Recently, White House experts expounded upon key lessons learned regarding the pharma supply chain based on the pandemic. As part of this analysis, they cited the specific need for a focus on quality management maturity.
The dirty secret that many life sciences and medical device companies don’t want people to know is that, to date, quality management has primarily been paper-based AND an afterthought in comparison to key strategic initiatives such as product development.
Why is this? These companies haven’t had the tools, knowledge, or talent to streamline the quality management process and bring it digital, which has made quality management increasingly challenging — especially amid the pandemic when many workers were forced to abandon their offices and work from home.
For those who think quality management and building a culture of quality within life sciences and medical device companies shouldn’t be a priority, here are some recent and well-publicized examples that communicate the opposite:
- Recall due to low levels of a cancer-causing agent in sunscreen.
- Contamination of up to 15 million doses of a Covid-19 vaccine due to a manufacturing issue.
- Errors in Covid-19 tests from a single laboratory that led to about 300 flawed and misleading results at nursing homes across Massachusetts.
What one thing do these three examples have in common? Each is a result of lackluster quality control processes internally and across their supply chains. Still, the prior examples are not meant to demean the companies involved; rather, they stand as reference points for what can and will go wrong if creating a culture of quality is not prioritized.
Based on lessons learned from the pandemic and the increasing likelihood that some companies will continue to embrace remote work, life sciences and medical device leaders need to prioritize building a culture of quality from the ground up moving forward. To do so, they should consider prioritizing these actions:
- Change of Mindset at an Organizational Level — Today, quality management is still seen as a burden. In order to shift this inherently flawed mindset, life sciences and medical device leaders need to prioritize the quality management function and put the quality management team on a pedestal. Giving quality management a seat at the leadership table is an important first step in making this change a reality.
- ‘Just Say No’ Policy to Data Fragmentation — Quality management isn’t a “one-trick pony.” Rather, this critical function touches all parts of a business and its supply chain. Adopting a no-paper policy is a great start. If healthcare providers can make the move to electronic health records, surely life sciences and medical device companies can do the same. A digital and cloud-based approach to quality management is mission-critical to putting dangerous information and data fragmentation issues to rest.
- Investing in Talent and Education —With growing demand for quality management skill sets, the labor pool is dwindling. Smart life sciences and medical device companies should invest in educating their current workforce on emerging quality management best practices and tools. These organizations can also consider partnering with local universities and colleges to build quality management collaborations and programs that will help fill the growing need for this invaluable skill
It is important to also note that creating a culture of quality cannot just be an internal initiative for a specific life sciences or medical device company — it needs to be a consideration for all the partners that an organization collaborates with to bring a product to market, from clinical trial collaborators to manufacturers and distributors. One seemingly minor quality management error in any part of the supply chain can have a massive impact down the line for all parties involved, including consumers.
Changing the perception of quality management as a burden versus a business differentiator is not an overnight endeavor. Luckily, the pandemic has shed light on how devastating poor quality management can be, as well as how incredibly impactful quality management is when it comes to bringing high-value products, like vaccines, to market with speed.
