Koven cardiovascular innovation

Your Biomedical Design & Development Partner

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New product desgin

Your Quality Management System (QMS)

March 22, 2023

The Road to Medical Device Commercialization

New product desgin

Medical Device Development

July 5, 2022

Resolving Technical Uncertainty

New product desgin

Medical Device Development

May 10, 2022

Diagnostic Engineering and the Future of Modern Medicine

New product desgin

Medical Device Concept Ranking

July 18, 2019

A New Product Development tool to help remove bias from important decision making.

New product desgin

Infographic Infographic: Can You Say Sphygmomanometer?

January 7, 2019

Reducing repetitive wrist strain injury though a new product design.

Video 9 Ways for Medtech Startups to get Back on Track!

July 18, 2018

Getting stuck is a normal part of a product developer's life. Here are 9 ways to fix that!

Unlearning in Engineering

Unlearning in Engineering

June 19, 2018

"The illiterate of the 21st century will not be those who cannot read and write, but those who cannot learn, unlearn, and relearn." -- Alvin Toffler

Medical Device safety and risk management

Infographic Infographic: Risk Management & Medical Device Safety: 24 Definitions You Need to Know

June 5, 2018

Where risk management and medical device safety meet: 24 definitions you need to  know.

Risk Management in Medical Devices

May 29, 2018

What is risk management?  Here is a beautiful presentation to help you understand what risk management in medical devices looks like in compliance with ISO 14971....

Risk management in Medical Device design

ISO 14971 Let's Go!  The Ultimate Guide to Risk Management in Medical Devices

May 15, 2018

Risk Management is defined as the "systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk ...."

Engineering Design Specifications

How to Turn User Needs into Design Specifications (With Tables)

April 10, 2018

Creating your Design Input Specification (DIS) should be the first stage of any product design process.  It is a vital tool your design team will use as the framework for the design and development of your medical device, and is necessary for regulatory compliance....

Design Input Specifications

Kickstart your DIS: 6 Approaches to Generate Design Inputs

April 3, 2018

A Design Input Specification (DIS) plays a critical role in any product design process. The product DIS contains all the characteristics of a device that are used as a basis for product design.  The level of detail that your design inputs cover can be the deciding factor that makes or breaks a smooth run to market....

Maintain Productivity

Proven Strategies for Startups to Maintain Productivity Levels

March 15, 2018

Getting bogged down is common in busy startup Medtech companies as well as bigger, well-established companies.  However, established companies usually spend less time being bogged won than start-ups.  Why?  Because through experience they have developed methods to steer clear of "the bog"....

Expert tips to get back on track

Stuck?  These Expert Tips Will Get You Back on Track

March 8, 2018

You're sick and tired of being sick and tired.  You gave it all you can... with all that you have... but you're still stuck.  Let's get back on track.

Painted into a corner

Painted into a Corner:  Common Product Un-Developments

March 1, 2018

Getting stuck doesn't make you a failure -- it makes you human.  Accept that you are stuck and look for clues to answer this question:  How did you get here?

Advice for start-up companies

Overwhelmed?  Advice for Start-Up Companies

February 22, 2018

You may be thinking "Why me?"  Overwhelmed and stress out, you may feel like the odds are stacked against you.  You may feel angry or scared.  Worst of all, you may feel embarrassed. Take the steps to get out of the slump and back on track.