New Guidance on Postmarket Surveillance from the FDA

New Guidance on Postmarket Surveillance from the FDA

Mark Crawford

The FDA continues to roll out new guidance documents for medical device regulations—this time presenting updated rules for postmarket surveillance.
The draft entitled “Postmarket Surveillance under Section 522 of the Federal Food, Drug and Cosmetic Act,” released by the FDA on August 16, provides a summary of the revised postmarket surveillance program, including new modifications. (more…)

Lean Is the Cornerstone of Quality

Lean Is the Cornerstone of Quality

Mark Crawford

Eliminating waste in a process is essential for reducing complexity, lowering risk, increase productivity, improving quality, and reducing overall costs—savings that can be passed on to the client through lower pricing. A simpler, more streamlined process also makes reproducibility and validation easier.

There are lots of ways to tackle quality improvement, including monitoring equipment and software. But one of the easiest and least-expensive ways to improve quality and reduce risk is value stream mapping (VSM), one of the key principles of lean manufacturing. In fact, VSM is so simple it just requires a pencil and a piece of paper. (more…)

Take the Lead when It Comes to Compliance

Take the Lead when It Comes to Compliance

Mark Crawford

Even though it’s easy to complain about regulatory agencies, without them things tend to get worse, not better (the financial industry, for example). There will always be companies that, when regulatory agencies aren’t looking over their shoulders, are tempted to slack off a bit, especially when the economy is tough, money is tight, and there are plenty of fires to put out.

So resist the temptation to slide (it’s always rough at the bottom). Be your own regulatory cop, whether you are being watched or not. Invest in whatever is necessary to fully understand compliance regulations, meet them, and even exceed them—for the simple reason that it is the best thing to do to protect yourself and your customers. (more…)

FDA Wants Four-Star Reviews

FDA Wants Four-Star Reviews

Mark Crawford

The FDA is tired of being the rate-determining step when it comes to the medical device approval process. In the field of chemistry, the rate-determining step is the slowest step in a chemical reaction—the reaction cannot go faster than the rate-determining step. To speed up their game, the FDA recently announced its medical device reviewers will undergo more extensive training, starting in September 2011.

The Process

The medical device review process of the FDA’s Center for Devices and Radiological Health (CDRH) has been heavily criticized over the years for being cumbersome and slow. A major factor in these complaints, especially for 510(k) and Premarket Approval Application (PMA) procedures, is high FDA reviewer turnover. (more…)

FDA Upgrades Human Factors and Usability Expectations

FDA Upgrades Human Factors and Usability Expectations

Mark Crawford

Less uncertainty from the FDA, and a smoother 510(k) submission process, is always a good thing. That’s why most medical device manufacturers (MDMs) support the new FDA guidance document released on June 22 that will improve the safety of medical devices by conducting more human factors engineering.

The 37-page document, entitled “Applying Human Factors and Usability Engineering to Optimize Medical Device Design,” states that its “recommendations are intended to improve the usability of devices to reduce use error, injuries from medical devices, and product recalls.” (more…)

Make Risk Work for You

Make Risk Work for You

Mark Crawford

Risk is everywhere—from the time you get up to the time you go to bed, and even while you sleep (earthquake, fire, carbon monoxide poisoning, sleep apnea, alien landing, etc.). The question always is: How much risk is tolerable, or reasonable? What kinds of risk need to be controlled the most? What is the cost benefit in doing so? Where is the trade-off?

Over the last decade risk management has become big business

Universities now provide advanced degrees in risk management. The Division of Social and Economic Sciences, part of the National Science Foundation, is writing grants for studying risk. A plethora of risk organizations has bloomed as well, including the Decision Analysis Society, Society for Judgment and Decision Making, Society for Risk Analysis, Risk Management Association, Global Association of Risk Professionals, Risk Management Society, American Risk and Insurance Association, Security Analysis and Risk Management Association, and others. (more…)

483s Can Be a Good Thing (Really)

483s Can Be a Good Thing (Really)

Mark Crawford

According to FDANews, the increasing rate of FDA inspections and warning letters is continuing this year—as of June 2011 the FDA had issued 874 letters in fiscal 2011, compared with 673 last year. If FY 2011 is like 2010, leading issues will be quality unit deficiencies, inadequate batch failure investigations, lack of follow-up procedures, validation of manufacturing processes, and handling deviations. For international inspections, deficient laboratory controls, quality unit deficiencies, and deficient procedures led the list last year.

It usually starts with Form 483, which “lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance.” (more…)

FDA Struggles with Rising Imports

FDA Struggles with Rising Imports

Mark Crawford

It’s been a long time coming—overwhelmed by an ever-increasing flood of imported products that need be inspected, in June the FDA announced a plan to better address monitoring and regulating these goods. And, facing the stark realities of restricted funding, outdated technology, and sometimes less-than-willing global partners, it won’t be easy.

Over the last 10 years, FDA-regulated imports rose from 6 million shipments to about 24 million for 2011—an estimated annual growth rate of 15 percent. In the food industry, according to the FDA, about 45 percent of fresh fruit and vegetables and 70-80 percent of the seafood Americans consume are shipped from other countries. In the medical field, about 80 percent of all active pharmaceutical ingredients in U.S. drugs come from overseas, as well as about half of all medical devices used in the U.S. (more…)

Perfect Harmony Across Your Global Organization

Perfect Harmony Across Your Global Organization

When you think of harmony, you’re more likely to think of a group of people singing in perfect key together than a global organization working in total agreement. Just like in singing, not all people are singing the same notes, but the notes that they do sing are in perfect alignment and compatibility with the others. That’s what global harmonization is – alignment of business processes and data for global standardization and enforcement. It’s not performing identically, but in a way that complements performances of others.

The Benefits of Global Harmonization are many, including:

  • Global consistency
  • Business process improvement
  • More operational control
  • Leverage best-practices for success
  • Enterprise visibility
  • IT cost-savings

(more…)

Monitoring Supplier Performance throughout the Product Life Cycle

Monitoring Supplier Performance throughout the Product Life Cycle

Knowing your suppliers is as important as knowing the resources themselves. If you have a product defect, it doesn’t matter if it was a supplier’s fault or your own – the only thing the public will see and react to is your product and brand. Ouch. It pays to keep a tight control on supplier management.

The first step in understanding suppliers is through an evaluation and acceptance process. What are their business systems? Are they financially stable? What does Dunn & Bradstreet have to say about them? What percent of their sales is the product or resource you need? If it’s not substantial, will that affect the quality? (more…)