Design & Development Case Studies & White Papers

1. Look, Ma! I Solved These Wearable Device Challenges 1/21/2021

   Wearable medical devices bear expectations of medical-grade efficacy, plus consumer-grade comfort and aesthetic appeal. Micro molded thermoplastic parts help OEMs live up to these expectations.

2. How To Establish High-Quality, Sustainable, Dock-To-Stock Programs 12/1/2020

   Effective dock-to-stock programs ensure optimal outcomes by identifying risks up front, setting clear timelines, and assigning unambiguous responsibilities to all shareholders.

3. Quality By Design And Design Control Roadmap For Combination Products 11/30/2020

   Quality by Design (QbD) principles help to facilitate design of products and processes that maximize the product’s efficacy and safety profile, while enhancing product manufacturability. A proposed roadmap to utilize QbD principles in conjunction with design control requirements (21 CFR 820.30 and ISO 13485) for design and manufacture of drug-device combination products based on sound science and risk management is presented.

4. Finding The Ideal Balance – Where Risk And Cost Of Quality Meet 10/6/2020

   It is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.

5. Moisture And Oxygen Risk In The Medical Device Industry 9/18/2020

   The majority of medical device packaging is porous in nature. Some medical devices require a different layer of defense protecting against oxygen or moisture ingress. For some devices the ingress of moisture or oxygen over the shelf-life of the product can impact the device performance. Any time a foil barrier comes into play with a high-risk application, detection of microleaks is absolutely critical to assuring the shelf-life of the products.

6. How To Build A Resilient Supply Chain Post-COVID-19 8/12/2020

   COVID-19 put a kink in the global supply chain. And it exposed weaknesses with the power to halt the flow of business. Now, as the world takes steps to define a new business-as-usual post-pandemic, manufacturers are rethinking their supply chain.

7. 3D Printing And Injection Molding: Same Team, Different Roles 7/7/2020

   These complementary processes can be adapted to serve countless prototyping and full-production demands, boosting medtechs’ bottom lines and speeding time to market.

8. Keys To Successful Design For Manufacturability 6/3/2020

   A product’s manufacturability is influenced by the materials used, requested tolerances, part geometry, process control limitations, and more. A successful DFM process considers each of these factors from the start.

9. Medical Imaging Quality Starts By Selecting The Right Components 5/13/2020

   MRI machines use a strong magnetic field and computer-generated radio waves to produce cross-sectional images. Thus, the quality of the MRI depends on the uniformity of the magnetic field and the radio components inside it.

10. NovaPure® Components: A Proactive Approach To Reducing Particulate Risk 5/6/2020

    A biotechnology company that manufactures injectable large molecules was seeking to evaluate elastomeric components that would help them to attain the highest quality standards for their manufacturing lines. The company took a proactive approach to meeting and exceeding regulatory guidelines concerning the cleanliness of their lifechanging medicines and were keen to learn how a supplier’s tight packaging specifications could help them with their approach.