As new medical devices are introduced to the market in ever-increasing numbers, it becomes increasingly critical for clients to have effective, and concise brand identity-oriented messaging on their labels and packaging. Between sterile barrier issues, tamper-indicating features, and FDA mandated label information, ensuring that the label and package both complement and advance a device manufacturer’s […]
Writing Good Med Device Requirements
October 5, 2023 by
Many projects fail due to missing or incorrect understanding or decomposition of user or stakeholder requirements. According to Hussain [1], approximately 22% of software projects fail due to incomplete or changing requirements. Writing good requirements is not merely a task and should be given a significant priority in both effort and schedule as they set […]
A Consideration of ISO11607-1:2019 Performance and Stability Requirements
July 12, 2023 by
ISO11607 defines and uses three seemingly similar terms: “Sterile Barrier System”, “Protective Packaging”, and “Packaging System”. These terms each have a distinct meaning and usage within the standard, and a precise understanding of the differences is critical when planning and executing packaging validations. In this post we dissect the definitions and usage of these three […]
Medical Device Testing – Benefits of Outsourcing vs. Doing In-House
June 9, 2023 by
New technologies, process advancements and the aging population have all led to explosive growth within the medical device industry. This growth has also led to more strict and complex regulations with increased competition. The rising regulatory focus and increasing demand for high quality and standard products across the medical device industry has also driven the […]
The Fundamentals of Adhesive
May 25, 2023 by
As a packaging professional in the healthcare industry, it’s important to understand the basics of adhesive coatings, including why they’re important, and their impact on packaging materials. A better understanding of adhesive coatings will help you design and troubleshoot your sterile barrier system. Pouches (Coated vs. Uncoated) There are tradeoffs when using coated and uncoated materials […]
Why conduct formative evaluations?
May 8, 2023 by
We interact with interfaces all the time: our smartphones, the gas pump, online bank accounts. And we all experience times when these daily interactions are confusing, inefficient, or just plain frustrating. But when we’re using medical devices, these interactions can turn into an expense or even a dangerous situation. Consider the following three imagined but […]
Matching Your Penetration Tester to Your Medical Device Cybersecurity Program
March 28, 2023 by
What is a Penetration Test? Free-form security testing, or penetration testing (often called pen testing), is a minimally structured examination of the cybersecurity for a target device or system. For those familiar with requirements-based verification and validation (V&V) testing, penetration testing is different altogether. The intent of penetration testing is to find unknown security vulnerabilities […]
Vendor selection: How does a small medical device company select their vendor(s)?
February 28, 2023 by
The Problem: Medical Device start-ups in general, and small business executives in particular have many competing priorities for their time and resources and selecting the “best” vendor for the components and assembly of a Medical Device system can be very time consuming. It is always a consequential effort in which few are experienced. Hiring a […]
Will the EU Medical Devices Regulations certificate cliff edge in 2024 be avoided?
February 10, 2023 by
The European Commission’s Medical Device Coordination Group (MDCG), has undertaken a survey to collect data on notified body certification and application activities under the Medical Devices Regulation (EU 2017/745) (MDR) and In Vitro Medical Devices Regulation (EU 2017/746) (IVDR). The MDCG is composed of representatives of Member States and chaired by the EU Commission. Previous MDCG recommendations in […]
Branding and Medical Device Labeling: Backward Thinking?
August 2, 2022 by
As new medical devices are introduced to the market in ever-increasing numbers, it is increasing critical to have effective and concise brand identity on the packaging. Between sterile barrier issues, tamper indicating features, and FDA mandated label information, ensuring the label and package both complement and advance a device manufacturer’s brand identity becomes more difficult. A label […]