Product Design and Engineering, Design Control, Regulatory and Quality Management

From idea to launch…

We lead, support, or supplement your product development effort at all stages of the product lifecycle— we integrate seamlessly with your team to help make your products come to life.

Design + Engineering

We bring product ideas to life through ideation, prototyping, troubleshooting, manufacturing scale up-- with your end in mind, from proof-of-concept to full manufacturing launch.

Concept Development & Ideation

  • Product design and industrial design

    Industrial Design

    Artistic sketches, renderings, and visualizations to bring concept ideas to life and iterate on key features and ergonomics.

  • Patent images and IP support in medtech

    Intellectual Property Development

    Technical analysis of existing IP, ideation to create new IP, expansion of concepts to broaden IP.

Mechanical Engineering

  • 3D CAD mechanical design of medical device ideas

    CAD Design

    Computer-Aided Design using SolidWorks to produce 3D CAD files and component drawings.

  • 3D printing new ideas and concepts

    3D Printing & Prototyping

    Rapid prototyping designs using the latest 3D printing technology, including FDM and SLA printers.

  • rapid design and concept generation

    Reverse Engineering

    3D laser scanning of external surface geometry or CT scanning of internal assemblies to enable design modifications and updates.

  • benchtop testing including design verification

    Assembly & Feasibility Testing

    Look ahead functional testing with proof-of-concept prototypes de-risks the development process and timeline.

Electrical Engineering

  • electrical medical device circuit design

    Circuit Design

    Digital and analog circuit design for electromechanical medical devices.

  • printed circuit boards that comply with IEC 60601

    PCB Layout

    We design our PCBs with standards like IEC 60601 in mind to ensure device safety and functionality.

  • electrical medical device assembly and testing

    Prototyping & Assembly

    Fast prototyping of concepts with either off-the-shelf platforms (i.e. Arduino) or custom built PCBs.

  • electrical device design consultants

    PCB Testing & Debugging

    Board level circuit testing to ensure the end product will function as intended.

Firmware + Software

  • Firmware Development

    Firmware Development

    Device intelligence and algorithm development in C/C++ or Python.

  • Smart Devices + IoT

    Smart Devices + IoT

    Medical devices are getting smarter. Data capturing devices can improve patient outcomes and avoid clinical errors.

  • Sensor Integration + Data

    Sensor Integration + Data

    We are sensor integration experts for medical devices. Enable real-time remote data analysis and decision making by clinicians.

  • BLE Data Transfer / Analysis

    BLE Data Transfer / Analysis

    We can enable device data to be sent to the cloud for backend analysis and reporting, as well as access by doctors and clinical staff.

FREQUENTLY ASKED QUESTIONS

  • Great! We are the experts in the process of navigating medical device development from the earliest stages— even if it is only an idea. We can provide direction and advice on funding, patents, prototyping, and development, and can give realistic expectations on the time and cost to bring a device to commercial launch.

  • Our Client Agreement ensures that you retain 100% ownership of all the work product we create, including designs, schematics, intellectual property, etc.

  • A patent is not needed to begin a partnership with Ontogen and start designing, building, and testing. Our Client Agreement ensures Confidentiality of your device ideas and intellectual property.