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Survey: Unsustainable Regulatory Workloads Leave No Choice About AI Adoption

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It is now imperative for life science companies to optimize Regulatory Affairs resources using next-generation technology if they are to ensure affordable patient access to treatments and achieve commercial viability, new independent research finds.

BOSTON, Nov. 12, 2024 /PRNewswire/ — ArisGlobal, an innovative technology company at the forefront of life sciences and creator of LifeSphere®, today confirmed that while unsustainable workload increases have created an irrefutable urgency around advanced AI adoption in Regulatory Affairs (RA), many life sciences companies are standing in the way of their own progress. These are the findings of new independent research.

The study, conducted by Censuswide in September, is striking both in its confirmation of how vital AI-powered process change has become, and in its revelations about persistent barriers that are compromising companies’ regulatory transformations. That is as soaring workloads overwhelm already-overstretched teams.

ArisGlobal commissioned the exclusive survey of senior US regulatory professionals in pharma/biopharma companies to examine the growing appetite for AI within an RA context.

Key findings

Process inefficiency is out of control: workloads have soared beyond the pace of company growth, a rate that will not slow any time soonDossier production, maintaining labeling compliance, managing data, document checking, and performing regulatory impact assessments, are major challengesAllocating more people is not an option: 96% say AI is needed to solve RA bottlenecksInterest is high across a range of specific automation use cases:Maintaining labelling compliance and deviations;Managing Health Authority interactions;Creating regulated content translations for different markets;Suggesting improvements to submissions/dossiers;Performing regulatory impact assessments;Authoring and summarizing submission documents; andGenerating entire regulatory submissions.

BUT: outdated mindsets are standing in the way of progress

The survey identified a series of perceived barriers still holding RA departments back from investing or expanding their investments in AI, even where these are now unjustified, e.g.

Unfavorable existing IT landscapes (45%);Risks still outweighing the benefits (44%); andData/content not being of a sufficient caliber to see value from AI (42%).

Budget, on the other hand, is far less of an issue.

Confirming that companies’ perceptions have not kept up with AI’s progress, respondents said they would be more proactive about adopting AI in RA if:

They found their competitors were using the technology (41%);Existing resource pressures continued (40%);The technology became more mature and proven (36%);Specific tools became available geared to the tasks regulatory teams find most challenging or expensive (35%); andRelevant IT systems were easier and more affordable to deploy (33%).

AI is the future

Senior regulatory professionals DO see AI in their futures, meanwhile:

Almost half (48%) of respondents believe AI will transform routine regulatory work and considerably streamline processesOver 2 in 5 (43%) believe AI will drive up accuracy and quality in the information they produce for regulators and patientsAlmost 2 in 5 (39%) see AI as critical to the regulatory function’s ability to keep pace with market demandsOver a third (35%) say AI will save a lot of time and money.

Commenting on the research findings, Ann-Marie Orange, ArisGlobal’s CIO and Global Head of R&D, said: “The pressure from regulators to drive up product quality and safety cannot be ignored, but nor can the drive to bring critical treatments and therapies to market more swiftly and cost-efficiently.

“It is why the industry must now double down on its adoption of AI, especially next-generation technologies such as Generative AI and machine learning. Up to now, life sciences companies have been standing in the way of their own progress, not appreciating what is already possible. But now the urgency to find step changes in process efficiency make it imperative to overcome those barriers and transform the way they work.”

Preeya Beczek, a respected regulatory consultant and founder and CEO of Beczek.COM, said: “AI is coming into its own in the life sciences regulatory space now, and companies ignore its potential at their peril. Think about it: R&D organizations must be both stringent in their regulatory compliance, and hyper-efficient in securing and maintaining marketing approval in order to get products to patients faster. That requires a gear shift which next-generation automation and AI can help deliver.”

The full survey report, The Imperative to Automate: Unsustainable Regulatory Workloads Leave No Choice About AI Adoption, will shortly be available to download from the ArisGlobal web site at https://www.arisglobal.com/. As well as a full analysis of the findings, the report includes practical recommendations on how life sciences regulatory functions can embrace AI capabilities today within their existing IT environments.

About the research

This report is based on an exclusive survey conducted for ArisGlobal by Censuswide between August 30 and September 06, 2024. The research was conducted among a sample of 100 US respondents in senior regulatory roles at pharma/biopharma companies.

About ArisGlobal

ArisGlobal, an innovative life sciences technology company and creator of LifeSphere®, is transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan, and China. For more updates, follow ArisGlobal on LinkedIn or visit www.arisglobal.com

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Stryker launches next generation of SurgiCount+ to help improve the standard of care in hospitals for sponge management and blood loss assessment

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PORTAGE, Mich., USA, Nov. 14, 2024 /PRNewswire/ — Stryker (NYSE:SYK), a global leader in medical technologies, announced its launch of the next generation of SurgiCount+ within its sponge management portfolio. Now integrated with Stryker’s Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals.

Maternal mortality has been rising in the U.S. for decades,1 with approximately 50,000 cases of severe maternal morbidity occurring each year.2 Notably, 70% of pregnancy-related deaths due to hemorrhage are preventable.3 Stryker’s Triton software includes AI technology that can differentiate blood from other fluids and a Bluetooth scale that batch weighs blood-soaked items to help assess blood loss. This provides hospital staff with real-time information to help coordinate the clinical team’s hemorrhage response and make informed patient care decisions.

Surgical sponges continue to be the number one retained surgical item with 88% of retained surgical items occurring with a false correct count.4 For nurses trying to locate a missing sponge in the operating room (OR), that can take up to 10 minutes on average.5 Stryker’s SurgiCount+ software helps address these problems by featuring a wireless reader that counts, tracks and locates surgical sponges in the OR. RFID-tagged sponges enable unique identification, eliminating false-correct duplicate or unknown counts.

“We are committed to helping keep caregivers and patients safe from harm,” said Brandon Jominy, vice president and general manager of Stryker’s Surgical Technologies business. “Integrating our SurgiCount+ and Triton technologies on one platform will set a new industry standard for quantifying blood loss and continuing to help reduce retained surgical sponges in the OR.”

Additionally, recent studies show that nurse burnout is affecting more than half of all U.S. nurses.6 By integrating these two technologies into one solution, it provides additional benefits to hospitals and staff which includes:

Helping save time by standardizing clinical protocols for chartingSimplifying workflows and aggregating case data with backend dataHelping reduce manual data entry errors through real-time EMR integrationTracking and communicating patient information with one seamless workflow

For more information about Stryker’s SurgiCount+ integrated with Triton please visit safeor.com/products/surgicount-triton.

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. More information is available at stryker.com.

Media contact
Beth Sizemore
Sr. Director, Strategic Communications
beth.sizemore@stryker.com

 

1. Hoyert DL. Maternal mortality rates in the United States, 2021. NCHS Health E-Stats. 2023. DOI: https://dx.doi.org/10.15620/cdc:124678

2. Callaghan, W.M., Creanga, A.A. and Kuklina, E.V. (2012) “Severe maternal morbidity among delivery and postpartum hospitalizations in the United States,” Obstetrics & Gynecology,120(5), pp. 1029–1036. doi:10.1097/aog.0b013e31826d60c5.

3. Building U.S. Capacity to Review and Prevent Maternal Deaths. (2018). Report from nine maternal mortality review committees. https://www.cdcfoundation.org/sites/default/files/files/ReportfromNineMMRCs.pdf

4. Gawande, A. A., Studdert, D. M., Orav, E. J., Brennan, T. A., & Zinner, M. J. (2003). Risk factors for retained instruments and sponges after surgery. The New England Journal of Medicine, 348(3), 229–235. https://doi.org/10.1056/NEJMsa021721 

5. Double-blinded survey of 154 Operating Room Nurses from 154 different facilities across the United States. Data on file internally. Conducted August 2020.

6. Rotenstein, L.S., Brown, R., Sinsky, C. et al. The Association of Work Overload with Burnout and Intent to Leave the Job Across the Healthcare Workforce During COVID-19. J GEN INTERN MED 38, 1920–1927 (2023). https://doi.org/10.1007/s11606-023-08153-z

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14,000 Consumers Weigh In: Kearney Consumer Institute Releases Keeping Up with the Consumer – New Report Identifies Key Tension Points Informing Consumer Choices, Brand Selection, and What’s Behind “Unpredictable” Consumer Behavior

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Key Findings:

Brands are pumping out more choices than consumers need or want.Consumers streamline their needs spending to enable discretionary spend.Brands and retailers need to revert to EQ and great merchandising.

CHICAGO, Nov. 14, 2024 /PRNewswire/ — The Kearney Consumer Institute (KCI), an internal think tank of global strategy and management consultancy Kearney, today released a consumer research report that upends much of the conventional wisdom around brand proliferation, over-reliance on data, and consumer choices. Based on survey data from 14,000 consumers across the US, Europe, and APAC, Keeping Up with the Consumer examines buyers’ unpredictable, seemingly quixotic behaviors, identifies the underlying tension points that explain them, and concludes that brands are massively under-accounting for the human element that drives purchase decisions.

“Brands have more data than ever about consumer demographics, behavior, spending, and opinions. But we still often categorize consumer behavior as ‘unpredictable.’ To understand why, our research found three key consumer tensions that help explain this behavior,” notes KCI lead Katie Thomas. “As options and access grow, consumers’ lives are only getting more complicated. Sometimes we get lost in one side of a narrative, without realizing the strain it puts on consumers.” The research identified the following three friction points:

Options vs. overload: Consumers seem to expect a product that suits each type of skin, diet, or fitness need. Yet, in many major categories, most consumers believe there’s already plenty to choose from—if not too much.

Curation vs. control: Two out of three consumers say they like making all their decisions themselves. But it’s logical that consumers want (and need) some level of curation to make sense of all their options.

Facts vs. feelings: Consumers want to “do their own research” (and they trust themselves more than they trust brands and institutions), but have limited reserves of time, energy, and motivation.

Keeping Up with the Consumer explores consumer shifts since 2016, when the KCI released The Future Consumer. Then, brands were focusing on the power of influence, a socially driven approach centered on “authenticity.” However, as the “influence” approach became more common, it lost some appeal and started to feel less authentic. Meantime, dramatic changes to the consumer landscape—from COVID-19 to political unrest to the emergence of new social media and shopping platforms—helped consolidate this massive shift.

The research suggests that retailers and brands aren’t striking the right balance between facts versus feelings, curation versus control, and too many choices. Noted Thomas, “When retailers and brands balance the tension, applying emotional intelligence and great merchandising, they will better navigate the mindset of the future consumer to address their needs.”

“Here, we see the push–pull between consumers and brands,” Thomas says. “Sometimes brands should lead consumers forward; but sometimes, the better choice is following consumer behavior. The key is understanding the complex, nuanced, and sometimes unexpected tensions that will crop up next.”

Read the full report by clicking this link.

For more information, or to schedule an interview with Katie Thomas or receive a copy of the Keeping Up with the Consumer report, please contact:

MKPR/Meir Kahtan
+1 917-864-0800
mkahtan@rcn.com

About the Kearney Consumer Institute

The Kearney Consumer Institute (KCI) perspective. By leveraging consumer behavior data and insights, the KCI helps generate conversation, and ultimately action, around how to address consumer needs with meaningful benefits.

Using a consumer-first lens the KCI looks at today’s consumer revolution not by thinking about consumers, but by thinking like consumers. Our consumer-centric approach includes simple, precise, plain-language conversations on topics like trends, consumer communities, convenience, loyalty, service, fair pricing, and product development and technologies.

About Kearney
Kearney is a leading global management consulting firm. For nearly 100 years, we have been a trusted advisor to C-suites, government bodies, and nonprofit organizations. Our people make us who we are. Driven to be the difference between a big idea and making it happen, we work alongside our clients to regenerate their businesses to create a future that works for everyone. www.kearney.com

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GovInvest Reports Triple-Digit Quarterly Growth Fueled by New Customer Wins and Industry Recognition

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LOS ANGELES, Nov. 14, 2024 /PRNewswire/ — GovInvest, the pioneer of compensation analytics technology for government agencies, is celebrating a record third quarter in 2024, marked by significant new customer growth, regional expansion, and industry recognition. Over the past quarter (July-September 2024), GovInvest achieved an impressive 125% quarter-over-quarter increase driven by new client partnerships and strengthened relationships with existing customers through expanded solutions.

With its comprehensive suite of labor costing, budgeting, and compensation analytics solutions, GovInvest empowers public sector organizations to streamline operations, bridge the gap between HR and finance, and make smarter workforce decisions. By providing real-time, data-driven insights, the platform helps agencies attract top talent, optimize budgets, and improve employee satisfaction—critical advantages during today’s labor crisis.

Nationwide Customer Growth
Q3 2024 client wins and expansions included new deals in California, Georgia, Ohio, Rhode Island, Iowa, Texas, and Washington. These recent additions highlight GovInvest’s continued momentum in its core California market, where cities like San Bernardino, Beverly Hills, and San Marcos have deepened their use of GovInvest solutions. At the same time, the company is experiencing significant geographic growth, with new clients across diverse regions such as Georgia, Texas, and Washington, demonstrating its expanding national footprint and ability to address the labor costing and budgeting needs of government agencies nationwide.

“We’re excited to see such strong customer growth this past quarter in every geographic market, particularly in the southeast and pacific northwest,” said Michael Fryke, CEO of GovInvest. “This expansion underscores the trust that public sector agencies have in GovInvest’s ability to deliver powerful, data-driven solutions that address their labor costing and budgeting needs. We’re proud to partner with these organizations as they tackle today’s workforce challenges and plan for future success.”

Industry Recognition and Strategic Partnerships
GovInvest’s industry recognition further solidified its leadership in the government services sector. The company was named to the 2024 Inc. 5000 list, ranking 95th in the Government Services sector. This prestigious recognition honors the fastest-growing private companies in America and highlights GovInvest’s rapid growth even amid inflationary pressures and labor market challenges.

“We are deeply humbled by the opportunity to not only make the Inc. 5000 list but to have earned a position within the top 100 Government Services companies,” said Michael Fryke, CEO of GovInvest. “Our success is driven by the dedication of our customers and team, who work tirelessly to provide cutting-edge solutions to help governments make smarter, data-driven workforce decisions.”

In addition, GovInvest announced a strategic partnership with CPS HR Consulting, designed to deliver advanced, technology-driven solutions for compensation consulting. This collaboration further positions GovInvest as a leader in the government services sector, enhancing its value proposition for public sector agencies seeking smarter workforce strategies.

Strengthening Industry Ties
GovInvest’s involvement in key industry events continued to drive its momentum in Q3 2024, including being selected as a sponsor for the PSHRA (Public Sector HR Association) Annual Conference in September. GovInvest showcased its commitment to supporting human resource and public sector professionals with ongoing education and technological innovation.

Customer Webinars Resonating with Agencies
GovInvest’s client webinars also gained traction, with a particular focus on labor costing and workforce planning in the face of inflation and wage compression. The “Effective Labor Negotiations in an Era of Union Empowerment” webinar, featuring Chris Moses, Director of Human Resources for the City of Columbus, OH, provided public agencies with actionable insights into navigating today’s complex labor landscape with GovInvest’s tools. The session resonated with many participants, reinforcing GovInvest’s position as a thought leader in the government analytics space.

“With GovInvest, we’re able to show the unions exactly where we stand financially, making negotiations more transparent,” Moses said. “The trust that we’ve built through these accurate, real-time projections has been invaluable.”

Looking Ahead
As GovInvest looks ahead to continued growth, the company remains dedicated to providing the most advanced labor costing and compensation solutions for government agencies across the country. With a strong foundation of customer success and industry recognition, GovInvest is poised to drive further innovation and transformation in the public sector.

About GovInvest
Founded in 2014, GovInvest empowers over 1,000 public sector agencies nationwide to run their own labor, compensation, and benefits analysis at a fraction of the cost and time through powerful software solutions and hands-on consulting. With a commitment to transparency, efficiency, and equity, GovInvest empowers government leaders to make data-driven decisions, attract top talent, and enhance the effectiveness of their operations. To learn more, visit www.govinvest.com.

CONTACT: Christen Clegg, christen@govinvest.com

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