How Pre-Validated Medical Device Packaging Complies with ISO Standards
There is a lot of excitement in the medical device packaging industry about pre-validated packaging. Using pre-validated packaging may reduce time to market and minimize expense related to package development and validation.

Case Study: 3D Printed Functional Medical Device Transfer Case
An early-stage medical device company required a prototype of a unique instrument procedure case that involved unique seals and hinges that would experience high mechanical forces.

Establishing Shelf Life of Medical Devices
The FDA defines shelf life as the term or period during which a device remains suitable for its intended use. Fitness for use can be impacted by both maintaining sterility of the package and the performance characteristics of the device.

Choosing the Right Partner for Optimized Medical Textile Implant Manufacturing
Medical-grade textiles have been proven to deliver the high degree of versatility and performance that OEMs need to create implantable devices that best meet the needs of today’s surgeons – and patients. As a result, the market for medical textiles is rapidly growing.

The FDA Wants to Know What You Intend to do With That mHealth Mobile App.
There are thousands of mobile health apps available for download, and some will be regulated as medical devices. Final guidelines are forthcoming, but what has the FDA communicated about mHealth apps until now?

Case Study - Lean Product Launch with 3P Event Reduces Risk & Compresses Timeline for Energy-Based Device
3P team members included Viant manufacturing, quality, and packaging engineers, as well as senior equipment operators; 4 representatives from the customer company; and representatives from Viant’s automation partners, which would be designing and performing the full integration of the assembly equipment.

Case Study - Lean Product Development Dramatically Accelerates Time to Market for Laparoscopic Device
Viant formed a dedicated project team of experienced engineers to assess the design of the customer’s nonoperational prototype. Team members identified 4 priorities: optimizing cutting, adding power, adding a rotating coupler, and reducing cost. The team then used Lean Product Development, a systematic proces

Case Study - Reverse Engineering & Manufacturing Transfer Result in Cost Savings, Reduced Risk, and Increased Security
The Viant team leveraged its product design experience to reverse engineer 35 components, using in-house inspection as well as laser and CT scanning to get accurate 3D geometry.

Case Study - Advanced Energy Device Engineered with Ultra-Precise Tubing Tolerances for Superior Performance
Viant facilitated the design and managed the production of the inner and outer tube. Viant’s deep engineering and process expertise drove development to optimize critical areas of the tube to reach the extreme tolerances needed to achieve the desired performance.

4 Best Practices to Mitigate Risk in Manufacturing Transfers
Medical device companies can mitigate the inherent risks associated with manufacturing transfers by choosing a contract manufacturing organization that understands how critical it is to execute programs on time and on budget. The people you partner with can make or break your manufacturing transfer. Choosi

Case Study - Collaborative Transfer of Surgical Device Meets Aggressive Time Frame
A leading, multinational medical technology company needed to transfer manufacturing of a medical device to free up cleanroom manufacturing space for a new product. The customer was facing an aggressive 12-month time frame for the transfer to avoid interrupting product supply. The technology tran

Case Study - Quick Transfer of Tools for Complex Molded Components Increases Customer Satisfaction
A midsize, market-leading blood management company was having major quality issues with the molding supplier for critical components of its flagship product, resulting in supply chain interruptions and a high rate of customer complaints. The customer needed to transfer tooling for 3 acrylic, sing

Coating Technologies Review: How Orthopedic Implants Get Coated
Orchid Orthopedic Solutions focuses on both bone on-growth coatings and bone in-growth coatings with expertise in sintered coatings, spherical, asymmetric and porous foam used in on-growth coatings. In-growth coatings are usually done with plasma spray, using titanium hydroxyapatite, or titanium on PEEK (poly

Enhancing Your Global Footprint: cutting production costs without sacrificing quality
Markets like China and India are attainable, and there are numerous benefits to be reaped. The concept may be outside the paradigm of how many ... operate, but it can be achieved by partnering with a true global supplier.

The 6 Sciences of Medical Micro Molding
Free white paper on The 6 Sciences of Medical Micro Molding The medical micromolding industry is still fairly young, but is rapidly growing and evolving. Being aware of shifts in trends and changes in technology helps to see where ¬and how¬ the next major innovations and breakthroughs will occur.

Breathing Tubes -- Flow Rate with Back Pressure Specification
When it comes to breathing tubes, CPAP tubes, and any devices with similar air masks that support respiration, too much or too little air flow will impact the amount of oxygen the user gets, which can be dangerous.  Air flow within these devices must fall within a very tightly specified flow range. 

Coating Makes Drawing Stainless Painless
Metalformer Penn United Technologies, Cabot, PA, produces laminations and complex parts to exacting specifications. In many cases, stainless steel comprises the part material. For difficult stainless-steel forming, the company has chosen to employ a physical-vapor-deposition (PVD) tool coating.

3 Tips to meet FDA and IEC 62304 requirements
Medical device development is costly and time consuming. With stringent requirements driving the regulatory process, it is important to be prepared and organized throughout your product development journey. Here are 3 quick tips to ensure your process is efficient and prepared for FDA approval while meeting I

Die-Design and Simulation: Proven Successes
A look at how companies can and do use the technology to improve productivity and reduce mistakes when designing and building dies.

Design for Manufacturing (DFM) – Increasing Your ROI
Whether the issue is difficulty with product design, prototypes, creating a new product, or looking for a low cost manufacturing solution, both OEMs and manufacturing service providers need to work closely focusing their attention early in the design process to increase overall productivity, create high qu

Penn United Medical - Medical Industry Applications
Penn United's medical team, made up of skilled engineers, toolmakers, and technicians, offers innovative high precision manufacturing solutions to our customers.

What Plasma Does to a Surface to Improve Adhesion
Plasma surface treatment is used to improve a surface’s receptiveness to adhesives, inks, paints & coatings. Three distinct surface modification processes occur simultaneously when exposing a surface to plasma treatment: Cleaning, Etching & Functionalizing.

Ten Quality Indicators for Selecting Metal Stamping Suppliers
A Guide Designed Specifically for Medical Device Manufacturers

Membrane Switch Whitepaper

Expanding Opportunities with a Simplified Supply Chain
Transformational strategies for improving outcomes and cost along the medical device chain

Preparing for Change
Strategies for Reducing Costs and Protecting Profits in the New World of Medical Device Manufacturing

High Impact and Improved Corrosion Resistance 17-4PH Stainless Steel for Rasps, Broaches and Other Bone Cutting Tools
Orchid Orthopedic Solutions has developed a form of 17-4ph stainless steel which, following initial testing, increases the impact strength by up to 5 times and vastly improves its corrosion resistance, whilst maintaining all other properties, such as tensile strength and hardness. This is anticipated to make

HENIAPORE™-K VPS-TITANIUM COATING ON PEEK SUBSTRATE FOR MEDICAL DEVICES
Porous titanium coatings onto polymers are of great interest to medical industries. A vacuum plasma spray (VPS) process has been developed to coat PEEK with a micro porous biomimetic titanium coating. This study reports the experimental characterization of the topography and microstructure and of the mechanic

HENIA1000™ A NEW GENERATION OF POROUS VPS TITANIUM COATING ON METALLIC SUBSTRATE FOR MEDICAL DEVICES
The Henia1000™ has been designed to fill a gap in the market by producing a porous coating outside of the capabilities of a sintered coating. The Henia1000™ Titanium vacuum plasma spray (VPS) process can be applied to Ti6Al4V, CoCr and Zr-alloy substrates, which combines the biocompatibility of titanium with

Technical Data on the Orthopedic TPS Coating
The high chemical reactivity of titanium, especially in its powder form, makes it a challenge to plasma spray correctly. The most protective environment for spraying titanium is a vacuum. Bio-Coat has been vacuum plasma spraying titanium for dental applications for 7 years. We have succeeded in developing