Wednesday, June 7, 2017

Design for manufacturability redefines med device measurement and validation

In medical device development, design for manufacturability (DFM) is ultimately about designing for cost. The process involves every member of the product development team – technical, commercial and regulatory – to successfully deliver a product that’s not only easy to manufacture, but profitable as well.

Every critical feature must be measured and validated as a design moves through production. Streamlining the number of critical features in the initial design, as part of DFM, improves this process for everyone involved.

Experience shows it also increases the likelihood of a successful product launch.

Lowell’s Vice President of Operations, Edward Jaeck, will share more about implementing DFM during OMTEC  this June 13-15 in Chicago. His June 14 session, “Data Driven Design for Manufacturability –From Validation to PPAP,” explores how DFM affects and improves the steps of a product’s development.

DFM starts with the technical team
The technical team includes design and quality engineers, R&D and manufacturing. Success for this team means creating a complete and accurate CAD model and drawing set that can be measured and manufactured.

Reducing the number of critical features is one of the best ways to implement DFM, and critical feature confirmation (CFC) is a leading method to achieve this goal. This approach uses design of experiments to test design requirements against key design inputs, to define which features are critical.

CFC, partnered with profile tolerancing, simplifies a drawing and communicates key data points. It also helps the commercial and regulatory teams in developing costs and inspecting, measuring and validating each feature of a device.

The commercial team’s role in DFM
Commercial team roles include sourcing, commodity, purchasing and planning. For a successful product launch, these team members need to generate an accurate parametric cost model that takes into account “what-if” scenarios.

One series of “what-if” questions centers on critical features and how design changes may impact the bottom line.

Critical features often cost more than non-critical ones, and reducing the critical feature count helps drive down overall production costs. Understanding and examining the cost impact of these features are essential functions for DFM as it strives to balance expenses in production.

How DFM affects the regulatory team
While the FDA and EU establish device requirements, it is up to individual companies to define their approach to meeting these requirements.

Measurement and validation are built into the DFM process. With key data easily accessible, regulatory teams can more quickly review and approve designs against drawings, accelerating this vital step of product development.

To register for OMTEC and Lowell’s presentation, visit For a meeting at the show, email

Tuesday, March 7, 2017

Streamlined dimensioning data shows potential savings of 826 minutes on inspection process.

Data points and dimensions are critical in device design and development, but can also overwhelm the inspection process. Keeping data in balance is a tightrope medical device manufacturers and companies have to walk.

Inspection is one of the essential processes that’s slowed down by too many data points. Cluttered designs are time-consuming to program, machine and inspect. This issue is further magnified if the original drawings become part of the design history file for later use in product line extensions and product enhancements.

The entire programming, prototyping and inspection process timeline can be simplified through profile dimensioning, as part of Geometric Dimensioning and Tolerancing (GD&T), to remove unnecessary data points.

To test how streamlined the process can be, Lowell compared linear dimensioning with profile dimensioning on a cervical plate for a customer.

Across seven areas – including dimension drawing, coordinate measuring machine (CMM) programming, inspection reporting and dimensional inspection – profile dimensioning took 419 minutes. This was less than a third the time of linear +/- dimensioning, which took 1,245 minutes.

Choosing the right data points keeps product development efficient by focusing only on the dimensions and features that are critical to a design. By removing what’s unnecessary, the entire process is less complicated.

To arrive at the critical data points for profile dimensioning, Lowell works with a customer’s design team. Once they fully understand the part’s intended use and design, Lowell’s team can run a design of experiments and confirm features that are deemed to be critical. This critical feature confirmation (CFC) assists the engineer in the selection of features that are truly critical to a product’s design.

Weeding out critical from non-critical features saves time throughout the development, inspection and final production stages. Through the CFC process, the customer has a final device that functions as designed and isn’t caught in an endless and lengthy cycle of inspections and revisions.

Contact Lowell today to learn how profile dimensioning can improve inspection time on your next product. To download our White Paper on Profile Tolerancing click here.

How custom tooling quickens a device’s time to market and unlocks machining potential

CNC machines are the backbone of the precision machining environment, thanks to their precision and ability to manufacture intricate forms and features. Custom tooling is essential to fully unlock the potential of these machines and their technology.

A longtime expert in manufacturing complex medical devices, Lowell develops its own custom tooling to further enhance the CNC machines’ capabilities. This also ensures our production process can meet customers’ design intent and quickens time to market for their devices. Here are three key findings from this proven process.

1.       The quality of the tools affects the quality of the devices. Custom tooling improves both.

Often behind the scenes, tools touch every part of a product’s fabrication. They directly affect the quality of a device we manufacture for customers. By bringing the design and creation of custom tooling in house, we avoid the breakage and inconsistency problems we had with outsourced tools. We put our custom tools through the same rigorous design process and programming as our customers’ device components. This creates better and more reliable tools, which lead to better parts for our customers.

2.       By creating your own tools in-house, customers can get their parts to market faster.

By fabricating tooling in-house, we can build custom tools for specific applications and make any needed adjustments in a matter of hours. Before developing our in-house process, timelines were impacted by how quickly we could get a custom tool delivered. If internal testing showed the tool was wrong or needed modifications, it could take an extra week or longer to fix. Expanding our in-house capabilities is more efficient. This helps improve turnaround time for our customers, which ultimately impacts time to market.

3.       When tools are designed for a specific purpose, they lead to better results.

Not all projects require custom tooling solutions, but especially complex projects typically do. By creating tools for specific device needs, we can ensure that each piece meets the design specifications to deliver results for our customers. It also gives us flexibility to create tools from different materials – for example, carbide, tungsten or steel – based on the manufacturing process.

With custom tooling created in house, Lowell accelerates the product development process. To download our White Paper click here.