Quality System Maturity Model for Medical Devices

Assessing quality system maturity models that could help medical device companies drive quality beyond compliance

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Posted by George Serafin, National Managing Director, Life Sciences & Healthcare on July 28, 2015.

Deloitte Advisory recently collaborated with the Medical Device Innovation Consortium (MDIC) to conduct research sponsored by the Food and Drug Administration (FDA) into quality system maturity models that other industries are using. MDIC is a public-private partnership collaborating on regulatory science to make patient access to new medical device technologies faster, safer, and more cost-efficient.

While there are already explicit regulations globally for medical devices and diagnostics, the industry does not yet have a widely recognized maturity model for quality management systems (QMS). The objective of this project was to recommend specific maturity model options that could be adopted by MDIC stakeholders, including medical device industry members and the FDA.1


Potential benefits of a quality system maturity model

Implementing a recognized maturity model across the medical device industry could produce a wide range of benefits:

  • Consistency: enable standardization of assessments and benchmarking of operations; promote a strong functional orientation that can be used to drive improvements.
  • Quality beyond compliance: promote the development of actionable strategies to improve operations and quality; encourage self-improvement and QMS sustainment.
  • Transparency: improve communication and streamline interactions with the FDA and other regulators.
  • Increased effectiveness at lower cost: working toward higher maturity levels can help improve capabilities, promote more effective processes and governance, and reduce variability that leads to increased cost of quality and rework.
  • Alignment: shift the quality focus so it aligns—rather than conflicts—with speed and cost objectives.
  • Business partnering: track and monitor progress and ROI to improve clarity and communication with executive stakeholders.
  • Predictability and flexibility: identify areas to improve, and predict/plan next steps to achieve goals, while maintaining flexibility to focus on shifting priorities.
  • Cultural change: promote culture improvement by holistically evaluating the QMS across people, processes, and technology with metrics that link to organizational and talent performance.

Capability Maturity Model Integration (CMMI)

The research pointed to CMMI as a model that warranted further consideration as the basis for developing a quality system maturity model for the medical device industry. CMMI was selected because it is:

  • Globally recognized across multiple industries
  • Well-established with demonstrated success over 20+ years
  • Governed and maintained by an independent authority that also performs the assessments
  • Well-defined and holistic in terms of people, processes, and technology
  • Flexible enough to accommodate companies of different sizes, organizational and geographic structures, and product portfolios
  • Easy to update with regulatory changes

The MDIC is now sponsoring a working group to adapt CMMI to the medical device industry, with the goal of conducting a pilot in the first quarter of 2016. For more information about the maturity model research, see the full report here.

MDIC Case for Quality Program

As part of its Case for Quality Program, MDIC is also sponsoring several other working groups.

Competency Development. This group is focused on improving device quality and patient safety by promoting programs where regulators, payers, providers, and industry professionals learn together in a collaborative environment. Its mission is to move beyond cost-containment and compliance to a broader definition of quality that aligns with stakeholder needs.

Device Product Quality Metrics. The goal of this group is to increase the assurance of product quality by collaborating on a multi-dimensional system of predictive evaluation throughout the pre-production, production and post-production phases—coordinated with increased visibility into comparative quality.

Advanced Analytics to Improve Medical Device Quality. This group is developing and piloting a process to provide information that customers can use when making decisions about which medical device has the highest quality and greatest value to the patient. The goals are improved access to quality medical devices and improved patient outcomes.

Learn more about the MDIC Case for Quality Program on their website: www.mdic.org/mdicx

All of these initiatives show there is significant energy and a strong spirit of collaboration among industry stakeholders and the FDA to shift the medical device sector’s focus from baseline regulatory compliance to a sustained emphasis on improved device quality and patient safety. It will be interesting to monitor the progress of these initiatives and identify a timeline when the industry—and more importantly patients—will begin to reap the benefits.

1 source: MDIC.org

George Serafin
Deloitte Advisory Director
Deloitte & Touche LLP

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