MDDAP Introduces Strategy for Enhancing Medtech Appraisal Expertise

MDDAP is helping professionals excel in the medical device sector through a new learning pathway designed for the Voluntary Improvement Program (VIP). This initiative provides essential certifications leveraging the Medical Device Discovery Appraisal Program (MDDAP), equipping appraisers to grow in their careers, access new revenue opportunities, and contribute to continuous improvement efforts within the industry.

MDDAP is a tailored version of the CMMI framework and provides a model and method by which medical device manufactures can better understand, measure, and improve their capability to develop high quality devices. A specialized program developed in tandem with the U.S. Food and Drug Administration, the medical device industry, and the Medical Device Innovation Consortium (MDIC), VIP uses MDDAP as a key component to support medical device manufacturers.

The MDDAP certifications entail a mix of coursework, observations, and apprenticeships for aspiring MDDAP Appraisal Team Members (ATM) or MDDAP Appraisal Team Leads (ATL). MDDAP launched the ATL certification in late March by developing a new self-paced, eLearning course and observation process, thereby enabling medtech professionals to join the growing community of MDDAP appraisers.

“Through this new learning pathway, those earning an MDDAP certification not only have the potential to expand their business offerings, reach new clients, and become more skilled in their profession with new training, but also have the opportunity to contribute to the safety and efficacy of medical devices and patient outcomes,” said Kim Kaplan, ISACA principal product manager, MDDAP.

Becoming an MDDAP Appraisal Team Member

For aspiring MDDAP Appraisal Team Members (ATM)—individuals with the prerequisite experience and training to participate and support an appraisal of an organization against the MDDAP tailored view of the CMMI framework—the certification is valid for a three-year period upon completing the following steps.

1. After applying and then completing a program interview, prospective MDDAP ATMs must continue with two classes: the Building Organizational Capability course—a virtual, four-day introductory course—and the MDDAP Concepts eLearning course, which prepares learners to participate in an MDDAP appraisal.
2. After an ATM candidate completes a professional services agreement, he or she moves to the ATM observation stage, an in-the-field evaluation of candidates during which the applicant applies the knowledge he or she obtained during training.
3. Lastly, during the apprenticeship stage, individuals engage in on-the-job training with a coach over the course of one to four additional appraisals.
4. After becoming an MDDAP ATM, certified individuals can facilitate discussions, generate notes, and validate and obtain consensus around results.

Becoming an MDDAP Appraisal Team Lead

After earning their MDDAP ATM certification, interested individuals can pursue the MDDAP ATL certification, expanding the pool of professionals eligible to earn the credential.

1. After applying for the ATL certification, candidates participate in the Medical Device Discovery Appraisal Program (MDDAP) Appraisal Team Lead Training Course, which prepares them to lead an MDDAP appraisal. The course covers MDDAP appraisal quality and ethics, the roles and responsibilities of appraisal participants, ways to use the MDDAP Method Definition Document (M-MDD), details on using MDDAP appraisals to evaluate and improve business performance, and key aspects of the MDDAP appraisal approach.
2. Learners will complete this course feeling prepared to lead their first MDDAP appraisal and ready to schedule their ATL observation.
3. Following this observation, candidates are offered additional coaching through an apprenticeship stage to earn their ATL certification.

Individuals who complete the ATL certification can lead an appraisal of an organization against the MDDAP tailored view of the CMMI Framework, including scoping the effort level, setting objectives, creating a plan, schedule, logistics, resource management, and risk mitigation, and managing the appraisal team to support the effort.

Another path to the ATL is the MDDAP Appraisal Team Lead Bootcamp, which takes prospective ATLs on the full journey from Building Organizational Capability through Appraisal Team Lead Coaching in one year.

“Those who pursue this learning pathway have the opportunity to be on the ground floor of a growing and developing program,” ISACA Chief Operating Officer Simona Rollinson stated. “MDDAP certification holders will be able to work with some of the top medical device manufacturers around the world—helping these organizations build capability to save lives and produce higher quality products.”

MDDAP LLC is advancing quality and patient safety in the medical device industry through a tailored version of the globally recognized CMMI performance improvement framework. MDDAP empowers device makers to look beyond compliance and toward continuous improvement to elevate quality, drive innovation and increase performance. MDDAP is leveraged as the model and appraisal method in the Voluntary Improvement Program, part of FDA’s Case for Quality initiative.