Industry News and Innovations
Q1 Conference in Baltimore Highlights FDA Regulatory Challenges for Combination Products
Written by: Lisa KingMonday, July 19th, 2010 | FDA Medical Device Regulations, Industry News and Innovations, International Medical Device Requirements | No Comments
On July 12-13, 2010, MDCI participated in the Q1 Conference on Combination Products in Baltimore, MD. FDA officials and industry experts participated in presentations and panel discussions to address the regulatory framework and challenges of developing and gaining product approval for combination products or medical therapies that combine two or more regulated components. › Continue reading
FDA Could Tighten Focus on Human Factors Testing for Medical Devices
Written by: MDCI Blogging TeamMonday, July 12th, 2010 | FDA Medical Device Regulations, Industry News and Innovations, Medical Device Clinical Trials | No Comments
Medical device developers are accustomed to the strict demands made by the FDA with regards to the type of clinical efficacy and outcomes data that must be collected prior to a medical device being approved for the American market. However, there is another tier of product testing which is starting to garner more and more attention at the regulatory level - that which relates to a device’s usability by both patients and practitioners. › Continue reading
Shifting from a Treatment Model to Personalized Medicine - The Role of the Medical Device Industry
Written by: MDCI Blogging TeamThursday, July 1st, 2010 | Industry News and Innovations, Medical Device Market | No Comments
Personalized medicine is a term that has become something of a media buzzword over the past 12 months, due in part to the increased attention paid to the field by those on both sides of the current healthcare debate. While this phrase might be only now entering the common lexicon used by news outlets reporting on the health industry, MDCI has been actively involved in personalized medicine for many years, and we consider it one of our organization’s core competencies. › Continue reading
Pre-Market Clearance Changes - 510(k) Update
Written by: MDCI Blogging TeamMonday, June 28th, 2010 | FDA Medical Device Regulations, Industry News and Innovations | No Comments
At MDCI we have been keeping a close eye on the upcoming changes that could be made to the current 510(k) clearance process for licensing medical devices through the FDA. As we have stated in the past, although these types of changes may at first seem daunting to companies which have an established licensing process in place, brand new medical device manufacturers can take heart that at least some of the new practices and requirements being introduced by the FDA should make certain aspects of 510(k) clearance less of a headache. › Continue reading
FDA and NIH Roll Out Road Map for Personalized Medicine Medical Devices
Written by: MDCI Blogging TeamThursday, June 24th, 2010 | FDA Medical Device Regulations, Industry News and Innovations, Medical Device Quality Assurance | No Comments
Both the FDA and the NIH have recently taken public steps towards developing what they have referred to as a ‘road map’ outlining the future of personalized medicine. The decision to come forward and engage the industry in a frank discussion regarding in vitro and other forms of diagnostic and genetic testing is a positive indicator for medical device companies who have until now been forced to operate in an atmosphere of regulatory uncertainty. › Continue reading
In Vitro Diagnostic Companies Called Out Regarding FDA Approval
Written by: MDCI Blogging TeamWednesday, June 23rd, 2010 | FDA Medical Device Regulations, Industry News and Innovations | No Comments
The regulatory environment surrounding in vitro diagnostics and personalized medicine got a little bit murkier this month with the revelation that the FDA contacted five manufacturers of genetic testing products to inform them that they were operating outside of the law. Essentially, according to the FDA, the products being marketed by these companies qualified as medical devices, and as such required premarket review and approval prior to being legal for sale. › Continue reading
Trends in Paper, EDC, and the New Hybrids: Which Type of Clinical Database is Right for Your Medical Device Trial?
Written by: Leslie RoseMonday, June 21st, 2010 | Industry News and Innovations, Medical Device Clinical Trials | No Comments
The US FDA and other regulatory bodies worldwide are concerned with the integrity of the clinical trial data that is collected during new medical device development or required for post market surveillance activities or FDA approval. Stories about inadequate or even fraudulent data management activities have been and continue to be in the news. Clinical data management systems (CDMS) are customized relational databases used for the controlled collection, management and storage of data gathered during the course of a clinical trial. Under the current regulations (introduced in 1997 and narrowed in 2003), the FDA expects medical device companies to make use of a Part 11 compliant CDMS with system controls, audit trails and electronic signatures that ensure that all data meet fundamental quality standards (i.e. data must be attributable, legible, contemporaneous, original, and accurate).
Historically, for many clinical trials involving medical equipment data have been received from clinical sites on paper case report forms (CRFs). These data are entered into the database by a double data entry process that improves (but does not in itself guarantee) total accuracy. Further data cleaning activities (edit checks, queries, audits, etc.) are applied to the database to ensure that it is a valid representation of the actual patient data that were generated in the field.
Shortly after electronic data capture (EDC) was introduced in the late 1980s, it was embraced by the pharmaceutical industry, particularly for large Phase III and IV trials. EDC was heralded as “the future” and the industry expectation was that within five to seven years all clinical trial data would be collected and processed by EDC. Several top tier EDC products emerged, and through innovation and/or acquisition they have held prominent positions in the industry since that time.
The medical device industry on the other hand has been slower to adopt, or adapt to EDC. There are a variety of reasons for this reluctance. Medical device trials are generally smaller and of shorter duration, and the manufacturers involved are typically more cost-constrained than pharmaceutical companies have been. The up-front costs associated with licensing, designing, building and validating an EDC clinical trial database are significant and are often greater than what a medical device manufacturer may have budgeted for the entire study. Similarly, for a pilot medical device study the time associated with developing the database and training the clinical site-monitoring and sponsor staff on its proper use may be greater than the time required for the data acquisition and analysis combined. Some clinical sites are just not capable, either due to process or infrastructure, of participating in an EDC study. For these reasons, many medical device manufacturers continue to rely on paper-based, double data entry systems.
If the studies are relatively small and/or of short duration and the case report forms are well designed, paper systems are very cost effective and easy to use in comparison to EDC. Today’s paper systems are fully 21 CFR Part 11 compliant; they ensure data validity by providing system controls, audit trails and traceable query resolution. The completion of the paper CRFs by site staff is low-tech and requires minimal training of site coordinators and no dedicated hardware or software infrastructure.
To some sponsors, however, paper-based CDMS systems may not seem as “cutting edge” as EDC. This is one more indicator of the “pharmatization” of the medical device industry. Many manufacturers say they want to use EDC even though they do not understand the benefits, hurdles or the associated costs. They may have heard marketing claims that EDC is faster and cheaper. While this may be true for very large, long duration medical device studies - those studies that more closely resemble pharma studies - it does not necessarily apply across the board to all types of studies.
Real time access to the data as it is being collected is another attractive but risky characteristic of EDC. Until the data are verified as clean, there is a significant risk of making premature and erroneous conclusions based on incomplete information. There is a statistical “penalty” to pay for taking unscheduled “looks” into the data outside of the designated interim analysis schedule. These unplanned “looks” raise red flags at the FDA and likely will increase the sample size required for your study to maintain the same robustness. Used correctly, however, with the appropriate types of medical device studies and technology-savvy sites, EDC can be a powerful tool for safety reporting, providing status reports and for the efficient monitoring and cleaning of the study data. Good monitoring practices still apply, and data must be source document verified and site study files must be reviewed.
As with any technology, there are always trade-offs. The higher start-up and training costs associated with the implementation of an EDC application to a trial may be offset by reduced data cleaning and query resolution work later in the process. Furthermore, allowing edit check messages to fire during data entry at clinical sites creates a potential for undetectable fraud, as the site could use the edit check ranges or criteria to guide them in manufacturing acceptable data. This is not the case with paper CRFs, which accept “any and all entries” and are subject to query later as needed.
Because of the diverse needs of the medical device industry and the fact that each device trial is different, a hybrid clinical database model has evolved. Hybrid systems can provide both paper-based and EDC approaches to collecting and managing clinical data. When complete conversion to EDC did not happen in the medical device industry, the EDC vendors began to accept the reasons why paper-based systems remained in demand - at which point the hybrid systems started emerging. In the beginning these were systems that were quickly cobbled together, but as the niche for hybrid flexibility has become better understood true, highly-functional hybrid systems are becoming available and increasingly used in both the pharma and device worlds. These systems can be employed to build studies that are fully paper-based, fully EDC-based or which use a combination of paper and EDC from different data sources across sites and laboratories.
Today’s hybrid systems allow the user, be it a device manufacturer or clinical research organization to select the best model for each study, enabling the database structure to be driven by both the business need and the study design rather than trying to force every study to follow the same data acquisition and processing path.
Top 3 Most Common Mistakes Made When Choosing A Medical Device CRO
Written by: MDCI Blogging TeamThursday, June 17th, 2010 | Industry News and Innovations, Medical Device Clinical Trials | No Comments
Choosing the right Contract Research Organization (CRO) is an important part of gathering the data that a medical device company needs to bring their product to market and satisfy regulatory concerns. A CRO that is a great fit for your organization can play a critical role in the development process and help you put together a targeted and cost-effective clinical trial. › Continue reading
New CDRH Transparency Site - A Good 510(k) Submission Resource
Written by: MDCI Blogging TeamSunday, May 2nd, 2010 | Industry News and Innovations | No Comments
When bringing a new medical device to market, you can never get too many different perspectives on exactly what the process might entail. At MDCI, we enjoy helping our clients to understand the ins and outs of a 510(k) submission and we welcome information sources that could be helpful in their quest to successfully market a new medical device. › Continue reading
Massachusetts Life Sciences Center Launches Small Business Matching Grant Program
Written by: Lisa KingThursday, January 28th, 2010 | Industry News and Innovations | No Comments
The Massachusetts Life Sciences Center has launched its new Small Business Matching Grant (SBMG) Program.
The primary objective of the SBMG is to provide grants to commercialization-ready life sciences companies that have received at least the equivalent of a Phase II small business innovation research (SBIR) or small business technology transfer (STTR) grant from federal agencies such as the National Institutes of Health (NIH), National Science Foundation (NSF), Department of Defense (DOD), etc. › Continue reading
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- FDA Publishes Rule to Require PMA or PDP for Four Class III Preamendment Devices
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- FDA Update - CDRH Issues Medical Device Recommendations
- Q1 Conference in Baltimore Highlights FDA Regulatory Challenges for Combination Products
- FDA Could Tighten Focus on Human Factors Testing for Medical Devices