The startup pivot: How to rethink your medical device company

In the medtech market, startups have to be flexible; the startup pivot is crucial. “Companies have to morph as they go,” said Maria Palasis, CEO of bioresorbable drug delivery system company 480 Biomedical. Palasis explained that startups, and even mature companies should expect to shift their technology in one way or another through the course of

Webinar about combination products: Bridging the gap between pharma and medical devices – Oct. 18

Wednesday, October 18, 2017 11:30am EDT / 8:30am PST   We will provide a new understanding of key topics that separate the regulatory and quality process for drugs and combination products/drug delivery devices.  We understand the process for drug development and certification varies greatly from the process for medical devices.  We will cover the intricacies

FDA’s medical gas guidance offers clarity to manufacturers

FDA’s new draft guidance on current good manufacturing practice for medical gases closed for commentary in August. The revised draft guidance details the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003. A review under FDASIA in 2015 noted that minor guidance updates and better inspector training would improve the regulatory […]

Raumedic to present at CPhl Worldwide

Raumedic will be present at the pharma tradeshow CPhl Worldwide in Frankfurt, Germany, for the first time in several years. The event is scheduled to take place from Oct. 24-26. The company will showcase a variety of polymer products and components to trade show attendees as well as drug delivery systems and packaging solutions. Raumedic

Insulet touts real-world data for Omnipod insulin management tech

Insulet (NSDQ:PODD) touted real-world data today for its Omnipod insulin management system at the Congress of the European Association for the Study of Diabetes. The data come from a study of nearly 39,000 patients with Type I and Type II diabetes who received insulin through the Omnipod system and had at least three months of data […]

Medtronic recalls insulin infusion sets

Medtronic (NYSE:MDT) said today that it’s recalling some of the infusion sets used with its insulin pumps due to problems with a discontinued component. The Fridley, Minn.-based medical device titan said the problem involves a vent membrane that’s susceptible to blockage during priming and fill-tubing. No pumps or glucose sensors are affected by the recall, Medtronic […]

Cells can be programmed into living devices: Here’s how

Synthetic biologists at Harvard University have programmed microbial cells into living devices that can produce drugs, fine chemicals and biofuels and detect disease-causing agents. A team of biologists at Harvard’s Wyss Institute for Biologically Inspired Engineering fit cells with artificial molecular machinery that could sense stimuli like toxins in the environment, metabolite levels and inflammatory

How to ensure adhesion on hard-to-bond plastic substrates

Medical device companies are increasingly using plastic substrates that are tough and sterilization/chemical resistant. But they also come with adhesion challenges. Michelle Gumbert and Patrick Vaughn, Dymax  For medical devices such as catheters, prefilled syringes, vials, test tubes and injector pens, many manufacturers are turning to plastic substrates that are specifically formulated to resist harsh

Manufacturing drug device products: challenges and best practices

Integrating a drug with a mechanical device can, in some cases, improve patient outcomes and boost sales. But manufacturing these products is no simple feat: It often requires a specialized contract manufacturer with extensive experience in the field to make a drug-device combo buildable and scalable. There’s a lot to consider when manufacturing a medical

This tiny diaphragm pump could enable medical device innovation

Fraunhofer researchers have created a tiny yet powerful diaphragm pump that can deliver ambient air to gas sensors. The sensors are attached to a smartphone that warns a user of heavy exposure to particulate matter. “Our smart pump measures only 25 sq mm, making it the world’s smallest pump. That said, it still has a

9 battery and power source advances you need to know

In the drive toward tinier implantable medical devices and wearable health sensors, battery and power source technology has been a major stumbling block. As experts noted in a discussion about battery technology during DeviceTalks Minnesota in June, battery innovation in the field is especially slow. Going too fast has its risks, too. Case in point

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Icon beats Street on Q2 earnings, acquires Mapi Group

Drug development provider Icon PLC (Nasdaq: ICLR) saw its stock jump about 6% in value today after announcing second-quarter earnings that beat analysts’ expectations. The Dublin, Ireland–based company, which serves the pharmaceutical, biotechnology and medical device industries, also said it has acquired the Mapi Group, which provides patient-centered health outcomes research and commercialisation. Financial terms of

How a built-in refrigerator ice dispenser can dispense medication

An Arizona State University student recently designed an automatic medicine dispenser that could replace water and ice dispensers on refrigerators, according to a case study from Model Solution (Milpitas, Calif.). The device can dispense pills for two different users and gives audio and visual signals for the times that the users have to take their

How MRI can power mini-robots inside the body for targeted treatment

Scientists at the University of Houston and Houston Methodist Hospital are harnessing the power of magnetic resonance imaging (MRI) to drive mini-robots through the body for targeted treatment. The researchers are developing control algorithms, imaging technology, ultrafast computational methods and human-machine immersion methods that could enable the steering of dozens or even thousands of tiny millimeter-sized

Why Abbott’s CEO is excited about Bigfoot Biomedical and diabetes treatment

Just one week after Abbott (NYSE:ABT) said it inked a deal with Bigfoot Biomedical to develop an automated diabetes management system, CEO Miles White told analysts that he thinks Bigfoot is playing an important role in the strategic change taking place in the space. “It’s a fairly clever service and approach that I think will create, not just an