Medical Device Design & Development


  • Selecting The Best Human Factors Method For Your Medical Or Drug Delivery Device Evaluation

    A robust human factors process has become critical to product optimization and market competitiveness for medical devices and drug delivery devices, but not all companies have the resources, funding, or time to conduct such user studies. This article from Genentech's head of human factors engineering examines the three major categories of evaluation that you should consider, the pros and cons of each, and how to select study participants.

Retro-Validation: 6 Factors To Resolve Validation Deficiencies

A retro-validation is a re-execution of the method validation with the method parameters, setup, and everything kept the same as before to retrospectively cover all prior generated data. It is not the same as past validation because you would shore up the validation deficiencies or gaps. This article discusses the 6 important considerations.


4 Lessons For AI In Medtech: Case Studies From Breast Cancer Detection

Recent advances in artificial intelligence (AI) and machine learning, especially deep learning, are poised to help further advance many medical fields. One of the physicists involved in helping advance breast health solutions through AI shares his 4 lessons learned in working with AI in mammography technology, and those lessons can be applied to many other medtech fields.

How Is Medtech Design Evolving — & Are You Keeping Up?

Couple the pandemic with the last decade’s trend toward overhead reduction through distance care and the combination is driving more rapid change to the medical device environment than ever before. This article takes a glimpse at the recent evolution in medical device design and speculates how it might evolve in a post-COVID world.

Shorten Your Medical Device Development Timeline Using These 3 Design Research Strategies

Design research can shorten the development process by making your FDA submission quicker and easier. Plus, you are making it more robust by doing the work now as opposed to later. Too many people wait until later in the process for this work and end up guessing on things or adding “filler” to their usability data. This article recommends three design research strategies.


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.


Intelligent Vision Sensor (IVS) machine vision systems are high-speed, noncontact optical sensors

Colder's new SRC connector is a unique small bore connector that eliminates the potential for misconnections with luer fittings. The intuitive design is simple to operate and provides a secure, leak-free connection.

In MicroMo's DC-Tachogenerators, the commutator and brushes are made of a high quality gold alloy. This results in a very low, constant transition-resistance, minimum starting friction and virtually insensitivity to environmental conditions

PICMA® Stack Ceramic-Insulated Piezo Actuators for Pumping and Dosing

  • Sub-Nanometer sensitivity
  • Superior lifetime (>100 billion cycles)
  • Non Magnetic and High Vacuum compatible
  • Microsecond response and high stiffness
  • Very large operating temperature range
Excelitas Technologies’ PAX Family of Precision-Aligned Xenon Light Sources offers OEM customers "plug-and-play," pre-aligned and calibrated pulsed Xenon Light Engine Modules. These compact, precision-aligned Xenon light engine modules generate light over a continuous spectrum from ultraviolet to infrared and are ideally suited to a wide range of clinical diagnostics, invitro diagnostics, life sciences, drug discovery, proteomics, and analytical instrumentation applications.

The IMH Precision Orifices for plastic installation are miniature flow restrictors with a simple, press-in design for easy installation. With forward and reverse flow directions for both liquids and gases, these orifices are economical, reliable, and highly accurate.