Newsletter | December 3, 2022

12.03.22 -- November's Most Popular Articles & Solutions
 
Featured Editorial
Should I Request A Q-Submission For My Medical Device?
 
By Caitlin Bancroft, JD, RAC, senior regulatory affairs specialist, Pharmatech Associates

Q-Submissions are a mechanism available to request feedback from the FDA. It is the pathway for a medical device sponsor to reach out to request a meeting or written responses related to a product’s regulatory strategy or testing plan. The time and money for a Q-Submission pales in comparison with what is needed to correct testing and regulatory strategies later on.
India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022
 
By Mathini Ilancheran, principal analyst, R&D, Beroe Inc.

To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?
Robotic Tech’s Opportunities To Revolutionize Surgery
 
By Todd Wilson, M.D., chief medical officer, EndoQuest Robotics

Innovation in robotic technology has continued to progress rapidly. This article discusses the benefits of minimally invasive robotic surgery to surgeons and patients, and it also shares an overview of the types of robotic technology disrupting the industry, such as capsule robots.
Top Industry Insights
Considerations When Choosing A Biomaterial For Your Orthopedic Device: Part 1
Article | By Albert Llenas, DSM Biomedical

In this two-part series from DSM Biomedical, Albert Llenas, the global marketing director of orthopedics, discusses how to select appropriate materials when developing devices for rotator cuff repairs. Defining needs up front while working with a diversified biomaterials supplier, such as DSM Biomedical, enables companies to find a material that satisfies device performance requirements.
Meeting The Challenge Of Delivering High-Volume Biologic Therapies
Article | By Alex Vasiev, Ph.D., and Pete Evans, SMC Ltd.

As the industry moves toward self-administration to reduce healthcare costs and improve patient convenience, there is a compelling need for simple-to-use, low-cost, disposable devices.
Sketch To Scale: The Importance Of Relationship-Building At The Prototyping Stage
Article | By Swati Patel, MA, Secant Group

We review what items a device manufacturer and supplier should align on and what essential assets a manufacturer should look for in a supplier team.
Top Resources
High-End, Medical RF Electronic Solutions
NuWaves RF Solutions
Optical Micromolding
Accumold
Diagnostic Products Manufacturing
Carclo Technical Plastics