Case Studies

Case Study 1

Avoiding market access delay due to incorrect product classification

A start up company (with the help of two innovative physicians) developed a tool that provides a safer, more effective way to alleviate a common orthopedic condition.  Although early funding came at a cadence that kept progress moving steadily ahead, rounds for managing the entire life cycle to reach commercial distribution were relatively small.  But by correctly classifying the device, time to market was minimized.

The Client’s Challenge

The company had no staff that was acquainted with FDA regulations regarding medical device submissions. It initially assumed that, because of the invasive nature of the product, it had to be a Class II device and would therefore require a 510(k).

The RCRI Approach

An RCRI senior principal advisor took the time to integrate into the client’s team in order to identify both the technology and business goals. Starting with the critical questions “why” and “how”, RCRI identified a new strategic approach. First, a Class I predicate was identified and a regulatory strategy was developed.

Then, a pre-submission package was prepared to allay regulatory strategy concerns from the board of directors and to demonstrate the feasibility of the concept. After a successful FDA interaction, RCRI consultants further helped manage an iterative and interactive pathway to complete the design process and design validation.

The final step was to design a CFR820 compliant quality system addressing the unique needs of supplier management and complaint handling in a virtual company. This approach kept the overhead burden down while at the same time providing a solid launch pad for future growth.

The Outcome

The client was able to enter market faster and with less expense by using a regulatory strategy and data supporting registration and then listing as a Class I device. While typical concept-to-bedside timelines for devices can vary anywhere from 18 month to 8 years, by carefully examining the requirements for Class I devices, the Company was able to gain FDA agreement that the device was a Class I, requiring only general controls.

This strategy shaved years off the development pathway and successfully avoided many pre-clinical and clinical costs. From concept to market the product was in the hands of physicians within two and a half years.  At the same time, the company’s quality control system and selection of vendors has assured full compliance with FDA design controls and all regulatory responsibilities.

Case Study 2

Lessons learned from missing the mark with FDA hot buttons

A surgical device manufacturer pursued their first 510(k) clearance for their CE Marked product but was faced with considerable challenges during the FDA review process.

The Client’s Challenge

Unfamiliarity with the 510(k) clearance process and working with FDA cost this device manufacturer significant time and resources and produced only frustration.  An initial 510(k) submission generated deficiencies from the FDA that could not be addressed during multiple rounds of questions and requests for additional information.  Due to a lack of alignment between the FDA expectations regarding the data and testing approach, the manufacturer had to withdraw the submission.

The RCRI Integrated Approach

RCRI’s team was experienced with similar devices and used this knowledge to evaluate the entire submission package, along with the deficiencies issued by the FDA, to identify weaknesses and gaps in the information.  An analysis of the preclinical evidence generated by a contract animal testing laboratory identified inadequate controls and reporting procedures which (along with other testing anomalies) ultimately had caused the FDA to issue deficiencies across multiple areas within the submission package.

By working with the team to clarify FDA expectations, address testing deficiencies, and determine how existing animal study data could be leveraged, a comprehensive plan to rescue existing animal study data was developed, including a histologic re-analysis by an independent expert.

The RCRI team worked with the manufacturer to interface directly with the FDA and gain buy-in on the leveraged data plan. By working with the FDA on the deficiencies identified, the team was able to address the client’s issues and achieve the evidence required in order to provide substantial equivalence to the legally marketed predicate.

The Outcome

After two 510(k) submissions, several years of interaction with the FDA, and a full reanalysis of the animal study histology data, clearance to market the device in the US was successfully achieved.

Case Study 3

Intensive BIMO Preparation is Key to Successful Inspection Results for Sponsors and Sites

A medical device manufacturer conducted a successful randomized IDE clinical trial, but at the time of study closure they decided not to file the Premarket Approval (PMA) application for business reasons.  However, five years later, the business climate had improved and the company proceeded with its PMA application.  The sponsor knew this unique situation would present significant challenges readying the long-closed study sites for the expected FDA BIMO inspections.

The Client’s Challenge

Many of the 30+ clinical study sites had study team turnover, archived study documents, or in some cases, actually ceased to exist.  Additionally, RCRI had also archived the sponsor documents.  The sponsor needed to ensure all study documents at all locations were accessible to FDA and in excellent order and that study sites were well-prepared to participate in successful BIMO inspections.

The RCRI Integrated Approach

Senior clinical staff at RCRI worked with the sponsor to develop a multi-tiered plan to prepare both sites and RCRI for the BIMO inspections.  First, RCRI contacted all the sites, updated their contact information, documented the location of the study files and the process required to retrieve them from archives. A list of all sites and the status of their documents was provided to FDA as part of the PMA application to help FDA with its BIMO plans. Next, RCRI retrieved its archived study documents, which included most sponsor-required files and the paper case report forms and subject questionnaires, and meticulously cataloged and filed them.  RCRI developed detailed electronic tracking documents to record all items and to allow for rapid retrieval during the inspection.  At the time of the PMA submission, RCRI spoke with all of the sites to notify them of the submission and pending BIMO inspections.  Each site was offered customized, proactive training via webinar to ensure that current site personnel were refreshed on the specifics of the study and the site’s participation in it.  Training also included proper inspection conduct, how to interact collaboratively and effectively with FDA, and to ensure personnel were comfortable with the inspection process and could answer FDA’s questions honestly and confidently.  RCRI trained the principal investigator specifically on what to expect during the inspection and refreshed his memory about the study and his site’s results, adverse events and protocol deviations.  RCRI also offered to come to the site in advance of an announced inspection to facilitate document organization and to be present during the inspection as support to the PI and site staff.

The Outcome

As expected, the FDA conducted intensive BIMO inspections at RCRI and two study sites. All inspections went very smoothly with no issuance of a Form 483 for any entity, and the inspectors were highly complementary to all involved. FDA noted the level of organization of the documents, quick responses to their questions and document requests, and the professionalism and collaborativeness of the inspections.  One of the two sites requested RCRI’s presence before and during the inspection and the FDA inspector expressed her sincere appreciation the support RCRI provided. She acknowledged the challenges for a site to be inspected by FDA under more typical circumstances, such as during a study or immediately after closure, but also commented on the unique burden placed upon the site during the inspection of a long-closed study.  She stated that FDA recognized that sponsor/CRO support is very helpful to both the site and FDA in reducing that burden.  Well-planned and well-executed preparation for any BIMO inspection is key to a successful outcome for sponsors and sites, and the on-site support of the sponsor or CRO can ensure a successful result especially under unique circumstances, such as this long-closed trial.

Case Study 4

Innovation can be viewed as the application of better solutions that meet existing market needs 

A start-up medical device manufacturer developed an innovative orthopedic device designed to gain full knee extension following total knee replacement surgery.  The technology was simpler and more effective than existing alternatives, but there was a major problem:  the manufacturer had no billing code.

The Client’s Challenge

The manufacture’s device is used in the home setting and therefore required a Healthcare Common Procedure Coding System (HCPCS) code.  Existing HCPCS codes are approved by the Medicare Pricing Data Analysis and Coding (PDAC) contractor.  On its own initiative, the manufacturer submitted an application for an existing code to PDAC but was denied.  Instead, the device was given a code describing exercise equipment which has no assigned Medicare payment.

The RCRI Integrated Approach

An RCRI senior principal Advisor assessed the current reimbursement landscape to determine what was needed to obtain the desired coding assignment of the knee aid device.

First, the Advisor reviewed orthopedic knee devices that had won approval for the code the manufacturer sought.  With a slight change to the thigh strap, the manufacturer’s product was redesigned to closely fit the descriptions of a similar device previously approved by PDAC.

Then instead of just submitting another application which may have been denied again, the Advisor scheduled a meeting with the PDAC’s Medical Director and other key decision makers. In that meeting the manufacturer had the opportunity to fit their knee aid device on the PDAC’s orthopedic specialist, thereby demonstrating to the right decision-maker how the technology worked. A revised coding application was also provided at the meeting with the required information necessary for approval.

The Outcome

Following a review process, the PDAC sent the manufacturer notification assigning the desired HCPCS code for billing. The coding assignment is on the PDACS public website so that all payers know the manufacturer is authorized to bill for its innovative knee technology using a billable code.