By Kenneth A. Fine
A software engineer conducts a code inspection session with team members and other stakeholders. Peer review is a crucial element of the culture of quality for medical products.
At a Glance Enhancing regulatory compliance
Promoting vital knowledge
Every company has a "corporate culture," a unique personality that includes fundamental values, beliefs, ethics, and rules of behavior. Corporate cultures define such factors as whether it is a fun work environment, the hours that employees work per day, the dress code, how employees interact and work together, and more. In highly successful companies, the corporate culture is consistent with the goals and mission of the company.
Medical device companies present a unique challenge with respect to corporate culture. How does a medical device manufacturer embody the regulatory and quality requirements found in the FDA Quality System Regulation, European Union Medical Device Directive, and ISO 13485 quality management system into the corporate culture? Does it even matter?
There is a significant body of literature that suggests that successful companies develop a corporate culture that enhances their effectiveness. For example, "Corporate Culture and Organizational Effectiveness" by Daniel R. Denison analyzes the relationship between an organization's corporate culture and its financial effectiveness. Through case studies, it describes how leading companies, like Medtronic, support the culture and effectiveness model.
Regulations and Quality StandardsThe QS Regulation, in Title 21 Part 820 of the Code of Federal Regulations, is meant to ensure that medical devices are safe and effective for their intended use. The QS Regulation requires that manufacturers have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices that are to be commercially distributed in the United States.
The European Union directives, including Directive 93/42/EEC for general medical devices, Directive 90/385/EEC for active implantable medical devices, and Directive 98/79/EC for in-vitro diagnostic medical devices, must be fulfilled to allow a company free trade of medical devices in the EU member states. Under each of the directives, compliance to applicable "essential requirements" is mandatory for medical devices and is supported by testing based on harmonized standards. A fundamental aspect of meeting the requirements of the directives involves implementation of a suitable quality assurance system.
ISO 13485 is the harmonized quality standard for the medical device industry. The EU device directives implicitly require medical device companies to employ a quality system consistent with ISO 13485 or ISO 13488. Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485 or ISO 13488. In the U.S., the Quality System Regulation was based on the ISO 9001 and ISO 13485 quality system standards.
Management CommitmentHaving a quality system that complies with the domestic and international regulatory mandates does not imply that a company has a corporate culture that embraces the intent of the regulations. The FDA's publication "Medical Device Quality Systems Manual: A Small
Rigorous product testing against specified requirements using predefined plans and procedures should be commonplace in the medical product corporate culture. Above, an engineer prepares product for long-term life performance testing.
Similarly, ISO 13485:2003 places emphasis on the importance of management leadership and involvement in establishing a corporate culture that embodies the quality attributes required for medical device development and manufacture. Section five of the standard, which describes management requirements, goes to great lengths to define management's role in supporting quality; focusing on customers; establishing quality policy, plans, and objectives; and controlling the quality system.
To effectively create a corporate culture that embraces the Quality System regulations, management needs to constantly promote the importance of quality and the need to meet customer requirements. Management needs to effectively and repeatedly communicate the company's quality policy and practices. Management must clearly define responsibilities and authorities, and ensure that employees are empowered to implement the quality system on a regular basis. It is necessary to demonstrate that all employees are responsible and accountable for enacting the principles of the quality system on a daily basis. When the company benefits from its adherence to quality, it is important for the company's management to share in the rewards with the employees to reinforce the integration of the quality system into the corporate culture.
Training and EducationIn addition to management involvement and leadership, a company's employee training program and training materials help entrench quality compliance attributes of the QS regulation into the corporate culture. Constant reinforcement of GMP principles and readily available educational opportunities regarding domestic and international safety standards can provide a foundation of knowledge and understanding that helps embed essential elements of regulations and safety standards into the corporate culture. Reinforcing basic concepts such as proper methods to document work activities, making notation corrections with initials and dates, and following written procedures and standard operating procedures can instill basic desired behaviors into the corporate culture.
Ensuring that the company's employees are versed in the relevant standards also helps make domestic and international regulatory and quality standards part of the corporate culture. What often separates a company that excels in the medical device marketplace from one that merely participates is often the employees' understanding of the standards that are particular to the medical device industry. The relevant safety standards vary depending on the particular medical device a company makes. However, understanding the requirements and intent of safety standards such as EN 60601-1: "Medical Electrical Equipment - Part 1: General Requirements for Safety" or ISO 10993: "Biological Evaluation of Medical Devices" often means the difference between correctly designing a medical product from the start and spending multiple design and prototype iterations to successfully pass a compliance test. Companies with employees who readily know, for example, that standards for electrically generated alarms can be found in EN 475, or graphical symbols for use in the labeling of medical devices are defined in EN 980, or validation and control of medical device sterilization are defined in EN 550, EN 552, and EN 554 are less likely to make design errors that are costly to correct during the regulatory review process.
Another key tool for educating employees is the company's employee manual. Employee manuals contain significant information that communicates the corporate culture. In addition to defining basic company policies such as working hours, paid time off, and benefits, the employee manual can include corporate elements such as the company's goals, mission, quality policy, ethical standards, and guidelines for conduct. Generous references to fundamental principles of the medical device regulations and quality standards can further instill those principles into the corporate culture.
Working ConsistentlySuccessful regulatory approvals depend on providing evidence that the medical device is safe and effective for its intended use and that it will consistently perform to its specified requirements. Disciplined design and process controls, along with the associated procedures, records, and other documentation, are necessary elements in providing the required objective evidence to the regulatory bodies.
The QS regulation requires the manufacturer to maintain records that may include design history files, device master records, device history records, maintenance schedules and records, personnel training records, and more. Furthermore, the QS regulation and ISO 13485 require that procedures and processes must be documented and that documentation is controlled.
An integral part of working in a medical device company that differs from non-regulated commercial ventures is the degree to which work needs to be documented. Those who enter the medical device industry from commercial industry are often stunned by the amount of documentation required. Working in a consistent manner, according to clearly defined procedures, typically eases the burden of generating documentation and performing tasks within an organization. As such, consistency helps minimize errors. Providing templates, training tip tools and mentoring guidance helps promote the procedural and documentation requirements of the regulations and quality standards within the corporate culture.
Hiring the Right PeopleWhen hiring, in addition to finding individuals with specific skill sets, it helps to identify a particular type of person that will adapt to the corporate culture, regardless of job category. Attributes such as a positive attitude, propensity to perform well in a team environment, and a willingness to learn about global quality concepts help form the basis of employees who will shape the corporate culture.
Once the company is staffed with employees willing to embrace quality system concepts in their daily work, a powerful tool for further molding a corporate culture involves encouraging the employees to be more responsible and act and think like owners. Empowering and encouraging employees to use the tools found in the quality system, such as liberal use of the corrective and preventive action systems, reinforces those behaviors in the corporate culture.
Decorate in the Right DécorCorporate culture manifests itself in various ways. From the architecture and decor of the building to what people wear, the overall environment of the company is often readily apparent. Interjecting artwork, posters, or objects that provide daily reminders of how employees' actions affect patients' and clinicians' lives provides both an esteem impact, in which the employees understand how they are important to the organization, and a quality impact that demonstrates how employees' actions can have a profound impact on the lives of others. Together with posters and artwork that reinforce major quality system elements, the décor of the work environment can provide a positive bridge between the corporate culture and the practice of regulatory and quality standards.
ConclusionEngineers and companies that excel in the medical device industry ingrain the core requirements of QS regulations and medical device quality standards into their cultures and every day tasks. Establishing such a culture is a difficult endeavor. It requires a multifaceted effort that includes management leadership, training, hiring the right type of employees, communication, and vision. However, compared to companies that do not fully embrace regulatory and quality concepts in every day activities, the rewards include gaining significant advantage in terms of product quality, cost effectiveness, and time to market.
ONLINEFor additional information on the technologies and products discussed in this article, visit Proven Process Medical Devices at www.provenprocess.com. 
Kenneth A. Fine is president and co-founder of Proven Process Medical Devices, 141 Washington St., East Walpole, MA 02032, a contract development and manufacturer for the medical device industry. Previously, he served as manager of electrical and software engineering at Pfizer Infusaid Inc. Fine has over 24 years experience in the development, validation, and manufacture of Class II and critical Class III electro mechanical medical devices. He can be reached at 508-660-9045 or firstname.lastname@example.org .