August 2012 Posts

Sustainability Impacts Medical Devices, Too

Mark Crawford

“Sustainability” has become a trendy, mainstream term over the past decade. However, applying the triple-bottom line aspects of sustainability—economic prosperity, social well-being, and environmental stewardship—is of growing importance to customers, employees, investors, and non-governmental organizations (i.e., stakeholders of manufacturing and institutional organizations). Wayne E. Bates, vice president of Capaccio Environmental Engineering Inc., a comprehensive environmental, health and safety consulting and engineering firm in Marlborough, Massachusetts, discusses how sustainability applies to the medical device community. (more…)

How to Build a Multi-Functional Validation Team

How to Build a Multi-Functional Validation Team

Mark Crawford

The current practice within cGMP-regulated industries is that validations are conducted by teams of people, working cooperatively toward a common goal. Quality-driven organizations have come to recognize the limitations of clearly defined roles, responsibilities, and organizational boundaries and are starting to use multifunctional teams that integrate all stakeholders’ efforts toward a validation project. (more…)

Integrating Risk Management into the Design Process

Mark Crawford

Ron Litke, a senior development engineer with Orchid Design, a division of Orchid Orthopedic Solutions, has over 15 years of design and project management for orthopedics and medical devices. In this brief interview he shares some thoughts about implementing risk management during the design and development process. (more…)

Social Media Can Be a Dangerous Tool

Social Media Can Be a Dangerous Tool

Mark Crawford

It’s not too hard to slip up with social media and get the unwanted attention of the FDA, which is getting serious about policing off-label promotion of products.

With companies scrambling to utilize social media (often without dedicated management), and the confusion that exists about what companies can do legally with off-label promotion, mistakes are going to happen. (more…)

Clinical Trials Guidance: Q&A with Patrick Stone

Mark Crawford

Patrick Stone is president and lead consultant for TradeStone QA LLC in Austin, Texas (www.tradestoneqa.com). A strong advocate for human subject protection, his specialties include bioresearch monitoring in human clinical and pre-clinical trials. The following interview focuses on the FDA and clinical trials. (more…)

FDA Seeks to Standardize Electronic Data Submittals

Mark Crawford

In February the FDA released a guidance document proposing a standardized format for submitting clinical and nonclinical data to the agency. The FDA maintains that by following this protocol early in the product development cycle medical device and pharmaceutical companies can reduce bottlenecks and speed up the approval process. (more…)