All Features
Ayush Soni
Audits and inspections are critical components of industrial safety management. These processes help organizations ensure compliance with legal requirements, identify risks, and improve workplace safety and operational efficiencies. Conducting regular audits and inspections is not just a regulatory…
Angie Basiouny
Wharton management professor Peter Cappelli is routinely asked to predict the future of work. His expert answer is always the same: “The future looks like the past.”
He’s not trying to be cryptic. It’s just that the big changes ushered in by the pandemic five years ago are still unfolding—remote…
Stephanie Ojeda
In April 2018, the U.S. Food and Drug Administration (FDA) approved the first artificial intelligence-powered diagnostic system, a software program used to detect diabetes-related vision loss.
Since then, the industry has seen explosive growth of AI in medical device manufacturing, which is…
Malcolm Chisholm
Data are the fuel of the Information Age, and all organizations acknowledge the value of well-managed corporate data assets. The problems start when we begin to ask just exactly how the data assets are to be well managed.
In response, many organizations have put data governance departments in…
Angie Basiouny
Hospital patients rate their pain on a scale of 1–10. Teachers grade on a curve. Sports fans spend hours debating stats on their favorite teams. Even the most ardent language lover can’t deny the power of numbers to convey information, especially when choices need to be made.
A new study from…
Prashant Kondle
Unplanned equipment downtime costs manufacturers an estimated $50 billion annually, according to a study by Deloitte. It is estimated that unplanned downtime costs more than $100,000 per hour. Traditional maintenance approaches—whether reactive or scheduled—are not sufficient to address these…
4C Consulting
ISO 27001 is a globally recognized standard for establishing, implementing, maintaining, and improving an information security management system (ISMS). Successfully implementing ISO 27001 can provide tremendous benefits, such as ensuring data security, building trust with customers, and meeting…
Horacio Falcão
Wouldn’t it be wonderful if we could outsource to technology the complex, laborious, and often emotionally intense process of negotiating? Until recently, the idea of merging negotiation and AI was only a dream. However, the launch of more sophisticated AI systems has changed how we approach the…
Megan Wallin-Kerth
It’s 2024, and the age of automation has largely taken over our phones, computers, and businesses. This isn’t entirely a bad thing, you understand. It gives us the ability to spend time and money elsewhere—from investing in staff to spending more time on innovating technology rather than whittling…
Erin Vogen
For many maintenance teams, the story is all too familiar: Limited resources make it difficult to anticipate equipment failures, which leads to frequent, costly breakdowns. During these moments of crisis, miscommunication and disorganization only amplify the problem. This perpetuates the perception…
Etienne Nichols
Compliance with industry regulations and standards is a fundamental part of medtech. Without proper medical device compliance, companies risk patient harm, litigation, and reputational damage.
Fortunately, compliance with medical device regulations and standards is not an impossible task. A…
Jennifer King
A study by Upwork has revealed that about 22% of the American workforce will be working from home by 2025. Remote work is here to stay, bringing many benefits along with it—including significant cost savings for businesses and the promise of a better work-life balance for employees. However, the…
Marian Merritt
Cybersecurity is a fast-growing field with a constant need for skilled professionals. But unlike other professions—like medicine or aviation—there’s no clear-cut pathway to qualifying for cybersecurity positions. For employers and job seekers alike, this can make the journey to building a team (or…
Rachel Byfleet
In an eco-friendly plot twist that would make Captain Planet proud, the European Union has rolled out the Corporate Sustainability Reporting Directive (CSRD), a blueprint that’s got big companies talking about more than just profits. Imagine a world where every major company’s reports don’t just…
Victoria Alestra
In regulated industries like pharmaceuticals, medical devices, and food manufacturing, compliance is crucial for operational excellence. A validated quality management system (QMS) is key to maintaining this compliance. Let’s explore how QMS software streamlines validation and ensures regulatory…
Gleb Tsipursky
As organizations increasingly integrate generative AI (gen AI) to boost productivity, innovation, and competitive advantage, they encounter a host of challenges. Many face resistance to change, fears of job displacement, and concerns about data privacy.
Understanding and overcoming these…
ISO
A customer calls asking for details about how they are registered in your company’s database so they can make sure their information is updated. You get a phone call from a business partner who needs to contact your colleague and asks you to check her calendar to see when she’s free. Although in…
Chris Rush
The U.S. Food and Drug Administration (FDA) recently published new guidance on conducting clinical trials with decentralized elements. It offers recommendations for sponsors, investigators, CROs, and other parties that are interested in implementing decentralized clinical trials.
By issuing this…
ISO
From small family-run companies to tech giants, the business world is changing at an unrelenting pace. Amid a constantly evolving economic landscape and sometimes dizzying technological advances, one thing remains constant: the need to maintain the highest level of quality.
Whether manufacturing a…
James Chan
Construction is an asset-intensive industry. Companies depend on building equipment, power tools, construction vehicles, and all heavy machinery for essential functions like excavation, construction, and demolition. This equipment must always be kept in safe, proper, and optimal working order so…
George Thuo
Data breaches and cyberattacks are things that small to medium-size manufacturers think won’t happen to them. Yet, according to the Verizon 2023 Data Breach Investigations Report, 43% of all cyberattacks are conducted against small businesses.
If that doesn’t grab your attention, consider this…
Chris Rush
While clinical trials are the gold standard for generating clinical data to use as evidence of your medical device’s safety and effectiveness, they are by no means the only way to gather clinical evidence.
Real-world data (RWD), which typically come from routine healthcare delivery or…
Stephanie Ojeda
In the highly regulated world of life sciences, data integrity isn’t optional; it’s essential. The ALCOA principles—attributable, legible, contemporaneous, original, and accurate—provide a foundational framework for ensuring data are reliable and trustworthy.
With the rise of digital…
Adam Zewe
In the 1960s cartoon series The Jetsons, Rosie the robotic maid seamlessly switches from vacuuming the house to cooking dinner to taking out the trash. But in real life, training a general-purpose robot remains a major challenge.
Typically, engineers collect data that are specific to a certain…
Adam Zewe
Despite their impressive capabilities, large language models (LLMs) are far from perfect. These artificial intelligence models sometimes “hallucinate” by generating incorrect or unsupported information in response to a query.
Due to this hallucination problem, an LLM’s responses are often verified…
