Zero-Defect Manufacturing: Paramit Comes Close (with video)

Zero-defect manufacturing. Is that even possible? Paramit Corporation claims it is. Well, they are as close to zero-defect as possible for a medical device manufacturer.

The Morgan Hill, Calif.-based company reports that it is able to achieve this manufacturing quality from its long-time focus on assembling printed circuit board assemblies (PCBAs) at Six Sigma quality levels, combined with its patent-pending vPoke system that enables defect-free mechanical assembly. The vPoke system is meant to simplify the mechanical assembly and testing of a complex product into hundreds or thousands of steps using sophisticated computer systems to validate and verify each step.

The company recently broke ground on a brand new 162,000 square foot manufacturing facility in Penang, Malaysia. The facility will focus on complex medical devices and life sciences instruments, in addition to its current customer base in Malaysia. The new Penang site will be designed from the ground up to replicate the company’s facility in California.

The architecture of the new Penang facility addresses the unique characteristics of the Malaysian climate and is designed to create maximum energy efficiency. For example, the facility will use canopies of trees to create shading and in-slab cooling to reduce power requirements, creating what is being called “the factory in the forest.” In addition, it is designed to be exceptionally employee-friendly, with gardens and waterfalls on multiple levels and large gathering spaces throughout the facility.

It’s with details such as these that Paramit achieves something close to an actual zero-defect manufacturing process. Company CEO Billoo Rataul sat down with MPO to discuss the company’s philosophy and processes.

Arrowsmith: Can you describe the history of the zero-defect manufacturing process that you use? What is it?

Rataul: Failure in many medical device and life science instruments has a direct impact on patient outcome, and the cost of failure is high for everyone involved. Naturally, quality is a primary concern for manufacturers. Yet, the mechanical assembly of complex, finished medical devices and life science instruments is done by hand, by individual operators, making it prone to variability and inconsistency. In contrast, high-volume industries – such as the automotive industry – have been successful in virtually eliminating manufacturing defects through the use of large-scale automation. To ensure better-than-best-in-class quality, Paramit set out to solve this problem and developed a patent-pending computer-directed assembly technology called vPoke:

vPoke is a programmable computer system that ensures that each device is built the same way, every time. The system exercises control on all inputs, forces conformance to established criteria and sequences, and automatically and securely documents every part and step to ensure 100% traceability for internal reviews and FDA inquiries.

In the vPoke system, when the operator completes a step, vPoke validates the work and creates a visual image, automatically storing the information electronically. The system allows the operator to continue with assembly only when the current sequence is successfully completed and the operator audibly confirms validation. By controlling each step in the assembly process and engaging the operator through interactive activities and multiple senses, vPoke ensures “zero defect” mechanical assembly of complex medical device and life science instruments.

Arrowsmith: How do you measure “zero-defects?”

Rataul: We focus on building highly complex medical instruments, which can include hundreds or thousands of parts and assembly sequences, making it challenging to catch every defect. Best-in-class mechanical assembly is considered 200 defects per million sequences, while Paramit achieves an average of only 3-4 defects per million sequences. This is a dramatically better quality standard than any contract manufacturer of which we are aware and a level that is virtually defect-free. In addition, after mechanical assembly, we have rigorous testing and quality inspections that further raise our quality bar.

Arrowsmith: How does the whole-team structure, as opposed to having a team leader, work to foster ownership of a product build?

Rataul: Paramit dedicates entire teams to each product; not simply a dedicated team leader. Each team includes deep engineering expertise, with engineers located on the shop floor only steps away from assembly, where they can easily solve problems in real time. Additionally, all functions in the manufacturing process are housed under one roof, with no outsourcing to other vendors or off-site facilities. These factors enable open interaction across functions and create synergies necessary for everyday ingenuity, problem-solving and continuous improvement. By immersing each team in individual customers and products, teams take full responsibility for the entire product lifecycle from beginning to end. As a result, Paramit customers tell us we give them peace of mind and remove the worry sometimes associated with outsourcing.

Arrowsmith: What made you decide to build a new facility in Malaysia?

Rataul: We recently broke ground on a dedicated facility in Penang, Malaysia. When completed, it will enable us to expand our better-than-best-in-class quality and services to customers across Asia, Europe and North America, rapidly scale up or down based on customer needs, and enhance our overall global capability for both current and new customers.

Arrowsmith: Could you describe the climate-driven solutions and how that contributes to energy efficiency? Why is this important to medical device manufacturing?

Rataul: The Malaysian climate is uniquely sunny, hot and humid, and offers challenges in creating energy efficiency. Most medical device manufacturers based there have not significantly addressed this unique environment. We have partnered with specialized architects and energy experts to design our new facility, the “factory in the forest,” with maximum energy efficiency. It includes canopies of trees to create shading, in-slab cooling to reduce power requirements, and gardens and waterfalls on multiple levels. Paramit benefits from reduced energy costs and an attractive and unique work environment.

Arrowsmith: What kinds of medical-related products do you make at the new site in Penang?

Rataul: Paramit plans to make complex, finished medical devices and life sciences instruments that require expertise in FDA compliance, mechatronics, fluidics, optics, RF, PCA assembly, subassemblies, system integration, final system assembly and testing.

Arrowsmith: What trends are you experiencing in the contract manufacturing space as it relates to medical device development and manufacturing?

Rataul: In the medical device and life science contract manufacturing space, customers are doing more outsourcing of finished products, while expecting higher levels of quality at a lower cost, as well as specific capabilities, like clean rooms and wet labs. Our greater focus on medical devices and life sciences instruments in comparison to competitors enables us to put all our investment and ingenuity into this space in order to provide unsurpassed quality, efficiency and service at an extraordinary value.

Arrowsmith: When identifying a contract manufacturing partner, what critical considerations do many medical device OEMs overlook?

Rataul: Sometimes medical device manufacturers get overly focused on costs, when what they should really be looking at is value. Low cost means nothing if the product is late, defective or the process is painful. We like to say we deliver peace of mind to manufacturers by providing a great value as defined by unparalleled quality, 100% on-time delivery, extraordinary service and true product ownership, within a cost structure that our customers are seeking.

Arrowsmith: What’s the most important question a medical device manufacturer can ask of a prospective contract manufacturing partner?

Rataul: There are two important areas that medical device manufacturers should consider when evaluating a contract manufacturer. First, before they even begin meeting with potential partners, they should ensure that they are specialists in medical and life sciences instruments and understand the customers’ unique needs. Second, they should ask for customer references, as current customers are best equipped to comment on what it’s like to work with the company and their ability to deliver what they say.