January 2005
Medical Device & Diagnostic Industry
Selected Contents
Editor's
Page:
Postmarketing
Studies: The Next Wave
Cover Story
Finding
Tube Materials that Make the Grade
William
Leventon
Top
tubing makers discuss material options, new developments, and how to make the
right choice for your application.
Packaging
Extra
Effort: Packaging for Combination Products
Erik Swain
Producing
a suitable package for a combination product requires device companies to understand
the regulations, materials, and processes behind drug and biologic packaging.
Sterile Compounding
USP
<797>: How It Affects Medical Device Manufacturers
Robert Reich and Hal Patterson
Manufacturers
of compounded sterile preparations have been faced with proving the compliance
of some of their products with USP’s new sterile compounding regulation.
Device Misuse
Addressing
the Problem of Medical Device Misuse
Michael
E. Wiklund
Medical
device misuse is unavoidable. But how much responsibility should device manufacturers
bear for creating safer products?
Quality
Good
Laboratory Notebook Practice
John A. DeLucia
Laboratory
notebooks can be an integral part of a company’s controlled documentation
but must be managed carefully to ensure quality.
Coatings
Using
Risk Analysis to Develop Coated Medical Devices
Phil Triolo
The
popularity of coated devices is at an all-time high. However, there are challenging
technical and regulatory obstacles when adding a coating to a device.
Sidebar: Regulatory Guidances
Sidebar: Surface-Modified
Devices and CDRH
Outsourcing
Eight
Simple Rules for Outsourcing to China
Ames Gross and Loren Heinold
Companies
looking to take advantage of China’s increased capacity for outsourcing
should also take heed of possible pitfalls in planning.
Materials
Stainless-Steel
Options for Medical Instrument Tubing
William Fender and Robert S. Brown
Understanding
the properties of different alloys is crucial to selecting the right material
for a particular application.
WASHINGTON WRAP-UP
FDA
Law Chief Troy Resigns
James G. Dickinson
Daniel
Troy leaves FDA giving no public explanation; his stint as chief counsel was
one of the most controversial in agency history.
NEWSTRENDS
- Artificial Disk Continues Trend in Shorter Hospitalization and Shorter Recovery Times
- Success in Asia Requires Understanding of Culture, Business Practices
- Prepare for Era of Electronic Submissions, Even if It's Far Away
- MDMA Appoints New Policy Director
- Merger Could Strengthen Carl Zeiss Glaucoma Treatment System
- Electronic Recordkeeping with the Stroke of a Pen
- Hands-Off Approach Best for Preapproval Publicity
- HHS's Tommy Thompson Resigns
- Devices of the Future Must Incorporate Nanotech and Biotech
R&D DIGEST:
- Contact Lenses Employed for Drug Delivery
- Electrode System Could Aid Paralysis Patients
- Studies on Heart Cell Cultures Could Improve ICDs
- Sticky Frog Holds Bioadhesive Potential
Product Development
Insight
Process
Mapping as a Route to Innovative New Products
David Warburton
Identifying customer
needs and creating a product that addresses them is difficult. Cross-functional
process mapping provides one way to approach the problem.
Regulatory Outlook
FDA
Third-Party Programs—Myth or Reality?
Harvey
Rudolph and John Stigi
Underwriters Laboratories Inc. and CDRH
Two
experts take a hard look at FDA’s third-party review and inspection programs.
Sidebar:
FDA’s Third-Party Programs
Q&A
MDUFMA:
How Far Has It Come?
Erik Swain
Experts look at
the benefits of MDUFMA and issues that need to be resolved.
