A target product profile (TPP) is a strategic process tool that streamlines medical device development through cross-functional strategic alignment. It’s a living document that defines the value proposition and key differentiators of an intended commercial product while assisting in product development strategy.
A TPP may take a lot of time and resources to craft, but it’s a strategy that promises a major return on investment for medical device development companies. Here are four ways a good TPP pays off.
1. Promoting Efficiency
A TPP ensures that a product development program is efficient and accounts for all relevant medical, technical, scientific, and financial information needed for commercial success.
Understanding the current market climate and economic potential of the device can help managers focus R&D efforts, making the most efficient use of available resources.
Additionally, by beginning with the end in mind, a TPP can identify issues early on and significantly reduce the chances of costly late-stage development errors. The document also minimizes poor study design choices and expensive unsuccessful clinical trials.
2. Facilitating Communication
The TPP model was originally developed by the FDA to facilitate communication between regulatory agencies and industry. Today, it functions as a useful tool for assessing, tracking, and communicating any changes during the lifecycle of the development program to various entities, including those within an organization.
By streamlining the research process involved in validating a product for development, a TPP facilitates cross-functional communication. Since device development is a multidisciplinary undertaking, it’s necessary to ensure each group involved stays on the same page.
Without a TPP in place, each stakeholder may create functional strategies in a vacuum without input from other groups. A well-crafted TPP promotes interdepartmental collaboration and synergy.
3. Ensuring Adaptability
While TPPs change over time, a good TPP front-loads most of the necessary planning that goes into medical device development. From there, this basic template can be tweaked to stay relevant at all steps within device development.
Additionally, careful research during collaborative brainstorming prevents groupthink by cataloging all possible ideas within the document. This is especially important, as innovative products are often developed from ideas that may seem counterintuitive.
4. Informing Future Strategies
By far, the greatest strength of TPPs is their ability to inform future strategies. A TPP serves as the initial cornerstone for the individual department strategy development that will happen later on.
As a strong foundation, information found in the TPP supports each aspect of product planning:
- Target cost of goods sold and pricing — manufacturing strategy
- Differentiating features and reimbursement climate — health economic outcomes and reimbursement (HEOR) strategy
- Identification of target indications and claims — Study design
- Regulatory classification — Type and amount of research needed
- Potential economic value — Informed portfolio decisions
Crafting a TPP for your next medical device is good investment of time and energy – check out our previous blogpost for information on putting one together.