Clinical Research: Phase 1 - Phase 4

The 5 Components of an Effective Target Product Profile

A target product profile is a document that presents a polished explanation and aggregation of all relevant information needed in validating product development. This common template can be used for all products across a company portfolio to guide and align regulatory, preclinical, clinical, marketing, and health economic outcomes and reimbursement strategies.

The concept of the TPP was originally developed by the Food and Drug Administration (FDA) to facilitate communication between the organization and industry. While the strategy was aimed at drug development, it’s easily adapted to the field of medical devices.

Writing a TPP

Essentially, a TPP is a detailed analysis of a potential new product in comparison to competitors and/or the existing standard of care. But who’s responsible for crafting a TPP? While it’s typically owned by project management or the project leader, TPP writing requires parallel — rather than sequential — input from other stakeholders.

A TPP needs a team of writers made up of stakeholders from research and development, regulatory, preclinical, clinical, marketing, operations and HEOR groups within a company’s product development program.

Additionally, the TPP process is iterative, needing multiple face-to-face meetings and detailed reviews of each version of the TPP as it progresses. Multidisciplinary cooperation and communication during TPP development ensures universal buy-in from all players.

1. Key indications

The deep research needed here makes a TPP’s first step also its most time-intensive one, requiring due diligence, market data analysis, and multidisciplinary brainstorming. The goal is to determine all possible indications and claims for the device, as well as the market potential associated with each indication and claim.

Identify the unmet patient needs the device can address, utilizing the voice of consumer research. Evaluate how the device performs by reviewing existing literature on the device itself, competing products, and treatment trends.

2. Safety and efficacy claims

This section allows a company to select indications and claims that have the highest potential reward and lowest possible risk. Outline existing data needed for effective trial design, along with what preclinical data may still be required to meet regulatory requirements.

3. Potential economic value of indications and claims

Begin by understanding treatment patterns and anticipate how the health care delivery system may evolve in the future. Outline the current standard of care, how it differs globally, and what predictions can be made of how that may change by the time the device is introduced into the market.

Assess the market size, competitor pricing, target cost of goods sold, target pricing, and reimbursement environment. Will your device still be relevant in five years when clinical study data is available? What is the expected return on investment for this product?

4. Best differentiating features or outcome

What sets this device apart? What data exists to support these differentiators, and what data is still needed? Additionally, are these features strong enough to support premium pricing?

Clearly outlining a product’s benefits is a crucial component of any marketing strategy.

5. Exclusivity strategy

This section positions the device for exclusivity in marketing. It gathers together information on product availability, reimbursement data, regulatory classification, trademarking, branding strategy, and intellectual property.

Keep in mind that a TPP is a dynamic, living document that should be revisited and revised as needed. Likewise, as a TPP changes, functional strategies may, in turn, need to be re-evaluated.

To learn more on navigating the development of a TPP, read our checklist, Target Product Profile Checklist: Laying the Foundation for Early-Stage Assets.