The traditional approach of marching head-first into development – with Gantt charts, project planning software, and sophisticated CAD models – does not work well for complex medical devices. We explain here an alternative approach, organized into a set of proven concepts and methods, for managing the special challenges product teams face in developing complex medical devices. We begin by analyzing those special challenges and what makes these development projects different. Then we describe how to fully leverage the crucial pre-development work that needs to be done before beginning commercial development, what we refer to as “Phase Zero on Steroids.” A second part of this whitepaper, to be published later in 2025, will continue with concepts and methods to address challenges throughout product development. Companies that are able to embrace these concepts and implement these methods will increase the chances for success for every product team.

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. The table below compares what we are referring to as complex medical devices with examples of non-complex medical devices.

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: Dozens of components Design requirements: 50 to 150	Product BOM: Hundreds or thousands of components Design requirements: Hundreds or thousands

A Proven Approach to Developing Complex Medical Devices
Whitepaper

This whitepaper combines all of the content of the MPO magazine columns listed below. The whitepaper will be regularly updated as additional columns are published.

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? – an article by Andre Esterhuizen (medium.com, MAY 2018) summarizing the key principles of knowledge-driven product development and contrasting it with typical approaches to new product development

Managing Complex Medical Devices – a recorded webinar with Russ Singleton, Aaron Joseph, and Walt Maclay – hosted by Voler Systems (May 2023)

What and Why of Phase Zero – an article by Product Creation Studio (OCT 2019) that summarizes the key aspects of this crucial part of new product development

Four Stages of 0 > 1 Products – an article by Julie Zhou (medium.com, NOV 2017) which describes key considerations when starting development from scratch. “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.”

The Lean Startup – the classic text by Eric Reis (2011) where he describes a systematic approach to creating and managing successful startups and explains how companies of all sizes can create innovative new products in an environment of uncertainty