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Bringing Your Ideas to Market Faster

Outsourcing models are being utilized to help OEM’s design, develop, and improve their product portfolio

Reduce Your Design and Development Costs

Partnering with Fix Surgical will allow your company to focus on key priorities without delaying time to market for new products and product enhancements

Design Based on Surgeon Input, Driving Better Outcomes

Surgeon input is key to bringing your product to life, with the patient life at the core of every decision

About Us

At Fix Surgical, we employ a private label and outsourcing model that dramatically reduces design and development costs for your organization.  Our technical team includes engineers, project managers, regulatory personnel, and our advisory board of surgeons who fully understand the intricacies of custom contract design and development and the stringent requirements of both the medical device industry and regulatory agencies.  Our in-house team work closely with our bank of industry leading engineers and surgeons alike to design innovative products in the most efficient manner possible.

Intuitive and Modern Solutions for several orthopedic markets:

Our Values

Commitment to Excellence

We are passionate about people, process, product and service excellence. Through a concentrated focus on customer needs and a need for urgency we are determined to stive to deliver quality services of unmatched value through simple and relevant solutions.

Move Fast

Tackle challenges without delay. Test, learn, repeat. We set a high personal goal, genuinely believe that nothing is impossible, and commit ourselves entirely to the goal at hand.

Build for Durability

It is our goal to create a business worth creating, one that will endure the test of time. We accomplish this by focusing on our customers’ success, as we believe that will translate to our long-term scale. We are driven by ambition in an effort to continuously improve.

What We Do

Concept Development

Concept Development – Our cross-functional team of professionals work together to brainstorm ideas and develop devices that come to life. We can provide a full design package or focus on improving just one component of an existing medical device or instrument tray.

Design for Manufacturability (DFM) – By evaluating device design and its critical properties upfront, we help our clients realize cost savings in production and assembly by using proven DFM techniques that leverage existing infrastructure and avoid unnecessary costs from inefficient of ineffective processes.

Concept Development

Concept Development – Our cross-functional team of professionals work together to brainstorm ideas and develop devices that come to life. We can provide a full design package or focus on improving just one component of an existing medical device or instrument tray.

Design for Manufacturability (DFM) – By evaluating device design and its critical properties upfront, we help our clients realize cost savings in production and assembly by using proven DFM techniques that leverage existing infrastructure and avoid unnecessary costs from inefficient of ineffective processes.

Design
Early concepts are translated into engineering design specifications, including drawings, component specifications, and detailed requirements documentation. We implement Design for Excellence (DFX) optimal practices that incorporate Design for Manufacturability (DfM), Design for Cost (DfC), Design for Assembly (DfA) and Design for Testability (DfT).
Regulatory
Our team works to achieve regulatory compliance throughout the design and development process. We identify applicable regulatory requirements, documentation, and recognized consensus standards to be fulfilled. While our design controls process and corresponding design history files (DHF) are designed to meet the FDA’s requirements, we take it a step further by closely mirroring the requirements that larger OEMs require, allowing for a rapid and easier transition of the medical device. We work closely with our regulatory team to obtain FDA 510k clearance and CE Mark with the strictest ISO 13485 quality standards.
Prototyping

Fix Surgical has the capability to deliver rapid prototypes that will streamline and expedite the development process while minimizing risk. Our team creates prototypes that look and feel like finished products to help advance design while evaluating form, fit and function of the device. Having the ability to deliver prototypes in a rapid manner helps to streamline and expedite the development process while minimizing risk.

Prototyping
Fix Surgical has the capability to deliver rapid prototypes that will streamline and expedite the development process while minimizing risk. Our team creates prototypes that look and feel like finished products to help advance design while evaluating form, fit and function of the device. Having the ability to deliver prototypes in a rapid manner helps to streamline and expedite the development process while minimizing risk.
Engineering
From concept to development, our engineers ensure that processes are developed for design, efficiency, lifecycle management and manufacturing. We utilize engineering methodologies that optimize the entire process to ensure that from feasibility, prototyping, risk analysis, validation and all the way through launch, your product will be successful.
Project Management
Recognizing all projects require basic controls and management techniques, we take a disciplined approach to project management, allowing us to achieve your desired outcomes on time and on budget. Our project managers ensure all team members communicate regularly to keep projects on track and ensure rapid delivery.

Contact Us

425 Fayette Street, #617

Conshohocken, PA 19428