Thursday, March 29, 2018

3 ways machine validation practices improve how contract manufacturers deliver product to customers

Machine validation is an ongoing part of a medical device manufacturer’s quality assurance. It’s an essential method to ensure they’re delivering products that meet customers’ specifications.

While this process occurs in house, it’s important for customers to understand how machine validation influences the products that their manufacturing partner delivers – from reducing inspection time to ensuring each component is made accurately.

Benefit #1: A documented master validation plan reinforces regular validation processes.

As part of a quality assurance program, machine validation processes are often recorded in a master validation plan.

Each piece of equipment must be validated against installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) protocols, according to FDA guidelines.

In addition to running IQ OQ PQ validation when a machine is first installed or after it’s moved, it’s important that PQ validation be an ongoing effort. Machine components can drift over time, and regular PQ validation ensures a machine repeatedly and predictably reproduces expected results.

When looking to work with a contract manufacturer, ask about its validation processes and if a master validation plan is in place. This plan will typically include IQ OQ PQ benchmarks and an outline of how frequently machines are validated.

Benefit #2: Validation ensures the manufacturer chooses the appropriate machine to create a component, which creates confidence that parts will be delivered to specification.

One of the biggest benefits of running routine validation is creating a high level of confidence that machines will repeatedly and predictably create parts to specification.

When a manufacturer like Lowell receives a CAD model from its customers, it surveys its equipment list to select the appropriate machines to create the components. Part of this decision is based on how well a machine can consistently manufacture a specific dimension, which is documented as part of process validation.

Machining cost is another factor. Equipment that’s capable of creating very tight tolerances to the submicron level is typically more expensive to run than machines with a wider capability range. By referencing validation documents, we can choose a machine that meets manufacturing requirements while also keeping an eye on the customer’s production cost.   

Confidence can also reduce inspection time, which helps products ship more quickly. The example below shows how this can work, based on guidelines in AQL1.0.

If we create 2,500 parts, the number of parts recommended for inspection is 42. If we create 500 parts, the number recommended for inspection is 29. Running five 500-part jobs separately means 145 parts total should be inspected.

However, if we know a machine is validated to reliably create 2,500 parts to dimension, we can run the five batches together and reduce the inspection numbers from 145 to 42. This delivers immense time and cost savings for the customer.

Benefit #3: Validating processes via historical data streamlines pre-production time.

Each time a component is created, data is collected on the part and machine. Manufacturers can use this historical data to decrease the amount of pre-production time using a process called retrospective process validation.

In its Guide to Inspections for Medical Device Manufacturers, the FDA defines retrospective process validation as “validation of a process for a product already in distribution based upon accumulated production, testing and control data.”[1]

This allows manufacturers to validate processes based on the data generated when similar parts were made – if the products have been shipped for distribution already – rather than create a brand-new validation process. Decreasing this pre-production time can help get a component into production sooner, improving overall time to market.

Process validation is a complex but essential part of any medical device manufacturer’s operations as they strive to deliver products in a timely and accurate manner. For more information about Lowell’s validation process and master validation plan, contact us at (763) 425-3355 or

[1] Guide to Inspections of Medical Device Manufacturers, U.S. Food and Drug Administration.

Building successful cost models is a critical step in design for manufacturing

Design for manufacturing is changing how companies approach medical device manufacturing. This is the second of a three-part series about design for manufacturing and its effect on different teams in the product development process. Click here to read part one.

Design for manufacturing (DFM) is a team approach to efficient, effective manufacturing. In the medical device industry, this is an important method for controlling costs while ensuring functionality.

A device’s development starts with the technical team, then moves to the commercial team once the CAD model and drawings are completed.

By examining the costs to make the product, the commercial team can identify ways to reduce expenses to improve a product’s development and future sales.

The role of should-cost modeling in DFM

The commercial team is responsible for should-cost modeling, also called cost modeling. Strategic and technical sourcing, commodity specialists, purchasing, buyers and planners may all be involved in this process.

The initial should-cost model is based on the drawings from the technical team. The model outlines how much a product should cost based on materials, machine time, machining capabilities, overhead, profit margins and a number of other categories.

Once the initial model is developed, the commercial team will begin to adjust numbers and inputs to determine how different features impact the overall cost of a product.

This process involves a series of what-if questions to determine potential cost savings. If a company has its own manufacturing capabilities, it may explore the cost difference to make a product in house compared to using a contract manufacturer.

Balancing excitement features and Voice of the Customer (VOC) with the bottom line

One of the biggest challenges for the commercial team is striking a balance among cost, excitement features and VOC research. The latter two are often high priorities for the marketing team, but may create manufacturability issues or increase production cost.

For instance, it only takes one excitement feature to make a commodity component into a specialty component – and have a corresponding increase in price.

In one customer example, a plate drawing included a complex cutout in the center for aesthetic purposes. The should-cost modeling exercise examined the cost difference of including or omitting the shape. The analysis revealed a price jump when the shape was included because the number of radii increased, which would require both additional machining and inspection time.

Thanks to should-cost modeling, the commercial team was able to identify potential savings on the cost of this product’s development. It flagged the cutout for further discussion with the technical and marketing teams, to determine if the feature was worth the added cost in terms of customer need.

Contract manufacturers can help identify cost savings

With the increasing interest in DFM, contract manufacturers are partnering with clients on their should-cost models. The manufacturer’s first-hand experience with machining technology, inspection data and associated costs is often a benefit to the commercial team’s process.

If you’re working with a contract manufacturer to machine your medical device, ask if they can help identify opportunities to save on production costs.

Lowell’s experienced engineers and machinists can offer insights into how different features may impact the cost of the product. To discuss your project and how we can help, contact us at (763) 425-3355 or

Wednesday, October 4, 2017

Effective design for manufacturing requires a systems perspective during the design phase

Design for manufacturing is changing how companies approach medical device manufacturing. This is the first of a three-part series about design for manufacturing and its effect on different teams in the product development process.

Adopting a design for manufacturing (DFM) approach to product design influences the work of each member of the product development team. For best results, a systems perspective during the design phase is critical.

All product designs start with the technical team. This group typically includes research and development, design and engineering, manufacturing, quality, and supplier quality. The team’s goal is to deliver an accurate, measurable and manufacturable CAD model and drawings.

Metrology planning, manufacturing and post-processing are three key methods to achieve this goal, and have a critical effect on DFM.

Metrology planning
Metrology planning defines how features will be measured and why specific methods are chosen. There are four key elements to have in place before any metrology planning session:

1.       A fully defined CAD model
2.       Tolerance analyses for all interfaces of the component and other components it touches
3.       Functional map showing the other components and how the designed product effects them
4.       An Excel file with each feature listed, including its nominal dimension and tolerance

To start this planning process, the full technical team reviews the CAD model and works through the function of the component. This includes not only what the product does, but also how it affects the components it touches. This analysis should entail the datum reference schemes for each component and the associated tolerance analysis justification. 

Once the team understands the design intent and datum reference scheme of the component, it’s time to discuss the optimal way to measure each feature.

The team must balance inspection cost (driven by speed) and test method validation requirements (GR&R) to take advantage of DFM. This starts by determining the best way to fixture the part, and then moves through the Excel file: critical features first, then major, minor and finally negligible. Critical features will need to pass gauge studies and therefore require metrology capable of passing those studies, while negligible features do not need this level of scrutiny.

Manufacturing review
Manufacturing review follows metrology planning. This review examines each feature from the metrology Excel grid – from critical to negligible – to determine the level of manufacturing risk.

If any concerns are identified during this review, they should be communicated to the design engineer. Once the engineer has re-designed those areas of concern there is a final manufacturing review to confirm the risk profile.

Post-processing review
The last step for the technical team is reviewing any post-processing procedures and their impact on DFM. It is imperative for the design engineer to be acquainted with the design rules for each of the post-processes.

There are a variety of procedures to be considered, both large and small. Color anodizing is one example. One color is less expensive than two because of the manual labor required to mask two colors. Two colors can also be more expensive because of the narrow processing range to get those colors. These details can have a big impact on cost and time to create a final product, which influence DFM.

If you work with a manufacturing partner, it’s important to understand how their methods influence the manufacturing process and align with a DFM approach. By taking a systems perspective, design engineers can better meet design intent while minimizing cost and ensuring an on-time project launch.

Contact Lowell at (763) 425-3355 or to learn more about our DFM capabilities to improve time to market.

Monday, August 14, 2017

OMTEC 2017: Three takeaways for medical device manufacturing

More than 1,000 people gathered for this year’s Orthopaedic Manufacturing & Technology Exposition and Conference, to learn about the latest solutions and the future of the orthopaedic industry.

As we walked around the show, attended speaker sessions and met other attendees, three key themes emerged: value-based care, additive manufacturing and design for manufacturing. Here’s how we see these impacting medical devices today and in the future.

Takeaway #1: Value-based care drives changes to the manufacturing process.

OMTEC’s keynote address featured a panel of experts who weighed in on a range of topics, including value-based care. As this approach continues to be in focus, medical device companies are more closely examining their roles in patient treatments.

Value-based care is most often thought of from the patient and care setting perspective. At Lowell, we’ve seen this change begin to affect device manufacturing too.

Data-driven decisions are changing the landscape of relationships between device providers and manufacturers. Companies actively seek new partnerships or consolidate vendors to create devices that work better and take less time to produce. With the ultimate goal to reduce error events and improve patient outcomes, reducing time to market through approaches like GD&T is also important to the decision-making process.

Takeaway #2: Additive manufacturing continues to make gains.

Additive manufacturing had a big presence at OMTEC, highlighting a number of benefits including flexibility, speed, small-batch production and surfacing.

As the number of successful, additive-manufactured device launches keeps growing, we see new options to pair additive with traditional machining. Tolerances are one example.

Traditional machining can often achieve tighter tolerances than additive manufacturing, thanks to the precise nature of these machines. A near net component created by additive can be finished on traditional machines to take advantage of each process’ strengths and achieve a better result.

Takeaway #3: Design for manufacturing expands its influence.

Design for manufacturing, or DFM, is growing more influential across device design and manufacturing. About 50 OMTEC attendees joined Lowell’s session, “Data Driven Design for Manufacturability – From Validation to PPAP,” to learn more about this trending topic.

DFM is focused on designing for cost, and limiting critical features is one of the best ways to reduce costs in the design and manufacturing process. Critical feature confirmation ideally starts at the earliest design phase, to streamline future manufacturing and inspection processes.

If you weren’t able to attend OMTEC, check out this SlideShare of Lowell’s presentation, or contact us at to learn more.

Tuesday, August 8, 2017

An Interview with Lowell Quality Assurance Manager Alejandro Romero

To expand its expertise in quality assurance and metrology for complex medical devices, Lowell recently added Alejandro Romero as quality assurance manager.

Alejandro brings more than 20 years of experience to the role, with deep knowledge of test method validation; process, product and tool validation; measurement system analysis; exploratory data analysis; geometric dimensioning and tolerancing; and multi-sensor CMMs.

What is your background in metrology?
Before starting at Lowell, I worked for Vention Medical, a medical device manufacturer, where I was part of the Quality Corporate Group. I held the subject matter expert role in metrology, supporting the seven device manufacturing services facilities in the USA, Puerto Rico, Costa Rica and Ireland. I helped design and implement a metrology platform that standardized the test methods in order to provide portability and efficiency.

Prior to Vention Medical, I worked for SMC Inc. East Coast, where I was the senior metrologist. I mainly focused on supporting the engineering and design and development teams with metrology requirements, statistical analysis and the development of robust test methods.

How are GD&T and metrology influencing quality assurance?
Any human activity progresses as fast as tools do – quality assurance it is not an exception. The acceptance of system solutions for quality management and compliance with the ISO 13485 and 9000 series of standards means that many companies have to face concepts such as uncertainty, calibration and metrological traceability.

Coordinate metrology and GD&T provide a scientific basis for carrying out measurements of 3D geometric objects. The accuracy and realization time are matched to the manufacturing rhythm. Because of new technologies and scientific developments, the scope of applications of these systems is constantly growing and measurement accuracy is increasing.

It is important to note that just a few decades ago, the inspection capabilities were dissociated. It was common to find a multi-step inspection that was composed of results from contact-based devices (CMM Tactile/Contact), optical (CMM Optical) devices and laser technology, among others tools. This created long inspection times and excessive handling of the product. The modern multi-sensor machines drastically reduce the inspection time since they provide the possibility of different sensors working simultaneously under the same datum reference frame setup.

Design for manufacturing and additive manufacturing are two methods defining the future of medical device manufacturing. How are you seeing these impact quality assurance?
A basic principle states that the manufacturing process dictates the final product’s risk level, inherent to such process. Additive manufacturing – which many specialists characterize as the first revolution of the 21st century! – will certainly force quality assurance teams to adjust the traditional techniques or, in some cases, even develop a completely new approach. Unlike subtractive manufacturing methods that start with a solid block of material and then cut away the excess to create a finished part, additive manufacturing builds up a part (or features onto parts) layer by layer from geometry described in a 3D design model.

The DFM (design for manufacturing) approach’s focus is to design for lower cost. The cost is driven by time, so the design must minimize the time required to not just machine the part, but also minimize the setup time of the CNC machine, NC programming, fixturing and many other activities that are dependent on the complexity and size of the part. It’s important to remember that this method requires a well-defined strategy that unifies the technical, commercial and regulatory goals.

What makes Lowell’s approach to quality assurance unique?
We reach and exceed our customers’ expectations through experienced and well-trained personnel and state-of-the-art test equipment, manufacturing protocols, opportune preventive maintenance, and calibration and gage management. These are integrated under the umbrella of precise and flexible manufacturing cells. The addition of a world-class metrology control room and new CMMs reinforce the Lowell Inc. commitment to precision as our priority.

What do you find most interesting about your work?

This line of expertise evolves constantly and its interaction with the rest of the quality system always demands our complete commitment to maintain a critical, proactive attitude all the time. Every product implies a challenge and the company mission statement – “Our purpose is to manufacture value into all that we do” – inspires me to work in harmony with it.

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.