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Market Focus: Medical 19412

May 3, 2000

9 Min Read
Market Focus: Medical

Medical molding hasbecome an appealing market for many molders. This is due in partto several factors: Medical ailments and their treatment occurindependently of the larger market forces that make other industriesso volatile. Also, as the baby boom generation ages, the demandfor medical products and services is expected to grow enormouslyover the next decade. Couple these two factors with advances inbiotechnology, and you have new and interesting applications andproducts popping up all over. And where there's product, there'splastic.

It was on this last topic that IMM recently spoke withthe sales and marketing manager at a major injection molder servingthe medical market. We probed this person, who requested anonymity,for his thoughts on good growth opportunities in the medical market.

Topping the list are specialty drug delivery systems. "Thehigh growth areas are on the pharmaceutical side, primarily pharmaceuticalpackaging and drug delivery systems specific to respiratory careand diabetes," he says. "There are a lot of new productscoming onto the market where you don't have to administer thedrug through a needle. They're giving it other ways, whether it'sthrough a continuous feed system or an inhaler-type product."

Two company names that spring to mind as examples are MiniMedand Inhale Therapeutic Systems. MiniMed, based in Sylmar, CA,makes an external insulin pump for diabetes patients. It's aboutthe size of a small beeper, clips on a belt, and continuouslydelivers insulin to the wearer at a customized and preprogrammedrate. MiniMed also makes an internal insulin pump, sort of a fauxpancreas, that is currently wending its way through the FDA approvalprocess. Both products are appealing as they eliminate the needto inject insulin with a needle. Both also present molding opportunities,mainly for enclosures and cases.

Inhale Therapeutic Systems, based in San Carlos, CA, specializesin developing drug delivery systems that use inhalers. The increasein asthma diagnoses worldwide makes such products popular, butthis firm hopes also to treat nonrespiratory ailments, such asdiabetes, with inhalants. Inhale's current product consists oftwo molded parts assembled to make an inhaler.

Our molder says his company expects growth in this segment to be greater than five percent annually for the next several years. Anotherpromising segment, he says, is the point-of-care product line.These include products that health care professionals can useto quickly and easily test for pregnancy, strep, diabetes, andother medical conditions. They're disposable, one-time use productswith a high percentage of molded components. See Table 1 for amaterials outlook in medical applications.

Finally, a term that's received much attention in the computermarket is now used on the medical side. Contract manufacturingis the term, and this molder says he's looking more for jobs thatoffer assembly or other value-added components.



Precision a must for pressure catheter

Monitoringcontractions when a mother-to-be is in labor is a critical partof the birthing process. These intrauterine pressure catheters,which are molded and assembled to exacting standards, do the job.

The catheter is designed and manufactured in Cherry Hill, NJby Ludlow Technical Products. It consists of a male connectorthat plugs into a contraction monitor. The other end consistsof a 1.75-inch polycarbonate connector that interfaces with ablue extruded component. This component performs the intrauterineduties and consists of an overmolded pressure sensor, providedto Ludlow by Illinois Precision.

Ludlow's responsibility is molding and assembling the connectorto which the blue catheter connects (see photo). Each unit istested before it goes out the door and must meet dimensional,performance, and pressure standards. The connector is molded byLudlow in two halves in a four-cavity mold on a Boy machine. Afterejection, the extruded catheter with leads is placed in one halfof the connector while the top half is welded over it.

Frank LaFrazia, manufacturing support resources manager atLudlow, says originally the design called for overmolding theconnector around the catheter, but concern developed about thenegative effects of high temperatures and the possibility thatthe catheter might shift in the mold. By moving to a welding process,Ludlow got better consistency and higher quality.

"The sonic welding process is consistent, and it's builtsuch that you get audible and visible signals of failure or out-of-specoperation," says LaFrazia. The Boy molding machine moldsthe parts in a portable cleanroom equipped with Hepa filters.

For more information:
Boy Machines Inc.
Exton, PA
Phone: (610) 363-9121
Fax: (610) 363-0163
Web: www.boymachines.com


Talc-filled PP goes to work in speculum

Thereare still applications in the medical field where thermoplasticsoffer not only a cost benefit, but an aesthetic and tactile benefitas well. In such an application, a talc-filled polypropylene calledPolifil, supplied by The Plastics Group of America, has been draftedfor use in a speculum used to conduct gynecological examinationsfor pap smear testing.

The material, used to mold the yoke portion of the speculum,replaces metal blades that require sterilization and cause notoriouspatient discomfort due to the coldness of the metal.

The speculum, manufactured by Welch-Allyn Corp. (SkaneatelesFalls, NY), features two ratchets built into the yoke for adjustmentand release of the speculum. Molded-in teeth on one part of theyoke work together with a ratchet to open and close separatelymolded acrylic blades for conducting the exam. Neil Hoselton,commodity manager of plastics at Welch-Allyn, says the use ofmolded plastic yokes has proved popular. "We see a trendtowards the single-use, disposable parts in the medical industryin general," he says.

During molding, this part requires consistent lots of materialto ensure tight tolerances and proper operation. A 16-cavity,valve-gated hot runner mold produces the parts in four colors.

For more information:
The Plastics Group of America
Woonsocket, RI
Phone: (401) 767-2700
Fax: (401) 767-2823
Web: www.plasticsgroup.com


Bed rail aids in birthing

Duringthe birthing process, patients rely on the efficiency of theirbed for movement, while caregivers need easy access to the patient.This birthing bed rail, developed by Hill-Rom (Batesville, IN)and molded by GI Plastek (Westlake, OH), consists of a three-partclamshell unit with a side rail component designed specificallyfor labor and delivery.

The rail, molded in a single-cavity tool, is produced via gasassist on a 500-ton machine from a UL-V2 flame-retardant polypropylenefrom M.A. Hanna. The use of filled polypropylene reportedly reducesexcessive flex, and features uniform wall thickness despite thepart's diameter thickness of almost 2 inches.

Gas assist allows for seamless tops on the side rails and therollover shroud between the patient and caregiver sides, reducingthe risk of accumulating moisture and biohazard material. Thenew design eliminates the need for a premolded gasket, and steelhex bars have been inserted for strength and to reduce torsionaldeflection.

For more information:
M.A. Hanna Co.
Cleveland, OH
Phone: (216) 589-4000
Web: www.mahanna.com
E-mail: [email protected]


Pump rotor benefits from polyaryletherketone

Thereare reportedly about 650,000 bypass operations performed eachyear worldwide. With procedures like bypass surgery, the surgicalinstruments and materials from which they're made must adhereto strict biocompatibility and purity guidelines. In the caseof an intracardiac micro blood pump, manufacturer Impella CardiotechnikAG of Aachen, Germany specified criteria for an optimum ratioof strength to ductility.

To do the job, Impella selected a polyaryletherketone fromVictrex USA to mold the pump's rotor. Not only does the materialdemonstrate good heat resistance, but because the rotor has directblood contact, the material's haemo compatibility is crucial.

The rotor, which is injection molded around a small metal insert,is designed to turn at more than 30,000 rpm to ensure a pumpingcapacity of 1.17 gal/min. "Because the rotor's blades requirehigh mechanical strength at very thin wall sections, injectionmolding requires a high-flow, processible polymer," saysKevin Jennings, marketing manager for Victrex.

For more information:
Victrex USA Inc.
West Chester, PA
Phone: (601) 696-3144
Fax: (601) 696-5702
Web: www.victrex.com


Surgical tray combines metal and plastic

Traysused to store, protect, and ship expensive medical instrumentshave to be durable and resistant to high heat and chemical exposure,while still providing options for customization. Manufactured,molded, and assembled by Poly Vac (Manchester, NH), the new Modultainer2 Hybrid was designed with the strength and stability of a metalbase and the flexibility of plastic components to custom configureeach tray.

The plastic snap-on brackets are press-fit with stainless steelpegs into a cross-shaped pattern machined into an aluminum base.This design allows the user to change and arrange the dividersinto a variety of configurations. The brackets and dividers, moldedin single-cavity molds on a 500-ton machine, are made of BP AmocoPolymers' Radel R polyphenylsulfone, which is resistant to autoclaving,the most common method of sterilization for medical procedures.The resin also reportedly demonstrates high impact strength.

"The material shoots easily," says Aaron Lamb, injectionmolding project engineer at PolyVac. "But one challenge isthe material's melt flow index, which fluctuates from 14 to 22.Still, there is almost nothing else out there that will take therepeated exposure to medical sterilization."

For more information:
BP Amoco Polymers Inc.
Alpharetta, GA
Phone: (770) 772-8200
Fax: (770) 772-8730
Web: www.bpamoco.com


Device frees dentists' hands

Dr.William Costello, a practicing dentist for more than 20 years,set out to develop a product that would solve the problem of howto hold the tongue and cheek away from the dental drill, keepthe patient's mouth open while using suction, and provide thedentist easy access to the surgical area. Managing the logisticsof this procedure has been a chronic challenge for dentists fordecades, and products designed to solve this problem never quitehit the mark.

Costello devised what he thought was the solution to the age-oldproblem and worked with Radius Product Development (Clinton, MA)to create the Hi & Dri. It's a one-piece disposable oral isolationdevice that creates 3-D space in the mouth in which the dentistcan operate in an efficient manner. It eliminates the need forcotton rolls, tongue depressors, and cheek retractors. Also goneis the need for an assistant to handle each item for the dentist.

Molded of an FDA grade polypropylene, the Hi & Dri is madein an eight-cavity tool and assembled by injection molder Nyproat its Chicago facility. This complicated part consists of a two-part,injection molded design that is assembled via ultrasonic welding.The complex C-shaped parting line is a molding challenge, as isthe fact that the part itself contains no flat lines.

The Hi & Dri was developed by Radius in cooperation with Costelloand Nypro. The design phase consisted of 3-D database testingand relied on the extensive use of Pro/Designer and Pro/Engineer.Stereolithography parts were created to assess surface geometry,and soft (RTV) tools were used to produce small quantities ofparts for testing. A prototype mold made parts for clinical testing,the results of which necessitated further design changes. Alltold, it took just eight months to design and engineer the Hi& Dri and start clinical testing.

For more information:
Radius Product Development
Clinton, MA
Phone: (978) 368-3200
Fax: (978) 365-2299
Web: www.radiusdevelopment.com

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