A Check-In on Quality’s Challenges

Two years ago, I outlined the pressing challenges facing Quality organizations. Since then, the landscape has evolved significantly, with additional trends shaping how we approach quality management. I’d like to revisit the rise of interconnected ecosystems, the digitally native workforce and the virtualization of work.

Rise of Interconnected Ecosystems

The interconnected nature of today’s business ecosystems has only deepened. The interconnected supply chain ecosystem has evolved from a buzzword to an operational necessity with supply chains being more complex, involving multiple tiers of suppliers, partners, and customers. This complexity demands a higher degree of collaboration and transparency to ensure consistent quality.

Data Integration and Visibility: Organizations are increasingly leveraging real-time data analytics to monitor quality across these networks. However, many still struggle to harmonize data from disparate systems.
Collaboration Across Boundaries: Building trust and fostering open communication between ecosystem participants is now a cornerstone of quality management. Shared quality standards and co-developed frameworks are becoming common practices.

I think organizations still need to be a lot more serious about performing:

Multi-tier supplier mapping to identify single points of failure.
Contingency plans for rerouting supplies during shortages.
Investment in supplier diversification and regionalized production to reduce dependency on geopolitically unstable regions.

Unfortunately the increased potential of trade wars just means most of us are behind the trend here. Interconnected ecosystems are no longer optional—they’re a regulatory and operational imperative. Companies excelling in this space combine data-driven agility with deep supplier collaboration, ensuring compliance while turning disruptions into opportunities. As regulations tighten and consumer expectations rise, the ability to orchestrate these ecosystems will define organizations in the latter half of the decade

Digitally Native Workforce

The workforce has shifted dramatically in the past two years, with a growing proportion of employees being digitally native—those who have grown up using digital tools and technologies.

Technology Expectations: Digitally native employees expect intuitive tools that integrate seamlessly into their workflows. Quality management systems must adapt by offering user-friendly interfaces and automation capabilities.
Skill Development: Training programs now emphasize digital literacy and data-driven decision-making. Employees are being equipped with skills to analyze quality metrics and use AI-powered tools effectively.
Collaboration in Digital Spaces: The digitally native workforce thrives in collaborative digital environments. Organizations are investing in platforms that enable real-time communication and knowledge sharing to foster innovation in quality processes.

Virtualization of Work

The virtualization of work has significantly transformed the employee experience since 2023, with both positive and negative impacts on workers. The tension between remote work flexibility and return-to-office (RTO) mandates has become a central issue in the evolving workplace landscape.

Impact on Workers

Flexibility and Work-Life Balance

Virtualization has provided employees with unprecedented control over their work environment and schedule. Remote work technologies have eliminated long commutes, allowing workers to better balance personal responsibilities with professional commitments. This flexibility has become highly valued, with many employees reluctant to give up the autonomy they’ve gained.

Productivity and Efficiency

For many workers, virtualization has led to increased productivity. Free from office distractions, some employees report working more efficiently from home. However, this varies among individuals and job roles, with some finding it challenging to maintain focus in a home environment.

Digital Skills and Adaptation

The shift to virtual work has necessitated rapid upskilling in digital technologies. Employees have had to adapt to new collaboration tools, virtual meeting platforms, and digital workflows. This has created both opportunities for growth and potential stress for those less comfortable with technology.

Mental Health and Well-being

While offering flexibility, virtual work has also blurred the lines between professional and personal life. This has led to concerns about burnout and isolation for some employees. In response, companies are increasingly focusing on digital wellness initiatives and virtual mental health support.

Tension with Return-to-Office Mandates

Many organizations are pushing for a return to physical office spaces, creating significant tension with employees who have grown accustomed to remote work.

Employee Resistance

Many workers are strongly resisting RTO mandates. Nearly half of those who work remotely at least part-time indicate they would be unlikely to remain in their jobs if required to return to the office full time. This resistance is not about laziness but about maintaining the flexibility and work-life balance they’ve come to value.

Emotional and Practical Challenges

RTO mandates are causing emotional resistance among employees, who may feel a valued benefit is being taken away. Practically, workers face challenges in readjusting to commutes, office environments, and the loss of flexibility in managing personal responsibilities.

Talent Retention Risks

Companies implementing strict RTO policies risk losing top talent. Studies have shown that rigid return-to-office mandates can lead to high turnover rates, especially among female employees and senior-level executives.

Hybrid Solutions

To address this tension, many organizations are exploring hybrid work models that balance in-office collaboration with remote flexibility. This approach aims to capture the benefits of both in-person and virtual work while addressing employee preferences.

As we move further into 2025, the debate between virtual work and RTO mandates continues to evolve. Organizations that successfully navigate this tension by prioritizing employee preferences, well-being, and productivity are likely to gain a competitive edge in attracting and retaining talent.

Looking Ahead

As we move forward, these trends will continue to shape the role of Quality organizations. Interconnected ecosystems demand greater collaboration and data integration. The digitally native workforce brings fresh perspectives but also requires tailored tools and training. Finally, virtualization is transforming how work is done, offering flexibility while maintaining rigorous standards.

Organizations that embrace these changes will be well-positioned to thrive in an increasingly complex and dynamic environment. By leveraging technology, fostering collaboration, and adapting to workforce shifts, Quality can remain at the forefront of innovation and excellence.

The Culture Wars Strike Clinical Trials

FDA purges material on clinical trial diversity from its site, showing stakes of Trump DEI ban

In recent years, the importance of diversity in clinical trials has gained significant attention in the medical research community. This focus is not just a matter of inclusivity; it’s a crucial scientific and ethical imperative that directly impacts the quality and applicability of medical research.

Why Diversity in Clinical Trials is Essential

Scientific Validity and Generalizability

Different populations may respond differently to the same treatment due to variations in genetics, lifestyle, and environmental factors. By including diverse participants, researchers can better understand how a treatment works across various groups, leading to more accurate and widely applicable results.

Addressing Health Disparities

Minority groups often experience poorer health outcomes in various diseases. Including these groups in clinical trials is a crucial step towards understanding and addressing these disparities, potentially leading to more targeted and effective treatments for underserved populations.

Innovation and Discovery

Diversity in clinical trials can lead to unexpected discoveries. For instance, the identification of PCSK9, which revolutionized our understanding of cholesterol homeostasis, was a result of studying variations in cardiovascular risk factors among different racial groups.

Alignment with ICH Guidelines

The International Council for Harmonisation (ICH) has recognized the importance of diversity in its updated guidelines, particularly in ICH E6(R3) and ICH E8(R1).

ICH E6(R3)

This guideline emphasizes the importance of including diverse patient populations in clinical trials. It encourages the use of innovative trial designs and technologies to enable wider participation and inclusion of diverse populations. The guideline also stresses the need for quality by design (QbD) and a focus on critical-to-quality factors, which inherently includes considerations of diversity to ensure the reliability of trial results.

ICH E8(R1)

ICH E8(R1) focuses on the general considerations for clinical studies and emphasizes the importance of engaging with a broader range of stakeholders, including patients and patient advocacy groups. This approach naturally leads to more diverse perspectives in trial design and conduct, potentially increasing participation from underrepresented groups.

The Impact of Recent Policy Changes

The recent purge of FDA pages on clinical trial diversity, as reported by STAT News, raises significant concerns about the future of inclusive clinical. This action, part of a wider executive order banning diversity, equity, and inclusion (DEI) initiatives, could have far-reaching consequences:

Reduced Guidance: The removal of these resources may leave researchers and pharmaceutical companies with less clear direction on how to ensure diverse representation in their trials.
Potential Setbacks: Years of progress in improving trial diversity could be undermined, potentially leading to less representative studies and, consequently, less generalizable results.
Health Equity Concerns: This move could exacerbate existing health disparities by reducing the focus on including underrepresented groups in clinical research.
Scientific Integrity: The quality and applicability of clinical trial data may be compromised if diversity is not actively pursued, potentially affecting the safety and efficacy of new treatments for certain populations.

Moving Forward

Despite this setback, the scientific and pharma community must continue to prioritize diversity in clinical trials. The principles outlined in ICH E6(R3) and E8(R1) provide a strong foundation for this effort. Researchers, pharmaceutical companies, and regulatory bodies should:

Continue to develop innovative recruitment strategies to reach diverse populations.
Engage with community leaders and organizations to build trust and awareness about clinical trials.
Design trials with flexibility to improve access for all populations, including the use of decentralized trial elements.
Maintain a focus on quality by design, ensuring that diversity considerations are built into trial planning from the outset.

It is important to remember that E6(r3) is the regulation in Europe, while it is a guidance in the US. So companies need to follow it for their EMA approval possibilities.

In conclusion, diversity in clinical trials is not just a matter of equity; it’s a scientific necessity that ensures the development of safe and effective treatments for all populations. While recent policy changes may present challenges, the medical research community must remain committed to this crucial aspect of clinical research, guided by international standards and ethical imperatives.

Dangers of De-Regulation

Nothing makes me decide someone is an unserious thinker than the line “There are too many regulations” when discussing drug development and manufacturing. Okay, which one? Point to me the regulation you want to get rid of? Because frankly they all exist mostly as reactions to the crap some corporation got up to.

I am going to be honest. I don’t trust corporations to do the right thing. Otherwise we wouldn’t have problems like we see in OTC and consumer goods. Just look at this recent article on cancer causing shampoos, sunscreens and tampons. And that is the tip of the iceberg if you ask me. Don’t even get me started on the risks in generics coming from China and India. Or the mess that is the supplement industry.

So definitely put me in the category of regulations are a good thing. Are some poorly written? Sure. Are there some that need updating? Definitely. But as a whole 21CFR chapter 1 is a pretty decent set of regulations (don’t ask me about the other chapters, I rarely use them). The European Eudralex, pretty straightforward (okay I would get rid of QPs and RPs and all the rest but that is a cultural thing).

I personally think we don’t go far enough. I want to write the regulation that requires every c-suite in every pharma, med device, OTC, consumer goods, supplement and food company to do an intense reading of the Jungle and then quarterly restorative justice sessions with victims of badly executed decision making. I want to see a regulation makes executives and board members truly accountable. I want to stop reading horror stories and seeing recalls.

Robert Morris and Koko are Violators of International Standards

The Declaration of Helsinki is the bedrock of international principles in human research, and the foundation of governmental practices, including the ICH E6 Good Clinical Practice. The core principle is respect for the individual (Article 8), their right to self-determination and the right to make informed decisions (Articles 20, 21 and 22) regarding participation in research, both initially and during the course of the research. Principles that Dr Robert Morris violated when his firm, Koko, used artifical intelligence to engage in medical research on uninformed participants. The man, and his company, deserves the full force of international censure, including disbarment by the NHS and all other international bodies with even a shred of oversight on healh practices.

I’m infuriated by this. AI is already an ethically ambigious area full of concerns, and for this callous individual and his company to waltz in and break a fundamental principle of human research is unconsciouable.

Another reason why we need serious regulatory oversight of AI. We won’t see this from the US, so hopefully the EU gets their act together and pushes forward. GPDR may not be perfect but we are in a better place with something rather than nothing, and as the actions of callous companies like Koko show we are in desperate need for protection when it comes to the ‘promises’ of AI.

Also, shame on Stonybrook’s Institutional Review Board. While not a case of IRB shopping, they sure did their best to avoid grappling with the issues behind the study.

I am pretty sure this AI counts as software as a device, in which case a whole lot of regulations were broken.

“Move fast and Break Things” is a horrible mantra, especially when health and well being is involved. Robert Morris, like Elizabeth Holmes, are examples of why we need a strong oversight regime when it comes to scientific research and why technology on its own is never the solution.

The Supreme Court’s Decision in Dobbs v. Jackson Women’s Health is a Bleak One for the Life Sciences Industry

I think it is no secret that I inherently view Quality as a progressive endeavor, and do not see eye-to-eye with colleagues who are conservative. How anyone can take our anti-Taylorist endeavor and not get to stands like the importance of human rights and the need to center those whose rights are challenged – like women – is beyond me. How can we stand for autonomy and not fight for the autonomy of all.

The silence of quality organizations is deafening.

What I want to write about now is how the roll-back of Roe in Dobbs should be a real clarion call to the life science industry, which needs to stop funding conservative politicians because those politicians do not have our best interests at heart.

The fight over Mifepristone and Misoprostol has already begun. The religious conservatives will go after it, and this reactionary court will need to gut the FD&C and the rest of the regulatory regime behind drugs in this country to let that happen. This will be really bad. It will cause life science companies to pull research, clinical trials, and manufacturing from this country as we will no longer be the gold standard in the life sciences. We will be a joke.

Take action:

Give to abortion funds
Check your company’s PAC and see exactly who it is giving to and make noise that funding anti-abortion, anti-science politicians is not acceptable
Support your colleagues. If you are male-identifying realize that most of your colleagues just got gut-punched today. Support them.