2012 Posts

CAPA Risk Management and ROI

CAPA Risk Management and ROI

Konyika Nealy, Director of Quality Assurance, Pilgrim Quality Solutions

CAPA systems provide a wealth of information regarding the quality of a product or process.  However, few companies fully leverage the power of this tool to realize its positive impact to the bottom line. For instance, it is commonplace for a CAPA to be initiated for each product quality-related complaint regardless of scope or severity. Over time, the system becomes laden with records, of varying degrees of severity, which are often vetted by issuance order rather than priority. As a result, the organization cannot optimally allocate resources to correct events that have the most impact on the business as a whole. So then, how can a company reclaim efficiency and perhaps even streamline the CAPA process? (more…)

Five Years, Twenty-Six Days

Five Years, Twenty-Six Days

Mark Crawford

On October 15, the FDA published guidance regarding new efforts to reduce the average total wait time for 510(k) decisions from an average of 150 days in FY 2012 to 124 days in FY 2017. They will seek to do this by hiring more reviewers and investing more resources, both made possible by the Congressional approval of the Medical Device User Fee Amendments of 2012 (MDUFA III) earlier this year. (more…)

Federal Commission Recommends Stricter Genome Protection Laws

Federal Commission Recommends Stricter Genome Protection Laws

Mark Crawford

On October 11 the Presidential Commission for the Study of Bioethical Issues released the 154-page “Privacy and Progress in Whole Genome Sequencing”report, which concludes that, in order “to realize the enormous promise that whole genome sequencing holds for advancing clinical care and the greater public good, individual interests in privacy must be respected and secured.” (more…)

Risk Management Also Pertains to Social Media

Risk Management Also Pertains to Social Media

Mark Crawford

You may be asking… what does enterprise risk management have to do with social media? Most companies have accepted social media into their marketing and advertising strategies—even if they don’t understand it, or invest in it, as a business tool.

This can be dangerous.

According to Michael Krigsman on his blog IT Project Failures, although the benefits of social media are clear, such as direct access to customers, shortened feedback cycles, and personalized marketing—the risks may not be. (more…)

Medical Device Tax Is Three Months Away—Are You Ready?

Medical Device Tax Is Three Months Away—Are You Ready?

 Mark Crawford

Even with the Affordable Care Act (ACA) providing up to 30 million or more Americans with health-insurance coverage (and first-time, affordable access to medical devices), the medical device industry is worried about the looming 2.3-percent medical device excise tax—also a result of the ACA. (more…)

India Flexes Its Muscles against Big Pharma

India Flexes Its Muscles against Big Pharma

Mark Crawford

Outsourcing to India is one thing; getting patent protection is another. Big pharma is entrenched in several high-profile cases in the Indian court system, including:

  • Bayer’s challenge to a decision by the patent office that forces it to license its drug, Nexavar, to an Indian firm
  • The patent office revoked Roche’s patent for Valcyte, which the company is appealing
  • India rejected two patent applications by Gilead for its HIV drug Viread; the case is under appeal
  • In 2006 India refused to grant Novartis a patent for its leukemia drug Glivec—Novartis is now challenging that decision in court

(more…)

Product Liability: How Exposed Are You?

Mark Crawford

According to regulatory compliance expert James Kolka, management too often ignores the legal and financial threats posed by product liability lawsuits.

“Management often believes that compliance with FDA’s Quality System Regulation (QSR) protects the company from product liability exposure,” says Kolka. “Consequently, the task of product liability management is invisible and not audited. It seems to materialize when there is a lawsuit and a mad scramble to find who is or should have been responsible.” (more…)

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…)