In the excitement of conceiving your killer ap, you instinctively want to “build a prototype” so that you can show it around to possible investors and partners. Or you want to build a prototype to see if your idea will work. You will eventually have to do both of those activities if your product will have a  physical embodiment, (as opposed to software or pharma for example, where the analogous “prototype” would likely be a written description, and not need a physical model to be constructed). A note for developers working in the digital device realm - most of this article will also be applicable to your activities; one important additional one being the need for additional fail-safe considerations for the patient. In your software or firmware controlled device under development, it could take a skilled "forensic" engineer tease out all the possible failure modes. 

The Three Pillars of Risk
To succeed at your product development project, you will have to overcome the three pillars of risk:     

1. Technology - can it be done?
2. Regulatory - will the FDA clear it? Is it patentable?
3. Market - will my target market buy it?

And the wrapper - can all of this be done/commercialized at a viable cost to meet my goals? 
​In discussion with a leading Product Development associate, we are reminded how complex each of these areas are, with Technology often being "easier" for a particular project than the latter two. Their advice? Focus on quantifying Market and Regulatory risk before getting too far into product development. This can be contrary to the instinct of inventors and engineers who typically focus on Technology issues while ignoring the many lurking deal breakers in the Regulatory and Marketing arenas.

Take a Step Back
So, before you contract with a professional to engineer and build your prototype, you will likely be better served by taking a step back and considering what you really need at this stage, and what the returns on your dollars invested will be. The goals here being that you want to map out the most efficient use of your starter/seed funds, and also to be able to go to your professional model builder with a clearly defined description/scope of work for your prototype needs. Firstly though, it’s important to understand that there are different kinds of prototypes, built for different purposes.
In your application, prototypes might represent the progressing evolution of your thinking. Or they might be just a subsection of the whole, intended for example to help assess your Value Proposition.  Or, to enable your eventual professional model builder, or your IP counsel, to better understand some aspect as they prepare their diagrams.

To be clear – none of the challenges mentioned should deter you – this is simply the Medical Device landscape in which you have chosen to operate.
​
​Suggested next steps
Roughly in priority order, and most of which will require some level of funding from your seed funds:

• Make an introductory contact with a Medical Device Modeler – to get a feel for what facilities they provide, for when you are in a position to contract for their services. (Ask us for introductions).
• Do a credible Market Needs assessment to ensure that you are addressing a real need, preferably with a Needs-pull rather than a Technology-push position. Will you be selling into a Value Based Purchasing environment and if so, assess your likely standing.
• Competition assessment.
• Recruit/identify a CMO/Clinical Advisory Council members. 
• Do a credible Value Proposition assessment to be sure that you are creating an excellent Val Prop for all stakeholders and decision makers.
• Obtain a Patent attorney expert opinion on the patentability of your idea.
• Obtain a Regulatory Consultant expert opinion on the regulatory landscape that you will face, including the need for a Doc Control system.
• Do a credible Biz Case assessment that will satisfy skeptical Investors.

Now you can go back to your Medical Device Modeler
Once you have accumulated enough GO flags, you can go back to your Medical Device Modeler and discuss your prototyping needs with confidence and credibility. 

A Heads Up
Don't underestimate early attention and seed funding needed (if you are not already set up and seasoned in this field) for the formal documentation of your R&D efforts on your device concept. It is beyond the scope of this article other than to give you a heads-up to become familiar with the main documentation requirements of the FDA, such as for starters: Design History File; Device Master Record; Device History Record; FDA Design Controls 21 CFR Part 820.30.The FDA can be quite severe in penalizing for transgressions, and my advice is to embrace the guidelines for the good they do and to never try to circumvent them - it is not worth it.

So whether you are experienced, or new in this business, now would be a good time to reach out to the experts at BizPush and MedSurgPI for a no-commitment exploratory discussion. Contact us!

Issue 6
​  Know the total world-wide/or your country-wide market size and growth projections. ​No matter your application, there will likely be several credible sources of usage and demand data, that you can apply directly, or extrapolate to create your demand, sales volume and revenue projections. 
The two most commonly available diagnostic codes in the US (CPT and ICD) provide usage data at the granular level.
The AMA's (Current Procedural Terminology) code describe tests, surgeries, and other medical procedures. 
Medicare (CMS)'s ICD Codes are used globally to track health statistics and causes of death.
The many professional societies such as the AMA, ASMBS, provide open source data in presentation friendly chart format.
(As always, be careful to avoid copyright infringement, and to attribute your sources. Noting that even if the information is made available open source, the owner might still require attribution if you use it in print or electronically).

​Doing Surveys and Focus Groups can add valuable data and insights to your projections.

Next Steps
If, after working through these issues, you decide on a “Cautious GO”, the next logical steps would be to develop a Business Case Assessment that includes Risk evaluation, Regulatory and and other issues. These would support your upcoming discussions with potential investors and partners. 
​
If your concept doesn’t provide solutions within your analysis findings, must pivot or it will fail.

If you are new to these concepts, you will notice how quickly the water is getting deeper than the wading pool it started out as - (Actually, it’s not water, it’s alphabet soup – FDA, USPTO, IDE, 510K, IRB, IACUC, and more). Experienced CEO/entrepreneurs will know how quickly a project can turn into an expensive time suck that they don’t have the time or inclination to manage.

So whether you are experienced, or new in this business, now would be a good time to reach out to the experts at BizPush and MedSurgPI for a no-commitment exploratory discussion. Contact us! 

Further reading
There are many publications (on line and hard copy) offering a wealth of data. Fortune Business Insights offers one such:
https://www.fortunebusinessinsights.com/industry-reports/medical-devices-market-100085.
While reports and publications may contain a vast amount of data that might be only loosely applicable to your project, they can be expensive enough to take a bite out of your seed funds, and still leave you with the necessity to do a lot of footwork and on the ground research.