Why Cost of Quality Process is Important in Medical Device Manufacturing


The Importance of Quality Process

Investing in great quality management is a business imperative. Quality and quality process has always been a priority for large medical device and healthcare manufacturers. They want to improve patient outcomes, reduce risk and retain customers while increasing market share.

However, many organizations avoid the leap to fully cloud-enabled quality systems. This creates risk opportunities even in the most important processes, and cannot invest in long-term solutions. Furthermore, immediate investments seem to be a greater risk in order to continuously cope with poor quality.

Do you know what your current quality process is costing, not just in terms of ongoing maintenance costs, but also in terms of lost revenue and poor patient outcomes? These systems’ costs can add up.

In a recent survey, respondents were asked to rate themselves based on their convenience with cloud platforms. The results showed that 26% of medical device manufacturers are curious about the cloud. Whereas 51% are comfortable in the cloud and 23% are taking a cloud-first approach.

Additionally, the companies that are comfortable in the cloud are resilient in nature. Aand better equipped to meet business, technological and regulatory challenges.

By investing in excellent, PLM processes now, you can save millions of dollars avoiding customer problems, audits, and delays to market. So it’s time to take the plunge.


How Poor Quality Process Can Damage Your Business

If you bring a product to market without guaranteeing quality, it can result in injured patients, severely damaged branding, and increased regulatory scrutiny. They harm others and themselves. The cost of investing in a better system is comparatively low and much safer.


Patients Can Suffer Injuries

That might be obvious, but patient results are at the heart of the life science business. If life is not improving, or worse, if your products are harming patients, you are not fulfilling the fundamental mission of implementing a cloud-based solution that enables rapid response to problems that arise.

Supporting the improvement of product quality over the entire life cycle and adhering to global regulatory requirements is the only way to bring departments together and identify problems before they go into action. 

Software stores information on-site and slows problem resolution, and when minutes can mean the difference between health and harm to a patient, your brand can’t afford to respond to complaints immediately.


Brand Reputation Can Get Damaged

In 2016 one could not forget the public quality debacle of consumer technology that was all over the news. The Samsung Galaxy Note 7 exploded in the hands of its customers! The overheating was caused by separate battery problems from two different manufacturers. Samsung was unable to identify both issues separately in their quality processes before the phone shipped.

While consumer technology has different challenges than the medical device market, both end up in the hands of the end-user and medical devices can do exponentially more harm to the patient. Secure income can be a costly mistake that not only harms your patients but the longevity of your brand as well.

Going the extra mile and delivering innovative results for patients is often an exciting part of working with medical devices. Major medical device manufacturers must prioritize patient welfare to protect their employees and parties.


Damage to Brand Trust

In a 2017 study in the International Journal for Health Care Quality Assurance on trust in medical device brands, the results showed that brand image is one of the most effective items that have the greatest impact on customer satisfaction and the benefit of health services.

Your brand reputation seriously affects whether consumers trust you, and that trust is fragile. By investing in better quality systems and identifying quality problems before they hit the market, medical device brands can maintain consumer confidence.


Regulatory Audits Will be Tough

Poor quality can ultimately lead to the involvement of the supervisory authorities through audits, fines, and even imprisonment. Audits slow innovation tenfold and damage morale and turnover. 

With systems that allow you to spot bugs early on, you can avoid most regulatory reviews, submit your approvals on time, and deliver great products without fear.

In a digital-first world where discerning patients, customers, agencies, and suppliers order great products faster, you can afford nothing less than near-perfect quality with a system that runs on servers on your office campus. This can cause a lot of expenses and increase your risk.


The Cost of On-Premise Solutions

General maintenance prices are a resource drain. you will be filing your server maintenance and system licensing expenses underneath “general” along with your accountants. However, that, in reality, is a high-quality system cost. 

Upholding randomized silos between QMS, PLM, and CRM only lets vendors dupe you. Unifying all of these product and client records in one place will simply be done by employing the proper tool.

Information debt accrues in old systems. What does one do once your in-house professional retires or leaves for another job? how does one document all the patch-throughs necessary for your workflows to flow smoothly? coaching may be a large hidden value connected to on-premises quality systems.


On-Premise Solutions Risks

unidirectional communication chains curtail time to market. You can’t beat your competitors if you can’t detect crucial documentation or provide compliance on schedule. 

M&As are far more tough and clumsy with on-premises hardware. Your brand value is less attractive to potential patrons if the acquisition is taking a few months longer than it would have if you were on the cloud. 

Your systems must scale with you. With on-premise systems, you would possibly encounter bandwidth, storage, and memory shortcomings that simply can’t keep up as you scale. Cloud-based solutions, on the other hand, hand, are scalable and may grow as quickly as your business.


Closing Thoughts

Technologically trending medical device brands can’t afford to hesitate on quality investment. McKinsey found that on average, the price of poor quality is double that of the cost of direct investment in higher systems. cloud migration solves your immediate quality concerns.

To drive quicker time to price and grow your company effectively, you need to replace the paper-based or manual legacy systems that are exposing you to larger risk with a cloud-based integrated platform. KloudPLM is the one-stop solution to your product development and quality process needs. Sign up today to start your digital transformation journey.


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