Russell M. Singleton, Ph.D., Russ Singleton Consulting LLC; Aaron Joseph, Sunstone Pilot Inc.06.04.24
In the last column, we introduced the ill-fated Eagle Project, which encountered significant delays in a multi-year development project even though they followed the company’s phase-gate process. In this column, we continue to identify challenges in the development of complex medical devices, which will lead to a different approach than what the Eagle team used.
Why does developing a complex medical device require a different approach than developing other medical devices? Following are the primary factors resulting from product complexity that drive new challenges and, therefore, new methods for new product development (NPD) and new approaches for medical device companies.
Challenges
Challenges
Challenges
Challenges
The more complex the product’s behavior and user interface, the more likely there will be use errors and the greater the need for human factors engineering and testing.
Challenges
Challenges
Challenges
Russ Singleton, Ph.D., president of Russ Singleton Consulting LLC, is a consultant based in California. He has extensive experience in VP R&D, general management, and C-suite roles in the semiconductor equipment and medtech sectors. He has had success in transforming development teams in inspection systems, DNA sequencing, and various medical imaging and surgical robotics systems. Singleton holds a Ph.D. and M.S. in electrical engineering from the University of Illinois and a bachelor’s degreen in engineering from the Pratt Institute.
Aaron Joseph, principal consultant with Sunstone Pilot, is a biomedical engineer based in Waltham, Mass. He has over 20 years of experience in medical device development across a broad range of products: surgical robotics systems, laser eye surgery equipment, wearables, X-ray imaging systems, drug inhaler devices, catheters, and multiple IOT and SaMD products. He helps clients with risk management and design controls, software validation, training, and implementation of software tools for documentation automation.
Why does developing a complex medical device require a different approach than developing other medical devices? Following are the primary factors resulting from product complexity that drive new challenges and, therefore, new methods for new product development (NPD) and new approaches for medical device companies.
No Hole-In-One
In the situation where no market exists, companies need to realize the first product launched may not be optimal and will need to be refined. Trying to launch with the “perfect product” may be counterproductive; launching sooner with a good product and then revising it based on customer feedback may be advantageous.Challenges
- Understanding what is a sufficient level of completeness for the first version of the product where there is no existing market
- The organization needs to respond to customer feedback rapidly to launch a follow-on version of the product. This needs to be part of the financial model for the product.
Large Product Teams
Coordinating the work of a product team of only a dozen people is very different from that of a product team with 150 people or more (often spread across multiple organizations).Challenges
- Coordination and communication among a large number of people
- Maintaining alignment and focus over a long-duration project
- Turnover of team members leading to loss of knowledge
Resource Intensive Projects
Developing a complex medical device can require a very large budget as well as more development partners and suppliers.Challenges
- Project failures entail much greater business risks, measured in wasted money and time
- Much harder and more expensive to change direction
- More expensive to resolve design flaws late in development
- Siloed development of various modules or subsystems
Interdependencies of Different Technologies
Complex medical devices frequently consist of multiple technologies (mechanical, electrical, software, optical, etc.) that must be tightly integrated.Challenges
- Difficult to predict system performance and behavior without modeling studies or building a prototype system
- Difficult to understand design tradeoffs and optimal system design
- Need multiple iterations to complete the system design
The more complex the product’s behavior and user interface, the more likely there will be use errors and the greater the need for human factors engineering and testing.
Challenges
- Need to visit customer sites to understand customer use cases and usage environment
- Optimizing the user interface and workflow (extensive human factors/usability engineering)
- Demonstrating usability for safe and effective operation
- Identification of all users (e.g., customers and field service)
Complexity of Product Information
Complex medical devices involve a large amount of product data, often orders of magnitude more than simple medical devices. For example, instead of managing 50-60 requirements, the product team needs to manage 500 or 1,500 requirements, or instead of managing a product bill of materials (BOM) with 15 components, managing a product BOM with 1,000 components.Challenges
- Defining and prioritizing product features (not obvious and team may not be able to achieve all of them)
- Safety risk analysis and management of risk controls
- Management of design requirements
- Management of product BOM and supply chain
- Magnitude of verification and validation testing
- Volume of DHF documentation to comply with design controls
Multiple Upgrades Throughout the Product Lifetime
Most complex medical devices, especially those with significant software components, will be upgraded repeatedly after the initial product launch.Challenges
- Rigorous control of product design changes years after initial product launch
- Maintaining design controls and DHF documentation across multiple upgrades
- Backwards compatibility with earlier configurations
- Designing architecture and subsystems to support future upgrades
Managing Project Risks
New product development is inherently risky. Companies that try to avoid the risks of product development only tackle incremental projects—low-risk, low-ROI projects (at the cost of not growing the top line). Companies that want truly innovative new products must accept that those projects will be risky and structure their product development around managing risks.
Innovation=Project Risk
Complex Products=Increased Project Risk
Categories of Project Risks
Product development organizations need to think broadly about the different categories of risk for NPD and how they will mitigate all of them for each project:- Technical Risk—Will the technology work (engineering/scientific challenges)? Are we trying to violate the laws of physics or biology?
- Marketing Risk—Do we have the right product? What is the job to be accomplished? Does the product add enough value customers are willing to pay for it?
- Business Risk—Can we produce this new product and be profitable? What are the basic assumptions on ranges for cost of goods and margin targets?
- Clinical Risk—Will the new product be clinically effective? Will the benefits of using it outweigh the costs of switching to a new product?
- Safety Risk—Will patients be harmed by the new product?
- Intellectual Property Risk—Do we have the freedom to operate?
- Resources Risk—Do we have enough money and the right people with the right skills to develop the new product?
Problems Track Back to the Beginning
Most of the problems of the ill-fated Eagle Project trace back to the beginning of the development project, where risks were not adequately identified and mitigated (root cause). The team proceeded optimistically as if there were no uncertainties, and the hidden project risks blew up in their faces later in development. The project was missing an important set of initial activities before proceeding down the development path. Successful development of innovative new products depends on critical work before development during a discovery/invention phase. This pre-development phase (Phase Zero) must be resourced and managed differently than development.Russ Singleton, Ph.D., president of Russ Singleton Consulting LLC, is a consultant based in California. He has extensive experience in VP R&D, general management, and C-suite roles in the semiconductor equipment and medtech sectors. He has had success in transforming development teams in inspection systems, DNA sequencing, and various medical imaging and surgical robotics systems. Singleton holds a Ph.D. and M.S. in electrical engineering from the University of Illinois and a bachelor’s degreen in engineering from the Pratt Institute.
Aaron Joseph, principal consultant with Sunstone Pilot, is a biomedical engineer based in Waltham, Mass. He has over 20 years of experience in medical device development across a broad range of products: surgical robotics systems, laser eye surgery equipment, wearables, X-ray imaging systems, drug inhaler devices, catheters, and multiple IOT and SaMD products. He helps clients with risk management and design controls, software validation, training, and implementation of software tools for documentation automation.