The Integrex i-300ST configured with a milling spindle and lower turret can process first and second operations simultaneously or perform required sequential operations on a single workpiece. The machine’s main horizontal turning spindle with 10" chuck is capable of C-axis indexing in 0.0001° increments. The main turning spindle is a 40hp integral spindle motor providing up to 4,000rpm spindle speed, while the second, opposed headstock with a 10" chuck features a 35hp integral spindle motor and 4,000rpm top speed.
A 30hp, 12,000rpm integral motor milling spindle rotates in the B-axis throughout a range of 210° and -30° from vertical. The milling spindle also travels 10.24" in the Y-axis. For increased versatility, the Integrex i-300ST accommodates workpieces up to 25.9" in diameter and 59.8" in length. Tool magazine capacity ranges from 36 tools up to a maximum of 110 tools.
The machine’s lower drum turret accommodates nine tools and can work at either the main or second spindle with the same tool, enabling the turret to perform balanced cutting operations on one part working in tandem with the machine’s vertical milling spindle. An option for milling with the lower turret provides flexibility to process a workpiece’s second operation with the second spindle or perform first and second operations simultaneously.
The Integrex i-300ST uses the Mazatrol SmoothX CNC, part of Mazak’s Smooth Technology, which is a complete process-performance platform spanning part-production from programming and setup to metal removal operations, automation, monitoring, and data collection/transfer.
Medical device manufacturers must establish and follow quality systems in accordance with U.S. Food and Drug Administration (FDA) current good manufacturing practices (CGMP) to ensure that devices are safe and function as intended. The quality system regulation (QSR) doesn’t prescribe how to produce a specific device, but states manufacturers “should use good judgment when developing their quality system and apply those sections of the QSR that apply to their products and operations.”
It’s the manufacturer’s responsibility to establish the appropriate methods and procedures to design, produce, distribute, and deliver devices meeting these requirements, which involves creating or selecting a quality management system (QMS).
Many factors can steer QMS solution decision-making. Every stakeholder should consider the entire product release process to avoid myopic decisions. Take into account siloed information and disconnected teams, so everyone has full context throughout the new product development and introduction (NPDI) process.
To help ensure broader business objectives can be met, consider these five key questions when assessing your quality needs.
1. Does the QMS manage the entire product record?
Product records for complex medical devices include documents, components, assemblies, and the entire product record – organized in a relational, multitiered bill of materials (BOM). The complete BOM needs to aggregate parts and documents, track them by controlled revisions, and link every part or document to associated quality records and processes.
Traditional document-centric QMS solutions have significant gaps in managing the entire product record and BOM comprised of vast amounts of mechanical, electrical, and software components. They focus on collections of documents. However, product-centric QMS solutions are built on the product record to provide a relational, hierarchical BOM with every component, drawing, specification, manufacturing work instruction, standard operating procedure (SOP), and training record linked together for maximum visibility and transparency. These BOM structures are organized in the same manner as upstream design systems (CAD) and downstream manufacturing systems (ERP) to enable seamless passing of controlled BOMs from design to QMS to manufacturing. This product-centric approach gives engineering, quality, operations, and supply chain teams a complete picture of all records and related processes to ensure devices can be built as designed, while complying with FDA, ISO, or other regulations.
2. Does QMS elevate the corrective and preventive action (CAPA) process?
When any issue or problem occurs, having a way to quickly identify the root cause and correct the problem is critical. Determining the cause requires thorough documentation of the issue and the ability to efficiently drill into the product design record and/or manufacturing process. Only after the what/when/why/where/how questions are answered can the corrective action be identified and executed.
To design, test, and deliver high-functioning products, a quality system should improve visibility and traceability between the product design and the CAPA process. A product-centric QMS approach is the best way to manage all related documents in context with both product and quality processes. Having a single connected system simplifies investigating and resolving quality issues.
3 . Does QMS empower disparate teams to collaborate effectively?
Proactive, real-time notification speeds collaboration. And providing historical audit trails for design, test, and approval processes is critical to prevent cross-functional team blind spots. If an organization’s QMS solution can’t easily provide access to every impacted player at every stage of the NPDI process, product development and quality issue resolution delays are more likely to occur. Failing to prevent or identify issues early in the development process or after the product has been shipped to customers can prevent a medical device company from continuing to sell into a given market.
Web-based cloud solutions such as product-centric QMS connect teams 24/7 and speed communication, eliminate design errors, and spur rapid innovation. This multidisciplinary collaboration makes it easy for every team to review information and respond immediately by reviewing product designs, associated documentation, and quality records in a single system to drive continuous improvement, increase product reliability, and enhance manufacturability.
4. Does QMS support quality processes before and after products are shipped?
The importance of quality management doesn’t diminish after initial compliance to regulations or after products are delivered to market. Medical device companies must have a fully traceable quality and design process that spans many years and many patients. Since quality issues can arise before or after devices have gone to market, having a QMS that provides a historical audit trail for everyone involved in designing, testing, delivering, and sustaining is key. This ensures the medical device manufacturer can trace the design and quality records to determine design or manufacturing issues throughout the entire product life cycle.
5. How difficult is it to validate the QMS software?
The FDA requires medical device manufacturers to validate software used in the design or delivery of devices. However, validation is often considered an overhead cost. Meeting the FDA’s validation regulations for traditional on-premises or document-centric QMS environments requires significant internal resources and an understanding of the software capabilities, and specific use cases.
Product-centric QMS solutions with multi-tenant cloud architecture eliminate traditional obstacles and alleviate resource challenges, simplifying a large portion of the validation process. Your QMS vendor should design and support validation requirements to reduce the impact to internal teams. Be sure to ask whether the QMS has standard validation services and documentation to remove the heavy lifting for installation qualification (IQ) and operational qualification (OQ) – leaving mostly customer-specific performance qualification (PQ) requirements to be executed by your internal team. Multi-tenant cloud solutions offer greater scalability of IQ and OQ validation support since they leverage the same infrastructure across all customers.
Designing, producing, and supporting complex products is challenging with distributed teams and supply chains. For medical device manufacturers, the ability to ship quality devices is more difficult due to stringent FDA and ISO regulatory compliance. To innovate and ensure compliance and positive patient health outcomes, it’s essential to have a product-centric QMS approach. These five questions will help identify whether a QMS solution can support the delivery of high-quality devices while maintaining regulatory compliance and providing better traceability throughout the entire product lifecycle.
Coiled spring pins were designed for assembly. Compared to other pins, the square ends, concentric chamfers, and lower insertion forces ease installation. Additionally, coiled pins can accommodate wider hole tolerances better than any other pin type because they compress during installation and conform to the shape of the hole. Coiled pins are the easiest type of pin to install and are designed to be serviceable.
The coiled pin’s nominal diameter represents the recommended hole size for the product into which it’s being installed. Coiled spring pin design guidelines provide the recommended hole tolerance range. The coiled pin’s pre-installed diameter is greater than the hole size, and the chamfer diameter is smaller than the hole. During installation, the swaged chamfer aligns the coiled pin with the hole and facilitates compression of the coils as it’s driven into position.
Installation options
Most manufacturers prefer to use a hammer when only a handful of prototype assemblies are needed. When the pins are too small to hold while hammering into the hole, some opt for a pin-driving chuck so that they don’t have to hold onto the pin while it’s being inserted. Automatic pin inserters are preferred for high production volumes because they provide a significant return on investment (ROI) and are also preferred for difficult-to-handle small diameter pins.
Hammer – For the simplest coiled-pin installation method, align the coiled pin up to the hole by hand and hammer the coiled pin into the hole like a nail. Drive the pin to the desired insertion depth and be careful not to damage the host.
Using a hammer is great for prototyping a handful of assemblies or trying out a coiled pin for the first time. This installation method is not recommended for short pins or pins with small diameters because it can be difficult to hold them in place by hand.
Manual press or air hammer with pin driving chuck – Secure the pin driving chuck into the press or air hammer, then manually insert the coiled pin into the end of the driver. Next, place the exposed end of the pin into the hole and complete the installation by advancing the press handle or actuating the air gun.
Heavy, standard, and light duty coiled spring pins.
Photo courtesy of Spirol Corp.
Presses and air hammers with pin chucks allow for better axial alignment, control, and quicker cycle times compared to a hammer. These are great solutions for small- to medium-volume production. Pin-driving chucks are cost-effective and versatile tools allowing manufacturers to control alignment and insertion depth. Also, the chuck will hold the pin securely in place prior to and during installation. The pin-driving chuck has an internal punch with a diameter smaller than the hole but greater than the pin’s chamfer diameter, critical for effective installation.
Automatic installation equipment – Ideal for efficient, high-volume production, automated solutions are completely self-contained. The fastener is oriented in a vibratory feeder and fed to a shuttle mechanism that positions the fastener directly underneath the insertion quill. The shuttle is mounted on a retracting mechanism that positions the pin exit bushing as close to the assembly as possible for insertion, then retracts for unobstructed loading and unloading.
Installation is simple with an automatic pin inserter. The operator will load the assembly onto the fixture, activate the machine to insert the pin, then remove the assembly from the fixture. The operator doesn’t handle pins during any part of the installation process; all that is required is to pour the pins from the shipping container directly into the feeder bowl when the quantity in the bowl needs replenishing.
Many options are available to customize the automatic inserter such as adding adjustable workstations, infrared safety light curtains, force monitoring, distance monitoring, part presence sensing, rotary index tables, feeder bowl level monitoring, drilling and pinning combinations, and multiple pin insertions per cycle. The feeder bowl can also be designed to sort out errant product or debris.
The coils on coiled spring pins compress during installation.A pin driving chuck.Figure 1An automatic pin installation machine.
Photos courtesy of Spirol Corp.
Additional considerations
Fixturing – Devices that hold, support, and align components during installation are critical to the performance of the installation equipment and the quality of the final product. Effective fixturing also improves cycle times, reduces the risk of scrapped assemblies, and poka-yokes the beginning of the assembly process.
Spring-loaded alignment pin – Recommended for assemblies with through-holes, spring loaded alignment pins ensure alignment is maintained between the pin and the holes of the assembly components throughout the installation process. A spring-loaded alignment pin affixes to the installation table and aligns the assembly prior to and during installation. Spring-loaded alignment pins (also known as locating pins) have spring mechanisms so they retract as the pin is inserted into the assembly (Figure 1, below). Fixtures using the periphery of the assembly components as datums rather than a disappearing pin require tighter tolerances on the parts to maintain proper alignment, increasing manufacturing costs without adding value compared to using a disappearing pin for assemblies with through-holes.
The center can print high-precision titanium (Ti64Al4V) parts on Renishaw’s RenAM 500 series of laser-powder-bed-fusion AM systems. For industrial production applications, the RenAM 500 series allows automatic powder sieving and recirculation within the compact system, reducing manual handling and material exposure.
To provide a complete picture of metal AM, the center features wet downdraft, heat treatment, support, machining, insp ection, and part removal equipment, working in concert with the AM system to ensure parts are printed and finished to specifications.
Senvol earns NIST grant for AM analytics
The National Institute of Standards and Technology (NIST) awarded a grant to Senvol for its “Continuous Learning for Additive Manufacturing Processes Through Advanced Data Analytics,” project, demonstrating that data analytics can be applied to additive manufacturing (AM) data to establish process-structure-property (PSP) relationships. Senvol ML data-driven machine learning software for AM will be used to conduct the analyses. Analyzed data will come from NIST’s various round-robin test studies and its AM Benchmark Test Series.
Senvol ML will analyze model reliability, adaptive sampling, generative learning, hybrid modeling, and transfer learning. Additionally, Senvol will parameterize in-situ monitoring data, non-destructive testing (NDT) data, and microstructure data so it can be incorporated into NIST’s AM Material Database (AMMD). The project will culminate by integrating Senvol ML and AMMD, so data stored within AMMD can be analyzed by Senvol’s machine learning software.
“The work in this project will demonstrate the power of a data-driven machine learning approach for additive manufacturing process understanding and material characterization… [showcasing] hybrid modeling, whereby physics-based models and data-driven models are joined under a single framework,” says Yan Lu, senior research scientist at NIST.
Pilot 250 and Pilot 450 – building parts in Somos EVOLVE, Element, WaterShed; Industrial RSPRO 600 and 800
Benchmarking part builds for evaluation of SL technology machines as a 3D printing option
Investment casting to rapid tooling, metal clad composites, and prototyping applications
Warehousing, logistic support
Final assembly, managing quality control of the equipment Jim Reitz, general manager of UnionTech says the center provides “a convenient venue for a first-hand, close-up examination and hands-on evaluation of the UnionTech fresh dimensions approach to stereolithography, open-sourced materials, software options, and robust, keep-it-simple-and-solid engineering that provides cost-effectiveness with excellent part aesthetics.”
UnionTech uses internationally sourced components from suppliers including Panasonic, SCANLAB, Advanced Optowave, and Materialise.
The Nakamura-Tome MX-100 multitasking machining center with advanced software, smart features, and a 96-tool capacity delivers accuracy and productivity. The high-precision multitasking turning center is equipped with a 15hp, 20,000rpm upper tool spindle with turning capability. An 8,000rpm milling turret offers 12 tool stations with 24 indexing positions.
The machine has several smart features including the NT Work Navigator that recognizes coordinates of machine parts with non-round shapes without any additional costs involved, eliminating the need for positioning fixtures and clamping devices. The included Advanced NT Nurse System all-in-one software delivers easy-to-use support for operation, programming, and production. Critical functionality includes phase recognition (key for multitasking), direct chucking enabling transfer without positioning error, and precise synchronization of the left- and right-hand spindles. Additional functions include a load monitor for identifying tool wear/breakage, tool life management, and machine monitoring.
A standard electronic-detector safety feature reduces the impact and force of a machine collision. Should a crash occur, servo-motor feeding direction reverses, and the machine stops within 4 milliseconds.
The FPC milling/drilling chuck line now includes Slim Line models to enhance 5-axis machining productivity and versatility. Available in 1/8” to 9/16” (2mm to 14mm), the compact, slim design with tapered shape enables easier access to the work, especially in confined areas and for challenging angles.
FPC chucks are available in five shank styles (CAT, HSK-A, SK, BT, and PSC) in 68 different SKUs for various applications. A full range of high precision collets and accessories are offered. FPC collets come in three size ranges (FPC 14, FPC 20, and FPC 25) in more than 110 different SKUs, from 1/8" to 1-1/4" (2mm to 32mm).
Additive manufacturing (AM) process monitoring software
InfiniAM Sonic acoustic process monitoring software uses the monitoring systems’ acoustic energy sensors to detect vibration and collect sound waves for build quality analysis. Using four high-frequency sensors in different locations results in a slight time difference, which the software uses to triangulate the position and magnitude of the noise on the build plate. These data can then be combined graphically with other sensor data to build a comprehensive view of the part and the conditions at the time of build.
InfiniAM Sonic works in conjunction with InfiniAM Central and InfiniAM Spectral, which improve understanding of build quality, build process confidence, and process development. The InfiniAM Central mobile app delivers real-time build process notifications to users.
Posted by Elizabeth Engler Modic
