A successful life science start-up company needs more than a good idea backed by good science to be successful.
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It also needs to fund its research, obtain patent protection, negotiate good deals, obtain FDA authorization, develop good manufacturing practices, sell the product with sufficient margin to cover all of these early expenditures, and to comply with all post-market FDA requirements.
Clearly these very different tasks require people with different expertise, and no single person could do it all. Yet at the beginning, a new company may be on a shoe string budget—often financed with an inventors own savings—so that one or a very few people DO have to do it all.
Here are 10 tips to help the entrepreneurial scientist make the transition from the lab bench to the marketplace.
Hopefully, with these tips you can avoid some of the potholes along the way and make your start-up a success.
- 1. Getting it in Writing - Before you get too far along in the process, it's imperative that you put together written contracts that define ownership rights, confidentiality and other important obligations and understandings.
- 2. Cultivating A Culture of Invention - Encouraging invention is the first step to creating valuable intellectual property. We look at what organizations must do in order to motivate employees to create proprietary science and apply for patents.
- 3. Getting Inventorship Right - Patent laws require that you get inventorship right. Get it wrong and you can lose the patent. Here are some simple ways to avoid making a mistake in the naming of inventors.
- 4. Using Hardbound Notebooks - Your lab notebook could end up being used as evidence to invalidate your patent claim. We discuss the proper use of hardbound lab notebooks to ensure proper IP protection.
- 5. Planning a Patent Strategy - Filing patents can be an intimidating endeavor, but there are some best practices for scientist entrepreneurs that you ought to know about.
- 6. Planning an FDA Strategy - Knowing these tips for getting FDA approval will come in handy if you are working on new drugs or medical devices.
- 7. Loosening the Reins - You can't do it all. Scientists entrepreneurs must know when to transition leadership and when it's time to bring in the pros.
- 8. Stirring Public Interest - Promoting your science before you commercialize can smooth the road to funding...but there are a few mistakes you can make if you are not careful.
- 9. Financing the Company - It takes money to make money. Here are a few things to know about the funding process.
- 10. Preparing for Due Diligence - Due diligence involves intense scrutiny of all of your documents. It's critical to keep your documents well-organized and readily accessible.