Design & Development Case Studies & White Papers

  1. Delivering On LSR Market Demands For Critical Cardiac Component 2/23/2021

    A global medical device company came to Donatelle for help perfecting a silicon seal component to meet the new ISO 27186:2010 standard. In this case, a seal with micro-features is needed to reliably isolate the four-pole electrical contacts between the pacemaker and defibrillator and fit inside the 6.3 mm medical device.

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  2. A Functional Application For A Commercial Biomaterials Surface Modification Technology 2/17/2021

    The surface design of devices should aim to minimize trauma during insertion and removal, reduce tissue inflammation, enable maneuverability through tortuous blood vessels, and improve patient comfort.

  3. 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.

  4. 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.

  5. 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.

  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. Experimental Design And Positive Controls For Package Integrity 4/9/2020

    Given that the experimental design has only two conditions, leaking and non-leaking, this variable is extremely important to understand. Proper use of positive controls and knowledge of how alternative approaches are applied to challenge a test method support the validity and reliability of the method.

  9. Dye Ingress For CCIT: A Poor Bet In A High Stakes Game 3/23/2020

    The dye ingress test method continues to be a widely used test method for container closure integrity. This paper explains why the dye ingress test method is not a suitable approach.

  10. Medical Device Design & Manufacturing Challenges: 2020 And Beyond 3/9/2020

    Medical device manufacturers and designers must overcome various challenges to succeed in an expanding global marketplace, challenged along the way by aspects of design, research, validation, and bringing their devices to a competitive market in a cost-effective manner.