Koven cardiovascular innovation

Your Biomedical Design & Development Partner

Medical Device Development

Resolving Technical Uncertainty

July 5, 2022


When medical device start-ups first venture into prototyping their device concepts, they often feel compelled to provide a complete solution.  With some exceptions, this is not always needed and, often, uses up scarce resources unnecessarily.

At Koven, during the early proof-of-concept prototyping phase, we focus on de-risking the overall concept by resolving any technical uncertainty.

"Technological uncertainty exists when knowledge of whether something is technologically feasible, or how to achieve it in practice, is not readily available or deducible by a competent professional working in the field." - Gov.uk


Many design elements of a device concept are "known" and can therefore be overcome by simply assigning the appropriate and enabled technical skill sets.  While it is exciting to see a complete device concept come to life, it may not be essential to advancing the start-up in the early stages of commercialization.

By directing resources at the unknown elements of a design [the technical uncertainty], you better use available funds to position the start-up as a more attractive early investment opportunity.

A Common Mistake in the Early-Development Stage and How to Avoid It

Understandably, it can be very easy to get a little disorientated in the early design stages.  In fact, ideating concepts and brainstorming SHOULD be a bit like going down a rabbit hole.  That said, we do see first-hand a common mistake that is made in the preliminary stages of development.

Spending too much time and money hammering out the fine details and solving all the riddles related to your design specification in the early development stage is a common mistake. It is natural to want to deliver a complete solution before asking for investment dollars, but there are drawbacks to this approach.

It eats up your precious budget early on. Many times, the design specification will evolve and transform throughout the design process. The natural evolution of the original product design often presents problems you didn't anticipate. In turn, solutions emerge along the way as you better understand the market and the user needs.

The goal in the infancy stage is to show appropriate technical feasibility to meet investor expectations and keep the ball rolling.

Establishing Technical Feasibility

For start-ups, the big question is: Can this be achieved without spending excessively in an early-stage design campaign?

The answer, of course, depends a lot on the complexity of the intended device, but for most cases, the answer is YES.

The next question is: What does a start-up do to demonstrate early concept feasibility appropriate with the early stage of commercialization?

There aren't one size fits all methodologies for medical device feasibility prototypes. Take it only as far as required to demonstrate the functionality and to verify that a certain concept feature CAN be achieved with dedicated development effort. You must consider the intended function, need, benefit, or proposed improvement.

I like to think of technical feasibility as "I can work with that"

Ian Maclean, P.Eng., Koven cardiovascular innovation.

Consider the development of vascular access systems that use Doppler ultrasound in an IV needle.  These medical devices are used to differentiate arteries from veins during vascular access.  The device monitor and the IV needles are well established technology, but the piezoelectric crystal, used to generate the sound wave, was not produced in such a small size at the time.

Could such a crystal be sourced? Would the cost to produce the crystal be reasonable?

A full prototype was not required to secure funding, but a basic understanding of the effort required to miniaturize the piezo crystal was!
How to Drive Your Medical Device Prototype Forward

Attracting early investors is achieved by highlighting the commercial potential of your medical device COMPANY.  Early investors are not looking for perfection per se, but more so for a what's possible.

Get empowered to know what investors expect from your start-up at critical commercialization stages and how evolved your design solution needs to be to meet those expectations.

Let's look at the following example of a compelling medical device technology:

This Start-up company has patent approval on their concept and a fully working prototype.  There is however no clarity regarding the regulatory / Quality system burden, no clarity regarding the reimbursement mechanism and no evidence of market need.  Even though this start-up had a protected functional prototype, they were unsuccessful securing their next round of investment.  They did not meet enough investor expectations as they overcommitted to the technology to the detriment of validating the commercial opportunity.

Technology is critical, of course, but alone it is rarely enough to communicate your value proposition to an investor.  If you can demonstrate an addressable market, a well balanced Team, a regulatory & reimbursement plan, and some evidence of customer need, bringing a 3D appearance model to the table may be all you need to help secure some early-stage funding.

According to statistics, in October 2021, medical device global venture investment increased 61% over last year reaching $2.7B, funding a total of 86 investment deals. The breakdowns are:

  • North America 46 deals for a total of $1.92B
  • Asia Pacific 25 deals for a total of $0.49B
  • Europe's activity included 12 deals for a total of $23B (source)
  • Tips to Get Your Medical Device into the Marketplace

    One of the complexities associated with medical device evaluations is that any decision about the adoption of the device can consequently impact the ability to gather more evidence.  Unfortunately, additional research efforts to try and resolve uncertainty may affect any future commercial developments of the technology.

    Understandably, it can be tempting to rush the feasibility components and begin to scale your product as soon as a viable prototype becomes realized. The amount of money and resources needed to get your device into the market creates the desire to want to recuperate funds as expeditiously as possible.

    Any prototype efforts will be advanced by those honing these key steps. More importantly, these steps tend to provide more clarity to your design. As stated above, it is quite normal for the design schematic to change and evolve which forces constant evaluation along the way to the final product.

    • Clearly Identify Your User (Buyer) and Function by Addressing Critical Pain Points

    There are important pain points that need to be addressed to help improve the overall patient experience, such as:

    • Clinical need and function
    • Affordability and ease of bringing it to market
    • Forecasting device lifespan
    • Novel features and engineering factors
    • Device type
    • Evaluate What is Currently on the Market (Competition)

    Knowing your competition is key.  Understanding what's currently available and how your device stacks up against them. Whether your design elements simply improve upon an existing design or is a novel medical device design, you'll want to spend some time understanding what makes your device design concept distinctive and define any competitive advantage(s).  Market research should reveal details such as length of time on market, user bio statistics, market reception, inventory standards, platform, etc.  Consider direct and indirect competitors.

    • Demonstrate and Clarify Your Value Proposition

    There are 4 main potential value proposition avenues that your medical device may lean toward.  Your device design may not check off all the boxes but defining a clear strategy to enhance your position will help bring your device to the market successfully:

    • Identify the ways your design will improve patient outcomes.
    • Highlight the potential for improved patient experiences.
    • Feature qualitative analysis studies to illustrate enhanced design efficiency.
    • Showcase novel design metrics that demonstrate efficacy.
    Partnering with the Koven Team

    At Koven, we find that streamlining the process works to everyone's advantage. Koven uses a planning schematic which outlines various types of prototype planning to correspond with the development stage, i.e., Appearance Model, Proof-of-Concept, ALPHA, BETA, Pilot.

    Partnering with Koven allows you the expertise to strengthen your medical device platform through thoughtful engineering techniques and quality assurances unique to our firm.  Our aim is to help bring ease and clarity to the overall development process.

    We understand first-hand the steps involved to bringing medical devices to market here in North America and have a successful track record of doing so. The goal is simple -- let's get your design strategy right the first time so you don't have to waste valuable time and resources recalibrating failed attempts.

    For more information on how Koven resolves technical uncertainty and creates prototypes that suit your current design phase, please contact one of our team members.

    If you enjoyed this article or know of anyone who would find it useful, please feel free to share on any social media platform.

    If you have questions, please contact Ian Maclean on LinkedIn or through our contact page.