MEDICAL DEVICE MANUFACTURER

The Challenge:

EFFECTIVELY MANAGING COMPLAINTS IN ACCORDANCE WITH FDA REQUIREMENTS

This medical device carries a Class III designation, meaning they are high risk devices and subject to the highest level of regulatory control. Prior to being marketed, Class III devices need to undergo clinical trials and obtain approval from the FDA as well as the regulatory bodies of other nations where it is being sold. Once approved, there are strict regulations governing the safety and efficacy of the devices during the manufacturing process and throughout the entire lifespan of the device.

“Product quality and patient safety are our top priority and we are under very strict FDA regulations,” comments the Medical Device Manufacturer’s Senior IT Director. “Everything we design, manufacture and distribute is highly regulated. We have tight controls over record keeping, employee training and corrective action as well as all of the software we run. Anything that can impact product quality and affect patient safety receives a significant amount of scrutiny.”

As part of its inspection process, the FDA performs unannounced company-wide inspections several times a year. One aspect of these inspections is a review of how the manufacturer handles and resolves patient complaints. Complaints can come from a variety of sources including surgeons, VAD coordinators within the hospital, or even relayed from the company’s own field team. The information contained in these complaints allows the device manufacturer to evaluate any potential safety concerns and determine the root cause, but also address any longer term issues and improve the design of the current VADs as well as future products.

After a comprehensive, cross-functional review process, the manufacturer defined and designed a new complaint management process that would streamline and automate many steps and eliminate manual processing errors.

The work flow process includes:

• Receiving and documenting the complaint

• Gathering relevant information from surgeons, VAD coordinators or field personnel

• Determining the nature and severity of the complaint

• Reporting any adverse events to the FDA

• Reviewing and completing a CAPA (Corrective Action/Preventative Action) as required

During inspections, the FDA determines if the device manufacturer has handled complaints in a timely manner, if all documentation is in order and if the company is following their own complaint management processes.

“Before we had QAD EQMS, our complaint handling process was manual, error prone, time consuming and costly,” adds the Senior IT Director. “We had a home-grown system with multiple different databases. There were many steps involved and it was siloed without integration among the design teams, manufacturing, distribution and Quality Assurance (QA).”

“We needed an integrated complaint management system which would eliminate redundancies of information,” notes the Senior IT Director. “We needed a holistic approach that used information from QAD ERP and EQMS.”

The Solution:

QAD CONFIGURES EQMS FOR THE MEDICAL DEVICE MANUFACTURER’S EXACTING COMPLAINT MANAGEMENT NEEDS

“We had looked at various EQMS systems for years, but we were never able to commit to a new approach,” comments the Senior IT Director. “We have been a QAD customer for more than 15 years and when we had discussions with the QAD EQMS team, we were very impressed with the workflow engine and how we could automate functions and integrate quality into core processes. We knew we could depend on QAD to help us develop what we needed.”

The medical device manufacturer defined an extensive list of user requirements for the complaint handling solution.

There are 14 steps in the process and many departments can be involved; the people who receive the complaints, those who analyze, plan and implement corrective action and field staff working directly with the hospital. A great amount of input was gathered from across all of the departments and all of those users needed to be trained. The training was done in-house by the IT team who worked on the implementation.

“Many of our employees use the new QAD EQMS complaint management system on a regular basis,” notes the Senior IT Director, “and they are very happy with the new system. There were a few hurdles, as always expected, but I give credit to both our internal and QAD EQMS teams. It was a lot of hard work, but we stuck with it, no one gave up – and we got it done.”

The Benefits:

FASTER, MORE EFFICIENT COMPLAINT MANAGEMENT RESULTS IN SAVING TIME, MONEY AND EVEN LIVES

The new QAD EQMS complaint management system has proven beneficial both for the medical device manufacturer and patients with faster and better management of complaints.

Some of the benefits the company has experienced with QAD EQMS include:

• The timeframe for investigating and resolving complaints has been reduced, leading to a 62% reduction in late report submissions.

• There has been a 53% reduction overall in open complaints and a 54% improved complaint closure rate.

• There is now greater visibility of complaints during the entire process across multiple departments with data more easily and quickly accessible.

• Reports and information can now be pulled in a fraction of the time it took in the past, whether internally or by FDA audit request.

“Before we had QAD EQMS it took a lot more effort to get things done,” concludes the IT Director. “It makes a big difference day-to-day for the people involved in complaint management – the process is quicker and much more efficient.”