5 Common Medical Injection Molding Business Mistakes

Polymer Conversions, a contract manufacturer for medical injection molding , always has a recurring theme when customers come for their first visit.

Clients are always highly impressed with the cleanliness of the facility on a day-to-day basis; they enjoy the family-friendly nature of the entire PCI team and its culture; the experience and dedication brought to the table from a cross-functional and customer-centric management team is second to none; and the amount of detail and attention Polymer places on design, functionality and overall manufacturability of the product(s) being discussed is as much of a priority for them, as it is for the customer.

Other medical injection molding companies however, seem to ignore the basic fundamentals of running a world-class facility.  This translates into an advantage for a family-owned business such as Polymer Conversions.  Quite often they see these other common missteps being made in their industry as well:

  1. Quoting (“apples-to-apples”)Many contract manufacturers skip the time and detail necessary to put into quoting a job properly with the customer’s best, long-term interest in mind.  For years, Polymer’s team has seen companies choose the quote with the lowest price, which often means the customer isn’t receiving all the facts surrounding the investment that was just made.  They will likely see add-on fees or increases in other areas earlier in the relationship than expected so that the supplier can attempt to make up for dollars lost quoting low to secure that job.
  2. Service: More than 40% of the work in-house at Polymer Conversions is from medical injection molding programs being transferred in.  Much of this is due to a customer receiving unsatisfactory service, inferior quality or a lack of honesty and transparency from their previous supplier.   Polymer’s approach is more about considering the customer’s entire manufacturing process and honing in on how PCI can partner Medical Moldingwith the company as an extension of their business rather than becoming just a “supplier” of components, assemblies, and complete devices.  Pooling resources and working together through constant communication and collaboration during the entire partnership, allows Polymer’s team to lower the customer’s risk considerably.  Sadly, there are many contract manufacturers that won’t bother going this extra mile for a customer because there are costs involved.
  3. Validated Manufacturing: Many medical injection molders do not use a validated system for process or product control during manufacturing.  This leaves a high level of risk for the customer to manage.  At Polymer Conversions, they use a Real-Time, Fully Validated Product & Process monitoring system that is networked to all 23+ injection molding presses, and is continuously backed up through a cloud-based and secure server off-site.  This allows customers to have instant records of the conditions and environments under which all injection molded products were manufactured.  It also ensures batch repeatability and reproducibility for world-class quality and service, which the customer both expects and deserves.
  4. Safety & Cleanliness: Most injection molding machines and auxiliary equipment come with basic safety features, which seems to be enough for most other contract manufacturers.  Polymer, on the other hand, goes above and beyond to install additional guarding and safety components once the equipment arrives in their facility.  Not only are their employees incredibly safe throughout the plant, but customers and guests also have the highest level of safety and comfort while touring through each department.Cleanliness is second nature to Polymer teammates.  Keeping the facility and its equipment in “as new” condition and providing a clean, neat and safe work environment throughout, is mandated by ownership.  All employees are trained on cleanliness expectations when hired, and are encouraged to foster this environment the entire length of their employment.A large percentage of medical injection molding companies still do their manufacturing in old, antiquated buildings that are dirty, unorganized and house abused equipment.  These are the suppliers that usually offer cheaper pricing on quotes because they are not re-investing in their facility, equipment, a skilled workforce, or the processes used to create the customers’ products.  Precision, cleanliness, quality and high-tech solutions are not attainable under such conditions, which is why Polymer Conversions chooses to purchase brand new pieces of equipment, and fully validate them prior to being used against a customer’s purchase order.
  5. Skilled Labor: Manufacturing environments are well known for high turnover workforce rates.  It seems the larger a company becomes, the less focus and attention is paid to its “people” because they are too preoccupied with creating profits for shareholders and top management.Polymer believes in the exact opposite.  Slow, controlled growth with a focus on a family environment and its people, have been two of the highlighted strategies from the owners.  Hiring skilled employees can be difficult, but Polymer has proven they can, and do, secure some of the best.  Turnover in their organization is very low, with an average of 13½ years for employment length (and that does not count the earlier years of employment from people that had left for other experiences and come back).Operating with a “family” atmosphere helps workers feel appreciated and important, especially considering they spend a majority of their waking hours at work, and away from their families.  Longevity of employment contributes to a larger company-wide skill set.  It also helps provide an environment for cross-training, continuing education, and movement for the employees within the organization.  This may cost more in overhead, but Polymer believes that that investment is critical to its growth and success.

Global pressures from the medical and pharmaceutical industries will continue to tighten from the top down, which makes focus in each of these five areas so important.  It is crucial, especially for small businesses, to keep true to their missions, visions, goals and ideals.  A full-service medical injection molding company like Polymer Conversions, should never lose sight of the most important parts of a business; parts that are necessary to help its customers be highly successful by keeping them at the forefront of technology, and in front of their competition.

Value-added Medical Device Injection Molding Services Save Time and Money

When Polymer Conversions, Inc. uses the term “value-added” or “secondary services”, they are referring to the post-molding operations that are done to precision thermoplastic components they produce in their Western New York medical injection molding facility.

Before a project starts, PCI engineers find out the customer’s current method of manufacturing, assembly, and packaging, whether it’s done at their own facility, or outsourced to suppliers.  The team then figures out whether processes can be consolidated and brought in-house to Polymer, saving the customer from having to invest thousands of dollars in areas that they’d rather not waste their time and resources on.  This means OEM’s and small start-up companies worry less about overhead, raw material inventory, machinery/asset expenditures, tracking the performance of multiple suppliers, etc. and can concentrate more on what really matters – the bottom line.  It would allow their personnel to re-focus on designing next-generation products, beating competitors to market, and ultimately increasing overall profitability.

Some of the most common processes performed at a turnkey contract manufacturer such as Polymer Conversions are:

Pad printing (decorating) (“pad transfer printing”) = is one of the most popular “secondary” services performed at the Orchard Park medical injection molding facility.  Customers can utilize this service to create visual interest with logos and graphics, graduated scales, contact information, or usage instructions.  Processes like shrink wrap applications and silk screening can be messy, time consuming, and are usually limited to simple product geometries.  These processes also lack the precision output that a cliché and silicone pad can gently transfer to critical medical device components.  All inks used, are permanent and specially formulated to adhere to thermoplastic resins that range from standard stock to highly engineered resins.  This allows the printing to withstand the constant use of hospital cleaning agents, high-volume handling, and/or environmental factors such as water, sun, and pollution.  PCI can print just about anything, and can process from one part at a time, to a 2-color roll printing station, to using a 6-station pad printing cell that can decorate parts with multiple colors using quick dry ink.  Less popular processes that are still available include the hot stamping of foils, and adhesive/pressure sensitive label applications.

Ultrasonic welding (joining) = another highly performed value-added service is the ultrasonic welding of components.  Many surfaces can be joined together, including: two plastic components, a plastic component and a paper filter, etc.  The advantages of ultrasonic welding are the accuracy, quality, cleanliness and speed.  When done properly, there should be no flash and components should seal together airtight.  In addition to the standard operator-aided assembly, the Polymer team also utilizes Fanuc 6-axis robotic assembly cells and in-line vision systems in their medical injection molding facility, to ensure every product produced gets 100% quality checked for critical dimension accuracy, and presence of all required components.  Spin, vibration or hot plate welding is also available, although not as popular.

Heat Staking Thermal Inserting = There are a few different versions of “heat staking” or “staking”, but full-service medical injection molding companies like Polymer Conversions, prefer the thermal pressing of inserts into pre-molded thermoplastic bosses, for the assembly of various sized brass inserts.  This process provides permanent insertion and if programmed properly, shows no burn or sink marks and is ultra-precise and particulate/flash free, which is ideal for the assembly of medical device components that need to be disassembled by the end users for easy cleaning or repairs.  The difference with this type of insertion is that the staking post enters the inside of the insert to heat it from the inside out, melting the plastic directly contacting it at just the right temperature to flow around the outer threads and to grip the knurls for proper seating.   Polymer’s machines are customized to handle multiple sized inserts seating at different depths at the same time.  Coupled with 6-axis robotic assembly stations and in-line 100% vision systems, this saves the customer time and money by leaning out the process for quicker lead times and the critical requirements of repeatability and reproducibility that is a must-have for medical device manufacturers.

Two-shot molding (or “over molding”) = the use of soft-touch plastic material over-molded onto a more rigid first-shot plastic component, offers a unique look and feel, allowing end users to comfortably grip the product so that it doesn’t slip from their hands.  This is a highly desired feature on medical injection molding products that are used in an environment with the potential presence of liquids, such as hospitals.

Product packaging, bagging, kitting =  If a customer can find a full-service medical contract manufacturer like Polymer Converisons who can produce precision plastic parts, provide in-house value-added services and also do full packaging/kitting/labeling of those products produced, they can keep their supplier base extremely small.  It gives them less suppliers to audit and oversee, as well as the confidence that they are getting the highest levels of quality, precision, repeatability and reproducibility.

Onshoring your Medical Device Injection Molding

Onshoring your Medical Injection Molding is the RIGHT thing to do. The economic financial crisis of 2008 gave cause for American Original Equipment Manufacturers (OEMs) to take a deeper look into their business models.
They studied alliances with business partners & suppliers, looking for ways to streamline processes, lessen expenses and re-gain profitability for stakeholders.

With uncertainty came the shift of outsourcing medical injection molding and assembly processes to overseas manufacturing companies in an effort to reduce costs, assets and overhead. China, India, Mexico and Brazil were the top four that benefited from this trend. China was the largest recipient despite their reputation for lower quality and dirty, unsafe work environments in their medical injection molding facilities. As a result U.S. manufacturing lost jobs, some plants closed, and angst was felt amongst suppliers that had projects pulled from their factories simply based on cheaper pricing.

It only took OEM’s a few years to figure out that their decisions to follow the trend meant something other than obtaining positive results. Serious issues began to plague their businesses in other ways unforeseen:

Lead Times = the length of time it took from purchase order placement to product receipt ended up being much longer than originally anticipated. Lengthy transportation time by cargo ships and even air transport took its toll - each with its own exhaustive international paperwork and shipping procedures.

Intellectual Property (IP) Issues = everyone knows that patent/copyright infringement & reverse engineering is rampant overseas. Stolen product designs later sold in a medical device market are cause for high concern. Device failure from a product that appears to have been manufactured from a global device maker, but indeed was not, could ruin that company’s reputation and cause millions of dollars in financial damage. As a contract manufacturer, Polymer Conversions Inc. signs non-disclosure agreements (NDAs) as well as confidentiality agreements, before they work with product designs, to exemplify their commitment to the customer’s right to privacy.

Cultural differences, language barriers & lack of technology = unless these overseas suppliers have English speaking employees or the OEM hires a translator to make sure their critical specifications are met for medical injection molding, the supplier has little chance at keeping the business it just pulled from the U.S. manufacturing sector.Medical device manufacturing must have complete document & process/design control, and full understanding of what the customers’ expectations are for their final products and its end users. Any misinterpretation of critical specifications at any point in the manufacturing process, and it could mean costly mistakes that could also impede time-to-market. A lack of robotics, in-house tooling and engineering expertise, as well as a lack of scientific injection molding knowledge, makes for an unattractive long-term partnership. Polymer Conversions, however, thrives in these specialized areas and has a no-risk, comprehensive and fully documented transfer tooling program to keep your products on-track for market entry.

Quick flexibility = for an American-based company to outsource its processes outside of the United States, it must deal with the challenge of slow reaction times to changes in production requirements or tool revision changes during early stage validations. Polymer is incredibly flexible and quick to respond when it comes to a customer’s increased production runs, tooling/part dimensional changes, or emergency pull-in requests. Everything is handled by a highly skilled, cross-functional team so that no detail is left untouched.

Strict Quality Management System (QMS) = some overseas suppliers tout that they use a QMS and follow procedures, but most are found to be quite inadequate once an OEM has visited them to do an in-house audit of their medical injection molding facility. To keep costs low, they cut corners and have poor record retention and document control, which is unacceptable to the medical device industry in the U.S. Any OEM that does not do its due diligence to audit a new foreign supplier (or even a domestic one) and keep vigilant during the entire length of their business together, is risking product quality/safety, a visit from the FDA, a failure in the field, and a ruined reputation.

This just scratches the surface of the extensive list of issues facing OEM’s today. Although China’s economy and medical device quality has seen a bit of an uptick, there are still many issues to be addressed before they can be considered a true solution to bottom-line profitability. Mexico will always be used for low cost labor but their volatile environment, lower quality and lack of ability to keep up with the expertise and technology of the U.S., will still keep them as a less-than optimal selection. Polymer Conversions, Inc. believes Western New York lends itself to an ideal manufacturing corridor. It’s close to the Canadian border, Eastern seaboard, Buffalo/Niagara Int’l. airport, can easily service the entire country, and as of 2014 is 15 minutes away from a new medical innovation center located at the University of Buffalo (UB). There are no tsunamis, hurricanes, typhoons, mudslides, floods, earthquakes, etc. that effect the Orchard Park, NY location. They also have a formal written Disaster Plan should anything out of the ordinary occur.

The OEM’s focus should now be shifted to supplier consolidation, reducing the base to only a select strategic few. Only those manufacturers, like Polymer with true full-service capabilities, the ability to stay technologically advanced, and who are highly committed to the strict standards of the FDA and ISO, will win new business returning to the States.

Polymer Conversions, Inc. is a world-class, full service contract manufacturer that focuses on medical injection molding, tooling, engineering and value-added post-molding services. Their Validated Product & Process Monitoring System linked to every injection molding machine captures real-time SPC & provides accurate & retrievable document control for each batch produced, proving highly repeatable and reproducible throughout the product’s life cycle.

Medical Contract Manufacturing in Western New York

MedTech, the leading voice of bioscience and medical technology (Bio/Med) in New York State, today released its 2014 Bio/Med Industry Report, Bio/Med Breakthroughs: Advancing New York State’s Innovation Economy, at MEDTECH 2014. The report is sponsored by the National Grid, the Workforce Development Institute (WDI), NYSEG and RGE.

According to the report, pharmaceutical preparation, in-vitro diagnostic substance surgical appliance and supplies manufacturing as well as life science commercial research and development are emerging subsectors in Western New York, where employment rose by 4 percent between 2007 and 2012.

Responses and numbers indicate workforce and talent development is a major strength for Bio/Med in New York State. Western New York and the neighboring Finger Lakes region are the most-targeted area for recruiting bioscience talent. The Rochester Institute of Technology, University of Rochester and the University of Buffalo are the top three education pipelines in New York State.
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(via http://www.medtech.org/)

Custom Injection Molder helps inventor successfully market device

A new product and a new partnership are leading to success for custom injection molder Polymer Conversions Inc. and its customer, SensGard LLC, maker of hearing protection devices. Rob DiNardo and Greg Post, co-founders of SensGard LLC in Fairport, NY, obtained an exclusive license from Syracuse University to manufacture, market, and sell a technologically advanced hearing protection device developed by Jozef Zwislocki, a former Harvard Fellow from Switzerland, former professor at Syracuse University, and research fellow who founded the Institute for Sensory Research. Zwislocki maintains an office at Syracuse University.

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(via http://www.plasticstoday.com/)

Full-Service Contract Manufacturer exemplifies opportunities for WNY

Bioscience and medical technology (Bio/Med) companies are taking advantage of numerous opportunities in New York State, where support for the industry has led to recent growth.

Buffalo-based Polymer Conversions, a full-service contract manufacturer specializing in clean room manufacturing for the healthcare industry, recently expanded its clean room manufacturing capabilities by adding an additional 22,000 square feet to their headquarters in Orchard Park. They excel with products such as enteral feeding pumps, disposable syringe components, hearing protection devices, drug delivery systems and ear, nose and throat devices. They also recently established Silikon Technologies LLC, a new sister company created to support customers’ needs for silicone injection molding in the healthcare, aerospace and electronics industries.

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(via http://nybiomedreport.com)