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  • Home
  • About
  • Contact
  • Proof of Concept
  • Fractional CTO
  • Board Support
  • Fundraising
  • Product Development
  • Program Management
  • CDMO Management
  • Strategic Marketing
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YOUR CART

Proof  of Concept

Good ideas can come from anywhere. Whether you are full-time doctor or a company that already has some products on the market, you may wonder if a new idea has the potential to change the world.  Our Proof of Concept projects de-risk a product by verifying technical feasibility, market size and User need. 

Technical Feasibility
Technical feasibility means that the laws of physics and physiology support the concept.   In this phase, we are not developing a product. We are assessing whether or not a product is even possible.  Hence, a key tenant to our work is keeping things "Phase Appropriate" or "scrappy".  If a zip tie will work instead of an injection-molded bracket, we opt for the zip tie.  If an off-the-shelf Raspberry Pi or Arduino controller will suffice instead of a PC or custom integrated circuit, we go for that.
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Speed is Everything
As they say with startups, "Fail fast."  We are not here to make a career out of a project. We aim to prove out a concept quickly, thereby minimizing capital expenditure and keeping the option open to pivot.  The overall timing of a project is driven by prioritizing the right tasks, rushing the shipping and fabrication of the right components, and having experienced technical team members. 

In-house Fabrication Capabilities

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Modeling
•Biophidelic modeling
•3D-CAD
Fabrication

•3D-printing
•Electrical circuits
•Arduino & Pi controllers
•Mechanical assemblies
•Welding (TIG, MIG, Gas)
•Plasma Cutting
•Drilling
•Adhesives
•Casting/ Pressure molding
•Sanding, Blasting
•Thermo-forming
•Soldering
•Cutting
•Painting
Test

•System Performance
•Data acquisition
•Accelerated Aging
•Transit
•Service Life

We have trusted partners for additional capabilities.

Case Study: Therapeutic Hypothermia System Proof of Concept

A start-up company had conceived of a method for inducing therapeutic hypothermia much faster than the state of art. The treatment method was initially prototyped using existing, off-the shelf components and manual control. Rapid  heat exchange was demonstrated in a pre-clinical setting resulting in a 6x reduction in cooling time compared to the state of the art. Angel funds were raised with the objective of showing that living humans would cool at a similar rate. 

Our project plan involved a series of preclinical experiments, each consecutive experiment with increasing complexity.  Initial prototypes were housed in a phase-appropriate wooden box with manual controls and a mixture of custom and off-the-shelf electrical hardware. Once the requirements and electrical hardware size were locked, a more elegant enclosure was fabricated from an inexpensive, off-the-shelf enclosure.  These step-wise experiments created milestones to drive the team and meaningful checkpoints to characterize the technology and instill confidence in investors. 

​Within 6 months, the first-in-human system, was designed and verified for biocompatibility, sterilization, cleaning, electrical safety, radiated emissions, conducted emissions, stability, transit and critical performance. This system was also was also phase-appropriate and not intended for commercial use, using an off-the shelf enclosure and tubing. Several humans were treated and it was determined that humans cool rapidly. This was sufficient evidence to raise an A-round of funding. 
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1st prototype utilizing wooden enclosure

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Clinical trial system

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