Orchid Orthopedic Solutions names new CEO

Orchid Orthopedic Solutions has promoted Jerry Jurkiewicz to the CEO spot. Jurkiewicz, the company’s former chief operating officer and president, replaces Mike Miller, who retired on Dec. 30. Miller is now the vice chairman of the company’s board of directors. Jurkiewicz joined Orchid as president and COO in 2016 after having been president of Optics

GE wants to dominate 3D printing: Here’s how

A new big gorilla has entered the 3D printing space, and it is called General Electric. GE said Wednesday that GE Additive will work with GE Capital to both sell and finance metal additive machines. The news is but another sign of just how important officials at the multinational industrial company view 3D printing’s potential

Vention Medical has new medtech extrusion tubing services

Vention Medical recently announced three new services to aid its extrusion customers. “In the medical device industry, speed to market is everything. These tools and services are meant to help design engineers from startups to large device companies get quick access to the extrusions they need so they can develop clinically effective, complex devices and

How Proto Labs is helping the blind to see—with their tongues

Injection-molded polycarbonate parts from Proto Labs played a significant role when it came to Middleton, Wis.–based Wicab ramping up production of its BrainPort “oral electronic vision device.” The BrainPort V100 received FDA de novo marketing approval last year for use among the profoundly blind. It uses a small headset-mounted video camera to capture visual information. The

Is a single contract manufacturer the best option?

Eric Sugalski/President/Smithwise For medical device startups, entering the manufacturing stage can be a daunting, frustrating and time-consuming process. Often, medical device startups will meet no-quotes or show stopping quotes from contract manufacturing organizations (CMOs) for their pilot builds. This is often due to the economic realities facing CMOs. It takes a significant amount of up-front

What should be considered when pursing nitinol-based products?

Norman Noble, Inc. The nickel-and-titanium alloy known as nitinol is a super-elastic shape-memory alloy responsible for major advances in medical technology over the last 15 years. Nitinol is a highly elastic material that can be processed to maintain a desired geometry. These properties, combined with high fatigue resistance and its ability to provide constant force

Phillips-Medisize builds new 80,000 square ft facility in Menomonie, Wis.

Phillips-Medisize announced plans to open a new 80,000 square ft manufacturing facility on its Menomonie, Wis. campus. The state-of-the-art facility manufactures high volume prefilled drug delivery systems and is planned to be complete in 2017. Investment in the new facility is driven by the signing of a new supply contract with a major biopharmaceutical company and is

Qosina adds new barbed Kynar connectors to its product line

Qosina announced the addition of new barbed Kynar connectors, in stock and ready for immediate delivery. Configurations include straight connectors, elbow connectors, T connectors and reducers, which are constructed to fit a variety of both flexible and rigid tubing sizes, including 1/16, 3/32 and 1/8 inch ID. These BPA- and latex-free connectors are Reach and

Qosina receives ISO-13485 certification

Qosina is pleased to announce that we have received ISO 13485 Certification, a globally recognized standard that specifies the requirements for a quality management system that can be used by organizations providing medical devices, components and delivery of related services. This certification allows Qosina to comply with the ever-changing needs of our customers while meeting

Final FDA rules clarify adverse event reporting for contract manufacturers

The FDA last week issued final guidance for medical device companies on the requirements for reporting adverse events that walked back much of the burden for contract manufacturers. The federal safety watchdog’s draft guidance for “Medical Device Reporting for Manufacturers,” issued in July 2013, put both the contract manufacturer and its customer on the hook for reporting adverse

New multi-cavity channel clips with guide wire slit from Qosina

Qosina is pleased to announce the addition of four new multi-cavity channel clips (#12536 – #12539) to their line, in stock and ready for immediate delivery.  Equipped with a unique slit which is designed to retain guide wires, these channel clips help to hold a wire in place when not in use. Three of these

ARC Group worldwide announces sale of non-core division

ARC Group Worldwide, a global provider of advanced manufacturing and 3D printing solutions, announced the completion of the sale of Tekna Seal LLC, a non-core subsidiary of ARC, for $10.5 million USD. “Tekna Seal is a great business with a strong team,” said ARC CEO, Jason Young. “While we are disappointed it will no longer

A few ideas for improving supply chains

Randy Ahlm, CEO, NPI/Medical Improving profits is every company’s goal while reducing costs is every company’s challenge. The improving profits part is almost easier: Introduce new products and expand operations into global markets. The drawback is that newer and longer supply chains produce upward cost pressures. Recent supply chain improvements can provide relief from the

Three IP issues in outsourcing medical devices

By Andrea D. Merin and Neil P. Ferraro You’ve developed an idea for a new medical device and you’ve even found a manufacturer to actually create it. Don’t forget to protect your product from those who might take credit for it or create a competing product. In order to do so, keep the following three

“Know Thy BOM”: Best practices for transitioning from design to production

For a medical device startup, selecting a contract manufacturer for part production can be difficult, especially if a company hasn’t done its research. Developing a detailed bill of materials positions a startup to receive high-quality quotes ahead of production. Here’s the story… You’ve spent countless hours refining your design and preparing for the manufacturing phase