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Your Medtech vision. Our expertise.

We’re a medical device innovation & development firm based in the Pacific Northwest. From early-phase viability evaluation to commercialization, we partner with ambitious medical device entrepreneurs and established companies to bring their ideas to patients worldwide.

Trusted by leading medical device innovators, entrepreneurs, and manufacturers globally:

Our motto

Innovation delivered

The worlds of medical innovation and medical device start-up are filled with ideas from innovative doctors, brilliant engineers, and seasoned entrepreneurs that never see the light of day. Why?

Developing a medical device is a high-stakes endeavor. The pathway is fraught with regulatory, quality management, funding, development, and commercial challenges; it’s complex and it’s hard.

It is estimated that over 75% of MedTech startups fail. Countless ideas never make it to patients who desperately need better solutions. Endeavor45’s core mission is to deliver these innovative solutions to those patients. Our company is expertly and strategically designed to be hyper-efficient with capital and time so that together, we can deliver your innovations to patients, physicians, and our healthcare systems around the world.

Patients are waiting.

Our services

Get seasoned medical device experts in your corner

Idea & Vetting

Market Research, Voice of Customer, Studies, Applied, Market Expertise, Concept Validation, Initial Regulatory Strategy

Venture Strategy

Project Scoping and Planning, Finance & Budgeting, Capital Raise Strategy & Planning, Capital Raise Mechanics, Risk Identification & Risk Mitigation Planning, Initial Commercial Planning & Forecasting, COGS & ASP Estimations, Distribution Planning

Funding

Pre-seed Finance, Seed Finance

Design & Develop

Proof of Principle, Proof of Concept, Project Management, Design engineering, Development engineering, Quality Management System Strategy, Design Enhancement, Design Freeze, Validation and Verification Planning, Regulatory Strategy and Management, Manufacturing Strategy, Vendor Identification and qualification, Pre-Sub Regulatory Meetings

Validation & Verification

Comprehensive Product Testing, ASTM Testing, Biologic Testing, Packaging Testing, Sterilization Testing, Manufacturing Partnerships, Surgeon/User Simulation Labs

Regulatory

Regulatory Submission, Regulatory Clearance/Approval

Manufacturing

Manufacturing Strategy & Execution, Manufacture Qualification, Manufacturing Contracting

Commercialization & Launch Planning

Go to Market Planning Sales & Distribution Channel recruitment Sales & Distribution contracting, Marketing Assets Design & Creation, Website Development, Technique guides/IFUs Design & Creation, Sales Assets & Demos created, Surgeon & Sales Training Program, Development

Growth & Exit

Sales Channel Growth, Market Share Acceleration, Strategic Partner Negotiations, License Agreement Strategy, Exit Planning & Strategy

Client love

Kind words from our partners

At CurvaFix, we’re fortunate to have a strong core platform with multiple avenues for growth. However, in a resource-constrained environment, we needed our internal team focused on executing the current business. We had several high-impact strategic questions that could influence asset value and the future product pipeline, and determined it was best to outsource this work. While our team brings deep industry knowledge, it was important to me to get an objective, unbiased perspective on our opportunities. Endeavor 45 delivered exactly that. We were impressed by their speed, industry insight, and disciplined approach to gathering and presenting market intelligence. In a relatively short period of time, they provided actionable feedback that allowed us to make informed decisions about our future product portfolio. I’m pleased to recommend the team at Endeavor 45 and appreciate the value they brought to our business.

Mark Foster

CEO, CurvaFix

We engaged with Endeavor45 on two separate projects. The first was a VOC project to gain feedback from two different user groups on new product innovations. We wanted to understand when and how a potential product may be used by the different customer types. Endeavor45 did an outstanding job familiarizing themselves with the product in order to appropriately guide the VOC conversations. They were able to identify an excellent mix of customers, conduct the interviews and provide a robust report in record time. We were extremely impressed with both the quality of work as well as the speed at which the work was completed! The second project was to help us create a category brand name for a new line of products. Endeavor45 conducted analysis of our overall corporate brand as well as other category names, they interviewed various stakeholders, and facilitated naming workshops. From there presented naming options that were in line with both the brand ethos as well as the design elements of the new product line. We were extremely pleased with the work they conducted!

Rachel Edwards

VP of Marketing, Medartis

We recently engaged Enveavor45 to assist us with a high-priority project to help us bring over a hundred of our legacy drawings up to current standards. This involved reviewing designs, datum structures, tolerances, product specs, and GD&T callouts. They were extremely responsive, hit the ground running, and were able to quickly make the updates we needed. Endeavor45 is very knowledgeable, professional and the integration with our internal team was seamless. Next time we have a project where we need added horsepower, they’ll be the first ones we call.

Ray Czerwinski

Sr Project Manager at Acumed

Blog

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Black Swan Events in MedDevice

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The Endeavor45 Story: Patients are waiting

Let's build something amazing together

Have a medical device idea? Wherever you are in the development journey, we’d love to hear from you. No idea is too small and it’s never too early. Let’s explore it and see how we can bring your ideas to reality.