Getting a new product into the customers hands as quickly as possible is critical to medical device manufacturers. Perhaps during the rush to hand off a product to the manufacturing floor, corners are cut. The end result can be manufacturing delays that prevent the product from going out the door - or even defective product reaching the customer.
Paying attention to the details up-front can save time in the long run. Resolving issues early in the process lends itself to a seamless transfer in house or to a contract manufacturer.
Continue reading "Device Design Transfer - A Smooth Hand-off"
A little over a year ago, the FDA issued a draft guidance document (Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection) regarding the types of actions that would be considered to obstruct an FDA inspection and potentially lead to a supposition of adulteration. Last month, the final guidance was issued. The document attempts to define what behaviors are considered to mean an intentional delay or refusal. The FDA has the authority to enter any facility under the jurisdiction of the FD&C Act at reasonable times and conduct inspections.
Continue reading "Not Obstructing the FDA - Be Reasonable"
The purpose of MDR reporting is to provide a means to collect data that may indicate the presence of a safety problem. MDR reporting can be confusing and it is certainly an area where mistakes are abundant. Some mistakes however will garner more scrutiny from the FDA. In extreme instances incorrect reporting or lack of appropriate reporting can lead to criminal charges.
Continue reading "MDR Perils –Avoiding Entanglement"
When questioned if their company has a focus on quality, most managers and employees will say yes. This might be because at a minimum, it is the right thing to say. They may also believe that since they have some procedures or a quality policy that this suffices and that quality practices will just fall in to line. Under further scrutiny, however the differences between perception and reality become apparent.
The view from higher levels in the company may be that it has a well disseminated quality culture. But as you travel down the organization chart, the response may not be so positive. A culture of quality is a full time commitment to quality. It is not just referencing standards in a few SOPs. Everyone should understand who the customer is and what they expect.
Continue reading "Building a Culture of Quality- More Than Words Can Say"
Supply Chains have never been more dynamic than they are today. Their complexity has increased leading to risks associated with geography, compliance - even natural disasters. This occurs on the vendor and the customer side. It follows that as complexity increases, so do costs. When these risks are not appropriately managed companies can lose customers, profits and reputation.
Supply chains have gone global for a number of reasons. They may be seeking cost savings or they have capacity issues. Companies may outsource certain tasks seeking subject matter expertise or to allow themselves the ability to focus on core capabilities. Whatever the motivation there are times when it seems like the sky is falling but there are some best practices for supply chain risk management that can reduce the company’s vulnerability.
Continue reading "Supply Chain Risk Management"
The goal of each medical device manufacturer is to produce safe and effective products. These manufacturers are responsible for carrying out postmarket surveillance activities to monitor and collect the performance of their products. In the current regulatory environment, companies are under scrutiny for their complaint procedures and their ability to react and respond.
The FDA annually receives hundreds of thousands of medical device reports of serious harm, deaths or malfunctions. These are not only from the manufacturers but also the end users. The regulation provides a means for the FDA to monitor significant issues regarding medical devices.
Continue reading "Medical Device Reporting - Getting it Right"
The risk device companies assume is great. This requires a comprehensive planned approach. A policy on paper is not enough. It must be inherent in the day to day activities throughout the organization. Risk is constantly assessed and appropriate and timely decisions made. The goal is a reasonable assurance of safety and effectiveness of the product. In the simplest terms risk management results in the following:
- Identifies hazards
- Evaluates /estimates risk
- Determines risk acceptability
- Controls risks
Risk can take many forms. Certainly, the most concerning is the risk to the patient but risk to an operator or employee must also be considered. There are regulatory and legal considerations and finally, there are issues that propose a business risk.
Continue reading "Risk Management for Life"
A high quality product is the goal of most Life Sciences companies. Quality by design is touted in many industries. If you build it correctly from the very beginning, there will be fewer problems once the product is in a customer’s hands. To this end, a managed process for developing a product is employed. This contains interrelated procedures that make the core of the development process. Design controls make discrepancies more evident and ensure that once the product is transferred to production it will consistently meet requirements.
Continue reading "Excellence By Design"
Social media has grown from its simple beginnings of sharing personal information, pictures, opinions and current activities. Companies now utilize its power to reach customers regarding products and specials and news agencies send out headlines and teasers. The reach and purpose has grown beyond updating an individual’s status to a tool to communicate with potential customers. You can even like the FDA on Facebook. (For some Life Sciences manufacturers, there is a tinge of an oxymoron there.)
Continue reading "Product Communications Using Social Media - Like this…or Not"
We would all like the questions to a test ahead of time.
But unfortunately, an FDA audit doesn’t work that way. The FDA inspects many facilities every year across the spectrum of product types. So how do they determine how to get through this mountainous list? Manufactures have to register with the FDA and provide a list of products that they make. Different products have different risks-an implantable is different from a toothbrush. Those products with a higher risk have a greater need for an inspection.
They will look at reportable records and recalls not only for severity but frequency as well. Consumers or healthcare providers complain directly to the agency as well. This will draw attention to you. The newness of a device will also contribute to putting you on the list.
Continue reading "FDA Audit GPS"