Design & Development Case Studies & White Papers

1. Manufacturing Process: Tools For A Successful Startup 3/11/2021

   Medbio offers a number of tips to follow for a successful startup in designing and producing injection-molded parts. 

2. Elements Of Design: Dealing With Suspect Parts 3/11/2021

   Injection molding has numerous key parameters that must tie together in order to make a repeatable molding process. Medbio offers a solution that utilizes cavity pressure curves, key process parameter tolerances, and automation to automatically reject parts that do not make the cut in in the molding process. 

3. Managing Cost And Speed — DFM Considerations For Plastic Medical Products 3/2/2021

   Designing a product with consideration for the manufacturing process can reduce production times and costs, as well as simplify development of transport, storage, and protection solutions.

4. 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.

5. Reducing The Surface Friction Of Medical Devices - A New Functional Application For A Commercial Biomaterials Surface Modification Technology 2/17/2021

   Devices such as introducer sheaths, delivery catheters, endoscopes, and neurovascular microcatheters aim to minimize trauma during insertion and removal, reduce tissue inflammation, enable maneuverability through tortuous blood vessels, and improve patient comfort. Surface properties should promote smooth movement between certain device components.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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. 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.