Imagine for a moment that you are a medical device startup. There are probably thousands of things you are concerned about and have to do before you can go to market. Where do you begin?
It’s easy to get bogged down realizing all the stuff you have to do. But you have to make progress. And in order to do so, you need some structure. You need to focus. It requires discipline. Before you start every day, you need to ask yourself this simple question:
What do I need to accomplish for my medical device startup today?
If “today” is too big, break it up into smaller chunks. Yes, you need to have some idea of where you are going–the end goal. So figuring out the smaller chunks should be based on that. Once you set the target, then you need to put your head down and get busy.
It’s important to every so often put your head up and make sure you are still headed in the direction you want to go. But you need to be prepared for the startup pivots. They will happen. (I’m not going to dive in lean startup methodology too much in this post though.)
Okay, you want to know what 3 things you should do first, right?
3 Things I Recommend Medical Device Startup Do 1st
Here are 4 things you should be doing with your medical device startup first:
- Build the Business Case
- Come Up With a Plan
- Find Money
Build the Business Case
You have to prove you have a valid idea for your medical device startup. There has to be a clinical need. There has to be market. You have to build the business case. You should be answering things like:
- Why is your product necessary?
- Does your product fulfill an unmet need?
- Are there existing competitive products?
- Who will use your product?
- Who will buy your product?
- What regulatory issues are involved?
- Is there a market?
Yes, this is good to do even for a medical device startup. Of course because you are in the medical device industry, there are plenty of precautions you need to take when doing so. Those early prototypes should only be used in simulated uses and NOT on actual patients. But getting end-users involved early with your medical device startup is so important.
End-Users – Great Source For User Needs
While capturing user needs, you also need to define and document Intended Use and Indications for Use.
- User needs describe how the product is going to be used.
- User needs help establish the framework for your products design.
- Intended use describes the clinical issue your product addresses.
- Indications for Use pertain to clinical applications use, environment, and end user.
Building the business case will set the stage for every thing else you will encounter with your medical device startup. If your business case suggests you should kill it, then do so and do it quickly.
Come Up With a Plan
I don’t know who first coined the phrase “. . . fail to plan and plan to fail . . .” but there definitely is some truth in this. Your medical device startup needs a plan. The plan should be comprehensive enough to cover all aspects of your medical device startup product development project.
You’re basically creating the business plan. Leverage what you learned and captured while building the business case.
- What needs to be done?
- What questions need to be answered?
- Who is doing what?
Let me suggest a couple of things you I don’t want you to overlook when planning.
Establish Regulatory Strategy
You are developing a medical device. There most definitely is some level of regulatory involved, regardless how simple.Identify applicable regulatory product codes and product classification (based on intended use / indications for use) for all desired markets. This will help determine the type of regulatory submissions which will eventually be required.
In the U.S., the FDA has a database to help with product classification. Other regulatory bodies also have guidances and other documents to help with regulatory product classification. Knowing how regulatory bodies classify your product has a significant impact on:
The Beginning of a Design & Development Plan
Yes, you’re medical device startup is still pretty early in the product development process. You may not even have funding yet. But all these things I’ve shared so far will help your cause for getting funding.
These tips and suggestions will also help your medical device startup with required Design Controls. This includes planning.
Your startup needs a plan. I recommend your plan start to incorporate Design & Development Planning criteria defined in 820.30(b).
- Identify major milestones and define responsibilities.
- Establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation.
- The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process.
You built the business case and created a plan. Now it’s time to find some money. Getting funding is a full-time job. And your medical device startup needs to establish a funding strategy.
The funding strategy needs to consider several aspects.
- Do you want to fund the entire medical device startup right away?
- Do you want to fund the first few “phases” / “milestones”?
- How much equity are you willing to part with?
- Valuation . . .
- Bootstrap versus Friends & Family versus Angel Investors versus Venture Capitalists.
Like I mentioned above, getting funding IS a full-time job. And keep it mind it will take WAAAAY longer than you think. The more homework you do to prove there is a market, the more it will benefit your medical device startup when it comes to raising funds.
Jon Speer has been in the medical device industry for over 16 years. In 2007, Jon started Creo Quality to help medical device companies with project management, quality systems, and regulatory submissions. As a result of his experience in the medical device industry, Jon had an idea to develop a software solution to improve how companies handles Design Controls. Because of this greenlight.guru was born. You can find him on Google+,Twitter, and LinkedIn.