How a Medi-Tech Company Mitigated Its Product Quality Issues with Stringent Quality Assurance Framework?

A medi-tech company, that is a global producer of medical devices and therapies such as insulin pumps, pacemakers, and diabetes therapies despite being in the business for decades, found itself in a fix with FDA approvals and product quality negligence. The company authorities turned to Research Nester seeking its services for developing strategies for incorporating better and more stringent quality check framework.

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An overview:

The medi-tech company is best known for its revolutionary cardiac devices, such as battery-powered and miniature pacemakers, which had provided cutting edge to the industry. But the company faced repercussions from the FDA. The quality of their product started causing minor problems initially which led to negligence and resulted in a lawsuit against the company. To strategically develop a solution for effective product analysis using their knowledge and experience, the company authorities approached Research Nester.

1

A well-established medi-tech company, faced a class I recall (A class I recall is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death) from the FDA due to negligence in manufacturing.

2

After learning that certain Cobalt/Chrome implantable cardioverter defibrillators (ICDs) and resynchronization therapy defibrillators (CRT-Ds) have short circuit protection (SCP) alerts that cause reduced-energy electric shock delivery rather than a second phase of high voltage therapy, the company was forced to recall these products.

3

A reduced-energy electrical shock may either exacerbate an erratic heartbeat (arrhythmia) or fail to fix it. A reduced-energy electric shock's side effects or a mistaken response to an SCP alert's warning might result in severe damage or even death.

4

The company failed to assess the problem during the product’s evaluation, as there was manufacturing and quality testing negligence.

5

Subsequently, Research Nester was brought into the field to assist with an approach for efficient product analysis and to implement competent quality assurance frameworks.

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The Story

The company was founded in 1949, as a medical equipment repair shop, but evolved into one of the world’s leading medical technology firms that designs, manufactures, develops, and markets a wide range of medical devices and solutions. The business achieved milestones in the field of pacemakers and has a wide range of options to offer. It also provided the world’s smallest pacemaker. Despite this, the company’s sales were hindered due to negligence in one of their product’s quality tests. The company did try to make amendments accordingly but wasn’t appropriate at that due to their inappropriate product analysis. Furthermore, inadequate documentation regarding the quality check brought pressure from the FDA. At this critical juncture, when the firm was suffering losses and struggling to stay abridge, Research Nester was brought to the scene.

Our Solution:

The major point of failure in the product was the negligence of quality assurance of medical devices such as cardiac implants. Research Nester analysts suggested a calculative approach. According to this, the company issued a communication to its customers. Customers and/or users were given the following management suggestions and concerns in the communication:

  • Patients were given free follow up in the clinic for device reprogramming (if necessary)
  • A software update to correct the issue. This update will ensure that the full shock energy is delivered in the presence of a secondary, low-level current pathway in the high-voltage circuits.

Apart from these the following strategies were suggested by RNPL analysts-

  • Firstly, a thorough inspection is to be done on the particular batch of products.
  • Secondly, all parts are to be tested for quality assurance before assemble
  • Thirdly, the whole product is to go through remote quality testing before the product is introduced in the market.
  • Finally, evaluation is to be done from the user’s end through regulatory check-ups.
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Results

The company’s sales were waning from the beginning of 2020, with sales figures at USD 9 billion. With COVID-19, disrupting supply chains profoundly, the authorities failed to re-strategize their product analysis plans and as a result, their productions and marketing plans were hampered. To get the business back on track, the management of the firm acted upon the counsel and recommendations provided by RNPL experts. After a fully maneuvered product analysis, the company’s sales improved considerably, so much so that in 2022 the sales figures were 29 billion, witnessing a rise of 5% in their annual sales, and the firm was named one of the 2023 world’s most ethical companies. The use of experience and expertise of the Research Nester consultants has been used to implement appropriate product analysis methodologies in the company. That's how the startup was able to build a strong market position, which enabled it to have attractive prospects for future growth.

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Swara Keni

Head- Global Business Development

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