 |
|
Upcoming Events
September 9th 2010 07:30 AM
- Successful Office Kaizen Events
September 9th 2010 08:00 AM
- Sup 1: Fundamentals of Leadership for Manufacturers - St Paul
September 9th 2010 09:00 AM
- Sup 2: The Next Stage for Improving Performance for Manufacturers-Plymouth
September 9th 2010 01:00 PM
- Sup 1: Fundamentals of Leadership for Manufacturing - Plymouth
September 14th 2010 08:00 AM
- Results-Driven Sales Incentives
September 14th 2010 08:00 AM
- Fraud and Misconduct at Investigator Sites
September 14th 2010 01:00 PM
- Failure Mode and Effects Analysis (FMEA)
September 21st 2010 08:00 AM
- Project Monitoring- The Earned Value Method
September 21st 2010 08:00 AM
- Project Monitoring: The Earned Value Method & Project Management
September 21st 2010 01:00 PM
- Project Management for Product Development
Article Index
The Clinical Research Associate's DegreeArticle by: Mike Schollmeyer In my previous column I presented my thoughts on the good attributes one would look for in a person applying for a Clinical Research Associate's (CRA) position. |
||
|
Medical Device Manufacturing and the Regulations Article by: Thomas Pepin The close out meeting: You have diligently accompanied the auditor and taken copious notes during the audit. |
||
|
Reimbursement and Its Role in Regulatory Strategies Article by: Jack Slovick Unlike the rest of America's economy, reimbursement is not a simple matter of supply and demand. |
||
ADVERTISEMENT
|
||
|
The Clinical Research Associate's Degree |
||
|
In my previous column I presented my thoughts on the good attributes one would look for in a person applying for a Clinical Research Associate's (CRA) position. Now, I'll share my thoughts on the type of educational program that would prepare an individual for a position in clinical reserch in the device industry. To my knowledge there is no Bachelor's Degree in Clinical Research. In 2000 the National Institutes of Health (NIH) invited educational and research institutions to apply for the "Clinical Research Curriculum Award." The NIH recognized the need for highly trained clinical researchers to support the developments and discoveries in research as they translate into the clinical setting. These programs, however, when awarded, are only open to post-graduate students and are master level programs. I am aware of two-year associate degrees offered at community colleges in "clinical research" but no four-year degree. Why does it matter? If CRAs in the device industry were polled, the results would show little consistency in their training and educational background. Since the device industry is so varied, with so many aspects of clinical research, formulating a program that would meet the needs of every device company is impossible. However, there are basic tools with which all CRAs should be equipped, no matter what type or size of company they work for. As with any four-year degree program there is the basic general program that is required that can vary based on the interests of the student. Because so much of our daily work involves communications, whether written or oral, a command of these skills provides a strong foundation for building blocks in the educational sequence. A communications foundation also provides the student with skills that are so important and used so frequently in the clinical research arena. A core program for a CRA degree should revolve around the biological sciences. Basic courses in biology, physiology, and anatomy would be mandatory with corresponding advanced coursework in subsets of physiology, such as cardiology, immunology, and pharmacology. Courses in basic chemistry, biochemistry, physics, and genetics would help round out the core sciences. From these core courses the program should precede into courses related to clinical epidemiology, the branch of science that provides the clinical researcher with the practical tools in clinical trial design, observational study design, issues of bias, and methods for clinical measurement. Basic biostatistics and computer-based training for data management and analysis should also be included in the coursework. Students who finish a four-year degree program with these courses are not guaranteed a position in clinical research, but they will be equipped with a set of tools that will put them in a better position to not only obtain a job in the medical device field but to also give them a better chance of succeeding and moving up the career ladder. The next column will explore the role of the Clinical Department in the Product Development Cycle.
|
||
ADVERTISEMENT
|
||
|
Medical Device Manufacturing and the Regulations |
||
|
The close out meeting: You have diligently accompanied the auditor and taken copious notes during the audit. Items have been observed which demonstrate good quality practices. Other items surfaced in which there was either a discrepancy between what was observed versus documented practice, or what may be interpreted as a departure from 21 CFR and or ISO 13485-2003 requirements. Now what? Most auditors will not surprise you at the "end of audit" close-out meeting. Potential problems are almost always discussed at length during the audit in an attempt to find evidence of compliance. Should there be an item of marginal or significant departure from the respective standards or code, it will be readily obvious. It is possible that a departure, from documented practice or the regulations, may be open for discussion if only additional documentation can be discovered. An end of day debrief meeting during the audit is the time to identify if the auditor has issues with findings of the day. If the auditor has confirmed that concern exists, then the company has an opportunity to mitigate the potential finding(s) prior to the close-out meeting. As part of audit preparation, key stakeholders should have been put on alert to support the audit. This is the time to engage a rapid response team to search for necessary documents and or clarify existing data for discussion with the auditor. A close-out meeting date should have been targeted at the beginning of the audit. Assuming minimal problems during the audit, this date will be reasonably certain. The auditor has discussed the audit with emphasis on those areas in compliance and those areas of concern. If you have been unable to convince the auditor that those areas of concern are in compliance, the auditor will prepare either a Form 483 (FDA) or a nonconformance report (ISO) and present it to you at the conclusion of the audit. The next issue will walk through postaudit observations and corrective action.
|
||
ADVERTISEMENT
|
||
|
Reimbursement and Its Role in Regulatory Strategies |
||
|
Unlike the rest of America's economy, reimbursement is not a simple matter of supply and demand. Reimbursement is complex and consists of three elements: coding, coverage, and payment. All must be present for a service, procedure, drug, or device to be "reimbursed." Reimbursement coverage decisions are payer-dependent. Decisions are based on the demonstration in clinical trials of improved outcomes for patients and on broad adoption by the healthcare community. The types of trials (the randomized control trial is definitely the gold standard), number of subjects in the trials, and the publication in peer-reviewed journals are critical. This can present a chicken or egg scenario since it is difficult to get adoption without first obtaining a code, positive coverage policy, and adequate payment. The Centers for Medicare & Medicaid Services (CMS) recently implemented a new Medicare rule specifically increasing financial reimbursement for evaluation and management (E & M) services. The intent is to reward for time and effort that physicians spend with patients evaluating patients' conditions and advising them in managing their health. Despite these increases in E & M codes, physician reimbursement continues to lag behind practice inflation. The American Medical Association (AMA) has said that nearly half of physicians it surveyed (or 45 percent) will stop seeing Medicare patients as reimbursement continues to lag behind practice cost- increases. Thus, it is extremely important for the regulatory professional to appreciate the company's position on the reimbursement strategy. In some cases this author has experienced certain "payers" interpreting an indication to their favor (i.e., they don't pay in certain situations). For example, one of my clients has a current FDA indication that is in my opinion, limiting this client's ability to properly position the clinical benefits of the company's products. Because of this, the reimbursement activities to obtain proper codes, coverage, and payment are linked to a limited indication. CMS (located in Baltimore), known as a code granting entity, believes existing or combinations of existing codes already describe the therapy. The local payers on the other hand look at a more literal definition of the existing codes and do not believe the therapy is appropriately described by the existing code or combination of existing codes. This is a challenge that likely occurs regularly throughout the industry. Clinical and regulatory strategy must be developed with the reimbursement strategy since the results of the regulatory strategy will determine indications and the clinical trials will support the coverage of new therapies and products. In this way, some of the issues surrounding reimbursement may be cleared. 1) Centers for Medicare & Medicaid Services. CMS announces proposed changes to physician fee schedule methodology. Available here. Accessed May 11, 2007. 2) American Medical Association, New AMA survey shows Medicare cuts will harm seniors' access to physician care. Available at www.ama-assn.org/ama/pub/category/16117.html. Accessed May 11, 2007.
|
||