Karl Neuberger on the Work That Makes, or Breaks, a Device Market Launch
Millstone CEO Karl Neuberger on the readiness work OEM teams cannot afford to treat as an afterthought, and why “one PO” changes how complex programs perform.
Medical Device Shelf Life Validation: Avoid Launch Delays
Key Takeaways Shelf-life failures are often packaging failures. Most validation delays stem from seal degradation, material breakdown, or packaging design flaws. Accelerated aging is not enough. Regulatory bodies like the FDA and EU MDR require real-time aging data to support long-term shelf-life claims, especially for complex or coated devices. Generic protocols create risk.…
Robotic-Assisted Surgery Device Testing: The Next Step
Key Takeaways Robotic-assisted surgery device testing must evaluate the whole system, not just individual components. Traditional verification and validation often fail to address risks associated with packaging, sterilization, and cleanliness. New regulatory standards expect integrated, real-world validation. Millstone’s integrated testing model supports faster, more compliant submissions. Why Robotic-Assisted Surgery Device Testing Must Evolve Robotic-assisted…
Why Robotic Assisted Surgery Device Packaging Demands a New Approach
Robotic Assisted Surgery Device Packaging: A New Approach Key Takeaways Robotic assisted surgery devices require advanced packaging to protect delicate components and ensure surgical precision. Outdated workflows lead to delays, rework, and failed validations. Standard protocols don’t address robotic workflows or mechanical tolerances. Robotic assisted surgery device packaging has a direct impact on…
Biocompatibility Testing for Orthopedic Combination Products
Key Takeaways Start testing early. Begin biocompatibility testing in the design phase to avoid late-stage failures. Plan for complexity. Combination products require integrated validation of device, drug, and packaging. Don’t rely solely on ISO 10993. Include extractables and leachables, cytotoxicity screening, and sterilization testing. Test sterilization impact. EO, gamma, and steam can degrade…
Sterile Packaging for Combination Products: What OEMs Must Know
Key Takeaways Combination products require complex sterile packaging that prevents chemical interaction and supports drug stability. OEMs face higher scrutiny for sterile barrier integrity, traceability, and ISO 11607 validation. Delaying packaging decisions can lead to rework, missed deadlines, and submission risk. Outsourcing sterile packaging works best when integrated early with the right partner. Millstone…
Medical Device Testing: The New Rules
Key Takeaways Regulatory demands for medical device testing are rising across the FDA and the EU MDR. Disconnected vendors increase the risk of delays, errors, and noncompliance. Core areas like sterility, shelf life, and biocompatibility now face tighter scrutiny. Centralized testing reduces risk, accelerates launch, and boosts submission success. Millstone’s ISO 17025 lab…
Streamline Medical Device Packaging to Get Ahead of Regulatory Demands
Key Takeaways Regulators have raised the bar – FDA and EU now require deeper proof of medical device packaging integrity, sterility, and shelf-life performance, even for legacy devices. Validation complexity is growing – OEMs face increased sample sizes, expanded documentation, and greater demand for end-to-end traceability. Non-sterile is not exempt – Medical device packaging…
Comparing Microbiology and Bacterial Endotoxin Testing
An endotoxin is what? The term “endo” in endotoxin denotes an internal entity. Endotoxin’s “toxin” component refers to a poisonous substance. Endotoxins are produced by the cell walls of gram-negative bacteria and can be fatal to humans. The endotoxins themselves are molecules that contain complex sugars (also called polysaccharides) and fats (lipids). Endotoxins are…
How to test injectables for light-obscuration using particulate matter testing
Why is particulate matter testing crucial for injectable medicines, and what does it entail? The American USP’s requirements for injectable particulate matter testing are in line with those of the European and Japanese Pharmacopeias. In injectable solutions, undissolved particles (apart from gas bubbles) are referred to as particulate matter. The parenteral formulation does…