medical device development company
Transforming the healthcare industry through innovative and advanced medical device design and development services, offered by a leading medical device development company and design firm
medical device design and development
Your One-Stop Medical Device Design and Development Services Company for Low-Cost Production
At American Engineering Group (AEG), we specialize in transforming breakthrough ideas into FDA-compliant, market-ready medical devices. With decades of engineering expertise and a proven track record, including development of hip and knee implants, orthopedic braces, and sports protection gear, we partner with innovators to turn concepts into commercial successes.
Whether you’re a startup, academic lab, or global manufacturer, understanding and executing the FDA-regulated development process is crucial. It’s not just about building a functional product, it’s about managing technical risk, meeting regulatory demands, and accelerating time to market.
Why the Medical Device Development Process Matters
Medical devices directly affect patient health and safety. In the United States, the FDA’s five- phase regulatory framework ensures that devices are not only effective and safe but also manufactured under controlled, high-quality systems.
Following this process is vital: Over 80% of U.S. medical device startups fail, often due to poor execution or regulatory missteps. With AEG’s integrated engineering and regulatory approach, including cutting-edge AI technologies help reduce time, cost, and risk from concept to commercialization.
The Five FDA-Regulated Steps in Medical Device Development
Every successful device begins with a real-world medical problem and a clear user need.
Key Activities
- Identifying the clinical need and target population
- Concept sketches and early prototyping
- Market and competitive landscape research
- IP landscape review and strategy
- Risk and feasibility assessment
- Planning the regulatory and manufacturing roadmap
AI Utility
At this stage, AI tools can assist with market trend analysis, patent landscape mining, and technical feasibility modeling, helping you validate the need and define the concept faster.
AEG Insight
A well-planned concept is the foundation for success. We integrate AI powered design exploration to optimize your early concepts and prepare for scale.
Here we turn ideas into tangible designs, ready for lab testing and validation.
Key Activities
- CAD modeling and 3D printing of initial prototypes
- Mechanical, electrical, and chemical testing
- AI-based simulation of performance under use-case conditions
- Usability engineering and formative testing
- Compilation of the Design History File (DHF)
- Design transfer preparation for manufacturing scale-up
AI Utility
AEG applies generative design algorithms and FEA simulations using machine learning to reduce design iterations. AI helps predict failure modes, improving test efficiency and accelerating development.
AEG Insight
We compress development timelines using AI-driven virtual prototyping – getting you from lab bench to validated prototype faster and more cost-effectively.
This is where regulatory strategy meets real-world validation.
Key Activities
- Device classification (Class I, II, or III)
- Q-sub (pre-submission) meetings with FDA
- Investigational Device Exemption (IDE) strategy and submission
- Clinical trial design and protocol development
- Human factors engineering and risk management
AI Utility
AI is leveraged for automated documentation drafting, clinical trial protocol simulation, and regulatory risk analysis, allowing earlier identification of bottlenecks.
AEG Insight
Missteps here can be costly. AEG uses AI-powered document management and submission tools to ensure every regulatory milestone is met with precision.
The FDA evaluates your device’s clinical data, risk profile, and quality systems before granting clearance.
Key Activities
- FDA submission via 510(k), De Novo, or PMA pathway
- Manufacturing audits and process validation
- Labeling, packaging, and Instructions for Use (IFU) review
- Addressing FDA questions and response tracking
AI Utility
AI tools help analyze FDA feedback trends, automate response generation, and simulate regulatory scenarios based on device class and historical data.
AEG Insight
We streamline FDA interaction through predictive analytics and automated submission tools, helping you avoid delays and gain faster approval.
After launch, maintaining safety, efficacy, and compliance is critical.
Key Activities
- Real-world evidence collection and analysis
- Adverse event monitoring and MDR reporting
- Periodic safety updates and recalls (if required)
- Ongoing compliance with ISO 13485 and FDA QSRs
- Design improvements based on field data
AI Utility
Post-launch, we implement AI-based monitoring systems to track user behavior, predict
adverse events, and guide proactive improvements.
AEG Insight
Our AI-enabled systems detect trends in real-world data early—ensuring long-
term product success and regulatory peace of mind.
FDA Device Classifications Overview
Medical devices are classified by the FDA based on their risk level, which determines the type of regulatory approval required.
| Class | Risk Level | Examples & Approval Requirements |
|---|---|---|
| I | Low | Bandages, surgical gloves – Most exempt from premarket review |
| II | Moderate | Infusion pumps, surgical tools – Requires 510(k) clearance |
| III | High | Heart valves, pacemakers – Requires PMA (Premarket Approval) |
Some of our medical device projects
