The Medical Device Innovation Consortium has developed a blueprint for U.S.-based early feasibility studies that provides an overview of best practices and ways to maximize positive outcomes.
Developed to supplement the FDA’s Center for Devices and Radiological Health guidance on EFS, the blueprint covers industry interactions with the FDA and institutional review boards, legal and intellectual property considerations and patient perspectives.
Though the FDA issued guidance aimed at bolstering U.S. early feasability studies in 2013, an estimated 50 percent of MDIC members said their companies had not yet adopted those kinds of studies, according to a 2015 internal survey. While many members did reveal a desire to conduct U.S.-based EFS, they first wanted to see documented success with the program.
Respondents reported that regulatory processes in the U.S. presented significant challenges for EFS. Moreover, the majority of respondents said they have conducted or plan to conduct their EFS overseas to avoid regulatory red tape.
“These challenges remain significant and need to be addressed in order to promote EFS in the United States,” the MDIC report said. The organization said the survey identified a lack of information and an opportunity to provide more education and training for stakeholders interested in conducting an EFS in the U.S.
Early feasibility studies are used to provide proof of concept and initial clinical feasibility and safety data. They are generally carried out on a limited number of patients at a small number of investigational sites, and are an important tool early in the development process when additional nonclinical testing methods are no longer sufficient.
The report clarifies that the goal of an early feasability study “is not to prove the device performs exactly as intended and requires no changes, but rather to provide information to help you make a better, more effective device.” It also notes that EFS are not always needed because often risks are mitigated by prior evidence that the design of the device is final or near final.
However, there are potential benefits to early feasabillity studies for patients, including earlier access to the device. This is especially beneficial when there are limited therapeutic options.
Another potential benefit for devicemakers is earlier regulatory input as well as input from technical experts and key opinion leaders.
In addition, good and credible EFS data is especially important for sponsors and smaller companies that need access to funding, the blueprint says. This is because positive EFS data can allow for: assurance of patient protection; an appropriate patient population and standard of care to support pooling of results later; good clinical practices; and a shorter time to market.
Since EFS require constant communication among mutiple stakeholders and organizations, the blueprint highly recommends that companies develop a comprehensive execution plan before they get started. To that end, the document suggests sponsors have in place a strategic device evaluation roadmap with objectives, milestones and timelines clearly defined.
The next step for MDIC’s early feasibility working group is to incorporate comments into a finalized blueprint to be released this summer. MDIC has already received useful comments aimed at improving the informed consent template, a spokeswoman told IDDM. The final blueprint will also include a more thorough section on reimbursements.