Prototype-to-Production Medical Parts on the Fast Track
NPI Medical has a Grade 8 certified clean room to meet more stringent demands, as well as two Grade 7 clean rooms for low-volume, short-run assemblies.
Photo courtesy of NPI Medical.
Featuring quick-turn manufacturing and advanced in-house capabilities, NPI Medical offers prototype to production capabilities at top speeds
One of the biggest frustrations for medical device companies is that when they have a new product in mind, the time it takes to go from concept to production could take two years. But the professionals at NPI Medical use a unique DynaClass™ tooling and molding system that provides plastic injection molded parts at the highest speed to market.
“That’s our competitive advantage,” said NPI Medical General Manager David Kelly. “We have the capability to design the mold in-house, build the mold in-house, and turn it around in a rapid manner.”
With a cutting-edge Quick-Turn Manufacturing department offering parts from one to 500,000, the DynaClass system has four options to meet a customer’s production, cost, and lead-time needs (see below chart). The system was developed to fill the void between prototype tooling and full-blown production tooling.
NPI Medical’s goal is to keep the customer with them from initial concept and prototype development, all the way through to production. The company makes prototype tools that are production quality and provides in-house capabilities, including DFM, clean room molding and assemblies, secondary assemblies, and specialty packaging/kitting. Full-process validation protocols — FAI (First Article Inspection), and APQP (Advanced Process Quality Planning), and IQ / OQ / PQ are also offered.
NPI Medical provides tremendous diversity based on customer needs and is not just a prototype molder.
“We will not only help the customer with the total concept and development side from a prototype standpoint, but our end goal is to have the customer stay here and let us develop the product all the way through to production,” Kelly said.
With two Grade 7, Class 10,000 clean rooms for low-volume, short-run assemblies, NPI also has a Grade 8, Class 100,000 certified clean room equipped with injection molding machines from 28- to 110-ton capacities to meet a customer’s tight tolerance medical device requirements.
“Our strategy is to not just be a prototype molder. We do prototyping for our customers, but we want the partnership through the whole project,” Kelly said.
Rapid and prototype molding are great alternatives to traditional prototype methods, but when the required end result is true production level components, the DynaClass system of molding and tooling serves up precisely what each customer needs, he said.
NPI Medical has full prototype to production capabilities, including assembly and packaging. Photo courtesy of NPI Medical.
Photo courtesy of NPI Medical.
Whether a customer requires fully-automated steel tools or aluminum inserts with hand loads, the DynaClass system’s multiple solutions match specific needs. NPI Medical’s tools are designed using the latest software, cavities, and cores. Electrodes are machined using one of NPI Medical’s high-speed machining centers, including a “lights out,” 24/7 automated electrode burning work cell with 6-axis robotics. These electrodes enable NPI Medical to create a customer’s parts with true-to-file CAD geometry, even with features beyond conventional milling capabilities. If part details are not machineable in the steel, they are burned using CNC EDM machines to attain exact parts without compromising any features.
“A lot of our competitors only want the end prize — that high volume, consistent production — and they’ll let someone else handle the design changes and low-volume assemblies, but that’s a niche business for us,” Kelly said.
Taking on that low-volume business will hopefully result in high-production work for NPI down the road. A customer needing low volumes to test a product in the market might have tremendous growth within three years or so.
“Now they need to go on and build a SPI Class 101 mold and they can just stay here (NPI Medical) for that,” Kelly said.
Being a “partner” through the whole process and providing both low and high volume work makes NPI Medical stand apart from typical prototyping companies. Recently, NPI Medical didn’t shy away from a customer who brought in a project requiring only 1,200 parts per quarter for the first few years.
“Most companies would say ‘forget it,’ but we help them because most of the time, those shorter-run companies end up hitting the market in a positive way and then they eventually need two-cavity production molds and 5,000 parts per week,” Kelly explained.
The key to NPI Medical’s success is growing with its customer’s needs and building strong relationships with customers so that when more jobs come up, they take advantage of all that NPI Medical has to offer.
NPI Medical has a 66,000 square foot facility in Ansonia, Conn., with the capability to produce medical device parts from one to 500,000 while focusing on increased speed to market.
Photo courtesy of NPI Medical.
It took four years to develop a relationship with one customer who only had minimal needs at first. But now NPI Medical is building 12 molds for them.
“We had to get them to be excited about doing business with us and now the flood gates are open,” Kelly said.
The company is using all of NPI Medical’s services, from short-run prototyping to multi-cavity tools for high-volume production.
“Their whole product line has a mixture of low volume prototype parts to high-volume production. Those are the customers that love our value proposition,” Kelly said.
NPI Medical, with the ‘NPI’ standing for ‘New Product Introduction,’ operates from a 66,000 square foot facility in Ansonia, Connecticut. The company focuses on medical device, life science, and healthcare markets. Many of its parts go into devices for biopsies, catheters, and blood analyzing. With ISO 13485 and ISO 9001 certifications, NPI Medical has eight injection molding machines from 25- to 165-ton capacity, 41 presses ranging from 28- to 300-ton capacity, and three certified clean rooms.
NPI Medical has a fully-equipped metrology laboratory that consists of CMM, non-contact vision systems, force gages, and hand-held inspection equipment. Once a product is quality approved, NPI Medical controls production using the established protocols along with SPC concepts — APQP, FAI, and PPAP.
NPI Medical’s Capabilities
NPI Medical offers full capabilities in the following processes:
Source: NPI Medical
- Insert molding for starting with manual loading of metal inserts for conventional, hydraulic, and vertical shuttle press molding.
- Operator-assisted, semi-automated loading of multiple part strips for offline loading fixtures in many tight-tolerance, mid-range volume applications.
- Automated insert in a continuous reel-to-reel molding process for when high volume precision molding is required.
- Liquid silicone rubber (LSR) molding for prototype and production with two in-house, 55-ton LSR production molding machines.
Using horizontal, vertical, or shuttle machines, NPI Medical offers traditional injection molding in hydraulic and electronic options. All machines are equipped to the company’s IQMS ERP system for real-time monitoring of jobs. NPI Medical can produce multi-material, multi-shot molding, and has CAD engineers that design all of the mold halves. CNC machined EDM is used to burn or wire in all critical mold geometries that cannot be milled.
NPI Medical (www.npi-med.com) specializes in tool transfers and has successfully transferred hundreds of tools from other suppliers for customers in the medical device market. Engineers discuss with customers if the tool has limitations. Following is the five-step tool transfer process:
- A design phase initiates the project and begins the collaboration with customer.
- A quality plan is established early to ensure no surprises.
- Key steps are developed to eliminate bottlenecks and improve the efficiency of the startup.
- Validation occurs to ensure alignment with customer needs.
- Production startup begins following customer approval.
Because NPI Medical has its own tool room and mold transfer process, many medical customers have switched to NPI Medical due to quality, cost, or delivery difficulties with current suppliers. Some medical customers have reshored work from China to NPI Medical after facing some “bad surprises,” with quality, Kelly said. (see Cheaper Doesn’t Mean Better)
“They hit problems, especially when the molds get back from Asia. That’s when they realize they paid for something they thought they were getting, but didn’t really get” he said. “We can show them that it’s not the same steel or design that they approved.”
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