According to a 2012 report released by Axendia, an analyst and strategic advisory firm, controlling product quality (raw materials or services provided) and maintaining consistent quality standards are the top issues that keep device executives up at night.1
As every medical device executive knows,

QUALITY MATTERS!

Quality is not an option; Quality & compliance are requirements in medical device manufacturing. OEMs cannot outsource liability and regulatory compliance…and what you don’t know can hurt you.

The International Standards Organization (ISO) defines quality as “the totality of an entity’s characteristics in relation to their ability to satisfy stated and implied needs, including people, processes, product environments, standards, and learning.” 2
In medical device manufacturing, Quality encompasses every aspect of the day-to- day activities and decisions within a company, and it is based on the principle of continual improvement – the ongoing effort to enhance products, services, and processes through incremental and breakthrough improvements.

An experienced Contract Manufacturer with a robust Quality Management System can help mitigate Quality risk, “the propensity for product shipped from a given establishment to fail to perform as intended due to manufacturing-related issues”, and reduce the ‘Cost of Quality’ (COQ).
The ‘Cost of Quality’ is not the price of creating a quality product or service. It is the cost of not creating a quality product or service. In other words, it is the ‘Cost of Poor Quality’ (COQP). Any cost that would not have been expended if quality were perfect contributes to the ‘cost of quality’.

Each time work has to be redone, the cost of quality increases. Examples include:
Based on the survey, it is clear that “above all else, Medtech OEMs want Quality from their CMs.” 4

The good news for Medtech companies is they do not have to go it alone. By ‘smart sourcing’, focusing on value over cost, expanding insourcing efforts, and considering regionally sourced products from local markets, OEMs can benefit greatly from the skills and experience of a Contract Manufacturing partner with specific expertise in advanced technologies, product development, Quality and Regulatory compliance, and project management.1

An experienced manufacturing partner (CM) whose quality system, documentation processes, and controls meet stringent regulatory requirements can be a great asset to an OEM. On the other hand, an inexperienced or under qualified CM may prove a hindrance at best and a liability at worst.

To determine a potential CM’s ability to meet project requirements, Medtech OEMs should consider the following key questions regarding the experience and Quality of a Contract Manufacturer:

Are the supplier’s focus, experience, and capabilities specific to the medical industry and the development and manufacture of medical products?

The medical industry is highly regulated and subject to specific requirements not required by other industries. It can sometimes be confusing or difficult for a CM to effectively balance and apply the requirements of one industry to another.

Does the supplier have the core competencies and specific expertise required for the project’s success?

Reworking a manufactured item
Retesting an assembly
Rebuilding a tool
Correcting a document
Reworking a service, (i.e., the replacement of a unit.)3

A focused company needs to have complete confidence in its manufacturing partner’s ability to meet the highest levels of quality, control, and compliance.
age of stricter regulations and intense on patient safety, a medical device
In a recent survey, the majority of device professionals surveyed identified regulatory pressures as the most concerning issue they will face in the next 5 years. Regulatory hurdles can delay time to market which is a major issue for most device professionals. Reducing costs and accelerating time to market remain paramount concerns for OEMs.

For the majority of device manufacturers, partnering with a Contract Manufacturer provides a means for achieving their objectives.
The primary features OEMs look for in CM evaluation and prioritization include:

#1 Quality Control
#2 Technical Abilities
#3 Price
#4 Certification – FDA Registered
#5 Time to Market
#6 Medical Device Experience

Performing a complete review of the potential contract manufacturer’s systems is critical for ensuring the required core manufacturing and quality competencies are in place.

The OEM should consider the CM’s purchasing and supply chain management processes, including their MRP/ERP system and the production processes managed within the system. The CM should be purchasing from an Approved Supplier List (ASL) and be able to provide evidence of the approval process used to qualify each supplier. The CM should have a documented system in place to effectively and efficiently manage supplier corrective actions to prevent repeat nonconformance issues, including the documentation 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 CM uses approved written work instructions, inspection protocols, and test instructions, and if they provide the OEM access to the data produced from these processes. It is equally important to know if the CM’s Quality department qualifies all of their manufacturing processes, and can produce the documentation that supports process qualification.

Does the CM have a proven track record of successful projects, and evidence of their ability to create the documentation needed for the OEM’s FDA submission?

The OEM is responsible for the submission; however, it is important to ensure that the contract manufacturer has the proven experience to support the sections of the submission with the correct documentation.

Does the CM know the FDA’s Quality Systems Regulation (QSR)/Medical Device Good Manufacturing Practices?

The QSR provides medical device manufacturers a framework of basic requirements to use in establishing a quality management system appropriate to the device and the manufacturing process. The QSR is a guideline. Due to the broad range of medical devices, the FDA leaves it up to the manufacturer to use good judgment to design an effective quality system.

For that reason, it is critical that the CM has a good understanding and familiarity with the QSR in order to take the framework and create an effective manufacturing process to meet regulatory requirements and deliver a safe and effective device.

Does the CM have proven Quality and Regulatory experience?

It is critically important to know if the CM has established and maintains a robust Quality Management System, and has the expertise and proven track record in the manufacture of medical products. It is also important to know if the CM’s Quality department qualifies all of their manufacturing processes, and can produce the data that supports process qualification.

Is the CM ISO 13485 certified and 21 CFR 820 compliant?

ISO 13485 certification is not a requirement for medical OEMs or contract manufacturers. However, certification is a strong indication of a company’s commitment to establishing 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 to ensure the finished devices will be safe and effective and in compliance with the FDA. It includes the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.

Is the CM’s facility registered with the FDA?

In accordance with the Medical Device User Fee Amendments of 2012 (MDUFA III), signed into law on July 9, 2012, and pursuant to the Food and Drug Administration Safety and Innovation Act (FDASIA), all contract manufacturers of “finished devices” must register and list the devices they make, whether or not they put them into commercial distribution under their own names. 5

Does the CM know the risk-based classification system that determines a medical device’s regulatory pathway?

The Food, Drug, and Cosmetic Act established a classification system to categorize the risk level of a medical device. Each device is assigned one of three regulatory classes, based on the level of control necessary to provide reasonable assurance of its safety and effectiveness.
As device class increases from Class I, to Class II to Class III, the regulatory controls also increase.

The regulatory controls for each device class include:

Class I – (low to moderate risk): general controls
Class II – (moderate to high risk): general controls and special controls
Classes III – (high-risk): general controls and Premarket Approval (PMA)

Does the CM understand the design controls incorporated into the design and development process?

This system of checks and balances identifies deficiencies in design input and inconsistencies between the proposed design and production requirements. This increases the likelihood that discrepancies can be corrected earlier in the development process, avoiding costly rework and delays.

Does the CM maintain internal documentation programs that integrate with the OEM’s system?

Complete documentation is part of the service provided by the CM. A robust document management system that integrates seamlessly with the OEM’s system is essential for establishing and maintaining complete records and avoiding liability issues.
DUE DILIGENCE Checklist for Potential CM

Experienced MEDICAL Contract Manufacturer:
In-house Capabilities
Engineering
Document Control
Supply Chain Management
Proven Track Record
Robust Quality Management

System:
ISO 13485 Certified o FDA Registered
Proven Track Record
ISO Surveillance Audits
Client Audits

Production Quality activities are established, controlled, and maintained for all:
Materials
Components
Subassemblies
Released products
Supplier Quality Controls
Establish (define, document, and implement) effective supplier audit program
A focused audit to assess technical capabilities, capacity, and supply chain6
Quality Agreement (before all other materials) containing the following statement:
“The Supplier agrees to notify Client of all proposed changes prior to [Supplier] implementing the proposed change(s).”7

Manufacturing Agreement Conclusion
“The global medical device outsourcing market is expected to more than triple in value over the next decade, reaching nearly 120 billion by 2023.” 8

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 partners with an experienced, high quality, full-service medical contract manufacturer will have:
A stronger organization
More capabilities
Freedom to focus on the future
The confidence of knowing that their partner is working for their success
A much better night’s sleep!

References
1. Walking the Global Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization.” Axendia, Inc., June, 2012
2. ISO 8402
3. Cost of Quality Overview – ASQ http://asq.org/learn-about-quality/cost-of- quality/overview/overview.html
4. Medical Device Outsourcing Landscape Report, ITG Research & MD&DI, March 2013
5. Title 21 CFR, Part 807, published August 2, 2012
6. Using Audits to Improve Supplier Performance, Bob Mehta, Mddionline.com, March 2013
7. What’s Really Important in Supplier Quality Controls? MD&DI, June 20, 2013
8. Medical Device Contract Manufacturing: World Market Outlook 2013-2023, Visiongain Report – January 2013

All Contract Manufacturers are not created equal. At Inteprod, we don’t make toys, pens, or widgets. We make lifesaving and life changing Medical and Diagnostic Devices. We know Quality matters. More importantly, we know Quality! We have a proven and robust Quality Management System, extensive medical device and diagnostics experience, and we are absolutely committed to and capable of producing the highest Quality medical products.

Inteprod is a full-service Contract Manufacturer supporting Medical Technology and Life Sciences companies with innovative ‘finished product’ services that provide a strategic advantage in reduced costs and faster time to market. Inteprod is committed to excellence and innovation, and passionate about creating complex medical products that truly make a difference in people’s lives.

WHAT MAKES INTEPROD DIFFERENT?

“Inteprod sets a high standard of excellence and they have become the ‘yard stick’ that I measure other electromechanical contract manufacturers against.” Senior Program Manager, CR Bard

Management Experience and Expertise
CEO – 30+ years in medical product design and development, 60+ patents for Devices & Diagnostic Products
EVP, Manufacturing – 30+ years in Quality, manufacturing, & process development
Quality Assurance Manager – 14+ years in manufacturing and Quality operations
Engineering Program Manager – 30+ years in Quality, manufacturing, & process development
QUALITY Experience and Expertise
ISO 13485 Certified for the design, development & contract manufacture of electromechanical medical devices, medical diagnostics, and disposables
FDA Registered
DON’T LET QUALITY ISSUES KEEP YOU UP AT NIGHT!
If you are looking for an experienced, high Quality partner you can trust to get safe and effective medical products to market, we can help! Together we can move medical innovation forward and change lives worldwide.