When it comes to designing and building novel medical devices to meet the needs of patients and healthcare systems, developers should rely on the core skills of engineering and design to inform their process. But there are “lessons learned” that are unique to the medical device development process. The team at Goddard has contributed to […]
Made precisely for the medical device market: Forward thinking from the First Step
When a surgical team steps into an operating room, each member of that team has a defined purpose and role to play in the procedure at hand. There is, however, the common thread that each are dedicated completely to the care of that patient and ensuring that the best possible outcome is achieved. Of the […]
How to secure Medicare coverage for your IDE clinical trial
By Jennifer Varela, Senior Manager, Reimbursement at Avania Mack Rubley, Executive Director, Business Development (US) at Avania Admittedly, requesting reimbursement for investigational device exemption (IDE) clinical trials in the United States is a complex, daunting process frequently overlooked by medical device manufacturers. However, if payers — most notably the U.S. Centers for Medicare and Medicaid […]
Dreams of a common engineering database during product development
By Chuck Smith, Principal Engineer at Sunrise Labs In working with geographically distributed teams, integration of the team members is critical to communicate effectively and to avoid misunderstandings or setbacks. Once the design of your medical device prototype is complete, a lengthy process may be required to input engineering data before orders for any of […]
Precision centerless grinding: Innovative approach to a traditional manufacturing process
Resonetics’ centerless grinding process enables a nearly limitless level of micro-scale geometries for mandrels, guide wires, core wires and catheter components. With expert process knowledge, machine fabrication, automation and 100+ grinding systems, Resonetics has one of the largest, most comprehensive capabilities in the industry. Precision, or centerless, grinding was invented in the early 1920s to […]
Component testing & analysis: How to gain deeper insights with a universal testing system
By Landon Goldfarb, Senior Applications Engineer, Instron Universal testing systems are most commonly known for performing tensile or compressive tests on raw materials, often with specimens in simple geometries. These tests are usually driven by testing standards, and insights are typically limited to what can be found in a material data sheet. Raw materials are […]
How to make your clinical monitoring efforts matter
How should sponsors and sites define successful clinical monitoring today, and what can they do to ensure they achieve their goals? By John Lehmann, Director of Business Development Whether you’re performing it on-site or remotely, clinical monitoring comes with many challenges. In the past decade (and even the past year), monitoring has evolved. How should […]
Micro 3D printing advances biomarker detection
Researchers in China have used Projection Micro Stereolithography (PµSL) to improve the fabrication of micropillar array electrodes (µAEs) for the identification and detection of biomarkers. PµSL, a micro-precision 3D printing technology from Boston Micro Fabrication (BMF), enabled researchers to produce 3D printed molds for reduced fabrication costs and increased device sensitivity. Most µAEs are fabricated […]
New project based rapid precision prototyping program
Your First Step Is the Most Important Designing for tomorrow’s precision instruments calls for a different set of rules. Leading OEMs in the medical device sector have redefined what they need to maintain a successful new product development and new product introduction pipeline. These elements include: Precision tolerance prototyping Access to a solid manufacturing support […]
Rethink post-market surveillance (PMS) for medical devices
How Smart, Connected Medical Devices Can Deliver Critical Insights Six years after receiving FDA clearance, a medical device company’s investment in a new therapeutic area is finally paying dividends. But a new patient injury report could send the company reeling if it can’t identify the root cause of the device failure quickly. The financial impact […]
Cloud gaming technology raises the bar for remote sales rep interactions
Groundbreaking Technology Allows Surgeons and Sales Reps to Perform Ultra-realistic Virtual Procedures Remotely By Tom Donnelly, Chief Revenue Officer, Level Ex When Netflix launched its streaming services in 2007, few people foresaw what that would mean for brick and mortar video rental stores. I’m reminded of the complete transformation of that industry as I stand […]