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Achieving Success through Partnership
A strategic partnership with a qualified, fully vetted contract manufacturer is critical for OEMs seeking to bring new medical products to market.
Rick T. Smethers
As more and more medical device manufacturers seek to gain and maintain a competitive advantage, many are creating strategic partnerships with contract manufacturers. Robust, innovative solutions, quality and regulatory compliance, and complete FDA compliant documentation are critical in medical device development and essential requirements when selecting contract manufacturers. The safety, effectiveness, and overall success of a medical device are directly affected by the knowledge, experience, capabilities, and resources of the contract medical device manufacturer.
Full-service contract manufacturers with a proven track record, specialized expertise, extensive experience, and a well-developed supply chain can deliver substantial benefits to OEMs. Among these benefits are reduced costs and accelerated time to market, along with significant risk reduction and maximized return on investment.
To ensure the successful commercialization of medical products, medical OEMs must fully vet potential suppliers and carefully consider many factors before selecting a contract partner. First and foremost, an OEM should have confidence in the supplier's expertise, core capabilities, and total commitment to quality. The supplier's commitment to quality should go beyond ISO 13485:2003 certification and FDA compliant systems. Although compliance is essential, how the supplier identifies and implements continual improvement throughout its Quality System is also important to the development of a mature Quality System.
Are the supplier's focus, experience, and capabilities specific to the medical industry and the development and manufacture of medical products?
Does the supplier have the core competencies and specific expertise required for the project's success?
Can the supplier provide a proven track record of successful projects, and evidence of their ability to create the documentation needed for the OEM's FDA submission?
Does the supplier have proven Quality and Regulatory experience?
Is the supplier ISO 13485:2003 Certified and 21 CFR 820 Compliant?
Is the supplier's facility registered with the FDA?
When considering a potential contract manufacturer, the OEM should dedicate the necessary resources to perform an audit, and assess the basic requirements listed above. If the assessment of each of these capabilities is anything but "yes," it is important for the OEM to determine how many additional resources they will be required to provide in order to manage the project through its life cycle. If the resources are not available, the OEM should consider an alternate contract manufacturer.
It is imperative that the OEM is aware of the supplier's organizational structure. The OEM should fully understand the reporting and independence between the decision makers for delivery and quality activities. While both groups are working on behalf of the OEM, quality should always be the priority. The quality and regulatory group should have full control of product quality, and the full support of senior management.
Trust plays a major role in the developing and ongoing relationship between an OEM and its contract manufacturer. The ownership of intellectual property (IP) may become blurred for some contract companies when their developers make changes or additions to the OEM's technology. The OEM should have absolute confidence that the contract manufacturer will not attempt to lay claim to any derivatives of its IP. The OEM should also have confidence in the contract manufacturer's ability to control and maintain all confidential and proprietary information.
The Design Life Cycle Process
Successful medical product development starts with detailed product requirements (Governing Documents). In the design life cycle process, a phase-based or gate review approach ensures that all design requirements are understood and met, as the process moves from phase to phase, to make certain that a robust device that meets customer requirements is ready for commercialization. The phases include Governing Documents, Research, and Concept Feasibility; Concept Development; Product Design Layout; Product Design Comprehensive; and Documentation, Supply Chain Management. They also include Alpha Unit Build; Design Verification; Beta Unit Build; Design Validation; and Final Documentation, Pre-Production ReleaseGoverning Documents (design input), Design Verification, and Design Validation (design output) are the most critical phases. Typically, the OEM will be required to provide this information with its FDA submission. It is critical for the OEM to ensure that the contract supplier has a solid understanding and strict approach to creating the required documentation throughout the entire design life cycle, making the delivery of the documentation necessary for a device submission a mere formality.
When selecting a contract medical product developer, the OEM should ensure that the supplier is an "experienced medical device developer" and not simply a proficient product designer. As previously stated, documentation is critical in medical product development. If the contract developer does not specialize in the medical industry, its documentation package may be incomplete and/or inadequate for FDA compliance, placing the OEM at risk when the time comes to deliver the appropriate documentation. Some contract developers claim they design medical devices, in addition to designing products for the military, aerospace, industrial, and consumer sectors. It is extremely important to distinguish the depth of expertise and experience of these types of suppliers. The medical industry is subject to specific requirements not required by other industries; it can sometimes be confusing or difficult for a contract supplier to effectively balance and apply the requirements of one industry to another. In some cases, the OEM may not be able to meet the specific FDA requirements with the supplier's completed design, and may spend an excessive amount of time reviewing the supplier's work.
Additional key factors to consider when selecting a supplier should include the following: Does the supplier have the ability to manufacture your device? Do they have processes in place to include input from the engineering, quality, and production teams early in the design process, and continue to provide refined input as the life cycle moves forward? Also, does the supplier have the key disciplines required to manufacture your device in-house?
- A multi-disciplined product development team: software developers, industrial designers, electrical engineers, mechanical engineers, manufacturing engineers, and quality engineers
- Quality and Regulatory: quality assurance, quality inspection, quality engineering, quality audits, CAPA Program, document control, 510k submission assistance, and ISO 13485:2003 certification
- Manufacturing: clean assembly, warehousing, inventory control, shipping and receiving, and Lean and 5s disciplines
- Supply chain management: supplier qualification; purchasing and planning; life cycle management; and alternate sourcing
- Post-production support: repair/refurbish and upgrade services, custom packaging, logistics, and distribution
Designing for Manufacturability
Design for Manufacturability (DFM) proactively addresses product issues early in the design cycle. It allows designers a means for integrating specific manufacturing issues into the product's design to simplify the manufacturing process and maintain the product's high quality.
All contract medical product developers are not the same. Some developers will simply follow the OEM's design specifications with no regard to the manufacturing process, long-term functionality of the product, or overall cost. A supplier with proven medical product experience and a comprehensive understanding of the product's technology and requirements will be more likely to design a robust product that will be successfully commercialized.
The OEM should ask these questions in order to determine the supplier's ability to design their product for manufacturability: Does the supplier's product development team consider the manufacturing process when designing a product? Does the supplier's development team take into consideration the manufacturability, serviceability, maintainability, efficiency, and cost-effectiveness of the product from the beginning of the design life cycle? Are DFM audits performed throughout the design life cycle, or just before the manufacturing process begins?
Ideally, DFM audits are performed in the engineering stages of the design to determine the processes, special handling requirements, environmental requirements, and cost feasibility.
FDA Compliant Documentation
FDA compliant documentation is required in the development and manufacture of medical devices. Medical product design engineers spend approximately 40 minutes of every hour designing, and 20 minutes of every hour documenting the process. The Quality and Regulatory documentation requirements are not optional. These requirements must be met, and the documentation must be controlled and maintained. The OEM should ensure that the contract supplier has a proven track record and will provide this documentation as part of the project's deliverables.
At a minimum, the supplier should be capable of providing the following documented deliverables:
Design History File (DHF)--A compilation of records that describe the design history of a finished device. The DHF includes a collection of the actual documents generated in the product development (PD) process, or an index of documents and their storage location.
Device History Record (DHR)--A compilation of records containing the production history of a finished device. These records verify the evidence that the finished devices meet and are manufactured in accordance with the specifications in the Device Master Record.
Device Master Record (DMR)--A compilation of records containing the procedures and specifications for a finished device. These records are required for the procurement of materials and components, and the manufacture and evaluation of the device, and include the device specifications, manufacturing process specifications, Quality Assurance procedures and specifications, packaging and labeling specifications, and, if applicable, installation, maintenance, and servicing specifications.
510k Submission Assistance--A process used to demonstrate that the medical device is at least as safe and effective, or substantially equivalent, to a predicate device. The OEM is responsible for the submission; however, it is important to ensure that the contract supplier has the proven experience to support the sections of the submission with the correct documentation.
Design Change Control
All design changes should be documented in the Design History File (DHF), including the reason for the change and the appropriate approval signatures from both the supplier and the OEM. Design changes should be verified and validated, if necessary, before approval.
The supplier should have a system and processes in place to control and maintain all documentation provided by the OEM. New documentation should be logged, stamped with an "original" stamp and the date it is received, and routed to the appropriate department. Old documents should be stamped "Obsolete" and placed in an "Inactive" folder.
Revision control processes should be in place to maintain and control all documents and ensure that employees are working from the most up-to-date procedures and instructions at all times.
Uncompromised Quality and Regulatory Compliance
ISO 13485:2003 defines the internationally recognized standards for the design, development, production, and distribution of medical devices. It ensures conformity with specified quality requirements in the development of medical devices, and emphasizes the importance of compliance with Regulatory and Customer requirements, risk management, and maintaining effective processes for the safe and effective development and manufacture of medical devices.
While ISO 13485:2003 is not a requirement for medical OEMs or contract manufacturers, continued certification is a strong indicator of a company's commitment to creating and maintaining a strong Quality Management System, and mitigating and minimizing risks.
U.S. Regulation 21 CFR 820 relates to the FDA's Quality System Regulation and establishes the basic requirements applicable to manufacturers of finished medical devices. Knowledge of and experience with current Good Manufacturing Practice (cGMP) requirements are essential for the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements are intended to ensure that finished devices will be safe and effective and in compliance with the FDA.
Quality Assurance begins with Document Control. Full traceability must be maintained throughout the product's life cycle. The OEM should ensure that the supplier has processes and procedures in place to control and maintain all documents. The following questions should be considered:
Are processes in place for controlling nonconforming materials?
Does the supplier provide continuous employee training utilizing current, controlled documentation?
Are all design phases documented in a complete Design History File?
When transferring a design to manufacturing, the supplier must provide a Device Master Record identifying all procedures, drawings, tests, inspections, and fixtures required for repeated manufacturing.
In manufacturing, a Device History Record is created for each device or lot to identify assembly and Quality Assurance personnel, procedures, and evidence of acceptance and labeling, and maintain traceability to raw materials.
Manufacturing Infrastructure and Capacity
Performing a comprehensive review of the potential contract manufacturer's systems is critical to ensure that the required core manufacturing and quality competencies are met. It is important to know the supplier's production capabilities, and if they are capable of handling the projected production volume. Many large contract manufacturers specialize in high volume/low mix products and have little interest in low volume/high mix products. While production capacity is important, the supporting functions are equally significant.
The OEM should consider the supplier's purchasing and supply chain management processes, including the MRP/ERP system used by the supplier, and the production processes managed within that system. The supplier should be purchasing from an approved supplier list (ASL) and be able to show evidence of the approval process used to qualify each supplier. The OEM should ensure that the supplier has a documented system in place to effectively and efficiently manage supplier corrective actions to prevent repeat nonconformance issues, and provide the reports verifying the resolution of quality issues.
The OEM should also consider how the supplier's Quality system is implemented into the manufacturing system. It is important to know if the supplier utilizes approved written work instructions, inspection instructions, and test instructions, and if they provide the OEM access to the data produced from these operations. It is equally important to know if the supplier's Quality department qualifies all of their manufacturing processes, and can produce the data that supports process qualification.
When investigating a supplier's manufacturing system, it is imperative to know what processes are performed in-house and what processes are outsourced to a subcontractor. It is also important to know if the supplier is maintaining control over the subcontractor's processes, and if all the quality requirements for the product are disseminated to the subcontractor in writing.
Another important aspect for qualifying a contract manufacturer is their ability to store raw material under controlled environmental conditions, and maintain control of material lot codes and shelf life. Many medical devices have components that require specific storage conditions and control of specific lot information. The supplier must be capable of meeting the storage conditions and maintaining lot control throughout the entire manufacturing process.
Supplier or Trusted Long-Term Partner?
As medical OEMs seek new ways to reduce costs, adjust to greater government scrutiny, minimize risks, and keep pace with innovation and advancements in materials and technologies, they will continue to recognize the immediate benefits and long-term value of a contract manufacturer with the specialized knowledge and experience required to successfully design, develop, and manufacture their medical products. More and more, medical OEMs are looking for a reliable, responsive, and trusted partner with the proven experience and focused commitment to deliver robust, innovative, high quality solutions. An OEM that finds a competent and proficient supplier and treats them as a true partner will have a stronger organization, more capabilities, freedom to focus on the future, and the confidence of knowing that their partner is working for their success.
Rick T. Smethers is president and co-founder of Inteprod LLC, Eagleville, Pennsylvania.
Founded in 2004, Inteprod (www.inteprod.com) provides product design, development, and contract manufacturing services for the medical device, medical diagnostic, and food safety diagnostic industries. Its advanced capabilities are said to include handheld devices, point of care diagnostics, bedside diagnostics, lab-on-a-chip (LOC) technology, patient monitoring, analytical instruments, minimally invasive surgical instruments, and pathogen detection diagnostics.
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