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We help Medical Device companies innovate faster, more confidently, and with reduced risk.

 

Product development for medical devices is fraught with pitfalls, from design challenges to regulatory compliance.

 

Our experience in designing and developing commercially successful medical devices has taught us that we can anticipate and avoid these issues. Challenges are inevitable, but with proper planning, we can smooth the path toward a timely, cost-effective market introduction. By teaming with Fulcrum, you get to the right solution, avoid the pitfalls, and position yourself for success more cost-effectively, allowing you to avoid expensive and time-consuming setbacks.

 

We can help you:

  • Evaluate and strengthen technologies for manufacturability & marketability
  • Design and develop new products
  • Identify the right concept to pursue and develop design requirements
  • Ready ideas for commercialization: prototyping, manufacturing, marketing planning

Customer Needs

We know how to ask the right questions and translate the clinician’s perspective into technical requirements, ensuring that you deliver the right product to the market.

Many times we’ve seen small changes in device design impact clinical practice to an extent that limits market adoption. In addition to technical proficiency, we have extensive experience in understanding the clinical user’s environment, how the device interfaces with other devices and how it impacts current practice. This ensures that our designs address user needs without sacrificing clinical performance.

 

Manufacturing

Our extensive manufacturing experience can help ensure that your design moves from prototype to production without a hitch.

We have seen many innovative designs and prototypes struggle to meet the rigors of manufacturing scale-up. These issues are costly and time consuming to fix, affecting profitability and payback on investments. Delays can impact launch and marketing plans, placing pressure on revenue targets.

Our specialty is making your idea makeable.  We help avoid manufacturability and cost issues early on, before capital is committed, reducing your financial and market risk.

Go To Market

We help you understand the pitfalls, minimize risk and position your medical technology for success.

Our experience in the medical device industry has taught us that optimism over new technology frequently causes companies to overestimate the size of the market and underestimate the challenges, leading to slower-than-expected market adoption.   Technical superiority, though important, does not guarantee success.

We’ve developed and launched market-leading devices, enabling us to help you critically evaluate market introductions. We also have access to experienced medical device marketers that can develop an integrated go-to-market approach for you.