Which material Medtech founders should prepare before contacting an IDH for best outcome

When engaging with an Independent Design House (IDH) for medical device development, companies must prepare a set of essential documents, materials, and resources to ensure a smooth collaboration. These documents help define the project scope, clarify requirements, and align expectations between the company and the IDH. Note that these materials are for your best utilization of the project. You can choose which materials are appropriate to disclose to your IDH partners.

1. Business & Market Documents

These documents provide market, regulatory, and commercial context for the product.

• Business Plan – Outlines the product vision, target market, competition, and revenue model.
• Market Research Report – Provides insights into potential users, competitors, and reimbursement strategies.
• Regulatory Strategy Document – Defines the expected regulatory pathway (e.g., FDA 510(k), MDR, PMA).
• Reimbursement & Payer Strategy – Explains how the product will be reimbursed (e.g., CPT codes, DRG payments).
• Go-To-Market Strategy – Defines sales channels, pricing, and distribution plans.

2. Product Definition Documents

These documents specify technical, clinical, and functional aspects of the device.

• Product Requirements Document (PRD) – Defines the key features, performance, and user needs.
• Use Case & Clinical Workflow Diagrams – Illustrates how the device will be used in a medical setting.
• Competitive Benchmarking – Highlights similar devices, key differentiators, and potential risks.
• Design Inputs Document – Captures functional, usability, and regulatory requirements.

3. Technical & Engineering Documents

These documents provide technical feasibility and engineering insights to the IDH.

• Preliminary System Architecture – Defines the hardware, firmware, and software architecture.
• Bill of Materials (BOM) (if applicable) – Lists key components for early cost estimation.
• Existing Prototypes or Proof-of-Concept (if available) – Provides physical or simulated models.
• Power Budget & Communication Requirements – Outlines power constraints, wireless protocols, and battery expectations.
• Software & Algorithm Descriptions – Describes any proprietary algorithms, AI models, or firmware functionality.

4. Regulatory & Compliance Documents

Ensuring compliance and risk management is crucial in medical device development.

• Intended Use Statement – Clearly defines the device's purpose, indications, and limitations.
• Risk Management Plan (ISO 14971) – Identifies potential hazards and mitigation strategies.
• Applicable Standards & Certifications – Lists relevant standards (e.g., ISO 13485, IEC 60601, ISO 10993).
• Clinical Validation Plan (if needed) – Outlines plans for preclinical and clinical testing.

5. Manufacturing & Supply Chain Documents

These help with DFM (Design for Manufacturability) and supplier coordination.

• Preliminary Manufacturing Strategy – Defines production volume, cost targets, and location (CM, ODM, etc.).
• Material Selection Preferences – Specifies biocompatibility requirements (e.g., ISO 10993, USP Class VI).
• Supply Chain Considerations – Highlights critical component availability and sourcing risks.

6. Legal & IP Protection Documents

Protecting intellectual property (IP) and defining legal agreements are necessary before engaging an IDH.

• Non-Disclosure Agreement (NDA) – Ensures confidentiality between both parties.
• Intellectual Property (IP) Ownership Agreements – Defines who owns the design, firmware, and software.
• Existing Patents & Prior Art (if any) – Provides insight into existing technology protection.

Final Thoughts

Companies that prepare comprehensive documents before engaging with an IDH can significantly reduce development risks, avoid costly misalignment, and accelerate product timelines.

If you need guidance in preparing these materials, ITR Vietnam can help. Contact us today to streamline your medical device development journey with expert IDH support.

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