Insights for Implementing Automation in the Lab

Automation is a boon for many labs, but implementing it can be a significant challenge. Following her insightful presentation at the recent Lab Manager Automation Digital Summit (now available on demand), Tina Yauger, principal consultant at Clarkston Consulting, sat down with Lab Manager to share more insights on how lab leaders can implement automation in their labs.

1. What are the essential factors of a cost analysis when calculating the ROI of an automated process?
2. What do you find to be the largest hurdle in gaining buy-in for automation from leadership? And lab staff? How do you address each?
3. Automation demands process standardization. How should a lab manager approach standardizing processes?
4. You have mentioned in the past that automation in R&D labs may inhibit innovation. How can R&D labs continue encouraging innovation without foregoing the benefits of automation?
5. With the advent of automation and AI, some workers are concerned about how these technologies will impact their job security. They cite the idea that even if an automated system cannot fully replace humans, it will displace enough workers that there will still be a net job loss. How would you recommend a lab manager address these concerns?
6. Bill Gates once said, “The first rule of any technology used in a business is that automation applied to an efficient operation will magnify the efficiency. The second is that automation applied to an inefficient operation will magnify the inefficiency.” Do you agree with this take?
7. How do you envision AI changing the landscape of lab automation?

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Under Armour Posed to Weather Tariff Headwinds, Company Says

“Tariff policies are currently in constant flux, leaving retailers and consumer unnerved. For U.S. retailers, this can mean higher costs for imported goods, uncertainty in pricing, and a shift in consumer behavior.”

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The Top 50 Women Leaders of Sacramento for 2025

“The impact of women’s leadership on our profession cannot be overstated. It is one of the reasons Consulting magazine has endeavored to identify and recognize those individuals through the Women Leaders in Consulting awards. As a voice for our industry, we believe it is important to point out the success and leadership of these outstanding consultants as they make an increasingly profound difference for their firms, clients, future women leaders and entrants to the profession. In an industry overwhelmingly dominated by men, the women leaders of our industry play an immense role in growing our profession, keeping it nimble and moving it forward. Women Leaders in Consulting epitomize the character and leadership that make a measurable difference, not only for our industry as a whole, but for the up-and-coming women leaders we have yet had the honor of meeting.”

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Looking Around Corners with Michelle Tartalio: Strategic Thinking in Today’s Supply Chains

Michelle highlighted that industry expertise is crucial to really get to the root of the challenge and determine a strategic direction:

“Every business needs a vision, strategic plan, competitive analysis. So there are things that are in that evergreen category, but I am a firm believer that industry expertise is very important and necessary. You could ask a pharmaceutical supply chain exec ‘Are you worried about your inventory levels?’ and you could ask a food company the same question. The answer in both cases would be yes, but the reasons would be very different. A food company would be thinking about products that are out of stock and consumer behavior and ultimately loosing consumer household loyalty which impacts revenue and feels like an emergency. If there is a product shortage on the pharma side, patients might not get life-saving treatments or medications which impacts communities at large. So, that’s where that industry expertise is really important in that strategy as well.”

When asked what drives her in current role, Michelle said:

“We’re delivering something amazing for a very specific segment of the market, and that is exciting – to try to find that match and to know that they’re going to be delighted! That just motivates me everyday, and we just got to keep finding the right matches [where we have the right expertise and where we know we can do a great job]. That’s what we’re looking for and that’s who we hope finds us, and when it works out, that’s so awesome.”

Listen to the Podcast Here

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TBJ reveals 2025 Life Sciences Awards winners

The Life Sciences Awards recognize both individuals and research organizations that are blazing trails and breaking ground in this field. The broad spectrum of the life sciences arena represents a number of focus areas, including biotechnology, pharmaceuticals, clinical research, human health, medical devices and diagnostics, and others. This year’s class of 12 winners reflect that dynamic diversity.

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Harmonizing Logistics In India

“The momentum in India is real, but the pace varies by sector and company readiness,” says Marcus McCray, associate partner with Clarkston Consulting.

At the same time, establishing supply chain operations in India requires navigating an environment that can be daunting. Among other challenges, the logistics market in India accounts for about 13% to 14% of gross domestic product (GDP), compared to eight to 11% of GDP in many more developed countries. A lower ratio indicates a more efficient logistics environment, says Rupal Deshmukh, partner in the strategic operations practice at Kearney.

Supply chain professionals can tackle these challenges with a solid strategy, strong and diverse supplier relationships, and local expertise. By operating effectively in India, companies can gain a competitive edge.

 Read the Full Inbound Logistics Article Here

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America’s Best Management Consulting Firms

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Top Consulting Firms of 2025

The ranking – measured across 7 key criteria – offers a window into an industry at the beginning of a transformation. The 2025 edition reveals emerging contenders breaking onto the list while some legacy firms, especially those serving the public sector, got knocked off because prestige and compensation are taking a hit relative to the market.

The list also reflects where growth (read: hiring) is taking place. Firms that are taking advantage of outsized growth in key areas like healthcare, tech, financial services, and supply chain are coming out ahead. And for the first time in ranking history, a government agency – the Department of Government Efficiency (DOGE) – has made the list.

Additionally, the ranking recognizes the growing influence of internal strategy groups, which are increasingly competing with traditional consulting firms. To reflect this shift, we’ve introduced a new Internal Consulting category, featuring three stellar groups at name-brand companies.

The 2025 Top Consulting Firms Ranking is your definitive guide to the world’s top consultancies. Explore the full list of 40 firms and discover the trends shaping the industry.

For each firm, we provide a summary of what they do, plus: prestige level, key employee considerations, and firm profile link to learn more.

View the Mention Here

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Breaking Down The FDA’s Latest Guidance On Electronic Systems In Clinical Investigations

“Clinical trials are becoming increasingly technologically savvy, with sponsors and sites integrating technologies such as electronic clinical outcome assessments (eCOAs), electronic patient reported outcomes (ePROs), and digital health technologies (DHTs). While each of these technologies has the capability to revolutionize both patient experience and data collection, they also present a unique set of challenges for clinical trial teams — challenges that can be mitigated with a proper implementation plan … if planned correctly, the clinical team should have corrective action strategies to implement to restore performance of a given technology. As you move throughout the plan, it’s important to highlight pitfalls (as noted above in the implementation strategy) you should take note of, as well as their corresponding corrective and preventive actions. While the future of digital health technologies is exciting, there are still lessons to learn in the field. From compliance to training time and costs and participant burden, digital health technologies come with their fair share of burdens. However, with the correct implementation plan and partners, you can eliminate or mitigate many of these obstacles to ensure digital health technologies help to improve your clinical trial, not hinder it.”

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Clarkston Consulting, a leader in supply chain and medical device consulting, announced today their sponsorship of two CMS Medical Device Share Groups in 2025: Supply Chain and Customer Service. This sponsorship builds on Clarkston’s 2024 partnership with CMS Consulting, reinforcing the firm’s commitment to promoting greater connection and collaboration with industry peers.

“Clarkston is excited to continue our partnership with CMS Consulting in this expanded role as a sponsor of their Medical Device Supply Chain and Customer Service share groups,” said Michelle Tartalio, Clarkston Consulting Partner and Head of Marketing and Corporate Strategy. “We look forward to connecting both in person and online at this year’s share groups as well as continuing to explore how we can leverage this sponsorship to maximizes benefits for members, attendees, and our clients.”

Clarkston’s sponsorship of the share groups will expand access for current members to Clarkston experts who can share their relevant project experience to address member issues and challenges. It will also extend share group membership to Clarkston’s network of life sciences clients and widen benchmarking to non-member medical device companies.

“We are very excited about this collaboration with Clarkston Consulting, which builds on our successful 2024 partnership with their team,” said Paul Fowler, Principal, CMS Consulting. “Their support has already helped us expand our professional team for share groups and identify and implement key meeting improvements. I look forward to seeing how this sponsorship will further enhance our forum for medical device industry peers to share ‘Connections, Answers, Practices and Fun (Shh!)’.”

The CMS Medical Device Share Groups were created in 2016 to provide a collaborative space for industry leaders and professionals to exchange ideas, share best practices, and network with peers to promote greater visibility and collaboration across the industry. In 2025, the CMS Medical Device Share Groups for Supply Chain and Customer Service will gather for two in-person meetings as well as a series of virtual meetings.

To learn more about Clarkston Consulting’s services in the medical device sector, please visit our Medical Device Consulting page. Additionally, you can locate more information about the CMS Share Groups here.

About Clarkston Consulting

Businesses across the life sciences, consumer products, and retail industries partner with Clarkston Consulting to enhance strategic decision-making, improve operational efficiency, implement new technologies, and promote business growth and market diversification. Leveraging deep functional and industry expertise, our people discover, design, and deliver solutions that fit your business, your goals, and your future. At Clarkston Consulting, your purpose is our purpose.

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FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products

“The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025.¹ The FDA stated in the federal register announcement² that it recognizes that the use of artificial intelligence (AI) in drug development is broad and rapidly evolving. This guidance proposes a risk-based credibility assessment framework relating to AI technologies, the data used to train the technologies, and governance around the technologies that may be used for establishing and evaluating the credibility of an AI model for a particular context of use (COU). When finalized, this guidance is expected to help ensure that AI models used to support regulatory decision-making are sufficiently credible for the COU.”

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FDA Issues Draft Guidance: Study Of Sex Differences In The Clinical Evaluation Of Medical Products

The U.S. FDA recently released a draft guidance on the Study of Sex Differences in the Clinical Evaluation of Medical Products,¹ which deduced that individuals whose sex is assigned as “female” at birth are underrepresented in clinical trials for drugs and medical devices as well as some therapeutic areas. This often occurs where the disease or condition affects both males and females, making it challenging to evaluate the benefits and risks of medical products for females, including dosing requirements. The FDA published updated guidance to provide insight on:

1. increasing enrollment of females in clinical trials and non-interventional studies to help ensure the generalizability of results
2. analyzing and interpreting sex-specific data
3. including sex-specific information in regulatory submissions of medical products.

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