Managing Development of Complex Medical Devices
Revised text
Non-Complex Medical Devices | Complex 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:
- What Makes Complex Medical Devices Different? A Project in Crisis (April 2024)
- General Challenges of Medical Product Complexity (June 2024)
- Phase Zero on Steroids in Medical Device Development (July 2024)
- Scouting Your Customers and De-Risking Your Medical Technology (Sept 2024)
- Finishing Phase Zero: Defining Medical Device Product Strategy (Sept 2024)
- Your Medtech Regulatory Strategy Is Your Market Strategy (Nov 2024)
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)