Managing Development of Complex Medical Devices

Revised text

Non-Complex Medical DevicesComplex Medical Devices
Intravascular catheter (stent)
Surgical instrument
Implantable knee joint
Capital equipment such as a radiation therapy system, medical imaging system, surgical robotics system, or laboratory diagnostic equipment

Complex disposables with software such as a wearable combined with a mobile app and cloud software (IOT architecture)

Software-only products (SaMD)
Product BOM: Hundreds or thousands of components
Design requirements: Hundreds or thousands
Product BOM: Hundreds or thousands of components
Design requirements: Hundreds or thousands

These concepts and methods are applicable to development of simpler medical devices and non-medical products but are especially important for complex medical device development.

A Proven Approach to Developing Complex Medical Devices
Whitepaper

This whitepaper combines all of the content of the MPO magazine columns listed below.
Note: the whitepaper will be regularly updated but there may be some delay before incorporating the latest column

MPO Magazine Columns

This content is published monthly under the Design Viewpoint column in the Medical Product Outsourcing (MPO) magazine:

Additional Resources

What Is Knowledge-Driven Product Development? – article by Andre Esterhuizen (medium.com) summarizing key principles and contrasting with typical approaches to new product development

Four Stages of 0 > 1 Products – Nov 2017, Julie Zhou, Year of the Looking Glass (medium.com) “Successful 0->1 products — ones that create valuable new intents for people at scale — don’t arrive into the world fully-formed. Like humans, products go through different life stages. You don’t use the same tactics and process to nurture a product that is just getting started as you do one that is mature and scaling.”

What and Why of Phase Zero – Product Creation Studio, Oct 2019.

The Lean Startup by Eric Reis (2011)

Managing Complex Medical Devices – by Russ Singleton and Aaron Joseph – webinar hosted by Voler Systems (May 2023)