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Hong Kong shows open minded thinking
on its regulations
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A brief commentary in Medical Design Magazine last year suggested
the time was right for a sort of ISO FDA, a worldwide organization that
would regulate the introduction of medical devices and give all device
makers in all countries the same rules to work by. The more you think
about it, the more sense it makes because there are dozens of such
organizations around the world, each with its own mountain of
regulations. Admittedly, there is a positive aspect to many regulations:
keeping track of changing rules provides job security for thousands at
device companies and consultancies. It’s not value-added work, but it
is necessary.
Two news items in this newsletter deal with changing regulations. In
Canada, Bill C-51 proposes far reaching changes to the country’s food
and drug laws. The other item, from Hong Kong, shows some forward
thinking and suggests that reams of China-only regulations might not be
necessary if your product meets some U.S., Europe, or Japanese regs. Say
what you will about Chinese quality control, but at least they are going
in the right direction—toward an ISO-based concept of "your rules
are our rules."
— Paul
Dvorak
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A 3D vision system for microsurgeries let's surgeons see the
procedure on a high-definition screen instead of having to hunch over
microscopes. Some doctors have called it Imax (the large concave-screen
theaters) for the operating room. The optical image ordinarily viewed
through a microscope is converted by equipment from TrueVision Systems,
Santa Barbara, Calif. (truevisionsys.com) to a...
Full Article
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The Role of Digital Microscopy in the
KAIZEN System
 Kaizen, a
management system for quality improvement, is being adopted by companies
worldwide to help them improve product quality, production capacity,
lower costs and reduce waste. Five new Kaizen guides from KEYENCE focus
on how the KEYENCE VHX-600 Digital Microscope is working in the Kaizen
system to improve imaging, observation and processing of research and QC
data.
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Important changes to Canada's food and drugs laws have been
introduced in Bill C-51 to the Canadian House of Commons by the Canadian
federal government. The Act Respecting Foods, Therapeutic Products, and
Cosmetics is to modernize and strengthen Canada's safety system for food
and health products. The bill is said to...
Full Article
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Medical Test Connectors
FasTest has the smallest connector
available for medical device leak test applications. The new ME001 style
connector quickly connects to ultra thin hypodermic or catheter
tubing.
Capable of sealing down to 0.015" OD, the ME001 connector is designed
for leak testing infusion set and drug delivery devices. The compact
0.84" OD easily mounts in limited space locations. The pneumatic
actuation is ideal for soft touch control of delicate components or
automation for ergonomics or high production testing.
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Manufacturers of medical devices approved for marketing in one or
more of the Global Harmonization Task Force’s founding member
jurisdictions by Dec. 31, 2004, may skip a key requirement for listing
their products in Hong Kong, says a recent directive from the Medical
Device Control Office. The notice reports that...
Full Article
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An online part configurator let a manufacturer of pharmaceutical
blister-package equipment specify parts and get them in as little as
three days. What’s more, since Micron PharmaWorks Inc. Odessa,
Florida (pharmaworks.com) has been ordering parts from Misumi USA Inc,
Schaumburg, Ill. (misumiusa.com) Micron has been able to cut its turn
times by up to 50%.
Full Article
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Freescale Semiconductor and Monebo Technologies have partnered to
deliver a platform for medical equipment using electrocardiogram (ECG)
technology. The “ECG-on-a-chip” combines Monebo's Kinetic ECG
software with Freescale's embedded processing so medical-equipment
manufacturers can develop easy-to-use ECG monitoring tools.
Full Article
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An elastomer has been developed using patent-pending technology so
that the material provides built-in antimicrobial protection in
silicone-based elastomers. Responding to the medical industry’s
heightened concern over bacterial contamination on critical device
surfaces, the StatSil elastomer let's product designers incorporate it
into medical devices to control microbes in or on the human body, and on
devices such as catheters and wound drains. The flexible elastomer
should be used only to control the growth of microbes in or on the human
body; it should not be used to provide general public health benefits.
Momentive Performance Materials Inc, 187 Danbury Rd, Wilton, CT
06897, (203) 761-2500
Full Article
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Fine MicroEtch Screens in stainless steel are manufactured by
photoetching which lets designers specify straight or tapered holes.
Such features facilitate liquid filtration and back-flow cleaning. Hole
sizes can range from 0.003-in. diameter and up. Unlike stamping,
photoetching gives a burr-free product resulting in cleaner more
efficient screens with greater material integrity. These screens feature
a tighter tolerance on hole sizes and greater dimensional stability than
woven-wire mesh. This makes them ideal in applications requiring
frequent cleaning or in devices with mechanical contact. Unlike
woven-wire mesh screens, the fixed photoetched openings will not change
through use. Typical applications for screens are in medical filters,
laser-light filters, extruding screens, and particle separation and
sizing. Other materials are available.
Tech-Etch Inc, 45 Aldrin Rd, Plymouth, MA 02360, (508) 747-0300
Full Article
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A two-shot silicone-thermoplastic is intended for molding medical
devices. The technique requires expertise in processing and material
compatibility, but gives medical OEM’s opportunities to design
multimaterial components at lower costs, with fewer assembly steps, and
greater design freedom. Molding silicone and thermoplastic part as one
costs less, improves part performance, increases bond strength between
components, and allows freedom to design without assembly. The developer
has a detailed material matrix for the two-shot silicone-thermoplastic
process, and will test a material’s compatibility as well as formulate
one to meet product requirements.
Saint-Gobain Performance Plastics, 2316 W. Wisconsin St.,
Portage, WI 53901, (800) 236-7600
Full Article
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A colorfast engineering-resin-selection chart is a color-coded
technical guide to OEM applications for an expanding line of demanding
engineering resins. The chart details the developer’s current five
polymer groups, PC, ABS, PC/ABS alloy, Nylon, and specialty resins and
alloys. The chart describes over 50 standard individual engineering
resins and the best uses across 15 categories for products that are
typically molded such as medical devices and appliances. The large chart
is suitable for wall mounting as a quick reference resource. For a copy,
contact:
LTL Color Compounders Inc, 20 Progress Dr, Morrisville, PA 19067,
(800) 863-4260
Full Article
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Cleveland Clinic Innovation Summit
slated for November 10 to 12, 2008
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Register now for the early-bird discount.
www.clevelandclinic.org
Witness the innovation revolution, invest in the future of medicine,
and envision the limitless possibilities.
Join Robert Rubin from Citigroup, Jim Tobin from Boston Scientific, Tim
Ring from CR Bard, Karen Licitra with Johnson & Johnson, Senator Ron
Wyden (D-OR), Tommy Thompson, former Secretary of the Department of
Health and Human Services and other leading experts in the field at the
6th Annual Medical Innovation Summit. The exciting lineup of speakers,
panel discussions, and clinical presentations will reveal the latest
trends in medical innovation.
The Summit provides an unrivaled perspective on the newest medical
technologies and the financial drivers behind those innovations. It is
dedicated to providing singular insights, networking opportunities and
actionable take aways for all participants. A few highlights include:
Candid exchanges with leaders shaping the future of medical
technology
First hand analysis on new directions for supporting innovation post
the historic 2008 election
World leaders who are shaping health care opportunities in important
international markets
Detailed insights into the newest innovations in the fast growing
urology and gynecology markets including live, interactive surgery
Top 10 Medical Innovations for 2009
www.clevelandclinic.org
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Spiral Rod And Tubular Medical Component Solutions
Surgical instruments, needles, trauma devices machined from metal or
plastics are a specialty of Marshall's.
Free component sample pack for qualified respondents.
More information at: www.marshallmfg.com
Boker's 2008 Washer Catalog
Boker's, Inc.'s FREE 2008 Washer Catalog has over 22,000 non-standard
sizes
available with no tooling charges. A wide range of ODs, IDs and
thicknesses,
plus 2,000 material variations provide millions of possibilities.
www.bokers.com
INTRODUCING THE NEW DIMENSION 1200es 3D PRINTER: CREATE LARGER,
STRONGER, WORKING MODELS.
Starting at $18,900 (Mfgs. worldwide
list price.) Visit www.dimensionprinting.com for your nearest
dealer.
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Contact Information
Editorial questions:
Paul Dvorak
216-931-9407
Advertising/sponsorship opportunities: Virginia Goulding
216-931-9893
Medical Design
1300 E. 9th St.
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©2008 Penton Media, Inc. All rights reserved.
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