Product development of any kind is challenging and full of unknowns, obstacles and pivots.

Medical device product development is certainly no different.

With med devices, when you throw in regulatory bodies, such as FDA and others internationally, it only complicates matters further.

However, when you ask entrepreneurs and startups in the medical device industry to define their single biggest challenge, their response is overwhelmingly clear:

Money.

Which kind of stinks. Especially for all those that have a fantastic idea for a medical technology that could improve the quality of life.

Seldom is having a good idea enough to secure the funding necessary to bring a new device to market. Unless you have quite the track record.

So what do you do? I mean everything during the medical device product development process requires funding. Right?

For the most part, yes. And there are things you can do to increase your chances of funding by reducing the business risk and starting to bring your idea to practice.

This is important. Early stage investors are inherently playing a risky game but like to mitigate risk where ever possible. Why? All investors have one thing in common: They want to make money.

And medial device product development is full of reasons to prevent investors from making money. Here are a few:

• Time to market
• Regulatory unknowns
• Reimbursement
• Market adoption

In order to improve your chances of funding, you are going to have to do more then just have that wonderful idea. Below are some actions you can start to take early on:

Establish the Need for Your Medical Device

You need to build the business case for your medical device idea.

Some may suggest that you put together a full-blown business plan. I think this is a little premature in the beginning.

There is some core, basic information about your medical device that you can define now without authoring a complete business plan.

Determine the Regulatory Issues

How is your medical device classified by the FDA? Is it class I, class II, or class III?

You should also evaluate how the medical device will be classified in other markets you are interested in pursuing, such as Canada and Europe. By doing so, you may find that one market has a simpler regulatory path.

Along with determining product classification, you should start to evaluate other products in the market with similar classifications and regulatory product codes.

This is important for a few reasons:

• Helps establish predicate devices for an FDA 510(k) submission
• Helps establish comparisons for clinical evaluation report for Europe
• Helps define the competitive landscape within your market

Start building your quality system, too, to comply with FDA regulations and ISO 13485.

Does Your Device Work? Prove It!

Simply put, build a prototype. Reduce your medical device idea to practice.

The prototype does not have to be perfect. It does not have to be final.

It can and should be a proof of concept. Something that conveys your idea and can be used to communicate to end-users.

Prototyping is important at all stages of medical device product development. And each type of prototype has a specific purpose.

In all cases, prototyping is proving it.

During the early stages of medical device product development, your proof of concept prototypes are crucial because others can now begin to better understand the vision for your product.

Funding Will Still Be a Challenge

Even if you do all the things I’ve described, funding will still be a huge challenge for your medical device product development.

But by taking these actions, you’re reducing the business risks, showing your commitment and putting together something tangible. These are all things any early stage investor will want to see.