Manufacturers Alliance E-Newsletter

March, 2008

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Article Index

Medical Device Manufacturing and the Regulations, Documentation Control
Article by: Thomas Pepin
This month I will discuss documentation system requirements. In a previous article, I asked a question regarding a pilot's training to fly an airplane. The pilot has absolute trust that the plane's engineering requirements have been well defined, tested and controlled to assure fault-free operation of the aircraft.

Industry News: Uroplasty Inc., Medtronic Inc. Starkey Laboratories
Article by: Medical Device Alliance
Uroplasty expects profit in 2 years

Challenges in Clinical Trial Enrollment
Author Unknown
In many Clinical Trials, investigators reach out to locate potential research subjects using direct strategies such as targeted radio advertising, recruitment posters, and newspaper advertisements.

Medical Device Manufacturing and the Regulations, Documentation Control

This month I will discuss documentation system requirements. In a previous article, I asked a question regarding a pilot's training to fly an airplane. The pilot has absolute trust that the plane's engineering requirements have been well defined, tested and controlled to assure fault-free operation of the aircraft.

Tight change control rules assure that any and all changes, minor or major, occur with proper oversight. A cross-functional engineering team develops, reviews, and approves all necessary design and manufacturing systems to assure that the change will result in the desired outcome with no unintended consequences.

The medical device industry has similar requirements which are defined in 21 CFR 820.40 and ISO 13485 4.2. The following are examples of material which must be under total documentation control:

Quality Manual

Quality system policies and procedures

Design history records and files

Device Master Record documents and Device History Records

Device History Record

Design and process validation protocols and reports

Design input and output requirements

Device and component specifications

Manufacturing and inspection procedures along with associated forms and records

Specific documentation control requirements include provisions for:

Designation of specific individuals to review and approve the documents prior to release.

Relevant documents must be made available to those individuals and functions that need the material.

Control of revision levels to assure that only the released version is available and all obsolete documents have been removed and or prevented from use.

Changes to original documents must be reviewed and approved by similar or same individuals and or functions as those who approved the original material.

Maintain records of all changes to respective documents.

A record of signature from those who approved the documents. With appropriate 21 CFR Part 11 controls, these signatures can be in an electronic document control system.

Companies which have inadequate change control practices often find themselves dealing with customer complaints that may result in recall of devices. Clean and crisp documentation control practices not only are a regulatory requirement, they are good business.

Thomas Pepin is active in the medical device manufacturing industry with 20-plus years of experience in both Quality and Operational systems. He is currently a Quality Assurance Director at a leading device manufacturer.

Industry News: Uroplasty Inc., Medtronic Inc. Starkey Laboratories

Uroplasty expects profit in 2 years
Uroplasty Inc. said it will become profitable within two years. David Kaysen, CEO of the Minnetonka-based medical device maker, said in an interview Wednesday that the company is expanding its sales force and buying or licensing products to sell in the United States.

Kaysen estimated the company would be profitable in 18 to 24 months, and said the potential market for its products used to treat bladder problems is worth $3.8 billion annually.

Original article written by Minneapolis/St. Paul Business Journal

FDA approves Medtronic device
Medtronic Inc. said Wednesday it has won regulatory approval to begin marketing a device used to treat abdominal aneurysms.

The device, dubbed the Talent Abdominal System, helps prevent aneurysms from rupturing. Ruptured aneurysms are the 10th leading cause of death for men over age 55, Fridley-based Medtronic said in a press statement.

Original article written by Minneapolis/St. Paul Business Journal

Starkey's new hearing aid for eyes, too
This is not your grandma's hearing aid. Just one message Starkey Laboratories will push to customers this year, as it prepares to launch its latest product line, dubbed Zon. In developing the products, Starkey focused heavily on aesthetics. The devices, for instance, come in hues that mirror common combinations of skin tones and hair colors.

The other major shift marked by the new line: the hearing aid sits behind the ear. In recent years, Starkey has concentrated on devices molded to fit directly into a patient's ear canal.

Original article written by Minneapolis/St. Paul Business Journal

The Medical Device Alliance includes press releases from local medical device companies every month. Please feel free to send all PR to kirbys@mfrall.com for potential future inclusion.

Challenges in Clinical Trial Enrollment

In many Clinical Trials, investigators reach out to locate potential research subjects using direct strategies such as targeted radio advertising, recruitment posters, and newspaper advertisements.

Likewise, other studies may depend on indirect methods of locating potential subjects and work through intermediary contacts in clinics and hospital outpatient departments. Here are some fast facts regarding potential research participants:

3 million people participate in clinical trials in the US each year

In 1995, 30% of participants self refer (Centerwartch,1995)

In 2004, 50% of participants self refer (Centerwatch, 2004)

HUGE increase in self referral, aided in part by the internet

60% referred by physician or nurse in 1995 Clinical Trials (Getz, K. 2003)

60% of consumers say they would volunteer in an appropriate clinical trial (Getz, K. 2003)

74% of consumers claim they know little or nothing about clinical research (Getz, K. 2003)

77% of consumers would consider participating in a clinical trial if their physician asked them to (Harris Interactive, 2003)

Only 23% of consumers said that they have spoken to their physician about participating in a clinical trial (Woolley, 2000)

Approximately 85% of Americans diagnosed with a life-threatening illness such as cancer reported they were either unaware of clinical trials or were not sure they were an option. In 81% of studies, enrollment is often delayed one to 6 months. As you see, there can be a variety of recruitment challenges to overcome.

Learn more about the specific challenges of subject recruitment for Clinical Trials and what local practitioners are doing to overcome them. Attend the next monthly seminar offered by the Medical Device Alliance. Click Here

Author Unknown

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