However, with all its strengths, the sector faces some serious weaknesses—especially when it comes to human talent. According to a skills gap study conducted by Deloitte Consulting LLP and the Manufacturing Institute, shortages and skills deficiencies in production roles (e.g., machinists, technicians, operators, etc.) are having a significant impact on manufacturers’ ability to expand operations or improve productivity.1
In addition to an insufficient supply of candidates with manufacturing-related skills, most medical device companies find it incredibly difficult to find skilled labor in the areas of quality, regulatory, research and development (R&D), and facilities. Each of these job categories tends to require specific skillsets and knowledge that are not developed in the current national education curriculum.
What’s more, candidates who do possess these skillsets but have gained them in other industries—such as aerospace or automotive—often are perceived as being unqualified for a related position at a medical device company because they lack specific medical device experience.
Another issue that arises due to a shortage of qualified labor is “pinching.” In some areas of the country where the medical device industry is clustered, some companies get so desperate for skilled labor that they consistently steal away (or “pinch”) employees back and forth between each other. Their main tactic is to offer more money to the worker, which ultimately drives up rates and creates a domino effect of additional problems.
Setting the Standard
To help the industry address its workforce supply deficiencies, the Obama Administration and the U.S. Department of Labor created the Medical Device Harmonization Initiative, a grant-based project that provides funding for the Community College Consortium for Biosciences Credentials (C3BC).2
Two main objectives of this initiative are to:
- Create a set of medical device industry standards for five functional areas: manufacturing, regulatory, quality, instrumentation, and engineering and R&D.
- Develop curriculum for a national network of community colleges that will elevate the skills and knowledge base of entry-level workers.
“That may sound rudimentary to some, but it’s actually quite difficult to find in candidates these days,” said Brian Sills, operations manager at Boston Scientific Corporation. “If applicants for entry-level manufacturing positions were able to take courses in these basic skills and receive a certificate that showed they successfully completed the classes, most medical device companies would feel like they’ve hit the jackpot. As long as they know the basic skills are there, most companies have the systems in place internally to teach them the specific manufacturing skills that they need to know.”
In addition to basic skills, additional certificates could be obtained in areas such as management systems, current good manufacturing practice, gowning and clean room protocol, and manufacturing and maintenance. Education that focuses on the competencies and capabilities most needed by the medical device industry will enable students to add more value to their employers. It also will reduce the amount of time and money that medical device companies need to spend training their new hires.
Coordinating the Curriculum
To establish the industry standards and develop a harmonized curriculum that will be universally recognized in community colleges across the country, the C3BC and its partners of medical device industry experts was assembled from various national organizations.
“Having both sides—the supplier and the user—at the table together, listening to each others’ requirements and expectations, makes the process of developing industry-relevant curriculum much more productive,” explained Russ Read, executive director for C3BC and an executive director at Forsyth Technical Community College in Winston-Salem, N.C. “Educators can often get stuck in their own unique paradigm when trying to create new curriculum. Through this collaborative process, the educators are hearing directly from the industry as to what skills and knowledge students need to attain in order to receive a certificate so that they can actually get hired by a medical device company. In terms of education, that’s a whole new way of thinking.”
In their curriculum development process, the consortium is focused on two types of students:
- Individuals who are entering the workforce for the first time; and
- Individuals whose skill set is no longer relevant in today’s job market and need to be “re-tooled” to meet the needs of growth industries.
The grant-based project will allow students to earn certificates that build upon other program elements in a pathway toward curriculum that meet industry needs. These certificate and program elements focus on one or more of the five functional areas: manufacturing, regulatory, quality, instrumentation, and engineering and R&D. In addition, students who want to pursue a more well-rounded education can “stack” their certificates and earn an associates degree.
“We think the stacking element is really important. Students need the flexibility and the opportunity to learn, grow and develop their skills and abilities,” said Read. “If, for example, they complete their basic skills certification and need to get a job right away, they might get hired for an entry-level manufacturing job. But if they want to work in a regulatory or quality position, they’ll need more advanced skillsets. Instead of getting passed up for those jobs because they don’t have the background or education, it’s important for that student to have the opportunity to go back to school and take additional courses or “stacks” at any community college in the country so that they can build on their foundational education.”
The C3BC Medical Device Harmonization Initiative also will provide greater opportunity for “non-cluster” states (i.e., states outside of Southern California, Massachusetts, Minnesota, the Eastern Pennsylvania/Northern New Jersey area, North Carolina and South Carolina).
A universally recognized and standardized curriculum means that community colleges in any state will be able to develop students with medical device-specific skills and knowledge. As a result, medical device companies will have access to a nationwide pool of qualified skilled labor, which would give them greater geographic flexibility over where they choose to headquarter or expand their operations.
“This new grant-based project managed by C3BC is something that medical device companies will be really excited about. For far too long there’s been a huge demand for labor, but not enough people with the required competencies to meet that demand,” said Sills. “The consortium is still in the early stages of ironing out all the details, but it’s clear to everyone involved that this initiative will be game-changing—not just for the medical device industry, but individual people, their families, their communities, educational institutions and healthcare in general. We’re all incredibly honored to be a part of such an innovative and value-added process.”
The process of determining the specific skills and knowledge that need to be included in the curriculum for each functional discipline began in October 2012 and is expected to be completed and rolled out in community colleges by September 2016.
- Boiling point? The skills gap in U.S. manufacturing. Deloitte Development LLC and The Manufacturing Institute. 2011. www.themanufacturinginstitute.org/~/media/A07730B2A798437D98501E798C2E13AA.ashx.
- Formally known as the Trade Adjustment Assistance Community College and Career Training grant program (TC-23761-12-60-A37) which is the funding mechanism for the Community College Consortium for Biosciences Credentials (C3BC). C3BC is made up of 12 community colleges including Forsyth Technical College and Ivy Tech Bloomington (Bloomington, Ind.)
Steve Sawin is president and CEO of Operon Resource Management, a Massachusetts-based staffing and on-boarding company of temporary labor for healthcare product manufacturers, including medical device and pharmaceutical companies. Sawin also serves as an advisory board member on the Medical Device Harmonization Initiative consortium.