Thomas Van Wilpe, Manufacturing Process Engineer, Lowell02.18.20
Manufacturing orthopedic devices involves much more than simply making parts. The goal is to create a part that meets design intent and is made to specifications in order to pass validation and inspection. In addition, the data and paperwork need to be in place for the part to be acceptable to meet both customer and internal standards.
Traditionally, both design review and design for manufacturing (DFM) meetings focus on the features of a part. During these sessions, recommendations are provided to improve features and/or tolerances to make the customer’s product more cost-effective and easier to manufacture.
To meet today’s expectations and paperwork requirements, however, customers and manufacturers should go beyond a simple design review. Instead, they need to review the entire manufacturing process by asking questions such as:
ngineers acquire these details quickly and efficiently. As one of the first steps in a new project, these meetings will prove valuable for not only a contract manufacturer or design house, but for the customer as well. Having this dedicated time to ask questions, review requirements, address issues that may come up during production, and share ideas and concepts that aren’t just about design is valuable beyond measure. By investing an hour of time at the beginning of the project, it’s possible for manufacturers and their customers to save hours of discussions and iterations later.
The following is a step-by-step overview of how these meetings should work, as well as some of the pitfalls that can emerge to help avoid them.
Step 1: Invite the Right People
Pre-production meetings gather key members from both the customer and manufacturer to review the upcoming project. Engineers from each organization should be involved, along with those in quality inspection roles. Since every company’s processes are different, it’s essential for both parties to learn what the other needs for the device to be successful.
It can also be beneficial to have the customer’s production, quality, and engineering representatives at the table, as they are able to speak directly to product features and why an aspect of the product was designed in a certain way. This can be extremely helpful when it comes to product features the manufacturer feels need to be changed or altered. The customer’s engineers can immediately provide feedback as to why a change can’t be made, or agree with a suggestion and move to quickly test the change.
Machinists and programmers who will be manufacturing the components should also be involved, as they have the best knowledge of machine capabilities and limits.
Step 2: Review Designs Before the Meeting; Come Prepared with Requirements
Homework and preparation should be accomplished prior to the pre-production meeting. The manufacturer should conduct both a design review and an inspection review of the customer’s drawings before the meeting and bring DFM suggestions and inspection considerations to the meeting. On the other hand, the customer should arrive at the meeting ready to discuss first article and validation requirements, as well as design intent.
It’s also helpful to have a physical sample. If the product is completely new, the manufacturer should ask the customer for a sample. In the meantime, the manufacturer can create a rapid prototype sample of the part to have in hand; however, this may be the only option if the customer does not have a sample to provide. This can help clarify answers to questions that require a visual reference point, such as:
There are four main discussion topics that take place during the pre-production meeting: design requirements, drawing review, inspection requirements, and purchasing.
Design Requirements
This agenda item focuses on DFM and design intent. The customer’s team will share the part’s design intent—how the part will be used, how the mating parts fit, and what tools are used to properly operate. The manufacturer’s team will have reviewed the drawings and put together ideas on how to make the device easier to manufacture and inspect. These two perspectives complement each other, and the discussion can lead to manufacturing efficiencies.
The following is a real-world example of this item from a Lowell customer project. The customer requested masking of threads when components were bead blasted so the parts would work as designed. The team at Lowell was able to demonstrate, based on past project experience, that bead blasting does not affect the threads’ conformance or functionality. The masking step was able to be removed from the manufacturing process, which saved the customer significant expense and time.
Drawing Review
The meeting’s drawing review goes over details including drawings, models, document transfer, and specifications. It’s also the time to discuss packaging and marking requirements. This is especially important with new customers and those who validate their packaging because if the packaging, labeling, or marking is wrong, so is the part.
Questions to pose during this session for resolving potential issues include:
Inspection goes beyond simply discussing first articles and samples; gauges, validation, and certification should also be included. This is an especially important part of the conversation to ensure the inspection and validation data gathered during manufacturing matches the customer’s expectations and requirements.
There is often a large amount of paperwork required for medical devices, and the inspection requirements conversation creates a roadmap for the inspection process. The more inspection requirement information a customer can provide to the manufacturer early on, the better.
Purchasing Review
A purchasing review finalizes the project by reviewing items such as supply and quality agreements, timeline, shipping location, and purchase order terms and conditions.
Once the pre-production meeting is complete, the manufacturer and customer both leave with an understanding of what success looks like and what steps come next. Updates may need to be made to drawings and specifications, or it’s possible to move directly into manufacturing.
Delivering Value Through Pre-Production Meetings
Pre-production meetings are a key part of hitting the ground running on a new project, so when manufacturing starts, the expected results have already been clearly defined by all stakeholders. From a manufacturer’s point-of-view, pre-production meetings are a good time to ensure all the details needed for successful device development and documentation are in place. From a customer’s point of view, these meetings help clarify the design intent. In addition, for a new product launch, it may inform the company’s representatives about features that may not be manufacturable. The ultimate goal is to walk away from the project with product results and data that meet requirements.
Thomas Van Wilpe is a graduate of Pittsburg State University with a degree in mechanical engineering technology. He came to Lowell in July of 2016 and started in the firm’s New Associate Training program. Thomas spent time in Inspection and Operations, before settling in engineering as a manufacturing process engineer, where his focus is on development of manufacturing processes, process validations, project management, and fixture design.
Traditionally, both design review and design for manufacturing (DFM) meetings focus on the features of a part. During these sessions, recommendations are provided to improve features and/or tolerances to make the customer’s product more cost-effective and easier to manufacture.
To meet today’s expectations and paperwork requirements, however, customers and manufacturers should go beyond a simple design review. Instead, they need to review the entire manufacturing process by asking questions such as:
- How is the device supposed to function?
- How does it look?
- How is it packaged?
- Does it involve a process validation, and if so, what are the requirements?
- How are we to prepare the paperwork that will accompany the parts?
|
15 Manufacturing Issues Pre-Production Meetings Help Avoid Pre-production meetings are a time for manufacturers and customers to connect on all aspects of manufacturing an orthopedic device, from design to packaging. Following are 15 manufacturing details and potential issues pre-production meetings have helped reveal.
|
The following is a step-by-step overview of how these meetings should work, as well as some of the pitfalls that can emerge to help avoid them.
Step 1: Invite the Right People
Pre-production meetings gather key members from both the customer and manufacturer to review the upcoming project. Engineers from each organization should be involved, along with those in quality inspection roles. Since every company’s processes are different, it’s essential for both parties to learn what the other needs for the device to be successful.
It can also be beneficial to have the customer’s production, quality, and engineering representatives at the table, as they are able to speak directly to product features and why an aspect of the product was designed in a certain way. This can be extremely helpful when it comes to product features the manufacturer feels need to be changed or altered. The customer’s engineers can immediately provide feedback as to why a change can’t be made, or agree with a suggestion and move to quickly test the change.
Machinists and programmers who will be manufacturing the components should also be involved, as they have the best knowledge of machine capabilities and limits.
Step 2: Review Designs Before the Meeting; Come Prepared with Requirements
Homework and preparation should be accomplished prior to the pre-production meeting. The manufacturer should conduct both a design review and an inspection review of the customer’s drawings before the meeting and bring DFM suggestions and inspection considerations to the meeting. On the other hand, the customer should arrive at the meeting ready to discuss first article and validation requirements, as well as design intent.
It’s also helpful to have a physical sample. If the product is completely new, the manufacturer should ask the customer for a sample. In the meantime, the manufacturer can create a rapid prototype sample of the part to have in hand; however, this may be the only option if the customer does not have a sample to provide. This can help clarify answers to questions that require a visual reference point, such as:
- Is this what the anodized finish should look like? Are color coupons available? Are we required to send a sample before we process batches?
- Where should the laser marking be located?
- What is our bead-blasting finish to look like? Is the blasting important to the functionality of the part, or is it purely aesthetic? Are we required to send a sample before we process batches?
- When the drawing calls out a “sharp edge,” how do you define “sharp”?
There are four main discussion topics that take place during the pre-production meeting: design requirements, drawing review, inspection requirements, and purchasing.
Design Requirements
This agenda item focuses on DFM and design intent. The customer’s team will share the part’s design intent—how the part will be used, how the mating parts fit, and what tools are used to properly operate. The manufacturer’s team will have reviewed the drawings and put together ideas on how to make the device easier to manufacture and inspect. These two perspectives complement each other, and the discussion can lead to manufacturing efficiencies.
The following is a real-world example of this item from a Lowell customer project. The customer requested masking of threads when components were bead blasted so the parts would work as designed. The team at Lowell was able to demonstrate, based on past project experience, that bead blasting does not affect the threads’ conformance or functionality. The masking step was able to be removed from the manufacturing process, which saved the customer significant expense and time.
Drawing Review
The meeting’s drawing review goes over details including drawings, models, document transfer, and specifications. It’s also the time to discuss packaging and marking requirements. This is especially important with new customers and those who validate their packaging because if the packaging, labeling, or marking is wrong, so is the part.
Questions to pose during this session for resolving potential issues include:
- Do the parts need to be individually packaged? Or are trays acceptable?
- Will we be shipping directly to the packager for the validation, or do they go to the customer first?
Inspection goes beyond simply discussing first articles and samples; gauges, validation, and certification should also be included. This is an especially important part of the conversation to ensure the inspection and validation data gathered during manufacturing matches the customer’s expectations and requirements.
There is often a large amount of paperwork required for medical devices, and the inspection requirements conversation creates a roadmap for the inspection process. The more inspection requirement information a customer can provide to the manufacturer early on, the better.
Purchasing Review
A purchasing review finalizes the project by reviewing items such as supply and quality agreements, timeline, shipping location, and purchase order terms and conditions.
Once the pre-production meeting is complete, the manufacturer and customer both leave with an understanding of what success looks like and what steps come next. Updates may need to be made to drawings and specifications, or it’s possible to move directly into manufacturing.
Delivering Value Through Pre-Production Meetings
Pre-production meetings are a key part of hitting the ground running on a new project, so when manufacturing starts, the expected results have already been clearly defined by all stakeholders. From a manufacturer’s point-of-view, pre-production meetings are a good time to ensure all the details needed for successful device development and documentation are in place. From a customer’s point of view, these meetings help clarify the design intent. In addition, for a new product launch, it may inform the company’s representatives about features that may not be manufacturable. The ultimate goal is to walk away from the project with product results and data that meet requirements.
Thomas Van Wilpe is a graduate of Pittsburg State University with a degree in mechanical engineering technology. He came to Lowell in July of 2016 and started in the firm’s New Associate Training program. Thomas spent time in Inspection and Operations, before settling in engineering as a manufacturing process engineer, where his focus is on development of manufacturing processes, process validations, project management, and fixture design.
