How Core Technology Bridges the Gap Between Science & a Salable Medical Device
You have a new technology or application for a medical discovery. That discovery will ideally turn into a successful medical device. At MindFlow Design, we think about this process from discovery through to product monetization in 3 broad stages:
Establishing the science
Core technology development: taking the science and applying it to the product
Developing the product for commercialization
Each of these 3 stages is important — and has its experts. The middle stage, developing the core technology, involves proving the science is feasible before investing substantial resources on the path to commercialization. This vital process ensures you don’t waste time and money on an unfeasible medical device.
This is one of the essential goals of core technology development.
3 Stages of Creating a Medical Device
Understanding the core technology stage is crucial. Let’s first review what each of the 3 stages involves with a hypothetical example.
Consider a time when there was no way to test for influenza — the common flu. A company attempts to develop an in vitro diagnostic (IVD) flu test. Here’s their process:
Stage 1: Establishing the Science
To begin, the company is simply exploring whether or not they can create a test for the flu. They have or hire top-notch scientists. These scientists are in a lab using manual processes to establish the science behind this new test. They’re using tools like petri dishes, microscopes, and other laboratory equipment to do so. Their top-notch scientists/virologists discover a novel approach that detects the virus and also suggests the best treatment for that specific strain.
Eventually, through several trials, they confirm their flu test works. Stage one is complete.
Stage 2: Developing the Core Technology
Once the science is established, a group of specialized engineers is tasked with (more on this to come) developing the method and hardware for a less manual testing process. And importantly, this commercial test requirement is that it must work outside of the controlled laboratory setting.
These R&D engineers work to figure out the constraints that this chemical-electro-mechanical analyzer requires to produce reliable requests. With the variables and constraints all well understood, the device is now one step closer to a flu test solution that can be produced en masse.
Stage 3: Product Development and Commercialization
Now that the core technology is fleshed out, a new team of product design engineers steps in with the goal of developing a reliable system that can be rolled out to users. Of course, this new flu test must be safe and effective when used in its designated use environment by the intended users.
Next off is to receive FDA approval, then commercialization into a salable medical product.
A Deeper Look at Core Technology and What Stage 2 Entails
What exactly is core technology itself? The core technology of a product makes possible what that product is truly meant to do. It enables the product’s ultimate purpose. For example, the core technology of a vehicle is what allows it to get you from point A to point B. It’s the engine underneath the hood.
Core technology development is focused on demonstrating that a certain science is technically feasible. It’s an exploratory stage that seeks to validate a hypothesis.
To prove technical feasibility, you’ll likely need a prototype. This prototype is typically called a breadboard prototype. Your breadboard prototype can be a custom-engineered solution or a combination of a custom solution and modified existing technology.
Activities involved in developing core technology often include:
Analyzing similar/adjacent technologies (also known as competitive product teardowns)
Reviewing existing intellectual property (IP) or patents to learn how other people are approaching the problem
Gaining access to or assembling a team of scientists, chemists, IP professionals, and physicians to consult about your core technology
Understanding what makes core technology stable by exploring its electronics, tolerances, chemistry, constraints, and boundaries of operation.
Only when the boundaries of the core technology are fully understood can you successfully dive into creating an elegant, functional design that can be produced en masse (Stage 3). This is why Stage 2 notably does not focus on:
Regulatory or compliance requirements
Creating high volume production quantities of your medical device
User needs or use cases are considered but may not be fully vetted
Benefits of Core Technology Engineering Done Right
Often fully vetting the core technology is short circuited by the urge to monetize as soon as possible. But with a full picture of what the core technology involves, the following third stage is much more straightforward because the entire team and all stakeholders have a clear knowledge of what to build.
Earn a Rock-Solid New Patent
Medical device companies frequently secure patents before the core technology stage of development. But nowadays, you can’t speak in vague terms and still earn that IP. The benefit of fleshing out your core technology is that your patent will be more robust. You can provide ranges of operation and constraints in the patent claims.
Patents are often the core value of a company. By having a thorough understanding of the core technology, a comprehensive patent can be put in place. The comprehensive understanding of the core technology also allows for blocking- or picket-patents (both of which prevent competitors from entering the market). This is an activity that MindFlow Design has been involved in with clients.
Secure Additional Funding
We don’t need to tell you that the entire product development lifecycle is expensive and requires substantial funding. Startups need to raise money while established companies need to obtain internal approval and budget for every project.
The good news is that proving technical feasibility — developing your core technology — is a major funding milestone. When you can show investors evidence that the science will work as intended, they’ll feel confident giving you additional financial support.
After each funding milestone, including after core technology development, risk is reduced and the value of your entire company increases.
Save Time and Money on Downstream Processes
It’s true that you’ll have to pay for proper core technology development upfront. But ultimately, investing in Stage 2 saves both time and money in product development for commercialization in Stage 3.
Fundamentally, spending time on core technology research at the outset makes the rest of your process smoother and quicker. You won’t have to backtrack and repeat testing because you will have already worked to understand your core technology and how it impacts your product.
Remember, Stage 2 defines the product’s boundaries and constraints. Consequently, the Stage 3 product engineers will know precisely how they need to design the product so the technology functions. They can go right to design and commercialization without missing important operational details.
MindFlow Design’s Core Technology Engineering Team
You can only realize the highlighted benefits of core technology development if you have the right team in place.
This Stage 2 process demands engineers who specifically focus on core technology development. They’re different from product design engineers in that they are at home with the theoretical “first principles.” Put simply, they’re not trying to solve any one problem until they grasp the core technology itself, including those all-important constraints and boundaries.
At MindFlow Design, we’ve intentionally hired specialized engineers and built our engineering team with the unique requirements of core technology development in mind. What’s more, we have the core technology amenities you need in-house — from an electronics lab to a prototype facility. The MindFlow Design team has also seen a huge variety of processes and products. Our understanding is not limited to a specific medical device type.
Once your core technology is developed, our separate product engineers can step in seamlessly. Let us be your one-stop shop for medical device development. We can take the science your company invented, flesh out your core technology, and take your product all the way to market. Contact us.