I’ve found that MedTech companies often struggle when it comes to executing product remediation programs. Even those who have their act together in R&D and product management can lose their way. Why? I’ve noticed some common themes. I think their problems are rooted in their organizational structure, strategic business decisions, and resource management. Let’s dive deep.
Organizational Structure
MedTech companies are typically not designed to handle large-scale remediation programs, nor should they be. These programs are temporary and don’t reduce manufacturing costs or grow revenue like new product development does. Instead, they only protect existing revenue streams of on-market products. There is no pre-established organization and governance set up and it would be wasteful to keep this structure around when it’s not active.
It’s often unclear which function should own the remediation program. While regulatory or quality issues usually initiate the need for remediation, these functions don’t have the skills and resources to lead the long-term effort. R&D may step in due to their expertise, but this distracts them from their primary goal of driving revenue growth through new products. Sustaining engineering groups might take ownership, but large remediation programs can quickly overwhelm their resources.
Strategic Business Decisions
The lack of clear ownership makes it difficult to drive critical business decisions. A large remediation program requires a dedicated budget, and taking funds from R&D can hinder future revenue potential. Proper budget controls are essential to prevent wasting money.
Business leaders must also decide on the scope of the remediation effort. This includes determining which products will be remediated, which will be discontinued, and which are candidates for next-generation designs. SKU rationalization and tough strategic decisions are crucial. And prioritizing which products to remediate first is vital, as resources are limited and some products are more critical or can be remediated faster.
Resources and Human Nature
Without dedicated resources, remediation programs will drag out as employees may prioritize their regular work over remediation tasks. Especially if their incentives are based on their normal functions. Human nature suggests that resources will spend more time on work they enjoy, which is typically new product development rather than remediation.
Overcoming Deficiencies
Several MedTech companies have successfully navigated remediation programs by leveraging innovative approaches and expert guidance. We’ve helped companies overcome these challenges by adopting several strategies.
- Clear ownership and leadership: Assign a dedicated program team to lead the remediation program. This cross-functional team should have the necessary skills and resources to manage the program effectively. Dedicated leadership can ensure the program remains visible and in control.
- Dedicated budget: Establish a separate budget for remediation programs to ensure that funds are allocated appropriately without impacting R&D or other critical functions. Link remediation costs to the future revenue of the remediated products to prevent gold-plating.
- Strategic planning: Develop a comprehensive plan that outlines the scope of the remediation effort, prioritizes products based on importance and feasibility, and includes SKU rationalization. This plan needs to be a living document, revisited when new they learn new information. Start with a gap assessment to understand the full scope. Many companies skip this step, and their program will appear to be out of control as it continues to expand after plans and budgets are set.
- Resource management: Allocate dedicated resources to the remediation program to avoid conflicts with regular work. Since this is a temporary effort, consider consultants or contractors to bulk up the organization. Incentivize employees to focus on remediation tasks by aligning their goals with the program’s objectives.
- Expert guidance: Partner with remediation experts with experience leading these complex programs. They can provide insights and support in setting expectations, identifying gaps, and minimizing disruption. Bringing in the right experts early can greatly reduce risks and save significant time lost to trial-and-error learning.
Conclusion
By recognizing and tackling their challenges head-on, MedTech companies can better navigate the complexities of remediation programs and maintain the integrity and safety of their products on the market. I’ve seen that tapping experienced experts, assigning dedicated resources, conducting disciplined planning, and following program management principles reduces the risk, hastens the completion, and keeps the leadership informed and in control of the program. And that lets them get back to growing their business.
April 2, 2025
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