In the last edition of Thinking Lean, we discussed quick changeover, a system for reducing setup time on equipment and allowing for smaller batches. In this edition, we will cover a more generally applicable concept known as leveling production.
Medtech entrepreneurs need to think like their investors and structure their operations accordingly. Excessive spending without achieving the critical milestones will not be tolerated; nor will an overly restricted cash burn that leaves a project limping forward.
Historically, startups haven't gone through the entire product development process. They’ve done the heavy lifting with innovation and engineering, but are at a loss when it comes to navigating regulatory approval and figuring out how to successfully (and compliantly) commercialize. This is where value can be lost.
Combination products represent a remarkable opportunity to extend the potential patient population for biologics and improve the delivery of drug therapies. This is one of the most dynamic segments in the life sciences , projected to grow to $115 billion by 2019.
As the FDA’s next deadline for the unique device identification (UDI) of Class II devices draws closer, medical device manufacturing companies are looking to further their UDI implementation, whether they are well on their way to success or they haven’t even started. Barcoding, or identifying products via GS1 regulatory standards, is essential for companies wishing to be up to date on UDI implementation. Unfortunately, companies may be delaying UDI implementation because they view the new regulations as something an organization can address quickly. This is not the case. This article discusses the importance of viewing UDI implementation as process that encompasses the entire company rather than just as a “quick fix.”
The industry must be able to demonstrate that it has been able to use the tax suspension to innovate and grow in order to avoid the tax’s reinstatement. The ability to show results will be paramount, creating a need for more efficient online reporting.
Radio frequency (RF) ablation uses RF energy to ablate or destroy unwanted tissues. When delivered via a catheter, it offers a minimally invasive treatment for a wide variety of conditions, including atrial fibrillation (AF). These systems typically include a peristaltic pump to provide cooling or temperature control, and this pump must be able to produce and control the high pressures (up to 130 psi) required in this application.
Shifts in healthcare have essentially changed suppliers’ role in the industry – especially when it comes to infection prevention. And, they’ve greatly impacted how both providers and suppliers think about the use of antimicrobials.
Labels often are an afterthought, because they don’t directly affect the capabilities of a medical device. However, they certainly affect the functionality of the device and users’ ability to effectively utilize all of its features. Consider these factors — and their importance — as you design your medical device overlay or inventory stickers.
A new handheld device may better equip patients in their decision-making process when choosing an intraocular lens (IOL) implant. The SimVis, developed by Spanish scientists, was tested with cataract surgery candidates, and researchers found patients had a clear preference for certain implants based on their experiences with the device.
Engineers at the University of Washington (UW) have devised a new method of wireless communication that converts Bluetooth transmission from mobile devices into Wi-Fi signals. Using this "interscatter" communications technology allows medical devices and implants with limited power sources to gain the ability to send data using low-power Wi-Fi signals to smartphones and smartwatches.
SeaSpine has acquired Israeli medtech NLT and its platform of minimally invasive fusion technologies for degenerative spine disease. SeaSpine CEO Keith Valentine remarked that the deal, potentially worth $52.5 million in cash and stock, marks the newly spun-off company’s commitment to innovation through acquisition.
Edwards Lifesciences has received from the U.S. Food and Drug Administration (FDA) expanded indication approvals for its Sapien 3 and Sapien XT transcatheter heart valves in intermediate-risk patients suffering from aortic valve stenosis. With the approval, Edwards brings significantly more patients into its captive transcatheter aortic valve replacement (TAVR) market, ahead of Medtronic and others.
The European Commission is offering guidance to define the criteria for the qualification and classification of standalone software used in a healthcare setting as a medical device or in vitro diagnostic (IVD).
A novel wound dressing for diabetic foot ulcers uses biomaterials science to compensate for the healing limitations experienced by diabetic patients. Researchers from Northwestern University claim the “regenerative bandage” promotes healing four times faster than a traditional bandage, and promotes a more natural healing process, without unnecessary and dangerous side effects.
Levita Magnetics has launched a first-of-its-kind magnetic surgical system for gallbladder removal shortly after receiving de novo clearance from the U.S. Food and Drug Administration (FDA). The device is said to be so unique that FDA had to create a new category to accommodate this new technology.
Molex, LLC, a global manufacturer of complete interconnect solutions, announced recently that one of its subsidiaries has entered into a binding agreement to acquire Phillips-Medisize Corporation, a global leader in outsource design, development and manufacturing services for the medical industry that is a portfolio company of San Francisco, CA-based Golden Gate Capital, a private equity investment firm with approximately $15B of capital under management.