Mike Treleaven, Tegra Medical09.01.17
Once deciding it’s time to outsource device manufacturing—as more original equipment manufacturers (OEMs) are doing these days—how does one choose the right partner?
Start by considering the OEM’s priorities. Is the goal to simplify the manufacturing process in order to focus on the research and development of new products? Is the marketing and distribution of existing products to new channels the driving force behind this decision? Or is the company entering into a merger or acquisition? A steadily increasing number of OEMs are focusing on their core business and hiring a contract manufacturer (CM) to create the finished device from top to bottom, handling the entire process from prototyping to production.
These medical device companies are engaging with manufacturers who offer end-to-end solutions, or “one-stop shopping.” While many companies claim to offer this suite of services, true end-to-end providers offer all the development, manufacturing, and packaging services necessary to get medical devices and components to market. Once a solid relationship is established between the OEM and an end-to-end contract manufacturer, it should be a smooth transition to accommodate evolving needs.
As a result, selecting the right contract manufacturing partner is a critical decision, but considering the following questions prior to engaging in the process can help clarify the options and ensure a true end-to-end solutions provider is chosen.
1. Refining a Product Design
The OEM’s in-house team has developed a medical device that’s going to enhance people’s lives. Now—during the design stage—is the best time to address the challenge of making it efficient to manufacture.
Design for Manufacturability and Assembly (DFMA) reduces cost, increases quality, and shortens the development cycle of a medical device. A contract manufacturer well-versed in DFMA will assess different approaches and discover the best solution for the product. In order to do this well, they must have deep experience with all the technologies involved in manufacturing the device. The CM should also be able to handle all of the qualifications and validations.
2. There Every Step of the Way
Getting a new product to market involves many phases, starting with refining the design, then progressing to prototyping and pilot production. Does the CM have skilled people and equipment dedicated to product development? When the device is ready for full-scale production, it’s likely going to need further work at the other end, such as assembly, labeling, and packaging. It’s much simpler for the OEM if a single partner can handle every step, especially if it’s in-house. It also becomes more likely the devices will get to market quickly and cost-effectively, with consistently high quality.
3. Broad Range of Capabilities
From the sharp metal tip to the ergonomic plastic handle, a device may require numerous machines in order to be completed. OEMs need a single manufacturing partner that offers all the required manufacturing methods—milling, machining, grinding, molding, laser processing, EDM, etc. Remember, however, that it’s not just what machines the CM has in-house; it’s about what expertise they have. Anyone can buy machines. If the “business end” of a device is sharp metal, ensure one of the manufacturer’s core competencies is in making the most important part.
When a contract manufacturer offers a wide variety of capabilities, it not only means they can produce the current project, but demonstrates it has flexibility to make different types of devices in the future.
4. Efficiency Expert
A device won’t make any money until it gets to market. The right partner knows how to refine a design to maximize efficiency and cost-effectiveness during the production process. Even slight tweaks to manufacturing can make a significant difference during large production runs. Does the CM offer efficient manufacturing processes that include features such as robots and automated cleaning systems? These can simplify and streamline production while reducing costs.
If a device project requires a truly specialized service, ensure the manufacturer has established partnerships with the suppliers offering them, keeping the experience efficient and seamless.
5. Device Handle
A medical device is more than just its “business end,” whether that feature is intended for injecting, poking, or cutting. Most likely, it has a handle as well, the design and function of which is very important to the person gripping it in an operating room. Does the CM manufacture the entire device, and do they ensure every inch of it is made with the utmost care and quality?
For the best of both worlds, seek a partner with deep experience in manufacturing the most complicated part of the device—the “business end”—coupled with the ability to make the handle and all other aspects.
6. Reputation for Quality
Substandard quality is intolerable, so choose a partner that implements robust quality procedures and cGMP practices. Some practices to inquire about include ISO and U.S. Food and Drug Administration compliance; examination of first-pass yields; use of real-time statistical process control; use of lean manufacturing/Six Sigma tools; use of Black Belt-certified engineers; and validation of special processes to ensure repeatability, minimize inspection time, and reduce cost.
7. Sharpness of Point
It’s critically important that many devices—such as needles, trocars, cannulas, guide wires, scalpels, and tissue and bone cutters—are extremely sharp. If the device must be sharp, ensure the CM is extremely careful to maintain the necessary sharpness. Some companies aren’t as careful as others at keeping a device sharp all the way through the manufacturing process, particularly during insert molding. But if working with metal is the CM’s core competency, it’s likely their processes have evolved in ways that preserve sharpness at every step.
8. Sharpness of People
Sharp people are important too. This is the team that’s entrusted with an OEM’s most valuable assets. Do Black Belt-certified engineers make up a portion of the team? Does the team understand the medtech industry and all its pressures? Does it have the expertise to take a great design and further improve it so it can be manufactured efficiently? Is it a dedicated, experienced production team with the latest skills in advanced manufacturing?
Equally important is the investment the CM makes in its people. Is it training staff to handle new and emerging advances in medical technology? Is it encouraging the brightest students and recent graduates to join the company through internship and apprentice programs? Also, is the CM investing in the happiness of its employees through on-site programs and events?
9. A Partner to the OEM
A contract manufacturer is doing more than just making an OEM’s products. It is a guardian of the medical device company’s reputation for quality. It is a partner that sticks with an OEM when all it has is an emerging product idea that needs serious refinement before it can be produced. The CM should be responding to the urgent need to get a product to market rapidly. It’s adapting technology, providing manufacturing capacity, and shifting resources to meet the special requirements of an OEM. While the CM should respect the knowledge the OEM has of its own customers, it should similarly engender that OEM’s respect of its own manufacturing expertise.
The right CM partner will offer the mix of capabilities, expertise, quality, and customer dedication necessary for a medical device project while providing the necessary support to the OEM when most needed.
Mike Treleaven is vice president at Tegra Medical, overseeing the company’s GENESIS Tech Center prototyping and product development activities. He has over 30 years of medical device manufacturing experience.
Start by considering the OEM’s priorities. Is the goal to simplify the manufacturing process in order to focus on the research and development of new products? Is the marketing and distribution of existing products to new channels the driving force behind this decision? Or is the company entering into a merger or acquisition? A steadily increasing number of OEMs are focusing on their core business and hiring a contract manufacturer (CM) to create the finished device from top to bottom, handling the entire process from prototyping to production.
These medical device companies are engaging with manufacturers who offer end-to-end solutions, or “one-stop shopping.” While many companies claim to offer this suite of services, true end-to-end providers offer all the development, manufacturing, and packaging services necessary to get medical devices and components to market. Once a solid relationship is established between the OEM and an end-to-end contract manufacturer, it should be a smooth transition to accommodate evolving needs.
As a result, selecting the right contract manufacturing partner is a critical decision, but considering the following questions prior to engaging in the process can help clarify the options and ensure a true end-to-end solutions provider is chosen.
1. Refining a Product Design
The OEM’s in-house team has developed a medical device that’s going to enhance people’s lives. Now—during the design stage—is the best time to address the challenge of making it efficient to manufacture.
Design for Manufacturability and Assembly (DFMA) reduces cost, increases quality, and shortens the development cycle of a medical device. A contract manufacturer well-versed in DFMA will assess different approaches and discover the best solution for the product. In order to do this well, they must have deep experience with all the technologies involved in manufacturing the device. The CM should also be able to handle all of the qualifications and validations.
2. There Every Step of the Way
Getting a new product to market involves many phases, starting with refining the design, then progressing to prototyping and pilot production. Does the CM have skilled people and equipment dedicated to product development? When the device is ready for full-scale production, it’s likely going to need further work at the other end, such as assembly, labeling, and packaging. It’s much simpler for the OEM if a single partner can handle every step, especially if it’s in-house. It also becomes more likely the devices will get to market quickly and cost-effectively, with consistently high quality.
3. Broad Range of Capabilities
From the sharp metal tip to the ergonomic plastic handle, a device may require numerous machines in order to be completed. OEMs need a single manufacturing partner that offers all the required manufacturing methods—milling, machining, grinding, molding, laser processing, EDM, etc. Remember, however, that it’s not just what machines the CM has in-house; it’s about what expertise they have. Anyone can buy machines. If the “business end” of a device is sharp metal, ensure one of the manufacturer’s core competencies is in making the most important part.
When a contract manufacturer offers a wide variety of capabilities, it not only means they can produce the current project, but demonstrates it has flexibility to make different types of devices in the future.
4. Efficiency Expert
A device won’t make any money until it gets to market. The right partner knows how to refine a design to maximize efficiency and cost-effectiveness during the production process. Even slight tweaks to manufacturing can make a significant difference during large production runs. Does the CM offer efficient manufacturing processes that include features such as robots and automated cleaning systems? These can simplify and streamline production while reducing costs.
If a device project requires a truly specialized service, ensure the manufacturer has established partnerships with the suppliers offering them, keeping the experience efficient and seamless.
5. Device Handle
A medical device is more than just its “business end,” whether that feature is intended for injecting, poking, or cutting. Most likely, it has a handle as well, the design and function of which is very important to the person gripping it in an operating room. Does the CM manufacture the entire device, and do they ensure every inch of it is made with the utmost care and quality?
For the best of both worlds, seek a partner with deep experience in manufacturing the most complicated part of the device—the “business end”—coupled with the ability to make the handle and all other aspects.
6. Reputation for Quality
Substandard quality is intolerable, so choose a partner that implements robust quality procedures and cGMP practices. Some practices to inquire about include ISO and U.S. Food and Drug Administration compliance; examination of first-pass yields; use of real-time statistical process control; use of lean manufacturing/Six Sigma tools; use of Black Belt-certified engineers; and validation of special processes to ensure repeatability, minimize inspection time, and reduce cost.
7. Sharpness of Point
It’s critically important that many devices—such as needles, trocars, cannulas, guide wires, scalpels, and tissue and bone cutters—are extremely sharp. If the device must be sharp, ensure the CM is extremely careful to maintain the necessary sharpness. Some companies aren’t as careful as others at keeping a device sharp all the way through the manufacturing process, particularly during insert molding. But if working with metal is the CM’s core competency, it’s likely their processes have evolved in ways that preserve sharpness at every step.
8. Sharpness of People
Sharp people are important too. This is the team that’s entrusted with an OEM’s most valuable assets. Do Black Belt-certified engineers make up a portion of the team? Does the team understand the medtech industry and all its pressures? Does it have the expertise to take a great design and further improve it so it can be manufactured efficiently? Is it a dedicated, experienced production team with the latest skills in advanced manufacturing?
Equally important is the investment the CM makes in its people. Is it training staff to handle new and emerging advances in medical technology? Is it encouraging the brightest students and recent graduates to join the company through internship and apprentice programs? Also, is the CM investing in the happiness of its employees through on-site programs and events?
9. A Partner to the OEM
A contract manufacturer is doing more than just making an OEM’s products. It is a guardian of the medical device company’s reputation for quality. It is a partner that sticks with an OEM when all it has is an emerging product idea that needs serious refinement before it can be produced. The CM should be responding to the urgent need to get a product to market rapidly. It’s adapting technology, providing manufacturing capacity, and shifting resources to meet the special requirements of an OEM. While the CM should respect the knowledge the OEM has of its own customers, it should similarly engender that OEM’s respect of its own manufacturing expertise.
The right CM partner will offer the mix of capabilities, expertise, quality, and customer dedication necessary for a medical device project while providing the necessary support to the OEM when most needed.
Mike Treleaven is vice president at Tegra Medical, overseeing the company’s GENESIS Tech Center prototyping and product development activities. He has over 30 years of medical device manufacturing experience.
