Post Market Surveillance effectiveness to properly face product complaints - Momentum Events

Life sciences is a  continuously evolving and transforming domain.  It requires endless cycles of drug and medical device innovations to discover potential new medicines and devices that are more effective and seamless to use.

The process involving the development of drug or medical devices, right from their conceptual stages to the finished product, is considered to be highly complex.  The process also scrutinizes every little aspect of the products and provides satisfactory assurances of its safety and effectiveness at the time of approval.

However, to determine the safety of new drugs and devices for human consumption and use, investigative studies are continued even beyond the first approval stage.  In the Pharmaceutical sciences field, these studies are commonly called ‘Post Marketing Studies’ (PMS)

Post Marketing Surveillance (PMS)

In simple terms, PMS refers to the continuous process of monitoring the safety of drugs and medical devices once they reach the market even after the successful completion of their clinical trials and pre-marketing trails.

The primary purpose to conduct PMS is to identify previously unrecognized undesirable effects and outcomes of the drugs or device’s use as well as positive effects.

While premarketing trials are conducted to establish the toxicity profile of a drug or the defects of a device, the data is frequently found to be lacking in capacity when it comes down to detecting additional side effects or defects in the products.

Causes of Recalls for Drugs

PMS data throughout the world shows that the manufacturing process was the most common cause of a withdrawing the product from the market.  This cause accounted for 28.8% of the recalls.

List of causes of Drug recalls:

Manufacturing Related: 28%

  • Inadequate control of a process
  • Inadequate environmental controls
  • Errors in storage
  • Incorrect packaging or labeling

Materials and Components related: 16%

  • Nonconforming to classification
  • Contaminated
  • Degraded
  • Counterfeit
  • Inadequately tested

Change control related: 11.9%

  • Changes in programs specifications
  • Changes in components or devices

Causes of Recalls for Medical Devices Recalls

For MDRs, the data shows that nearly 66.4% of the recalls were associated with a device malfunction; almost 29.5% were associated with a patient injury.  However, less than 2% of the devices were involved in a patient’s death.

Other recalls were associated with employee operating errors and miscellaneous concerns – 7.1% and 7.5%, respectively.

The actual cost to Life Sciences Companies due to Recalls

As per a 2017 Mckinsey Report, a major recall can cost large medical companies as much as 600 million dollars.  Industry-wise, life sciences related recall costs an average of $30 million.

Company Segments Effected

Business interruption costs – 49%

Business interruption is not only time and costs to get your company’s production back up and running, but also the time and marketing costs required to get the customer to buy your product again.

Recall costs -35%

Recall costs include the following costs suffered by a company.

·         Product disposal costs ·         Customer reimbursement
·         Sanitizing production facilities ·         Transportation costs,
·         Warehousing costs ·         Investigation costs,
·         Internal time and expense ·         External professional fees

Product rehabilitation costs – 10%

This cost relates to reputation damage or loss of brand value.  Damage to the brand or company reputation is very difficult to quantify and the challenges to recover financially are overwhelming.

The Solution

PMS – Integrated Product complaint and Risk Management System

The first step towards averting a recall is by preventing a complaint or paying attention to it.  Finding a way to automate your process so you can resolve customer issues proactively is the most resourceful course that your companies can implement.

Continuing business as usual without a competent product complaint and Risk Management System just is not an option for life sciences organizations – one of the major factors driving this change is that the FDA regulations are getting tougher and products are getting more complex.

The complexities of the issues have already been discussed.  To gain more insight into the streamlined processes used by industry leaders Register here

What does the Event include and what it means for you?

Reevaluate Your Company’s Approach and gain in-depth insights into the most streamlined processes of Life Sciences through this conference.

  • Does your company have a Reactive or proactive PMS Management System?
  • Is your ‘Product complaint and Risk Management System’ automated and seamlessly engages with all the stakeholders?
  • How can you Readjust your Processes After a Pandemic and embrace the Challenges that Come From Working Remotely
  • How to Optimize Your Recall Strategy… and much more.

The discussion also includes the benefits of a PMS system that is a combination of proactive and reactive PMS.  It also highlights the areas where improvements such as automation, process streamline, etc can be made.

  • 1- Gain insight on how to successfully thrive during the pandemic, learn from our experts, and how they are adjusting their processes nowadays while keeping the whole team connected and on the same page.
  • 2- Learn how to use the information from the Complaints in a Proactive manner, to enhance quality and to keep your customers engaged and satisfied
  • 3- Prepare and identify how to avoid inspection findings, be ahead of the curve, we will share insight and relevant information to make sure you are diligent and ready.
  • 4- Address the regulations and maintain compliance by hearing from the FDA.
  • 5- Get your recall strategy ready, make sure you are prepared for a recall and proceed the best way possible by learning fresh approaches.