical devices

Medical device design is a complex process, and grows even more complicated if design intent isn’t well communicated.

Design intent encompasses how a product will be used, and in medical device manufacturing, this influences how a product will be made. Clear communication of design intent is fundamental to create a development process with fewer product revisions, so a device gets to market faster.

Here are three best practices for improving communication of design intent.

#1: Keep it simple – move away from “more is better” dimensioning.

Cluttered drawings are a key reason for miscommunication of design intent. When every data point or tolerance scheme is labeled, it’s difficult for the manufacturer to understand what’s critical to the design. This creates opportunity for error, and it also lengthens the validation process.

To improve communication, limit tolerancing and dimensioning marks to only the features that will affect performance. This simplifies measurement and validation, which makes the entire development process more efficient because there is a clear delineation between features that are nice to have and those that impact the success of the design. It’s easy to be caught up in revisions and testing on features that do not impact functionality, and this can significantly delay introduction.

#2: Use precision GD&T to improve communications.

Precision Geometric Dimensioningand Tolerancing (GD&T) takes standard GD&T practice to the next level. While both use the same standards-based language, precision GD&T includes conformance criteria in addition to dimensions. Conformance criteria is a key difference that helps focus designs because it includes only the features that convey the design intent of the engineer.

For example, precision GD&T and 3D modeling were used to simplify the ring design below. Instead of specifying the hundreds of angles, radii and arcs of a ring, three critical measurements are shown in the final drawing. The second is much easier to read and understand.

Before













After











#3: Validate designs with 3D models.

Using 3D models is a best practice to validate designs and help determine early in the design process which factors are critical. This means that any confusion can be cleared up at the start of development, rather than affecting every iteration.

Pairing 3D models with precision GD&T is a powerful tool to ensure a part meets measurement requirements while conveying the design intent of the engineer. Once a 3D model is made, it should be compared to the original drawing. If any edits are required, those can be changed and updated in the final drawing to be used by the manufacturer.

With better communication of design intent, medical device companies can accelerate the development process with their manufacturers. To learn more about improving communication of design intent and its benefits, download our white paper here.



Tuesday, September 6, 2016

Lowell Wins AVA Video Award

Lowell, Inc. recently won an AVA Digital Award in the Overview Category for our "Technology at Lowell" video.  Click on the link below to view this and other videos produced by Lowell, Inc.

https://www.youtube.com/watch?v=0xSPe4IgD58

Thursday, August 25, 2016

More Space Saving at Lowell

Hanel Lean-Lift Model 2460-825
Our new Hanel Lean-Lift is slated for installation in our redesigned tool crib.  The Hanel is another vertical storage system that will securely hold cutting tools, fixtures, consumables and safety supplies while freeing up more valuable floor space for production equipment.


Hanel 2460-826

Thursday, May 26, 2016

Lowell Adds New Quality Manager - Ed Yaris

Ed Yaris has joined the company as our new Quality Manager. Ed comes to Lowell with extensive experience in Metrology, Management, and CMM Software development.  He will oversee the Quality Management functions at Lowell.  His experience includes leadership positions at National Security Technologies, Helmel Engineering Products, Renishaw and GE.Ed is a member in good standing of seven ASME/B89 standards committees including Coordinate Metrology, Uncertainty and he also chairs the Probes and Sensors committee.  He is on the steering committee for the North American Coordinate Metrology Association (NACMA) made up of the standards committees and leading industry experts from the United States, Canada and Mexico.

Ed Yaris

Tuesday, May 10, 2016

Keyence IM-6225T Added to Increase Inspection Throughput

Our new Keyence IM series image dimension measurement system is through validation and ready to roll. The Keyence instant measurement system creates consistent results independent of human vision, and can extract up to 99 data points simultaneously. The new Keyence will dramatically increase  throughput in the quality lab.

Keyence IM-6225T