The leaders of the medical and specialty device manufacturing fields are supporting innovation and evolution within the marketplace. This is the best way to support the improvement and process delivery for anyone needing specialty medical device manufacturing.

To this end, special conferences and exhibitions are organized to bring all of the most important players together. This speeds development processes, connects critical knowledge base carriers together and dramatically assists in the further discovery of heightened innovation and development.

Supporting the Evolution of Medical Device Manufacturing

Medical Design & Manufacturing (MD&M) East has developed an ongoing approach to keep this connection between groups of medical device development professionals adding to the inspiration, partnerships, education, and technologies needed. This fuels the drive for medical device innovation.

The next exhibition scheduled is from June 18-20. The next conference is happening from June 17-20. Market leadership for injection molding processes and specialty medical and other device manufacturing will be presenting at these events by hosting booths focused with new information and the newest edge-cutting discoveries to ease and support the device manufacturing process.

Crescent Industries is one of the most dynamic of these presenters because they are an employee-owned company that has helped to stabilize the markets and establish parameters for quality and service expectations for those in need of predictable quality control within the field.

To view the newest information and innovative approaches to processes for medical device manufacturers, be sure to visit Crescent Industries at Booth #3445. 

Up Close, Face to Face and Hands On

The medical device manufacturing industry has been both growing and stabilizing over the last decade. Take advantage of the opportunities to have face to face meetings, access to more information and expertise about the latest technologies, materials and equipment.

Some of the highlights of this event include:

The trend for commodity and engineering resins for the first quarter of 2013 appear to be trending flat-to-down according to an article in Plastics Technology April 2013.  The following pricing information was printed in Plastics Technology April 2013 article “Most Resin Prices Flat or Lower written by Lilli Manolis Sherman, Senior Editor.   ABS is the exception due to good domestic demand and other global factors.  Both PE and PP jumped up in the first quarter but a reverse in feedstock prices, lackluster demand and some improvements in supplier inventories now are pushing prices in the other direction.  The same goes for Polystyrene pricing, PC and Nylons 6 and 66.  This is the overall outlook according to Resin Technology Inc and CEO Michael Greenberg of the Plastics Exchange in Chicago.

HDPE, LL/LDPE Flat

Polyethylene price moves in February were split with HDPE injection molding grades up while LDPE and LLDPE saw no change after the January price increase.  Suppliers were seeking new increases for HDPE and LL/LDPE but implementation is doubtful because the lack of demand and declining monomer prices according to Mike Burns , VP of PE at RTI.  The move to hike HDPE prices was attributed by suppliers to increased demand and low inventories.  The tightness in PE supply appears to be more directly linked to pre-buying late last year in anticipation of price hikes and export demand.  Both Greenberg and Burns agree that, ethylene supply/demand should be quite well balanced. 

PP Prices Up but Not for Long

Polypropylene contract prices moved up in February following propylene monomer contract prices penny for penny.  This came after PP prices surge by in January, following the monomer’s increase plus a surcharge.  But a downward trend appeared imminent as at least one propylene contract price nomination in early March posted a reduction. 

Scott Newell, RTI’s director of client services for PP, foresaw a drop in monomer and PP prices in March with potential to keep going even lower.  Newell says “monomer tabs are expected to move downward from May through the fall” and he projects PP prices to follow suit.

Newell says February demand was very weak as there was a clear response from the industry to the sudden, whopping increases.  While some rebound in demand is likely, Newell says he does not expect much more growth this year over that of the last two years.

PS Prices Down

Utilization of sound scientific principles for your injection molding process are mandatory for consistent, repeatable, high quality production results. This process includes a sample run of your part at the end of the process
in order to guarantee correct molding and function.

Process engineers utilize scientific molding to decide both optimal molding conditions - as well as the molding window before going to production. Measurement equipment is needed for real-time monitoring of these production processes. Having an ability to measure both consistency and efficiency is a critical advantage.

Traceability for higher-end applications is required for products manufactured for the medical devices, defense and aerospace industries. This means having automated containment control over processes so suspect production quality can be diverted.

Evaluation of Critical Dimensions

A first article inspection is also needed for measurement of product specifications. Capability studies are also often required for critical dimension evaluation. This way variations can be detected and adjusted.

Limits are usually tested by the DOE (design of experiments) process during pre-production planning. This way effects on measurements, part attributes and other issues can be accurately gauged for repeatability and reproducibility.

Cavity pressure sensors are also used. This sensor is installed across form the gate end near the close of the final section fill. Molders will set sensor thresholds while close loop control combines gate and opposite gate-end sensors for making changes to compensate for machine fluctuation.

When pin and cavity sensors won't register pressure - the press automatically diverts parts using a chute or a conveyor. For consistent cavity packing, the press makes viscosity adjustments.

Important Scientific Injection Molding Principles 

Scientific injection molding enhances and streamlines the concept to assembly line process for augmented reliability and efficiency. Principles are now standard for use with scientific enhancements.

Validation processes can be daunting. Overcoming the hurdles to success can take a year for large scale systems. With robust validation systems and detailed product specifications, the process can be fast and efficient.

Partnering with experienced plastic injection molding manufacturers makes it possible to anticipate and plan for device production processes that meet all necessary regulatory, quality and commercial standards.

Reliable Approaches to Assembly Validation

In order to validate per ISO 13485 companies need to verify the device has appropriate manufacturing processes.  Regulations 21 CFR Part 820, specifically sections 820.30 (g) and 820.75 (a) require medical device manufactures to validate both the design of the device and processes used to manufacture the device.

According to the standard, ISO 13485, section 7.5.2.1: says that organizations need to validate processes for production and services, especially where provisions affect resulting output that cannot be verified by monitoring and measurement after-the-fact.

In the past the FDA overlooked the validation of components manufactured by suppliers however, in the last few years; they have looked beyond the finished device manufacturer and many times have zeroed in on the validation of supplied components.

21 CFR 820 820.30 (g)

Reliable design validation, according to this mandate, needs to be performed within stringent conditions. Validation includes making sure devices conform not only to the user design needs, but also intended and simulated uses.

Validation can include software processes, design identification and thorough documentation of details such as signatures of individuals who are performing various stages of validation.

A common popular method for cleaning plastic injection molds continues to be rooted in antiquated processes like scrubbing plates and tooling--one piece at a time.

The usual reasons;

• “This is the way we have always done it”
• “We cannot cost-justify other methods
• “Other methods do not clean as well”
• "We’re too busy, and there’s no time to experiment or investigate other methods.”

These obvious excuses cost companies thousands. It also costs in wasted time, worn tooling and inconsistent results. Cleaning typical injection molds and tooling components can be simpler, less time consuming and more cost effective.

Cleaning with Ultrasonics

Ultrasonic cleaning means using high-frequency sound waves. Injection molds with residues or fouling resulting from plates and tooling are immersed while heated in an aqueous solution of about 170 degrees.

Ultrasonic electric generators are used to convert a standard-line frequency current (60Hz or 50Hz) into high-frequency electrical energy (20,000Hz).

Connected generators host little transducers mounted to the bottom or sides of a wash tank. The transducers vibrate. These ultrasonic frequencies vibrate at 20kHz and above as this current passes through. This causes the bottom and sides of the tank to vibrate.

The vibration creates microscopic bubbles that loosen and scrub vent grime and residue. Energy is released from the microscopic scrub bubbles that produce forces of 10,000°F at 7,500 psi--powerful enough for loosening contaminates without damage to primary edges and surface finish.

Considerations for Ultrasonic Cleaning

This process and the types of resins being run will determine needed types of detergents that will be required due to specific kinds of all-gassing residue from resins.

Sodium hydroxide offers alkalinity for the job of removing stubborn contaminates. It is effective for heavy grease to light rust on most tooling and plates. There is no harm to most applied plating and coatings. Mild alkaline solutions available perform well on most residues with no caustic issues.

When companies are smart enough to take advantage of the expertise of their molding partners, the result is to have the most effectively molded parts possible.

There are many nuances and intricacies in the process of creating precision injection molded components. These fine details and comprehensions are best addressed by those who deal with them daily.

When presented with the challenge of producing medical parts, for instance, numerous designs and production issues such as aesthetics, design-function or maximized-optimization all need to be addressed.

Overcoming Intricacies: Medical Molding through Collaboration

All part designs must be mold-able. The mold and process must be well planned. Molding processes must incorporate very high levels of precision.

These are important considerations for any quality product emerging from any industry. Yet medical parts demand the highest available levels of expertise.

Poor designs create product flaws that present significant safety concerns. All weak-links in design or fabrication processes totally compromise the integrity of the final part - while leading to expensive redesign.

Collaborative efforts are the most effective approach for all involved parties to safely guarantee the parts are of the best design for ease-of-manufacture-ability.

To this end, designers should always rely on all expertise available from both mold-making partners and molding partners alike.

Highest Quality Parts and Design Emerge from Expert Cooperation

The most successful precision injection molded components are produced when the part designer, manufacturer and tool designer have all come together to offer ideas and input from the earliest possible stages of development.

Through this active, constant cooperation--any team of precision injection molded component designers can avoid the common molding snags and produce more efficient and cost-effective parts.

Confirm All Part Designs and Materials

The starting point for all quality production of finished pieces is part design. This drives the whole development process while setting the course for your precision injection molded components from mold design through production.

The specific features of any part’s design will hinder the tool-building and molding stages if not completely comprehended early-on in collaboration:

Every injection mold operator holds an opinion about how molds should be gated. Debate is vibrant about how many to use, where they can be placed, and what size or shape is best.

Most implementation of great mold designs emerges from experience, regardless if they are coming from a mold maker, a molder or material suppliers. Other heavy influences include aesthetic constraints of part designs such as gate vestige or the knit-line appearance - or by any number of tooling constrains like slides or lifters, for example.

Many have wished for a simple tool to predict how gating schemes are going to affect molded parts.  Injection molding simulation requires engineers with years of experience. Careful analysis needs specialized software for study of the injection molds. The true power of simulation software lies in your engineer's ability to get the best possible results.

Determining Optimum Gate Locations

The considerations are many. Tradeoffs appear along the way as well. Simulating every different gating possibility provides the way to determine the best overall choice which helps every other stakeholder make sound decisions based on project priorities.

Gating schemes can't be determined without considering part aesthetics:

• Are you working to avoid a visible gate vestige?
• Are there areas where visible knit lines are inappropriate?
• Will sink marks appear in ribs or thick wall areas?

Part Aesthetics: Using Simulation for Locating and Sizing Gates

When considering gate positions--what is good for knit line placement may not be best for warpage, fiber orientation or pressure balance among other things. Flow balance and flow direction are the next questions to address.

There are several risk factors for injection molds and easing those is the key to a strong supply chain that meets production requirements, aides in reducing the costs of manufacturing, as well as greater productivity, efficiency and higher quality.

Many OEM’s forget to consider the many risks involved when sourcing molds for molded components. Risk factors for injection molds and ways to ease them include but are not limited to:

• How many cavities are in a mold – the more there is cavitation, the greater the risk of parts that don't conform.
• Your mold-maker needs to be able to produce higher-cavitation molds with well-balanced runner systems. This provides cavity-to-cavity consistency and repeatability. The hardest case would be closing off cavities to avoid non-conforming parts from specific cavities.
• High numbers of critical dimensions intensify the risk that holding those dimensions will be much harder, causing the cost of quality to be much greater.
• High numbers of critical dimensions also means more in processing checks will be required, which adds to unit prices of parts.

Lifesaving innovation begins at MD&M Florida at the Orange County Convention Center in Orlando on March 6 & 7, 2013.  MD&M Florida will help to connect inspiration, partnerships, education and technologies that drive medical device innovation. 

You will find resources to solve your toughest medical device design, engineering, prototyping, manufacturing, assembly and packaging challenges whether you have an active project or an upcoming project, you’re certain to find what you need.  For example:

• Assembly and Automation Solutions
• Cleanroom and Sterilization
• Contract R&D, Design , Engineering
• Manufacturing Partners
• Electronics, Components, Subassemblies
• Sophisticated Medical Grade Materials
• Medical Packaging
• Testing, Inspection, Quality Control Products and Services
• Plus much more!

This information comes directly from the article “7 Myths on Purchasing Injection Molded Parts and Injection Molds” written by Bill Tobin.

Many companies think the purchasing of a mold is the tooling necessary to produce a part.  While correct there are some considerations that need to be made before your purchase.

Myth #1 Always buy the most economical mold.  Economical does not necessarily mean the lowest purchase price.  (Even if that’s the only budget you’re concerned with.)  If you take the lifetime volume of the part multiplied by the part price, add in the tool cost plus 15% for maintenance, then divide by the total lifetime volume you’d get the overall cost of that part.  As a second calculation, repeat this using the prices from several quotes.  While a mold will probably be between 15-25% of all the money spent on this project, the impact the “high” bidder or the “low” bidder on the total project is minimal.  Don’t waste your tooling dollars but consider the overall cost of a mold before placing the job.

The folks you know can probably deliver the best tool because they know you.  Going to someone you’ve never done business with or can’t give you a good feeling about being a good match is going to be an expensive education.    Calculate the total cost of the mold – even though travel is “Not my budget”, placing a job in Singapore is usually an invitation for a Road Trip for everyone with Manager on his business card.   Keep in mind how many days/person will be spent on following up etc.  Also remember the money spent on trips is coming from the company profits regardless how the bookies try to hide it somewhere else.   Once the mold is released from the mold maker and sent to the molder, who will do the tweaking to get the mold on-line?  Who will do the maintenance if they are not the original builder?  Who controls the designs or CAD/CAM drawings so that replacement parts can be manufactured?