Expert Medical Device Consulting

Orion Medical Device Consulting provides expert support for startups and established companies alike looking to innovate in the medical device space. With extensive experience in the full product life cycle, Orion ensures your project is positioned for success. Partner with Orion to navigate the complexities of bringing your medical device to market successfully, today.

Services

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Product Development Strategy

Orion collaborates with clients to craft tailored product development strategies that streamline the path from concept to market. With a focus on identifying internal and external stakeholder requirements, Orion supports the capture and reconciliation of requirements and risks at the start and throughout the program's lifecycle.

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Design and Development

Typically the most costly phase of any medical device project, Orion can help you right size the design and development effort. From architectural planning through technology and design tool selection, Orion has the expertise needed to ensure a smooth, timely, and cost efficient implementation effort.

DNA Genotyping and Sequencing.
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Testing and Evaluation

From in-house bench testing strategies to field based human factors, electrical/safety testing, and clinical trials, Orion can formulate and facilitate your program's needs to ensure the design satisfies verification and validation requirements, and most importantly, delivers the performance and reliability in the field your customer's expect.

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Manufacturing Transfer

Orion can ensure the design package provided to manufacturing operations is solid and ready to meet the challenges of pilot production and full commercialization. With an emphasis on DFx, the resulting design will be manufacturable, serviceable, and reliable. Orion can assist with the selection of supply chain and manufacturing partners to ensure the best fit possible with your business and operational goals.

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Quality Management Systems

Whether you need to establish a quality management system or improve upon an existing one, Orion can provide the expertise needed to streamline the process for your business needs and comply with global regulatory standards.

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Regulatory Insight

As a critical voice in the development process, identifying the appropriate approach to regulatory compliance is critical to the timely and appropriate sizing of project resources. When the time comes to submit regulatory applications, Orion can provide the guidance needed to support your program.

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About


Device Development Experience

With over 25 years of experience in complex medical device development that incorporates electrical, mechanical, and software elements, your projects are well within Orion's scope and capabilities.

Example projects include:

  • Surgical navigation for ENT and spinal applications

  • Surgical robotics for ENT and colorectal applications

  • Patient monitoring including bedside, ambulatory, and central station

  • Energy based devices for aesthetic treatments including RF and laser

  • Ultrasound imaging and analysis for cardiac applications

  • Infusion pump application for precision medication delivery


Areas of technical expertise

Complex designs require systems level understanding and consideration. Having experience in software and system design including real time command and control, user interfaces integrating electromechanical and graphical elements, as well as designing for manufacturing, serviceability, and reliability ensures your projects will receive the attention they need.


Other areas of expertise

Quality and Regulatory requirements come with their own challenges as they relate to the design and development process. With a keen understanding of all classes related to compliance and risk, Orion can ensure that consideration is given to these challenges and they are addressed cleanly and concisely.

This includes an intimate understanding of:

  • ISO 13485 quality management systems

  • ISO 14971 risk management

  • Electrical safety and essential performance including ISO 60601

  • Human factors and associated standards and guidance including ISO 62366

  • Software development lifecycle and cybersecurity standards and guidance including ISO 62304

  • FDA 21 CFR 820 and associated guidance documents

  • EU MDR and associated standards


Disposables

Disposables are an essential element of many medical devices. The challenges associated with high volume manufacturing, material selection, packaging, and sterilization need to be considered through the development process. Orion has the experience needed to support a device's disposables needs.


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