Medical device startups: Here’s how you handle verification and validation

The two “Vs” — also known as V&V, verification and validation — serve to link the medical device product that has been developed all the way back to the initial customer needs and product requirements. Bill Betten, Betten Systems Solutions While many think that verification and validation only occur at the end of the medical device development

These students redesigned scalpel packaging to prevent injuries

A group of Georgia Tech biomedical engineering students has created a new scalpel blade packaging that is designed to protect healthcare workers from injuries when handling scalpel blades. The invention is now a finalist in Georgia Tech’s annual innovation competition, Inventure Prize. The four students were tasked with redesigning a medical device and redesigned the

This new technology could help surgeons clear out leftover cancer cells

In some instances, as many as 30% of patients need repeat surgeries to get rid of cancerous cells initially left behind. The team from Lumicell wants to change that — and improve outcomes for cancer patients. After his wife died of breast cancer in 2003, David Lee stepped away from a decades-long career in the semiconductor

Why you need to care about marketing requirements to develop a medical device

Marketing requirements are actually a critical part of the medical device creation process. They establish a solid foundation for product development. Kit Gianforte, Product Creation Studio Developing a new product can be an exciting and overwhelming time. You have observed an unmet need in the world and have a great idea for a new product that will

Medical device startups: Here’s how you handle regulatory and reimbursement

The two “Rs” — regulatory and reimbursement — are critical elements of the environment in which a medical device product is developed. Bill Betten, Betten Systems Solutions This is the fourth in a series of articles that discusses the design of innovative products in the highly regulated medical environment.  But the “environmental” factors of regulatory and reimbursement actually

How to redesign medical carts to reflect changing healthcare settings

The way to redesign medical carts for better practicality and maneuverability for changing healthcare settings is making lighter power sources, according to a white paper from Accutronics. “Designs [now focus on innovative solutions to create smaller and lighter carts that are easy to maneuver,” Marty Carlos from the medical device consulting firm Paragon Group said.

5 trends that could affect medtech in 2018

Antoine Baschiera, Early Metrics The rapid advancement of innovation today is propelling fundamental changes in all industries. Among them, the health and medtech sectors are ones that will be transformed drastically in the coming years. The medical devices and technology market will reach $500 billion in sales by 2021, according to a new analysis from Evaluate.

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Rimsys launches software to help medtech companies manage regulatory changes

Startup company Rimsys (Pittsburgh) has launched its its first software solution that helps medical device companies effectively manage regulations around the world. Delays or blocks to medical devices entering the market can be caused by things like mismanaged information. Rimsys is trying to alleviate that problem with its software by giving them a platform that

The most disruptive medical device innovations of all time

When it comes to disruptive medical device innovations, it’s easy to lose the perspective of history. Here are devices through history that definitely made a difference. Chris Newmarker, Managing Editor and Danielle Kirsh, Assistant Editor Whether you’re talking about surgical robotics or efforts to bring more value to healthcare, the word “disruptive” seems to get

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How self-serve medical devices could make patients feel in control

Intimidating medical devices can cause anxiety for patients — in the same way that people can experience “white coat hypertension” when seeing a doctor. Devices that are smaller and more patient-centered could help patients feel better about their treatment and make them feel like they’re in charge, according to Leslie Trigg, CEO at Outset Medical (San

Designing for healthcare robotics: 2 things you need to consider

Have an idea for an innovative healthcare robot? Here are a few design principles to help you avoid common pitfalls. Ken Haven, Acorn Product Development When people think of robotics, they often think about warehouses or manufacturing lines, where robots automate multiple processes. But robotics has the potential to reshape the way healthcare is delivered in a

NN Inc. acquires medical device developer, manufacturer Bridgemedica

Diversified industrial company NN Inc. (Nasdaq: NNBR) announced today that it has completed its acquisition of Bridgemedica — which provides design, development engineering, manufacturing and packaging services to the medical device industry. Financial terms of the deal were not disclosed. Mansfield, Mass.–based Bridgemedica on its website describes itself as a “medical device turnkey concept-to-supply partner providing

Spectralytics launches DFM product development facility for laser services

In the new medtech manufacturing environment, design engineers need parts faster, with fewer iterations and quicker turnaround. Spectralytics aims to meet those needs with its revamped development center in Maple Plain, Minn. The laser cutting and processing contract manufacturer has a newly expanded facility dedicated to design and prototyping. The 15,000 sq. ft. facility is located

Medical device startups: Here’s how you handle requirements

Developing the product requirements is one of the most complex activities associated with product development, yet one of the most important.  Bill Betten, Betten Systems Solutions This is the third in a series of articles that discusses the design of innovative products in the highly regulated medical environment. The previous two articles focused on the

Medical device startups: Here’s how you successfully plan

The development of the product development plan is an evolutionary effort that continues through the life of the medical device project. Bill Betten, Betten Systems Solutions, and Tom Waddell, Waddell Group This is the second in a series of articles that will discuss the design of innovative products in the highly regulated medical environment.  The