Robert Fenton is the founder and CEO of Qualio, a cloud-based quality management system (eQMS) for life sciences teams.
The start of a new year is often a time for reflection. However, looking forward is just as important—particularly in an industry as ever-changing as life science.
As the effects of Covid-19 begin to loosen their grip, fresh headwinds should start to emerge. I see a year of both challenge and opportunity ahead as life science companies look to strike a delicate balance between innovation and speed on one hand and the realities of an economic downturn on the other.
I see four key things happening in 2023.
Those Who Collaborate Win In 2023
I previously wrote about how connectedness and interdependence would be the prevailing trend for successful life science companies in the 2020s. The shift in the economic environment since then with rising interest rates, runaway inflation and a steady teeter toward recession has only strengthened this impulse.
New and emerging startups and scale-ups in 2023 simply won’t have the resources or capital to own the entire life cycles of their life-saving products. Outsourcing, collaboration and smart supplier onboarding (from clinical trials to raw materials) will become crucial skills.
Collaboration was the name of the game when it came to battling Covid-19. Moderna’s vaccine took the combined muscle of over 3,000 mutually interacting companies. It’s a powerful testament to what’s possible.
This new symbiosis, of course, brings its own challenges. The company you outsource your business-critical functions to doesn’t assume total responsibility. You remain accountable. I expect that careful pinpointing of trusted, responsible partners will separate success from failure for companies trying to grow in this increasingly fragmented industry.
Digital Transformation Remains Priority No. 1
Proactive life science leaders must take advantage of the growing shift to a digital-first mindset. Many life science companies are still attached to paper like an umbilical cord. A 2022 survey we conducted found that over a third of life science quality professionals still rely entirely on paper and spreadsheets.
This isn’t only a risk for the patients at the end of the murky, manual and uncontrolled processes that accompany paper, but it’s also a colossal waste of time and effort—multiplying the compliance burden of highly regulated companies and sapping energy from the exciting and rewarding work of actually bringing life-saving products to new markets.
If one good thing came from Covid-19, it was the unprecedented emphasis on the need for digital transformation. Remote audits, decentralized clinical trials and “collaboration from a distance” since 2020 forced life science businesses to experience what the future could look like. Connected. Accelerated. Digitized.
How can life science companies make the jump to digital and get in on these benefits?
1. Find the processes that really matter. No matter how complex your business is, there is a handful of core, irreplaceable processes that you would grind to a halt without. Break from a departmental mindset and ask yourself, on a business-wide level, where digitization would make the greatest impact on how you do things. Quality, product development, sales, marketing and regulatory processes are great places to start. These are your targets for change.
2. Build a digitization A-team. No digital project will get off the ground without careful internal coordination. Two key groups need buy-in. Executives cut the check, assign resources and set expectations. Champions embedded in various layers of the business lead by example and create engagement, awareness and excitement.
3. Understand what digitization actually is. A common mistake on this journey is to treat digitization as a like-for-like upgrade. It isn’t. Simply mapping your current processes from paper and Excel into software will unlock some operational improvement, but neglecting the opportunity to optimize your processes as you digitize them is to rob your business of the full benefit of your new tools.
Prioritize software vendors that have a deep expertise of the industry challenges you face and can advise you on weaknesses and improvement opportunities within your processes as you digitize them. Renovate, don’t replicate.
Regulators Setting The Tempo
Recent regulatory updates show that bodies like the FDA and ISPE have a vital role to play in pushing this level of innovation.
The second edition of GAMP 5 and the FDA’s new computer software assurance (CSA) guidelines make it clear that regulators want life science companies to innovate, and they’re prepared to simplify the process with more flexible, “least burdensome” oversight.
Regulators no longer need to be seen as scary whip-crackers lifting mandatory hoops to jump through. It’s in their interest, as much as yours, that your company strengthens itself with digitization. Doing so means fewer defects for them to address.
We can expect more of this smarter regulation and a redirection from cover-all red tape to more targeted behavioral guidance and best-practice encouragement.
The FDA even scaled back its powers in its recent MDDS guidelines, announcing that digital medical device data systems no longer to be classed as devices at all and, therefore, won’t face the level of scrutiny reserved for heart valves and implants.
This friendlier attitude to digitization is both telling and extremely encouraging.
Quality First—Not Compliance
There’s a concrete example of what regulators want to see from life science companies in 2023—the quality management maturity program teased at the 2022 PDA/FDA Joint Regulatory Conference.
By providing objective quality “scores,” the FDA hopes to reward good practice, insulate supply chains from shortages and allow companies to make confident, quality-based selections of new partners and suppliers (see the first prediction).
Clause-by-clause compliance will no longer cut it. Businesses that can evidence a long-term quality focus, backed by leadership, will enjoy a higher score and more business.
It’s interesting that this isn’t purely top-down. The public also wants higher quality and more accountability for the drugs and devices they put into their bodies.
We surveyed 2,002 American household decision-makers in August and found that 84% of them wanted a public-facing FDA-backed quality score to help them make buying choices, while 56% wanted the entire life science industry to be digitized—with the goal of optimizing product and patient safety.
It’s about time we gave them what they want.
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