Combination Products Page | MedTech Intelligence

Featured Articles

December 27, 2017

Lack of Adequate CAPA Procedures Tops FDA’s List of Violations

By MedTech Intelligence Staff

The agency has issued its list of the most common inspectional observations for FY 2017.

December 15, 2017

2018 MedTech Events: FDA Submissions, Cybersecurity, Recalls and More

By MedTech Intelligence Staff

New virtual and in-person workshops will bring together FDA and industry experts and stakeholders on a variety of key issues.

November 27, 2017

Medical Device Software & Products Liability: The Homefront (Part II)

By Sara E. Dyson, Esq.

This second article in the 4-part series looks at the use of software in medical devices in non-clinical settings, particularly the home environment. It addresses software’s role in the home healthcare trend, explains the software-related risks that arise from home-use products, and discusses what manufacturers can do to make these products safer.

November 14, 2017

How “Big Data” Enabled a Paralyzed Man to Move His Arm

By Stephanie Kute

How do you find meaningful signals in the middle of masses of noise, correctly interpret those signals and apply them for a useful purpose?

November 13, 2017

2017 Update on the Diabetes Market in Asia

By Ames Gross

With the increase of diabetes prevalence in Asia and the rise of Asia’s middle classes, the demand for newer and better treatments will provide opportunities for Western medtech companies.

October 17, 2017

Safeguarding Medical Devices Against Cyber-Attacks

By Anura Fernando

By adhering to FDA recommendations and leveraging the expertise of proven cyber testing methods, manufacturers can tackle known cybersecurity issues today while also attempting to anticipate concerns that may lie ahead.

September 14, 2017

The Medical Devices Most Vulnerable to Hackers

By Mike Kijewski

In the past, few people thought about medical devices falling victim to hackers. But as internet technology and changes in healthcare converge, medical devices are proving to be an easier target for hackers than we thought.

August 18, 2017

Understanding and Overcoming Challenges of Medical Adhesives

By Bret Ludwig, Ph.D.

10 factors design engineers must consider when creating stick-to-skin medical devices.

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Columns

July 17, 2017

Devine Guidance

No Control

By Dr. Christopher Joseph Devine

Although not always subject to receiving inspection, defining control of non-inventory items, such as manufacturing materials, is critical.

December 5, 2016

MEDdesign

Building a Better Hemostatic Device: Why Collaboration Is Key

By Terrence W. Norchi, M.D.

The search for better ways to stop bleeding may benefit from international partnerships.

November 14, 2016

Devine Guidance

Who’s on First?

By Dr. Christopher Joseph Devine

An adequate structure must be in place to support a QMS.

December 15, 2015

Ameing for Asia

Are Clinical Trials Needed to Register Your Device in China?

In lieu of trials, some companies may be able to submit a CER.

October 30, 2015

MEDdesign

Science Fiction Meets Nano-Robots

By Klaus Jopp

A peek at the latest miniaturization trends, including nano-robots that transport therapeutics to tumors.

November 5, 2014

Reimbursement Report

HCT/P Regulation and Third-Party Reimbursement

By Elizabeth Brown, MD

Comprehensive and unwieldy payer policies for wound care, the tiered system of FDA regulation of human cells, tissues, and cellular and tissue-based products, and the use of brand specific names in HCPCS coding have created a challenging reimbursement environment.

March 13, 2013

Devine Guidance

MHLW MO 169 – Chapter 5 – Mutatis Mutandis

By Dr. Christopher Joseph Devine

The most important piece of information that you can garner for Article 80 is the change in time-period duration for record retention.

March 6, 2013

Devine Guidance

MHLW MO 169 – Chapter 4 – Documents & Records

By Dr. Christopher Joseph Devine

There are some unique record-retention requirements associated with Ministerial Ordinance 169: So employ a little bit of common sense and script just one well-written SOP for all of your organization’s needs.

Upcoming Events & Webinars

May 1, 2018 – May 2, 2018

Medical Cybersecurity: Vulnerability and Patch Management

This conference brings together leading experts from FDA, the medical device industry, hospitals, and independent consultants to share experiences and discuss strategies and best practices for designing and evaluating secure technologies and ensuring system and patient safety.

May 14, 2018 – May 15, 2018

Medical Device Recalls: Current Topics and New Initiatives

Join the sixth annual MedTech Intelligence Medical Device Recalls conference for presentations, panel discussions, and networking with senior FDA and industry experts to learn about recent and upcoming changes and their practical impact on how companies manage the decision-making and execution of recalls.