54 Timing is Everything
FDA struggles to keep its review times down as industry struggles to
keep up with a changing technology landscape.
62 Managing Cost in the Healthcare Supply Chain
A continual assessment of the supply chain helps device manufacturers
68 When do I Really Need to Perform an EO Requalification?
An examination of the changes in ANSI/AAMI/ISO 11135:2014.
April 2016 • Volume 14, No. 3
Medical Product Outsourcing (USPS #023-891) is published monthly, except February, August and December, by Rodman Media Corp., 70 Hilltop Road, Ramsey, NJ 07446. Phone: (201) 825-2552,
Fax: (201) 825-0553. Periodical Postage paid at Ramsey, NJ 07446 and additional mailing offices. POSTMASTER: Send address changes to Medical Product Outsourcing, 70 Hilltop Road, Ramsey, NJ 07446 USA.
Canadian Publications Mail Agreement No: 40028970. Return Undeliverable Canadian Addresses to Circulation Department, PO Box 1051, Fort Erie, On L2A 6C7.
Free subscriptions are available to qualified recipients. Others are as follows: U.S. one-year subscription $95; Canada/Mexico one-year subscription $120. Foreign airmail: one-year $195. Make
checks payable to in U.S. dollars through a U.S. bank. American Express accepted.
Authorization to photocopy items in Medical Product Outsourcing for internal or personal use, or internal or personal use of specific clients, is granted by Rodman Media Corp., provided a base fee
of U. S. $1 per page is paid directly to: Copyright Clearance Center, 27 Salem St., Salem, MA 01970 USA.
Medical Product Outsourcing’s circulation is audited by BPA International.
Cover and contents image courtesy of Raumedic.
40 Pushing the Limits of
The trend in medical design is toward smaller and
better, requiring more specialized extrusion
materials and equipment.