While all new OEMs dream of huge IPOs and industry changing inventions, those in the medical device industry play with even higher stakes. Patient's Health. With corporate goals to improve and save lives, every product quality issue becomes even more significant. In worst-case scenarios, the defective device that was made to improve the quality of life for thousands can potentially end up causing harm instead.
Considering these potential ramifications, while a medical device OEM’s dreams may be the same as any other OEM’s, its nightmares can be magnitudes worse. A regulatory mandated or even voluntary recall can be devastating. Arena Solutions’ Validation Program Manager, Lena Bolton, has worked at four Medical Device companies throughout the Bay Area and knows firsthand what makes Quality Managers toss in their sleep. With the number of medical device product recalls increasing every year, we decided to ask Lena about some of the issues that Quality and Regulatory Managers face.
1. Outgrown Infrastructure: When a new Medical Device company starts off with a handful of employees, it’s easy to keep product documentation straight and everyone informed about the product record. Just holler over the cube – or ‘sneakernet’. But as the company and number of new products (and their versions) grow, so does the product documentation set, including the design history file (DHF), device master record (DMR) and bill of materials (BOM). Many companies stick with their paper processes out of habit or a lack of resources dedicated to updating their Quality Management System (QMS). This shortsighted decision can soon leave a company with an outdated system, instead of upgrading to a Quality Management System that’s capable of keeping pace with the complexity of their product. Once an audit, internal or FDA, begins, finding every piece of required product documentation can be like finding a needle in a haystack. Even the most meticulously organized paper systems can add unnecessary delays and keep you from getting a good night’s sleep.
2. Departmental Civil War: Feuds between Quality and Engineering can seem like a never-ending battle. Engineers, focused on finishing projects and building products, may see Quality Managers as a roadblock. When Engineers and Quality do not have visibility into the same issues with a collaborative culture, the battle drags on. Arena Solutions' new Quality Module is part of your product lifecycle management (PLM) system, interacting directly with your bill of material, all controlled documentation, engineering change orders, quality records and more. This embedded nature makes for tighter integration than other alternatives. The benefit: Quality and Engineering can now work together harmoniously. Once a mistake is identified in the early stages of development, fixing this mistake with a properly integrated Quality Management System is a simple process. There is no chasing down the necessary stakeholders with a paper and pen for weeks on end; just a quick electronic signature and you are onto the next step.
3. Making the Same Mistake Twice: Quality Digest discovered that up to “80% of quality issues are repeat issues for which a corrective action has already been identified but does not persist.” It’s imperative your Quality Management Solution provide visibility and insight to past failures to prevent the same mistakes from happening again. And making this information available to all the necessary stakeholders is one way that helps. Your historical quality information should be integral to and a guiding force during product development, influencing design and allowing you to create better products. This creates a quality solution that not only solves quality issues but enables you to actively identify them earlier and prevent them from recurring. The ability to see mistakes across common parts and create a historical narrative is something paper processes will never be able to replicate.
4. Losing Invaluable Quality Knowledge: Companies lose valuable information in two primary ways: poor documentation processes and employee turnover. While the cause and result of the former are fairly obvious, the issues with the latter do not arise until it is too late. As they age, all companies experience some level of growth and employee turnover. If you are relying on key members to recall historical data and ensure all stakeholders are informed, then valuable information is in danger of never reaching the correct employee or even worse—leaving your company. Failure of knowledge transfer can affect your future product quality. Instead of relying on these key members to make sure the correct quality lessons are passed on each and every time, a strong quality management solution does this for you.
Does any of this sound familiar? If these nightmares are your reality, your company may be at risk for a dreaded recall. Or line down. As the capabilities of technology increase, so does the number of new devices. Stricter regulations with additional complexity are a combination that could be contributing to the increase in FDA recalls. This morass can seemingly create a feeling of inevitability when it comes to recalls; especially if your Quality Management Solution is two decades behind the product you’re developing.
Leveraging cloud systems, electronic signatures and an embedded product and quality records can turn the tide against the ever mounting list of regulations being mounded upon OEMs. The way Arena Solutions’ new Quality module integrates directly within your Arena PLM system is a seamless foundation for your Quality Management System. If you’re losing sleep from any of the issues recited above or are interested in improving your current quality process, contact us today. We’re more than happy to help you put an end to quality nightmares once and for all.