Digital Strategy

What’s Your Quality Process Costing You?

December 22, 2020

How on-premise solutions are holding back your patient outcomes.

Investing in great quality management is a business imperative, and naturally, quality has always been a top priority for leading medical device and healthcare manufacturers: You want to improve patient outcomes, reduce risk and retain customers, all while growing market share. 

However, many organizations are avoiding taking the leap to fully cloud-enabled quality systems, opening possibilities for risk even in the greatest processes — unable to invest in long-term solutions because the immediate investment seems like a bigger risk than managing poor ongoing quality.

Do you know what your current quality processes are actually costing you, not only in ongoing maintenance costs, but in missed revenue and poor patient outcomes? Poor quality can be the most expensive problem your company can have, and the costs of maintaining those poor-functioning on-premise systems can add up. 

A recent poll of life science professionals from Axendia asked respondents to rate themselves according to their comfort level with cloud platforms. Findings revealed that 26% of medical device manufacturers are cloud-curious, 51% are cloud-comfortable and 23% are taking a cloud-first approach, and that the cloud-comfortable and cloud-first companies surveyed are more resilient and better equipped to overcome business, technology and regulatory challenges. (Read the full findings in the eBook here.)

Investing in great closed-loop quality management processes now can save you millions of dollars down the line in avoided customer issues, audits and commercialization slowdowns. Here’s why it’s time to take the leap.

How poor quality can hurt your company

When you release a product into the wild without ensuring quality, it can result in injured patients, a significantly damaged brand reputation, and increased regulatory audits. You harm others and yourself. The cost of investing in a better system is small in comparison — and much safer.

Injured patients

This may be obvious, but patient outcomes are at the heart of a life science business. If lives aren’t improving, or worse, if your products are harming patients, you’re not delivering on the basic mission of your organization. Deploying a cloud-based solution that enables fast response to issues as they arise, supports improved product quality throughout the lifecycle, and meets global regulatory requirements, is the only way for departments to unite and catch issues early before they’re in the field. On-premises software silos information and slows issue resolution, and when minutes could make the difference between health and harm for a patient, your brand can’t afford to respond to complaints less than instantly.

Damaged brand reputation

In 2016, it was impossible to escape consumer technology’s biggest public quality failure to date: the Samsung Galaxy Note 7 was exploding in the hands of its customers! The overheating was caused by separate problems in batteries, which were sourced from two different suppliers. What went so wrong? Samsung failed to catch both separate issues in their quality processes before the phone shipped.

Though consumer tech has different challenges than the medical device market, they both end up in the hands of an end user, and medical devices can cause exponentially more harm to the patient. Caution is key — rushing to get a device to market quickly enough to secure revenue may be a costly error causing damage not only to your patients, but to your brand’s longevity.

Look no further than The Bleeding Edge, a 2018 documentary that chronicled innovative medical devices gone terribly wrong in the field. The film’s coverage of the dangers connected to the birth control device Essure led to it being removed from the market a week before the film’s release. 

Pushing the envelope and driving innovative patient results is often an exciting aspect of medical device work, but in order to avoid showing up on Netflix, leading med tech manufacturers must prioritize patient wellbeing in order to protect their employees and stakeholders in the long run.

Damaged brand trust

In a 2017 study on medical device brand trust in the International Journal for Health Care Quality Assurance, results revealed that the most effective items bearing the highest influence on customer satisfaction and on benefiting from healthcare services included brand image. 

Your brand reputation seriously influences whether consumers will trust you — and that trust is fragile.

“Before a consumer decides to let a doctor implant a medical device in their body, they need to trust that it will be safe,” Jeanne Hopkins, branding expert, writes on the Ipswitch blog. “A doctor isn't going to use a medical device or drug they're not confident in, either. Companies earn trust by delivering on their brand promise and by continuously building relationships.”

By investing in better quality systems and catching quality issues before they go to market, medical technology brands can preserve consumer trust.

Increased regulatory audits

Lastly, it must be mentioned: Poor quality can ultimately result in regulatory involvement through audits, fines and even jail time. Audits slow down innovation tenfold, and are bad for morale and turnover. With systems that allow you to notice malfunctions early, you can prevent most regulatory scrutiny, submit your approvals on time and ship great products without fear.

You can’t afford anything less than quality near-perfection in a digital-first world, with demanding patients, customers, agencies and suppliers all asking for great products faster, with a system that runs off of servers on your office campus. They’re too expensive and risky in the long term.

The cost of on-premise solutions

  • General and administrative maintenance costs are a resource drain. You may be filing your server maintenance and software licensing expenses under “general” with your accountants, but that’s actually a quality system cost. 
  • Upholding arbitrary silos between QMS, PLM and CRM only let vendors take advantage of you. Unifying all these product and customer records in one place can easily be done (in some cases, in just a few months) using the right tool.
  • Knowledge debt accrues in legacy systems. What do you do when your in-house expert retires or leaves for another job? How do you document all the patch-throughs necessary for your workflows to go smoothly? Training is a huge hidden cost attached to on-premises quality systems.

The risk of on-premise solutions

  • One-way communication chains slow down time to market. You can’t beat your competitors when you can’t find crucial documentation or ensure compliance on schedule. 
  • M&As are much more difficult and clunky with on-premises hardware. Your brand is less attractive to potential buyers if the acquisition is going to take months longer than it would if you were on the cloud. (Migrate now to get bought later.)
  • Your systems should scale with you. With on-premise systems, you might experience bandwidth, storage and memory shortcomings that just can’t keep pace as you scale. Cloud-based solutions, on the other hand, are scalable and can grow as fast as your business.

How to improve quality

Modern medical device brands can’t afford to hesitate on quality investment. McKinsey found that on average, the cost of poor quality is double that of the cost of upfront investment in better systems. Not only will cloud migration solve your immediate quality concerns, but it’s a 50% off deal down the road.

To drive faster time to value and grow your company effectively, you must replace the paper-based or manual legacy systems that are exposing you to greater risk with a cloud-based integrated platform.

Resolve cases up to 30% faster with the only true closed-loop QMS solution.




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Kathryn Kosmides

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