ARTICLES BY MICHAEL SONG
Medical Device Biocompatibility – Toxicological / Biological Safety Assessments2/26/2020
Despite ISO 10993’s utility, new technologies and materials may warrant additional considerations based on patient health risks. This article focuses on how to handle situations where deviating from recommended testing may be desired. In these cases, a biological safety / toxicological assessment is warranted.
Biocompatibility Considerations For Drug Delivery Devices — An Introduction To ISO 1099312/4/2019
A host of factors come in to play when evaluating biocompatibility, including how the medical device is sterilized, how the device is used, what body parts it makes contact with, and selecting testing approaches.
An Introduction To Prefilled Syringe Selection — Prefilled Syringes With Staked-In Needles10/15/2019
This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes. Part 2 examines the various aspects of prefilled syringes with staked-in needles and their impacts.
An Introduction To Prefilled Syringe Selection — Needle-Free And Dual-Chamber Devices9/30/2019
This two-part article will provide an introduction to the three general prefilled syringe (PFS) types and will share important factors to take into consideration for your drug product. In this first part, we will discuss the needle-free PFS and the dual-chamber system.
4 (More) Critical Considerations For Drug Delivery Device Development8/12/2019
The majority of biologic products today are launched as some form of combination product, stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.
4 Important Things To Consider Before Developing A Drug Delivery Device8/6/2019
This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development. In this installment, we will look at the areas of primary container, device development, device selection, and design control.