Todd Owens, Vice President of Engineering, Donatelle07.19.22
The events of the past few years have thrust the medical device industry into new actions to address challenges surrounding legacy programs. With global supply chains disrupted, skilled workers fragmented and harder to secure, further tightening of regulatory requirements, and a continual uptick of business acquisitions, many original equipment manufacturers (OEMs) are looking for ways to fine-tune their product programs to optimize resources and meet market demands. As a result, more now than in the past, OEMs are initiating programs to transfer business from their existing contract manufacturing (CM) supply chains to a condensed, preferred base that offers more stability and reliability.
Transferring programs can offer a variety of advantages—including with regard to streamlining resources as well as aggregating buys for more purchasing weight. There are several challenges with this approach, however, that differ from developing a new product. The following provides an overview of key considerations for transferring legacy work from one CM to another.
Equipment—The equipment used for manufacturing often varies from CM to CM with regard to type, size, specification, and capabilities. For example, an injection molding press used to mold an OEM’s thermoplastic component at an incumbent CM may differ from the press an alternate CM intends to use to mold the same component once transferred. As a result, the equipment differences could include controls, shot size and capacity, press clamp tonnage, whether mechanics are driven electrically or hydraulically, etc.
Generally, since equipment between CMs differs, mirroring process settings is often not feasible. Therefore, process settings and outputs need to be redeveloped in order to produce an identical finished product. As such, timing should be budgeted for these activities as part of the transfer. Additionally, the OEM and new CM should discuss and mutually agree on a high level of confidence that redevelopment and revalidation of processes on different equipment can yield equivalent results to those previously produced or develop mitigation contingencies if concerns exist.
Product quality and process validation expectations—During a transfer, as the new CM develops and qualifies the product at its manufacturing facility, it is beneficial to establish a baseline to verify equivalency to the legacy product, such as by providing the new CM with historical production lot-to-lot dimensional performance on critical features. It also helps build confidence in the anticipated success of the transfer.
For example, if a transfer product has historical data collected for critical dimensional features (data collected and archived by the incumbent CM or OEM) that has statistical capability performance greater than 1.33 Ppk, this can be very helpful in building confidence that when transferred, a high level of performance is likely achievable. However, if historical data suggests statistically low performance, this should be understood, and a mitigation plan established and agreed upon to address that lower performance prior to transferring the product. This will help mitigate unplanned delays or lengthy remediation activities.
In situations where historical data is not available, such as for non-critical, unmonitored features, then a first article baseline should be established from a sampling of the legacy production product prior to transfer. During the transfer process, it is not uncommon for OEMs and recipient CMs to discover marginally compliant or out-of-specification features during the redevelopment/revalidation of processes. Without taking precautions to anticipate and mitigate the potential of such situations, OEMs risk significant transfer scope changes and timeline delays.
Attribute requirements—These may be more subjective in nature than finite dimensioned features with specific tolerances. Examples of this could be loosely defined specifications surrounding color, surface imperfections, product cleanliness, fits with mating parts, etc. Early in the transfer process, the OEM and new CM should review existing product samples to bounce observations off of controlled product specifications and quality control documentation. This process will help ensure no inconsistencies exist and verify the accept/reject criteria along with the inspection method (e.g., distance, time, lighting, etc.) to avoid any downstream ambiguity leading to potential delays.
Process validation—Validation requirements and methodologies for OEMs and CMs have evolved and improved over the past several years to increase product safety and reliability. As a result, the legacy qualification approach used by the OEM and incumbent CM may need to be updated as part of the product transfer to meet current validation requirements. This should be evaluated and understood prior to the transfer, and mitigation should be put in place to address situations where current requirements for validation may exceed what was formally done. Statistical capability, confidence, and reliability sample sizes/acceptance criteria, normality of data, gage repeatability and reproducibility acceptance standards, etc., are examples of elements of validating transfer manufacturing processes where inconsistencies between past and current qualification methods could differ. If risks are anticipated to exist in passing today’s validation requirements, discuss how these items will be addressed prior to the transfer.
A detailed outline of all information desired is a good place to start the process of collecting important details to aid in the transition. CMs with extensive experience in transferring programs into their organizations often have controlled processes within their quality management system specifically designed to accommodate and aid in the transfer process, since these programs differ in flow and content from the development of processes for new products.
Most transfer programs contain gaps between the information needed and what is available at the time of transfer. This is not uncommon and to be expected. While information gaps often aren’t typically show stoppers, they do require careful consideration as assumptions generally need to be made until tangible baselines can be established with the new CM.
It is also a good idea going into a transfer to verify the accuracy of information when it becomes available. For example, verifying alignment among the physical product, 3D-part model, and 2D-part print to ensure they match may seem like wasted effort. Keep in mind, however, undocumented changes can occur to any one or all of these, particularly with older legacy products as they migrate through their lifecycle, which could create painful and unnecessary revisions in the future.
These compressed transfer timeframes don’t typically contain previously completed, longer lead-time elements, such as DFM design modifications, tooling development, design verification, etc. Although there is generally less overall work involved with a transfer project, not having the luxury of these longer lead-time steps artificially forces the decision- making, communication, and tactical execution that occurs through the project into a more compressed timeframe with less parallel activity flexibility.
For example, often during a new product development program, activities such as writing, evolving, and finalizing qualification/validation protocols between the OEM and CM occur in parallel with the design and build of the tooling to support the project. This allows team members adequate time to deliberate as they work to complete a task. With a transfer program, the longer lead-time tooling design/build phase of the project is already complete, so a finalized protocol needs to occur much sooner, requiring project resources to take action and make decisions faster.
Generally, transfer programs offer less flexibility to team members at both the OEM and new CM to balance activities for other work priorities they may be assigned that overlap with the transfer. Having resources strictly dedicated to a transfer program isn’t necessarily a must, however, ensuring team members both at the OEM and transfer CM are afforded the bandwidth to work to the timing at hand for transfer programs is important.
Todd Owens is vice president of engineering for Donatelle, where he leads the design, development, and validation of tooling and manufacturing processes for new products. During his 30-plus years, he has held a variety of engineering, program management, and leadership roles in the automotive and medical industries.
Transferring programs can offer a variety of advantages—including with regard to streamlining resources as well as aggregating buys for more purchasing weight. There are several challenges with this approach, however, that differ from developing a new product. The following provides an overview of key considerations for transferring legacy work from one CM to another.
Consideration 1: Keeping the Supply Chain Supplied
Transfer programs generally involve legacy products with an in-motion supply chain that should not be interrupted as it moves from one CM and is qualified at another. Some information can be shared to allow transfer activities to take place in parallel while continuing to manufacture product and support the supply chain at the incumbent. The OEM can provide items such as work instructions, designs, specifications, quality plans, bills of materials, etc., to the new CM without disrupting the supply chain. The physical assets necessary to manufacture the product (e.g., molds, fixtures, tooling, manufacturing aids, product-specific equipment, etc.), however, are often one-of-a-kind and, once transferred, render the previous supply chain incapable of manufacturing additional product. OEMs and CMs need to be cognizant of this and implement thorough plans, including accurate timelines with built-in contingencies (such as safety stock) to ensure all transfer activities are completed prior to the depletion of inventory from the former CM.Consideration 2: Accounting for Variations
Although physical assets like tooling, fixtures, manufacturing aids, etc., are moved as a function of a manufacturing location transfer, often the incumbent CM owns the capital equipment used to manufacture the product, and, as a result, does not transfer it. As such, there are several important considerations to address potential variations in the product production quality. These include:Equipment—The equipment used for manufacturing often varies from CM to CM with regard to type, size, specification, and capabilities. For example, an injection molding press used to mold an OEM’s thermoplastic component at an incumbent CM may differ from the press an alternate CM intends to use to mold the same component once transferred. As a result, the equipment differences could include controls, shot size and capacity, press clamp tonnage, whether mechanics are driven electrically or hydraulically, etc.
Generally, since equipment between CMs differs, mirroring process settings is often not feasible. Therefore, process settings and outputs need to be redeveloped in order to produce an identical finished product. As such, timing should be budgeted for these activities as part of the transfer. Additionally, the OEM and new CM should discuss and mutually agree on a high level of confidence that redevelopment and revalidation of processes on different equipment can yield equivalent results to those previously produced or develop mitigation contingencies if concerns exist.
Product quality and process validation expectations—During a transfer, as the new CM develops and qualifies the product at its manufacturing facility, it is beneficial to establish a baseline to verify equivalency to the legacy product, such as by providing the new CM with historical production lot-to-lot dimensional performance on critical features. It also helps build confidence in the anticipated success of the transfer.
For example, if a transfer product has historical data collected for critical dimensional features (data collected and archived by the incumbent CM or OEM) that has statistical capability performance greater than 1.33 Ppk, this can be very helpful in building confidence that when transferred, a high level of performance is likely achievable. However, if historical data suggests statistically low performance, this should be understood, and a mitigation plan established and agreed upon to address that lower performance prior to transferring the product. This will help mitigate unplanned delays or lengthy remediation activities.
In situations where historical data is not available, such as for non-critical, unmonitored features, then a first article baseline should be established from a sampling of the legacy production product prior to transfer. During the transfer process, it is not uncommon for OEMs and recipient CMs to discover marginally compliant or out-of-specification features during the redevelopment/revalidation of processes. Without taking precautions to anticipate and mitigate the potential of such situations, OEMs risk significant transfer scope changes and timeline delays.
Attribute requirements—These may be more subjective in nature than finite dimensioned features with specific tolerances. Examples of this could be loosely defined specifications surrounding color, surface imperfections, product cleanliness, fits with mating parts, etc. Early in the transfer process, the OEM and new CM should review existing product samples to bounce observations off of controlled product specifications and quality control documentation. This process will help ensure no inconsistencies exist and verify the accept/reject criteria along with the inspection method (e.g., distance, time, lighting, etc.) to avoid any downstream ambiguity leading to potential delays.
Process validation—Validation requirements and methodologies for OEMs and CMs have evolved and improved over the past several years to increase product safety and reliability. As a result, the legacy qualification approach used by the OEM and incumbent CM may need to be updated as part of the product transfer to meet current validation requirements. This should be evaluated and understood prior to the transfer, and mitigation should be put in place to address situations where current requirements for validation may exceed what was formally done. Statistical capability, confidence, and reliability sample sizes/acceptance criteria, normality of data, gage repeatability and reproducibility acceptance standards, etc., are examples of elements of validating transfer manufacturing processes where inconsistencies between past and current qualification methods could differ. If risks are anticipated to exist in passing today’s validation requirements, discuss how these items will be addressed prior to the transfer.
Consideration 3: Addressing Information Gaps and Inaccuracies
Moving from a CM with years of intimate understanding and experience in manufacturing a product to a CM with no historical background with that product can present challenges surrounding loss of institutional knowledge. Collection and organization of as much information as is available in advance of the transfer is an effective step toward shortening the learning curve for the new CM. In many cases, information pertaining to the tooling/fixturing (e.g., condition, 2D/3D designs, spare components, maintenance/repair history, etc.), historical quality records, resource needs for manufacturing, qualification protocols and reports, purchased material/outsourced supply bases, PM plans, etc., can provide valuable insight and potentially avoid costly or time-consuming activities downstream during the transfer or once production starts.A detailed outline of all information desired is a good place to start the process of collecting important details to aid in the transition. CMs with extensive experience in transferring programs into their organizations often have controlled processes within their quality management system specifically designed to accommodate and aid in the transfer process, since these programs differ in flow and content from the development of processes for new products.
Most transfer programs contain gaps between the information needed and what is available at the time of transfer. This is not uncommon and to be expected. While information gaps often aren’t typically show stoppers, they do require careful consideration as assumptions generally need to be made until tangible baselines can be established with the new CM.
It is also a good idea going into a transfer to verify the accuracy of information when it becomes available. For example, verifying alignment among the physical product, 3D-part model, and 2D-part print to ensure they match may seem like wasted effort. Keep in mind, however, undocumented changes can occur to any one or all of these, particularly with older legacy products as they migrate through their lifecycle, which could create painful and unnecessary revisions in the future.
Consideration 4: Resourcing the Transition
Transfer project timelines are often much shorter than new product development timelines—typically weeks to months vs. months to years. Once the incumbent CM is relieved of their manufacturing duties and everything is transferred to the new CM, the supply chain starts running off of a finite amount of safety inventory intended to bridge the time gap during the transfer to keep the distribution of product moving forward until the new CM can get the processes developed and re-qualified, and begin manufacturing the product.These compressed transfer timeframes don’t typically contain previously completed, longer lead-time elements, such as DFM design modifications, tooling development, design verification, etc. Although there is generally less overall work involved with a transfer project, not having the luxury of these longer lead-time steps artificially forces the decision- making, communication, and tactical execution that occurs through the project into a more compressed timeframe with less parallel activity flexibility.
For example, often during a new product development program, activities such as writing, evolving, and finalizing qualification/validation protocols between the OEM and CM occur in parallel with the design and build of the tooling to support the project. This allows team members adequate time to deliberate as they work to complete a task. With a transfer program, the longer lead-time tooling design/build phase of the project is already complete, so a finalized protocol needs to occur much sooner, requiring project resources to take action and make decisions faster.
Generally, transfer programs offer less flexibility to team members at both the OEM and new CM to balance activities for other work priorities they may be assigned that overlap with the transfer. Having resources strictly dedicated to a transfer program isn’t necessarily a must, however, ensuring team members both at the OEM and transfer CM are afforded the bandwidth to work to the timing at hand for transfer programs is important.
Todd Owens is vice president of engineering for Donatelle, where he leads the design, development, and validation of tooling and manufacturing processes for new products. During his 30-plus years, he has held a variety of engineering, program management, and leadership roles in the automotive and medical industries.
