Industry Insights

41. 5 Reasons Your Medtech Market Likely Is Smaller Than You Think 9/19/2018

    It’s best to be sure you understand the defensible, fact-based market need for your great idea before investing significantly in an intuitive belief of its potential.

42. What Are My Options For Reducing My Pharmaceutical Product Manufacturing Costs? 6/3/2015

    In order to set up a quality organization, the organization must have a culture of quality. Survey findings in the Forbes Insights-ASQ white paper published in fall of 2014 offer research findings which help illuminate what quality culture means to organizations globally.

43. Five Best Practices To Ensure Quality Active Pharmaceutical Ingredients

    It is important to develop robust, reliable processes to safeguard APIs. Explore the best practices to provide patients with the highest quality treatment that meets their therapeutic requirements.

44. Agile Software Development In Bio/Pharma & Medical Devices, Part 1 6/27/2023

    Under the FDA and other regulatory bodies, the bio/pharma and medical device industries have been using computer software/systems validation testing methodologies to validate software within the GxP environment. Let's dive into the use of Agile methodology in the planning phase of a software development plan.

45. Small Is Powerful And Sustained

    Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.

46. A New Model Approach To Drug Shortage Prevention 3/15/2024

    The ISPE's Drug Shortages Prevention Model revamps its predecessor, the more prescriptive Drug Shortages Prevention Plan, with a focus on 12 key performance areas.

47. Biologics Manufacturing In China: Competition Heats Up 10/23/2020

    China is demonstrating clear investment interest in participating in global markets for both innovative biologics and biosimilars produced at GMP quality levels.1 These factors are creating a strong market environment for CMO services.

48. Demystifying The Common Technical Document For Global Submissions 6/5/2025

    The CTD's Module 3 is notoriously complex and challenging. Here are strategies for an easier path toward CMC submission readiness.

49. Express And Implied Preemption For Premarket-Approved Medical Devices: A Dual Shield Against Tort Claims 4/9/2018

    In the past 10 years, manufacturers have used express and implied preemption to shield themselves from personal injury tort lawsuits involving PMA medical devices, but plaintiffs’ attorneys have sought to poke holes in these shields, occasionally establishing certain limited exceptions to these preemption defenses.

50. 4 Tips To Leverage Your Ingredient Supplier For Faster Formulation 8/3/2023

    Speed to formulation plays a critical role in recouping the investment for a new drug. Many ingredient suppliers have an experienced analytical group and material scientist group, and drug developers should reach out and leverage that expertise with these four strategies.