Have you addressed these four common challenges to sterile packaging for your medical device?

Neil Thompson

Congratulations! You want to sterile package your medical device. Now what?

Here are four issues to keep in mind to make your packaging project a success.

Concern #1—Specifications and Design

Since budget is always a concern, the first question you should ask yourself is, “How many products or product lines do I want to package?” A package that fits multiple product lines or product sizes will drop your costs significantly by reducing the number of validations you need to perform. You can also consider a package scheme that fits two or three sizes and covers all product lines.

Concern #2—Sterilization...

April 19th, 2017

Here's why a medical device manufacturer may want to consider parylene conformal coatings for implantable devices.

Sean Horn

The chemical vapor deposition (CVD) process is unique to Parylene compared to other common conformal coatings.

Parylene provides precisely deposited protective conformal coatings for medical implants, enabling the specific device purpose despite challenging physical configurations. Other performance properties amplify parylene’s ability to withstand operational duress throughout surgical implantation and long-term use in the body:

  • dependable elastometricity,
  • functional stability in the presence of bodily fluids,
  • exceptional biocompatibility, and
  • outstanding...
April 18th, 2017

A recent court decision in a case involving Intuitive Surgical serves as a useful reminder for medical device manufacturers to review their approach to product warnings.

Terry M. Henry, Melanie S. Carter, Lauren E. O’Donnell, and Naomi Zwillenberg

Washington State’s highest court set off a bit of a firestorm recently when it ruled that medical device manufacturers must warn those who buy their products about related risks. The court’s decision in Taylor v. Intuitive Surgical, Inc., seemed to undermine the customary view that a device manufacturer need only provide its warnings to the prescribing physician; the learned intermediary. A broader review of the law shows...

April 13th, 2017

Getting the medical technology industry's commercial model out of the 1980s will pay significant dividends for years to come. Here's what needs to change.

Brian Chapman and Peter Masloski

The 1980s were a time of great innovation for the medical technology industry. The field of in vitro diagnostics was exploding with relevant diagnostic tests being released every month. Self-monitored blood glucose meters were being commercialized, changing how diabetics managed their diseases. Implantable cardioverter defibrillators dramatically reduced the risk of death from ventricular fibrillation. Angioplasty, pulse oximetry, mainstream use of laparoscopic procedures, and more—the list of product innovation is staggering.

In those days, sales and marketing were...

April 11th, 2017

Dreaming up the next digital health disruption can be inspiring, but to move forward, the industry needs to share best practices, take on tangible applications, and collaborate.

Mike Sanders

It may be hypocritical, but I find most articles on digital health distracting rather than helpful to medical device development. That's because most media coverage focuses on the latest company, product, or service, instead of tangible examples of digital health in regulated medical devices.

Admittedly, following digital health technology is fun, but for me, most announcements about new products raise questions. Take, for example, the 510(k) clearance of the Samsung Health App...

April 10th, 2017

Here’s how to cope with new EU Medical Device Regulations requiring unique device identification.

Peter Rose

Back in 2014, the Department of Health started to take tentative steps towards setting a standard for tracking medical implants, supplies, and instruments. Its Scan4Safety program mandated that all 154 acute trusts adopt GS1 identification keys. These keys, used across many industries, provide a unique identification code to any real-world entity making the process of identifying it completely unambiguous, which helps to reduce errors and streamline the supply process. In 2016, a further step was taken to roll out a barcoding scheme for medical implants such as breast implants and hip replacements. Reducing errors is expected to bring benefits to patients and help reduce costs...

April 10th, 2017

Here are the four critical questions to ask before taking on the literature search and review process.

Scott Ahlberg

Whether your organization is about to bring a new medical device to market or preparing to submit a periodic safety update report, you must demonstrate that the device complies with all the relevant regulatory requirements. Additionally, more than establishing that the device delivers its intended benefits, you must also identify all known risks, capture any adverse events, and report the findings along with all the appropriate evidence.

It’s a big and difficult job, and one that relies upon efficient and effective processes—as well as experts to run those processes. And where auditors are concerned, process is the name of the game. Consequently,...

April 6th, 2017

An executive details the applications of MR-guided focused ultrasound, a developing technology for noninvasive surgery.

Maurice R. Ferré, MD

Insightec's Exablate Neuro is used for focused ultrasound treatment.

Advancements in imaging technology over the past 30 years have enabled physicians to see what is happening inside a patient and make accurate diagnoses. The logical next step is to use this technology to facilitate actual treatments, which is becoming a reality as noninvasive surgery gains traction. Today, we find ourselves on the precipice of a major shift in the way physicians approach patient treatment and care.

MR-Guided Focused Ultrasound (MRgFUS): The Next Iteration of Ultrasound...

April 6th, 2017

Medical device makers are uniquely affected by the 21st Century Cures Act, including at least one immediate impact. Here's what you need to know.

Brian Scogland

The  21st Century Cures Act left much for consideration and learning after being signed into law in December 2016. The Cures Act authorized $6.3 billon in scientific funding and has been closely scrutinized for its impact on patients and the healthcare industry overall. Manufacturers of medical devices were impacted uniquely by the act.

I work closely with several global device manufacturers and my colleagues and I are closely monitoring the long-term impact of...

April 4th, 2017



MedicusTek USA Corp.




Describe your device and how it will benefit healthcare.














In the last three decades,...

April 3rd, 2017