How Digitizing Operations Keeps Northeast Scientific a Leader in the Medical Device Industry

The company’s mission is to profoundly change the medical device industry, using innovative methods and compliant processes to remanufacture devices that are at least equal to the quality of new products produced by original equipment manufacturers (OEM).

“It’s really about finding high-cost, complex devices that we can reprocess, remanufacture, and bring that cost savings to the [physicians] where they can then reinvest those cost savings into delivering better health care.

Northeast Scientific is the only medical device remanufacturer to focus on high-cost catheters used in vascular interventions. These devices include VNUS ClosureFAST® Catheters, RF Stylets, Philips Volcano®, IVUS diagnostic catheters, and more. The company caters to a rapidly growing niche market of physicians operating in office-based labs (OBL).

As its market grew, Northeast Scientific needed a way to scale its operation to meet the growing demand for its products as well as an effective way to introduce new products. The company also needed to scale its efforts to remain compliant with the evolving regulatory requirements around these types of products.

Revolutionary Remanufacturing Processes

The medical devices in Northeast Scientific’s portfolio are challenging to remanufacture. Achieving regulatory clearance on these products is an ongoing uphill battle. The company pioneered a specific type of reprocessing that the U.S. Food and Drug Administration (FDA) had not previously seen nor awarded clearance to. This required close collaboration with the agency to achieve clearance. Northeast Scientific continues to innovate as its portfolio grows, which in turn challenges regulatory agencies to be regularly updating their methodologies.

Given the uniqueness of the company’s remanufacturing processes and the complexity of the devices, Northeast Scientific regularly faces stringent requirements for obtaining regulatory clearance specific to each product.

“There are no specific guidance documents from the FDA for medical device reprocessors that push what we need to do for 510(k) clearance. We have to work with the FDA continually to make sure that we’re meeting their ever-changing guidelines and standards,” said Matt Farley, director of engineering at Northeast Scientific.

Paper-Induced Bottlenecks

Speed, accuracy, and quality are essential in medical device manufacturing. Using paper-based processes, Northeast Scientific faced a variety of delays and obstacles. “There’s a slow turnaround time for reporting,” said Evan Rife, manufacturing engineer at Northeast Scientific. “We [often waited] for finished product to get out to determine what the yield is for the lot, and all the paper work moves in unison.”

Managing paper reports was problematic. When documents were in the wet room, there was a risk of the cleaning solution getting spilled on the paper reports. During the sterilizing and drying processes, the reports often became wrinkled, discolored, and illegible. And these were the documents they needed to present to auditors.

Digitization: The Next Logical Step

To meet its growth, scalability, and compliance needs, Northeast Scientific implemented MasterControl’s Quality Excellence and Manufacturing Excellence solutions. The transition from its paper-based system to digitization boosted the company’s overall efficiency, productivity, and speed to market.

“It would take months to get SOPs [standard operating procedures] created and filed. [Now] we’re getting the SOPs, validation, and the training done in a third or even a quarter of the time,” said Allmendinger.

Going Paperless Improved Collaboration and Process Management

“One of our biggest pain points with the paper system was ensuring that people are appropriately trained and the processes on the floor were being followed correctly,” said Farley. “With MasterControl, there’s a connection between production and the quality system that verifies and checks those parameters, those processes, to make sure they’re being done correctly by the correct people.”

“Before, we did one 510(k) a year. Right now, we’re doing four or five 510(k)s simultaneously. Now we’re competing at a level we should be.

Manufacturing medical devices is accompanied by an exponential amount of paperwork, as each device has a device history record (DHR). Managing all the necessary documentation for the many devices Northeast Scientific remanufactured was complex and prone to errors. Using MasterControl, the company is able to automate document control tasks — eliminating errors and lost documents and keeping document reviews moving and on schedule.

“It’s an easier process because you don’t have to chase people down. It’s easy for someone to just log into MasterControl and know exactly what they need to do and just push it through the workflow to get to me and keep going,” said Sharee Nicholls, document control lead at Northeast Scientific.

Digitization Streamlined Manufacturing Operations

On the shop floor, Manufacturing Excellence helps the company reduce disruptions and downtime for equipment maintenance, which optimizes productivity. “[Managing] all the tasks, due dates, who to bring in for which pieces of equipment, and how each piece of equipment gets calibrated was a monstrous mess of paperwork,” said Rife. “Transitioning to a digitized system enables the staff to be more effective with scheduling.”

“ With MasterControl, already having the data in the system, with the hit of a few buttons you can see graphs or bar charts or just straight numbers that we can perform our own analysis on to make more insightful decisions

More Transparency and Data Enables More Informed Decisions

Imran Hussein, manufacturing engineer at Northeast Scientific, appreciates how MasterControl’s Manufacturing Excellence is seamless and unifies the organization. It effectively tracks each lot through every single step and provides valuable data that’s relevant to multiple stakeholders such as engineering, quality, and management. This way, everyone can make more informed business decisions.

“Our manufacturing department works closely with the sales team who needs to communicate delivery schedules to customers,” said Hussein. “Through MasterControl, after a few months of data in the system, I can forecast more precisely when certain kinds of devices will be ready to be shipped. This will allow sales to give customers more accurate timelines for shipping and delivery.”

How Digitization Simplified All Aspects of Operations

Paper-based processes were cumbersome for the staff at Northeast Scientific. This was manifested in the day-to-day operations where a considerable amount of time was spent searching for reports on the status of employee training or equipment calibration.

With a digital operation, it’s easier for staff to find documents. It has also been helpful to have metrics readily available without having to ask where everything is on the production floor.

“[The staff] love not having to worry about out-of-calibrated equipment. They don’t have to worry about expired materials, and they don’t have to worry about not being trained on a procedure. They also love not having to do GDP [good documentation practices], having to cross everything out, footnote it, and sign and date it,” said Tian McCann, new product development engineer.