8 steps to successfully introduce your medical device product

There are eight major steps you need to know in order to successfully get a medical device to market, according to  Jim Medsker, president of Keystone Solutions Group. The steps provide a “general overview of the important issues to think about as an early stage company,” Medsker explained in a recent whitepaper. The eight steps

New requirements you should know for medical EMC

Plan now to ensure your medical devices comply with new EMC requirements by the December 2018 effective date. Since the development cycle can be 2-3 years, it is important to understand the new IEC 60601-1-2 EMC 4th Edition standard now when designing medical devices. To provide you guidance on these important changes and improve your

Navigation Aids Enhance Foot Control Usability

The ever-increasing functional capabilities of emerging medical devices have precipitated new requirements for the multi-function foot controls used to operate the equipment. These foot controls typically consist of multiple actuators … one for each required control function. For example, it is not uncommon to find foot controls for electrosurgical generators with 3 functions, foot controls

Survey: The fractured state of enterprise sales enablement and training

According to a recent Allego survey, 73% of salespeople in the medical/pharmaceutical industry believe insights from reps in the field would improve the sales enablement process at their company. Allego’s Inaugural Sales Enablement and Training Survey offers insight into the disconnect between current sales enablement and training programs and what’s needed to drive performance in

The 6 sciences of medical micro molding

The medical micro molding industry is still fairly young, but is rapidly growing and evolving. Being aware of shifts in trends and changes in technology helps to see where ­and how­ the next major innovations and breakthroughs will occur. In the medical device world, it’s often the smallest parts that carry the greatest importance relative

Taking the risk out of manufacturing transfers: Four best practices

If you’re considering a manufacturing transfer, you may be losing sleep over all the things that could go wrong: cost overruns schedule slips quality issues, to name a few. Missteps anywhere in the process can make the difference between meeting or missing your timeline and budget. Download this paper on MassDevice.com.

Take no (cyber) risk with your medical device

The rise of a SMART and connected world brings many challenges, especially as technologies continue to develop and evolve. The evolution of medical devices is no different. With more and more wireless medical devices hitting the market, the need for effective cybersecurity to safeguard patient data and ensure device functionality is critical. Manufacturers must integrate

From zero to six million – Using a component management process to scale up manufacturing of drug delivery devices

Drug delivery devices constitute one of the most rapidly growing segments of the medical device manufacturing market. Makers focus substantial R&D efforts on designing delivery mechanisms for new and existing drug formulations. However, even good initial designs can’t guarantee that all the parts for these devices can be manufactured correctly and assembled consistently, with few

New whitepaper: Elements of a regulatory inspection

While inspections of studies with pending marketing applications are considered routine, FDA has recently shifted its focus toward an early intervention paradigm. Under this design, BIMO Inspections can occur prior to trial completion. This approach allows FDA the opportunity to affect proactive change and continuously improve clinical investigator compliance. Early intervention inspections can be challenging to predict as the

Industry practices in medical device CRO outsourcing

Editor’s Note: This whitepaper is written by Harsh Parikh, a senior research analyst from Clinical Research, and Mathini Ilancheran, a lead analyst from Clinical R&D at Beroe. Abstract The global medical device industry is growing at a CAGR of 4.4% and is expected to reach USD $440 billion by 2018. 1 Medical device companies are turning to

Emergo whitepaper: Navigating labeling and symbol requirements in the European medical device market

A recent white paper published by Emergo discusses European rules regarding use of labeling and symbols for medical devices, and how electronic labeling as well as harmonization standards are impacting compliance under EU medical device and IVD directives. The EU recognizes more than 20 official languages, note white paper authors Jennifer Tribbett and Megan Gottlieb,

Telehealth 2016: All indicators point toward increased adoption for better patient care

For years, telemedicine has been regarded as a care delivery model for the future with extensive barriers to overcome. While many of these barriers—most importantly policy and reimbursement—persist, research and provider experience has proven that telehealth delivers better patient care, more effectively and less expensively. Today, while politicians debate expanding Medicare’s coverage of telehealth, providers

Frangible seal reagent blisters deliver precision performance

The complete whitepaper can be downloaded here. Integrating frangible seal reagent blisters into various technology platforms holds promise for more precise and reproducible results, compared to current methods in Point-Of-Care In Vitro Diagnostic testing. J-Pac Medical is a manufacturer of custom blisters for the medical diagnostics industry. The company creates the blisters according to application

Empowering Polyimides

Processing of aromatic polyimides synthesized from traditional diamines and dianhydrides has always been a limiting factor in their widespread use. Decreasing the molecular weight of these polyimides facilitates processing due to higher solubility and lower viscosity which, in turn, improves wetting characteristics. Higher molecular weight polyimides, on the other hand, are usually characterized by better

NEMA publishes NEMA/MITA CSP 1-2015 Cybersecurity for Medical Imaging

The Medical Imaging & Technology Alliance (MITA), a division of National Electrical Manufacturers Association (NEMA), published NEMA/MITA CSP 1-2015 Cybersecurity for Medical Imaging. This new white paper addresses how cyber threats pose a significant risk to patient safety, clinical and business continuity in the practice of medical imaging, and why a combination of people, processes,