Collaboration in imaging device development

Effective imaging device development programs involve a highly organized group of individuals who create and adhere to a strict protocol, developed by consensus, before reporting to the US FDA.

“Emphasizing the importance of consensus decisions, effective collaboration will strengthen the foundation upon which your study will advance to the pre-IDE meeting”

Falling under the category of "medical devices," imaging devices demand pre-market approval (PMA) from regulatory agencies such as the FDA. Emerging from high profile failings, the current regulatory environment calls for greater rigor in trial design with more clinical research data to support 510(k) applications. While the amount of data required remains stipulated by the three-class categorization of the device, all studies must be non-biased with methods, endpoints and sample sizes acceptable to the FDA. Thus, sponsors should develop thorough protocols that will:

• Minimize trial expenses through indications for use (IFU), which determine:
  • Cost-benefit ratios
  • Trial endpoints
  • Sample of patients
  • Sample of radiologists ("readers")
• Improve understanding of applications and effectiveness of a new medical device
  • Validation
• Expedite FDA approval to market
  • Pre-IDE meeting
  • 510(k) pathway
• Gather data to support marketing

To facilitate a streamlined process, select a contingent representing science, regulatory and marketing expertise to develop your protocol. The collaboration of sponsor representatives, statistician, content expert and CRO will provide you with timelines, procedures, logistics and necessary methodology to advance your program. In establishing this team, first consider the following qualifications:

• Record of timeliness and reliability

Initiating a study is only the first step of the timeline. Pursuant activities need to adhere to deadlines and goals focused on maintaining your program's path to approval. You want dependable and consistent partners whose behaviors will conserve your resources while abiding by your particular program's requirements.

• Familiarity with FDA guidelines and processes

Familiarity is one of your greatest assets when preparing for pre-IND meetings and other FDA pathways. Because federal guidelines are ever evolving to correspond with new associated risks and promised benefits, you will want to select an individual or group to navigate these processes.

• History of working on trials of similar projects

Experience not only necessitates knowledge, it creates a greater sphere of proficiency in conducting studies. As the 510(k) pathway allows the integration of predicate information (that which comes from a similar device currently marketed legally in the United States) with your development program data, selecting a partner whose experience suites your particular program will expedite the decision-making process and effect a more efficient study overall.

• Special expertise

Offering every facet of your development program the added advantage of insight, content experts provide the knowledge necessary to accelerating a program for thorough results. When you work with unique imaging technology, special expertise is vital to accurate and precise results.

Your team will be responsible for the protocol development process. Gleaning from the "best of the best," an effective protocol is based on FDA guidance, past experiences with similar technologies and published protocols of FDA-approved products. Here, the collective assets of your team come into play as they conference to discuss key issues in the imaging device development program. Emphasizing the importance of consensus decisions, effective collaboration will strengthen the foundation upon which your study will advance to the pre-IDE meeting. Established to supply you with greater insight to relevant and evolving medical regulations, the pre-IDE meeting provides you with immediate FDA feedback regarding issues of concern with your development program and areas of protocol vulnerability. Once the FDA has provided specific advice, your contingent will assess the risk and benefit of deviating from it and incorporate decisions into the final protocol.

Implementing the protocol in your study involves regular communication amongst the sponsor, imaging CRO, statistician, content expert and accrual sites, which must first gain IRB approval before proceeding with the study; the effective transfer of information is just as vital at this stage as in the protocol development. To facilitate the exchange of information, a series of documents is compiled to maintain the program's goals and objectives, including the independent review charter, statistical analysis plan, image acquisition protocol, clinical research forms and patient calendar. These documents begin a "paper trail" that will be of use in systems validation, FDA approval and the eventual marketing of your device; they establish mechanisms of image and non-image data transfer and management. As part of systems validation, electronic source (image) data must be attributable, legible, contemporaneous, original and accurate. Data must not only be complete and clean when it is collected, it must be protected from corruption, so you must ensure that your protocol provides for the medium of transfer. Once image data is transmitted to the statistician, the database should be locked for the generation of the analysis.

Team collaboration continues in the evaluation and analysis of data. New hypotheses may arise from the initial investigation due to a number of factors, such as "surprise" outcomes, which must be examined and explained before proceeding, and additional queries of the database might be necessary before FDA submission. The final report, written once repetitive iterations have been established, presents the information in its entirety - with its integrity preserved - so the FDA may examine valid and compelling evidence resulting from your imaging device study, all of which has been expedited and authenticated through the collaborative development of your imaging device protocol.