Medical Device Design & Development


  • How To Eliminate The Gate In Medtech Product Development’s Phase-Gate Approach

    We all know the phase-gate approach to medical device development is cumbersome and slow – the exact opposite of what’s needed for products essential to critical treatment or prevention of disease or chronic conditions. The good news is that there are ways to make dramatic improvements to the efficiency of the product development process while maintaining project phase controls. 

The One Trait A Medtech QA/RA Professional Can’t Succeed Without

We read studies showing that professionals who are successful and hold top positions in our industry possess certain traits: intelligence, commitment to our jobs, determination, etc. But those traits could describe many professionals. So, what is it that makes us unique and a good fit for this industry?

Are You Ready For The FDA’s “Data Effect” Tsunami? 8 Steps To Prepare

The FDA is moving forward with its Data Modernization Action Plan, the next leg of the Technology Modernization Action Plan. As such, you'll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more. Here's what you can do to position yourself for success.

The Top 10 Most-Cited Issues In FDA FY2020 Medical Device Inspections

The first article in this series discussed the background and a few high-level observations of the FDA’s summaries of its medical device quality system inspections. This article digs into the details of the FY2020 observations. What were the top 10 most-cited issues, and what are the takeaways you can implement?

Using System Risk Structures To Understand And Balance Risk/Benefit Trade-offs

The ICH 31000 guidance defines a risk as the “impact of uncertainty on objectives.” As a follow-up to his article on why we should replace the RPN with the adjusted risk likelihood (ARL), Mark Witcher describes how system risk structures can be used to simultaneously understand and manage both risks and benefits. 


Elements Of Design: Dealing With Suspect Parts

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. 

Managing Cost And Speed — DFM Considerations For Plastic Medical Products

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.

Delivering On LSR Market Demands For Critical Cardiac Component

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.

Reducing The Surface Friction Of Medical Devices - A New Functional Application For A Commercial Biomaterials Surface Modification Technology

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.


The SMC and SMF1 are Colder's smallest couplings. These twist-to-connect couplings provide a reliable and more secure alternative to luer-type connections. They also allow for tubing to rotate freely when connected. This important feature reduces the occurence of both kinked tubing and accidental disconnection during use.
ELCAN Optical Technologies can boast of being on the leading edge of technology while enjoying an accomplished history that reaches back to the very beginnings of modern optics.

ProMed Pharma is a division of ProMed that specializes in manufacturing polymer-based drug-releasing implantable medical device, and combination device components. ProMed’s 25 years of experience working with silicone-based implantables, combination products, and solid implants has allowed them to leverage their molding expertise for established and start-up medical device and pharmaceutical companies.

Engineers who design medical devices or equipment are constantly tasked with finding highly reliable solutions for the systems they’re creating. High reliability interconnect solutions are no exception, particularly where electrophysiology catheters, patient monitors, MRIs, intravascular ultrasounds, defibrillators, infusion pumps and laboratory equipment are concerned.

LED Fiber Optic Illuminators and Modules from Excelitas Technologies are based on state-of-the-art solid state lighting technology. These LED light sources are designed to couple high-intensity white light into fiber optic bundles for applications such as endoscopy, headlamps, microscopy, industrial borescopes, inspection systems, and machine vision. These LED-based products offer an energy-efficient, maintenance-free alternative to halogen and metal-halide lamp-based fiber optic illuminators.

Parker Precision Fluidics offers a line of miniature pumps used in medical devices requiring precision and high performance.  These miniature pumps offer a variety of features like a compact efficient design, low power, small size, and light weight ideal for medical device applications like patient monitoring, clinical diagnostics, analytical chemistry, portable gas detection, and medical instrumentation.