In the highly regulated and rapidly evolving world of combination products, where drugs, devices, and/or biologics converge, the need for strategic portfolio management is more crucial than ever. One strategy gaining increasing traction is the platform approach. This model involves designing a foundational technology, system, or component that can be leveraged across multiple products within a portfolio, reducing duplication and enhancing scalability.
However, while a platform approach offers compelling advantages, it also introduces a new layer of complexity. This blog will explore both the pros and cons of adopting such an approach in the context of a combination product portfolio.
Understanding the Platform Approach
Before diving into its benefits and drawbacks, it’s essential to define what a platform approach means for combination products.
In this context, a platform is a shared core technology or component architecture, for example, a standard drug delivery device (like an autoinjector, pen, or inhaler), a shared software module, or even a common container-closure system. This platform can then be adapted or modified slightly to accommodate various APIs (Active Pharmaceutical Ingredients), dosage forms, or therapeutic areas, enabling companies to build multiple products using the same fundamental base.
For example, a pharmaceutical company might develop a reusable autoinjector body that works across a portfolio of biologic drugs simply by swapping out the cartridge. Similarly, a digital health component like a connected app or Bluetooth module may be used across multiple smart inhalers or injectors.
Pros of a Platform Approach
1. Accelerated Development Timelines
Developing a combination product from scratch is time-consuming and resource intensive. With a platform approach, core elements are already developed, validated, and sometimes even approved by regulatory authorities. As a result, new products can often skip early-stage feasibility and design phases, accelerating time to market.
- Example: If an off the shelf platform injector is already validated, adapting it to a new drug or biologic might take months rather than years.
2. Cost Efficiency Through Reuse
Reusing key components across products leads to significant cost savings, both in terms of R&D and manufacturing.
- Shared tooling, manufacturing lines, and supply chain elements reduce capital expenditure.
- Device testing and human factors studies for the platform may not need full repetition, depending on the extent of modifications.
This reuse reduces per-unit production costs and offers a favorable economy of scale.
3. Regulatory Leverage
Although each combination product must undergo regulatory scrutiny, regulators are increasingly receptive to the idea of platform-based submissions. If one product on the platform has received approval, others may benefit from that precedent:
- Shared design history files (DHF)
- Reuse of clinical or human factors data
- Leveraging existing verification data
- Streamlined technical file generation
This can translate into simplified regulatory pathways, especially when changes between products are minor.
4. Improved Quality and Reliability
Using a proven platform helps ensure that subsequent products inherit the same robustness, usability, and quality attributes as the base product. This can lead to:
- Fewer post-market issues
- Increased patient and provider confidence
- Enhanced risk mitigation
In short, designing quality into the platform pays dividends across the portfolio.
5. Strategic Branding and Market Recognition
A consistent user interface and device design across multiple therapies can enhance brand cohesion. Patients familiar with the device platform for one therapy may find it easier to transition to another within the same portfolio, enhancing adherence and user satisfaction.
This also enables portfolio-level value propositions, e.g., offering a full suite of therapies through a familiar device ecosystem.
6. Facilitates Digital and Connected Health Strategy
For companies exploring digital health, the platform model allows for centralized software development and data integration. A common digital backbone across products simplifies:
- App development
- Data aggregation for real-world evidence
- Remote monitoring solutions
It also supports modular compliance with cybersecurity and data privacy regulations, such as GDPR and HIPAA.
Cons of a Platform Approach
Despite its advantages, a platform strategy is not without challenges. In some cases, the costs and complexities may outweigh the benefits.
1. Upfront Investment and Long-Term Commitment
Building a platform is a resource-intensive endeavor. It requires:
- Long-term planning across multiple product lines
- Cross-functional alignment (engineering, regulatory, clinical, marketing)
- Significant upfront investment in design, verification, and validation
This commitment might delay short-term product launches and is particularly risky if future pipeline products do not align well with the chosen platform.
This can be mitigated by use of platforms or off-the-shelf components that have previously been validated.
2. Reduced Flexibility and Innovation Constraints
While platforms enable reuse, they can constrain product design. If a particular drug would benefit from a unique delivery system or feature outside the platform’s capabilities, compromises may have to be made.
This may limit:
- Customization for specific patient populations
- Novel innovations in design or usability
- Competitive differentiation
In some cases, adhering too strictly to a platform can lead to suboptimal product-market fit.
It is important to approach from a holistic perspective early, to identify areas to best pivot upon for the platform, in order to control these limitations.
3. Change Management Complexity
A major downside of platform-based strategies is that a change to the platform affects all products that use it. This introduces significant regulatory and quality complexity:
- A minor design change may trigger reevaluation of multiple SKUs.
- Regulatory filings become interlinked, increasing the risk of cascading delays.
Managing configuration control and change impact assessments becomes a heavy lift as the portfolio grows.
4. Regulatory Ambiguity and Inconsistency
Although regulators are increasingly receptive to platform-based submissions, there is no universal global framework for platform approval. Variability between agencies (e.g., FDA, EMA, PMDA) may cause:
- Conflicting feedback
- Divergent expectations on documentation reuse
- Need for additional bridging studies or data
This ambiguity can introduce unpredictable delays or duplicative work.
5. Organizational Misalignment
For a platform strategy to succeed, R&D, commercial, manufacturing, and regulatory teams must work together under a shared vision. In many organizations:
- Misalignment of priorities can fragment the platform strategy.
- Functional groups may resist adapting to standardized tools or processes.
Without strong governance and strategic oversight, the platform may drift or become inconsistently applied.
6. Patient and Provider Confusion in Certain Cases
While consistency is usually a benefit, too much uniformity can backfire. For instance:
- Patients or clinicians may assume all products are interchangeable.
- Unique risk or usage instructions for a specific product may be overlooked due to familiarity with the platform.
This risk increases when products vary substantially in drug characteristics, dosing frequency, or route of administration.
When Does a Platform Approach Make Sense?
A platform approach is not universally applicable, but it’s highly effective when:
- Multiple products share similar delivery needs or patient populations.
- Long-term pipeline visibility allows for coordinated planning.
- There is potential to create a competitive moat through device, software, or manufacturing IP.
- Regulatory pathways can be leveraged based on prior approvals.
Industries like diabetes care, biologics, and connected inhalers have seen considerable success with this model. Conversely, highly differentiated or low-volume products may not justify the effort.
Best Practices for Implementing a Platform Strategy
If you decide to pursue a platform strategy, consider the following best practices:
- Establish Strong Governance Early
Create a cross-functional platform management team with clear accountability. - Design for Modularity and Scalability
Ensure the platform can be extended or customized without complete redesign. - Invest in Robust Documentation and Design Controls
Future products will depend on the quality and clarity of these documents. - Build Relationships with Regulatory Agencies
Early engagement with regulators can clarify reuse opportunities and requirements. - Create Clear Configuration and Change Management Protocols
Define how changes to the platform will be managed and communicated across the portfolio. - Train Internal Teams on Platform Thinking
Help R&D, QA, and commercial teams understand and align with the platform’s goals.
Final Thoughts
A platform approach to combination product portfolios offers compelling strategic, operational, and commercial benefits, particularly in accelerating development, reducing cost, and enhancing consistency. However, the model demands rigorous planning, governance, and cross-functional collaboration to navigate its inherent complexities.
The decision to adopt a platform strategy should be based on a careful analysis of pipeline alignment, market needs, and organizational capabilities. When executed well, it can be a powerful tool to scale innovation and deliver high-quality therapies more efficiently to the patients who need them.
At Ventura Solutions, we specialize in helping medical device, pharmaceutical, and biotech companies navigate complex challenges throughout all stages of development. Whether you need support with combination product or medical device development, platform selection, technical or DHF documentation creation, risk management, training, or more, our team of experts is ready to assist. Contact us today.
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