Trends to Watch For in Medical Device Industry
Access to recently developed materials, new technological deliveries and access to new markets are only a few of the trends that have affected changes in the medical device market and industry.
Apps: Fun or Medical Devices?
Popularity of smartphone applications, or apps, has increased explosively. Among the implemented functionality, more and more medical device features have started to creep in. In this article, we discuss when an app is simply fun and when it needs to be regulated as a medical device.
Choosing the Right Solution for Issue Management and CAPA
CAPA provides visibility into critical product quality characteristics, failures/ non-conformances, and resolutions to these issues for smarter decisions across the global, extended enterprise. With the right solution, design, manufacturing and quality improvement teams can share the same views of the information they need to directly impact Six Sigma and Lean initiatives.
3D Printing and the (New) Product Development Road Map
Whether you’re an engineer, designer, or technical tinkerer, here’s a basic road map to a few of the most important aspects of modern 3D printing.
Overcoming Barriers to Improvement in Product Development
Despite a clear need to get better development lifecycle management solutions in place, companies are restricted by tight budgets, validation overhead, and bureaucracy. In this Q&A, Matt Harp and Angie Pepiot at Seapine Software share their insights.
Silicone Adhesives – Challenges and Solutions
Customers have basic goals and expectation of silicone adhesives that it can hold the device or dressing in place while the device performs the intended function, until the time the clinical objective in achieved – Kris Godbey, 3M Medical Specialties.
Tapping 3D Printing Opportunities in Med-Tech
Additive manufacturing capabilities align well with the needs of the medical device segment, enhancing product customization and enabling efficient, cost-effective production and delivery, describes Deloitte’s Glenn Snyder.
HCT/P Regulation and Third-Party Reimbursement
Comprehensive and unwieldy payer policies for wound care, the tiered system of FDA regulation of human cells, tissues, and cellular and tissue-based products, and the use of brand specific names in HCPCS coding have created a challenging reimbursement environment.
Tips to Consider When Selecting a Contract Manufacturer
To ensure that you are choosing the contracting partner that will help carry both parties into the earning margins desired – it is essential that a set of criteria is used to establish the perimeters for how to choose that partner, including the specifics of what things to look for.
4 QFD Tips for Emerging Medical Device Technology
Defiant minds can conceptualize embodiment that customers actually want. But determining methods to best define what the customer wants with novel technologies can be challenging as many of the methods published just don’t fit early stage work. How can we then manage the process of quality function deployment?
