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 www.omtecexpo.com. For a meeting at the show, email phil.allen@lowellinc.com.

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.







Tuesday, December 6, 2016

Medical device design trend: Combining additive manufacturing and traditional machining for optimal product development

Additive manufacturing is cited as the new frontier for creating medical device components, with design flexibility that goes above and beyond what traditional machining typically offers.

Across the medical device industry, companies are increasingly adopting this technology in the search for faster product development cycles.

But additive manufacturing and traditional machining have different strengths that can’t be easily duplicated by the other. To take advantage of the best of each process, companies are beginning to connect these techniques to improve product development.

How traditional machining enhances additive manufacturing

Many companies turn to additive manufacturing when there is a feature or feature set that can’t easily be conventionally machined. It’s also ideal for custom builds or when low quantities of components are needed. Traditional machining is often best suited and more cost-effective when components are being made in higher production numbers.

Another use for additive manufacturing is building near net components. This is where traditional machining can best support additive manufacturing – by transforming these components into finished pieces.

For example, a product may be created via additive manufacturing with tolerances of ±0.01 inches, but the original design intent may require final tolerances of ±0.001 inches. That level of detail and finishing, to date, is best completed by traditional machining techniques.

Traditional machining is also ideal for finishing components that require different surface textures. Once the texture is created via additive manufacturing, machines can take over to cut flat surfaces, windows, corners and edges to precise measurements that meet the design intent.

This combined approach is an innovative trend for component design and fabrication, and will continue to grow with the widespread adoption of additive manufacturing. Talk to the team a Lowell to determine if this approach is right for your device. 



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.