Medical Device Handbook Archives - Page 3 of 5

Taking the extra steps to ensure medical device quality assurance

Here’s how medical device manufacturers can go the extra mile to address regulatory challenges and user needs with comprehensive and purposeful quality assurance systems.

Judith Antler, Eitan Medical

[Image from Unsplash]

Quality assurance (QA) control is a central component of any manufacturing process, ensuring the end product is reliable, safe and of the highest quality. This process is critical in the medical device industry, as faulty devices can have severe patient health implications.

When we consider the current COVID-19 pandemic and the abundance of critical care administered via medical devices, today more than ever, we must aim to ensure our products meet all safety standards and beyond.

Unfortunately, even with the current regulatory policies and systems, there are still recalls and field actions in the medical device industry. Both humans and machines are subject to error, but we must…

Ramping up manufacturing for single-use surgical instruments: What you need to know

Manufacturers can optimize functionality, use and volume to deliver high-performing, high-quality single-use surgical instruments to customers.

Steve Santoro, Micro

[Image courtesy of Micro]

Surgeons and hospitals increasingly need single-use surgical instruments — as they offer several distinct advantages over reusable products.

Disposable instruments designed for single-use don’t need to undergo expensive and time-consuming cleaning, sterilization and reprocessing. Reusable instruments such as articulating laparoscopic devices with sophisticated, intricate parts also can be difficult to clean and thoroughly disinfect, thus increasing the risk of infection to patients.

Single-use medical instruments are pre-sterilized and individually packaged. Health providers can dispose or recycle them after use.

Unlike their reusable counterparts, single-use instruments aren’t subject to wear an…

Here’s how you achieve proactive product development

Use strategic collaboration to overcome these five common medtech product development challenges.

Overcoming product-development barriers — the topic of a recent Device Talks Tuesdays webinar sponsored by Celestica — requires the elimination of design silos and the embracement of partnering opportunities. So how does this happen? Kevin Walsh, VP of Celestica’s HealthTech Division, and Kevin McFarlin, engineering director, had some answers.

“It’s all about protecting and nurturing a company’s intellectual property in order to get to market as soon as possible,” Walsh said.

As a service provider for OEMs and startups, “we’re looking to mistake-proof the manufacturing and assembly processes,” added McFarlin, who outlined five common product design challenges and strategies for overcoming them.

1. Usability engineering: Establish priorities

Stressing the criticality of a medical device’s ease of use, Walsh emphasized that it is fundamental to widespread adop…

Where are IoMT-based wearables going next?

Here are three significant trends shaping the Internet of Medical Things (IoMT) space.

Christopher Montalbano, MIDI Medical Product Development

Smartwatch with cardio app on screen and stethoscope, isolated on white background.

Home healthcare is an industry that has seen rapid growth in the past decade, with consumers taking more interest now than ever in understanding, maintaining, and improving their health and wellbeing. As a result, there’s an outpouring of demand for telemedicine and telediagnostic solutions that are simpler, faster and internet-enabled. Internet of Medical Things (IoMT) technology has opened endless opportunities for serving these needs.

Wearable IoMT biosensing lifestyle devices allow the collection of critical biometric in real-time, even outside medical facilities. Networked with smartphone and cloud-based apps, physiological and bio-sensing smart devices continuously measu…

How additive manufacturing can complement MIM prototyping

When designing medical device components, you don’t need to choose between additive manufacturing and metal injection molding. Think of them as complementary

Nick Eidem, Advanced Powder Products

[Metal injection molding image courtesy of Advanced Powder Products]

In today’s drive toward optimization, where projects survive or collapse in terms of days rather than weeks, it is imperative to consider all available prototyping venues. Time to market is especially critical in the medical field, where product maturation curves are shorter and regulatory efforts are extensive. In addition, moving a component from concept to production is often an arduous process; it needs to be accurate, repeatable and well documented.

Metal injection molding (MIM) technology can efficiently and economically deliver thousands or millions of parts. Still, it relies upon custom-designed and built hard tooling — the simpl…

How Medtronic fit a battery into a tiny pacemaker

Medtronic’s Micra pacemakers are one-tenth the size of what was previously out there. How the medtech giant did it provides lessons for anyone looking to shrink an implantable device. The next-gen Micra AV is the size of a large vitamin pill — the same as its predecessor. [Image courtesy of Medtronic]It was an all-hands-on-deck effort that consumed Medtronic in the early 2010s: the in-house creation of a pacemaker small enough to go inside the heart via a catheter.

The tiny pacemaker could be a game-changer because it would do away with connecting wires to the heart — a major source of complications. To get there, though, the Medtronic development team had to solve significant challenges involving battery life and energy use. How could they create a pacemaker that was roughly one-tenth the size of a traditional pacemaker but still last at least seven years inside someone?

“It would be like taking your car and reducing the size of the tank by a factor o…

How Medtronic fit a battery into a tiny pacemaker

Medtronic’s Micra pacemakers are one-tenth the size of what was previously out there. How the medtech giant did it provides lessons for anyone looking to shrink an implantable device.

The next-gen Micra AV is the size of a large vitamin pill — the same as its predecessor. [Image courtesy of Medtronic]

It was an all-hands-on-deck effort that consumed Medtronic in the early 2010s: the in-house creation of a pacemaker small enough to go inside the heart via a catheter.

The tiny pacemaker could be a game-changer because it would do away with connecting wires to the heart — a major source of complications. To get there, though, the Medtronic development team had to solve significant challenges involving battery life and energy use. How could they create a pacemaker that was roughly one-tenth the size of a traditional pacemaker but still last at least seven years inside someone?

“It would be like t…

Keys to protecting your medtech AI from competitors

AI is a hot area in medtech. A panel of intellectual property experts had advice on protecting the IP.

DeviceTalks

[Image from Pixabay]

Between 2002 and 2019, annual AI patent applications more than doubled, and AI patent applications increased from 9% of all patent applications to 16%. AI is a white-hot area for investment and creation of valuable intellectual property, including artificial intelligence related to medical devices.

Protecting medical device-related AI was the topic of a recent episode of MassDevice and Medical Design & Outsourcing’s DeviceTalks Tuesdays, sponsored by Finnegan, a law firm that handles all aspects of IP.

The discussion involved Anthony Del Monaco and Cecilia Sanabria, both partners at Finnegan, and two CEOs of healthcare companies that have developed exciting AI-related IP: Jan De Backer, CEO of Fluidda, a respiratory imaging company, and Todd Usen, CEO o…

Wearable devices and fragile skin: How to select the right adhesive

Design considerations are crucial when choosing an adhesive to stick wearable medical devices to fragile skin.

Del R. Lawson, 3M’s Medical Solutions Division

[Image courtesy of 3M]

Gone are the days where we had to be in the hospital to track and collect data from our bodies. We’re now able to create smaller, smarter, more accessible devices that integrate into our everyday lives. The advantage of adhering a device directly to the skin is it creates an intimate interface between the device and the wearer that enables a sensor to measure a key attribute and transfer data to the device. However, these conveniences mean new considerations for device design engineers, specifically when selecting adhesives intended to stick to fragile skin.

Skin is a major factor in the design and performance of a wearable device, but it often gets overlooked. When it comes to adhering a device to fragile skin, it’s not the s…

Advanced glass diffusers bring precision light delivery to the brain

Laser interstitial thermal therapy (LITT) has proven to be a successful and efficient treatment method for various brain diseases.

Anthony Cappabianca, Schott North America

It’s possible to use LITT during minimally invasive brain surgery to kill tumor cells or disrupt lesions responsible for epileptic seizures. [Image courtesy of Schott]

Thanks to advances in imaging, lasers and light delivery technology, it is now possible to use laser light to ablate lesions in the brain without the need for a craniotomy. This emerging neurosurgical procedure, known as laser interstitial thermal therapy (LITT) or laser-thermo ablation, can kill tumor cells or disrupt lesions responsible for epileptic seizures. Because the treatment is performed through a tiny opening in the skull about 4 mm in diameter (1/8 inch), recovery time for patients is greatly reduced.

Although just two LITT systems are approved for clinical u…

How Stryker is using 3D printing to advance orthopedics

Orthopedic device giant Stryker uses additive manufacturing to make porous geometries that wouldn’t otherwise be possible

DeviceTalks

3D printing, also called additive manufacturing, provides the ability to create new products and designs that are incredibly complex and hard to machine. For 20 years, Stryker has been on a journey to use additive manufacturing specifically to produce complex orthopedic implants. As a result, the company has made great strides when it comes to the way that orthopedic implants are designed and produced.

On a recent episode of our DeviceTalks Tuesdays webinar — sponsored by GE Additive, Foster, and Siemens — Stryker executive Naomi Murray detailed the company’s two-decade additive manufacturing journey. Murray, the company’s director of advanced operations for additive technology, described how innovations utilizing 3D printing make healthcare better.

Here are four takeaways on how additive manufacturing is advancing orthope…

The advantages of laser-cut tube (LCT) catheters

Here’s how laser-cut tube (LCT) catheters compare to traditional catheters: the design process, functional advantages, test methods and cost comparisons.

DeviceTalks

The medical device community has a long history of using braided and coil-based catheter constructs. But these traditional constructs present multiple performance-based issues. “With the advent of the laser-cut tube capability we have at Resonetics, it’s opened up a lot of options for catheter manufacturing,” said Dave Rezac, VP of design and development services at the company, in a recent DeviceTalks Tuesdays webinar.

Kevin Hartke, Resonetics’ chief technical officer, joined Rezac in the Resonetics-sponsored webinar to discuss how their company studied the comparative performance of LCT versus traditional catheter constructs.

Go to our sister site Medical Tubing + Extrusion and read four takeaways on how LCT compares to the traditional catheter construct.

Provided to Medical Design…