Developing High-Performing Leaders For The Medical Device Industry

What’s the fastest and most effective way to develop high-performing leaders? This is a pressing concern today, as the hundreds of books on business leadership, personal development, and mentoring attest. For the medical device industry, it’s even more critical, because leadership performance and quality impacts the health and survival of patients, as well as the businesses itself and healthcare providers.

Xavier University responded to this challenge by creating a Certificate of Graduate Study for medical device industry professionals, designed to take their performance and leadership skills to a higher level. The effectiveness of the 10-month course stems from the process Xavier University used to establish conferences and programs that improve global health.

In 2009, Xavier University took an active interest in creating a nurturing environment for industry quality and performance improvements, culminating in the creation of Xavier Health Initiatives. The objective was to foster education, collaboration and innovation among organizations that manufacture, distribute, or provide regulatory oversight to the drug and device industries. One widely recognized result of these initiatives is the MedCon Conference, which Xavier Health hosts each May.

Creating a vital network of industry experts and regulatory officials in support of the MedCon Conference has given Xavier Health a wealth of insights on the issues affecting the industry. It also has provided an invaluable resource for determining which methods, processes, and actions provide the most efficient results.

The Key Criteria For Successful Results

Xavier Health drew on the experience and insights of industry leaders, regulatory officials, business consultants, high-performing professionals, academics, and students to develop the structure and content of the “Medical Device Leadership Certificate for Patient Health and Business Success.” This collaborative effort resulted in practical solutions to common obstacles that medical device professionals face in acquiring new skills for leading performance, both in their workplaces and in the industry.

The following criteria for success can be applied to any personal leadership development effort, but they especially address the needs of professionals in the medical device industry.


General leadership development programs may offer insights to medical device professionals, but they place more of a burden on the individual, and rarely target the strategic priorities of the organization. Similar to the MedCon Conference, the medical device Certificate of Graduate Study program focuses on the top strategic priorities of the FDA. Many of these involve current and evolving quality issues throughout the supply chain, from suppliers and manufacturers to the ultimate end user, the patient.


The course further capitalizes on its industry-focused structure with a strong element of personalization. For example, at the beginning of the course, participants undergo a thorough self-assessment, involving management, peers, and direct reports. This information plays a vital role in the professional one-on-one coaching that takes place later in the course.

Industry-Wide Expertise

Professionals often attempt to improve their skill sets through mentoring. While this can enhance performance and leadership within an organization, it limits the scope of knowledge shared. Xavier Health’s course offers a broader industry perspective. Developed by industry leaders and regulatory officials, the curriculum focuses on critical skill sets and the practical application of proven business models. Participants also benefit from online classes taught by top FDA and industry leaders, one-on-one coaching, and facilitated collaborative learning. 

How-To Models

Skill development initiatives fail when there’s no clear path to implementation. People need direction and guidelines on how to achieve targeted goals. A major portion of the course focuses on proven processes, tools, and industry best practices that lead to successful results.

One example is the Total Product Life Cycle (TPLC) roadmap. The course uses a detailed case study to help participants consider technical, regulatory, and leadership essentials. The case study also clarifies the application and benefits of the Stage Gate Model for ensuring product quality, as well as personal leadership through the design and development, operations, and on-market (post launch) stages.

Flexibility - Timing

Work and family responsibilities create time constraints that frequently keep professionals from taking advantage of educational or personal development opportunities. The Certificate of Graduate Study course offers substantial flexibility to accommodate people’s schedules. With most of the course work available online and on-demand, students typically meet the requirements in approximately 4 to 5 hours a month. During the fourth and tenth months, students visit the Xavier campus for 2 days for one-on-one coaching and interactive sessions with other participants.

Plan Of Action

One of the most valuable and appreciated components of the course includes a personalized plan of action. Developed in conjunction with professional coaching assistance, the plan ensures that participants will achieve specific results by the close of the course with viable implementations. In addition, these targeted actions, along with the course concepts and resources, provide ongoing benefits to participants, their organizations, the industry, and patients.


Every personal development program should undergo a careful cost-benefit analysis to determine its value, considering both tangible and intangible benefits. The Certificate of Graduate Study provides immediate results, yet it also covers critical areas that establish the foundation for highly effective leadership. These include:

  • Improved FDA relations
  • Effective decision-making
  • Responsive leadership
  • TPLC competence
  • Stakeholder analysis.

The in-depth nature of the program and its ability to deliver results for high performers in a short span of time justifies the $8,000 tuition for many leading organizations. Cecilia Kimberlin of Kimberlin Consulting (formerly VP, Abbott Regulatory, Medical Strategic Affairs) offers this assessment: “With a unique personalized focus, this program isn’t just a body of knowledge, it transforms high performers in a way that would take years to gain otherwise.”

Among the recent program graduates are quality assurance and inspection readiness professionals from Abbott, Johnson & Johnson, Baxter, and Procter & Gamble, as well as an FDA investigator.

Xavier Health offers a bonus resource to support learning through its QARA Institute. For $2,000, enrollees have unlimited access to 35 webinars involving FDA faculty and industry experts and covering important medical device topics, such as design controls, regulatory submissions, postmarket surveillance, and medical device reporting. 

In keeping with the exclusive nature of the course, enrollment is limited to 18 students, twice a year. It’s targeted to high-performing individuals with a minimum of 3 years’ experience in the medical device industry and some level of TPLC competency. The next cadre begins in late January 2016. For further details, or for enrollment information, please visit or contact Program Manager Mason Rick at