Medtech Compliance Training: Does Online Education Work?Medtech Compliance Training: Does Online Education Work?

Scott Hewett

August 16, 2012

4 Min Read
MDDI logo in a gray background | MDDI

It wasn’t so long ago that many of us mocked the validity of an online education. Often this form of higher learning was dismissed as merely ‘mail order degrees’ that inferred an almost tabloid inferiority by comparison to real educations earned, of course, by attending college. That stigma is wearing thin now. Just have a look at the market caps of businesses like the University of Phoenix’s at $3.6 billion or Kaplan University’s (a division of the Washington Post) at $2.5 billion. These companies are proving that online education works on a global scale. For educating all ages, see Salmon Kahn’s Khan Academy, which offers more that 3000 free video courses on an overwhelming list of topics. Khan, who left a cushy hedge fund gig to devote himself entirely to this cause, gave this year’s commencement speech at MIT and has now attracted generous support from the Bill & Melinda Gates Foundation.

computer.jpgThe medical device industry recognizes that its audience, comprised mostly of physicians (customers) and engineers (employees), also needs educational content. And many business owners are looking to employ the convenience of online delivery. Instead of incurring costly travel expenses for a group to meet in a central location, many companies now opt to conduct product training online. This trend has created a cottage industry of sophisticated learning management systems (LMSs) that are deployed to, among other things, administer training centrally.

What to Look For in a Training Program

Top LMS firms include SABA or SAP’s Success Factors formerly known as Plateau, are popular among larger OEMs who have formalized training within their human resources or corporate training departments. They use course curriculum, known in e-learning as Sharable Content Object Reference (SCORM) compliant. SCORM provides administrators with easy LMS Integration for simple, convenient prescription to students.

Online delivery is also beneficial for OEMs whose managers are required to receive regular compliance training on global regulatory, clinical, reimbursement, and QA topics. As part of compliance audits, FDA regulators can choose to check the training backgrounds of everyone involved with any device under investigation. As a result, OEMs in good standing can retain their culture of compliance by providing their management with online educational courses that are self-paced, and thus conveniently amenable to their busy schedules.

Compliance-related training online has become a sensible outsource solution for many. Unlike an OEM’s product-specific application instruction, it’s cost-effective to utilize packaged compliance courses. Key educators include:

  • World Medical Device Org offers more than 150 online courses on global clinical, QA, regulatory, and other topics throughout the entire life cycle for medical devices. Globally-located subject matter experts provide. All course content is SCORM compliant. WMDO clients without LMSs have access to free cloud-based administration tools. Premium account holders gain access to SME’s for additional course questions.

  • The US Food & Drug Administration (FDA) offers workshops and conferences for medical device education. Online regulatory courses are also available via FDA’s partnership with Eduneering, div of UL.

  • The Regulatory Affairs Professional Society (RAPS) is a global organization specializing in regulatory training. Though their Online University and Certification (regional) events, they offer a comprehensive education in worldwide regulatory affairs. RAPS national conferences are held annually (2012 Seattle and 2013 Boston).

  • Eduneering provides the online regulatory training, documentation, and serves as the virtual university for FDA’s Office of Regulatory Affairs (ORA).

  • For QA topics, see the American Society for Quality. All educators should be accountable for their bodies of knowledge (BOK), so look for high quality instructional design, current regulatory knowledge, independent peer reviews, and accreditation where possible.

Accreditation

Educators meeting ISO 9001 will often seek accreditation according to ISO 17024 (competency validation, typically described as “the demonstrated ability to apply knowledge, skills and attributes). Commercially available course and program accreditations can be investigated through the Institute of Credentialing Excellence (ICE) along with the accreditation body, the National Commission for Certifying Agencies (NCCA). Educators fulfilling the requirements of the NCCA standards can maintain compliance via recertification (due in five years). In Europe, the Swiss Accreditation Service (SAS) examines and accredits conformity in a similar fashion.

Organizations and individuals seeking compliance courses can also follow industry organizations like the LSA (Lifescience Alley) and MDMA (Medical Device Manufacturers Association US) and for physicians, SoPE (for Physician-Surgeon entrepreneurs) via Twitter, Linked In groups, and other medical device online communities. Lastly, check for peer reviews, often available through course publishers, for candid consumer assessments of individual course content.

+++++++++++

Scott Hewett is an account manager at WMDO. Contact him at [email protected]

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like