NAVIGATION
Currently, the United States is the world’s leader in Medical Device innovation. The pace of innovation continues to increase rapidly. However, the development, clinical testing, and review/approval process required by Title 21 is lengthy, expensive, and can be seen as an impediment to the pace of advancements of medical technology.While the United States leads the world in the development of medical technology, it also leads the world in the production of safe and well tested technology. The mandate of the Food and Drug Administration is two-fold:
- Promote health and human safety by ensuring a constant and valuable supply of product.
- Ensure that the supply is safe and that safety has been effectively demonstrated.
As the number of Medical Device companies and the pace of development increases, achieving both of these objectives can be enormously challenging.
Currently, the FDA reviews hundreds of applications and supplements each month, without differentiating between innovative products and alternate versions of existing products. Recently, the Center for Devices and Radiological Health (CDRH) announced actions that will be taken in 2011 in order to identify innovative products and speed their pace to market. These steps have been designed to support innovation (reducing time to market by as much as 50%) while simultaneously maintaining quality.
These steps are collectively being referred to as the “Innovation Initiative,” and were developed in collaboration with industry. The following is a high level view of the cornerstones of the new program:
Development of an Accelerated and Collaborative Pathway for Review of Innovative Products
Implementation of a priority based review approach, designed to identify innovative products, and ensure that new generation technology reaches consumers as quickly as possible.
The following is an illustration published by FDA, comparing the current path to market, and the path to market newly developed for those devices that represent innovation in the market place. The most striking differences include the upstream involvement of FDA and the nature of that involvement (collaborative design of clinical trials and scientific problem solving).
Components of the accelerated pathway include:
- Center Science Council (CSC) – A regulatory body created to oversee device development and review/approval processes for innovative products.
- FDA Case Manager and Subject Matter Experts– An FDA point person, whose responsibilities will include development of a roadmap and timeline for the review and approval processes, regular and frequent communication with the sponsor, and identification of internal agency or external subject matter experts.
- Collaborative Development of Clinical Protocols – FDA will participate in an assessment of the technology and participate in the development of flexible approaches to clinical testing.
Strengthening of the Infrastructure and Promotion of Development
Components of these aspects of the program include:
- Third-Party Certification – Establishment of a program that would provide government certification to clinical testing centers, allowing the private sector to leverage centers, and reduce their clinical testing costs.
- Link to Academia – FDA will work with academia and the private sector to encourage educational institutions to create a core curriculum to formally educate future generations in the processes that are required to develop and market medical technology.
- Collaboration with Foreign Resources – In order to allow industry to leverage resources that are available to them outside of the United States, FDA will develop a Guidance Document speaking to the foreign test centers, guiding them in the practices required to allow them to participate in activities that will support US device applications.
- Advance Scientific Research – Expand the investment FDA makes in their internal research, and in participating in the research efforts of the private sector.
Preparing to Recognize and Respond to Innovative Technologies
Components of these aspects of the program include:
- Strengthen CDRH’s current horizon scanning process – FDA will reinvest in efforts to stay current with transformative technologies and the needs of the public sector in order to proactively position its working model to remain able to keep pace with innovation. These activities will enable the CDRH to anticipate and prepare for emerging device technologies by focusing hiring and contracting, staff education, and research efforts.
- Development of a wider network of experts – In addition to the existing advisory panels, which seek to reach a consensus within subject areas, individuals will be utilized as need to provide expertise to particular scientific questions about emerging technologies.
At this point in time, there are no plans to increase the size of the CDRH, however significant efforts will be made to effectively utilize existing resources. FDA expects that the current center capacity will allow one to two products to be handled under the initiative each year. As a result of these resource limitations, only true innovation will be handled by the new program.
Eligibility Requirements
In order to be eligible for the Innovation Initiative the device must be “radically different from any legally marketed medical device in the United States in its underlying technology or manner of use” and meet at least one of the following criteria:
- significantly improve upon currently available treatments or diagnostics for life-threatening or irreversibly debilitating diseases or conditions;
- treat or diagnose a life-threatening or irreversibly debilitating disease or condition for which no approved or cleared alternative treatment or means of diagnosis exists;
- address an unmet public health need as identified by the Council on Medical Device Innovation; or
- address an issue relevant to national security such as vaccine development and medical counter measures
As consultants, we are continually challenged to meet our clients’ needs with a minimal investment of resources, as quickly as we can.
As members of the greater life sciences community, we are also continually challenged to think in a consumer-centric manner.
We recognize that ensuring quality while promoting speed and innovation is the greatest challenge faced by our industry.
We recognize that FDA has critically assessed the agency’s internal practices in the face of the same challenges. We applaud them for the effort, support as much collaboration as possible, and encourage our private sector counter parts to participate in every way they can.
© Coda Corp USA 2011. All rights reserved.
References:
1. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm202717.htm
2. http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHInnovation/ucm242068.htm
3. http://www.fda.gov/aboutfda/centersoffices/cdrh/cdrhinnovation/ucm242067.htm
4. http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHInnovation/default.htm
