You probably won't get the chance to see this, however, yes I have definitely meet many people in your situation (DON'T BE DISCOURAGED). Taking on a solo-preneurship takes adequate planning, assessment, and diligent execution, so it's no small task. I would encourage you to consider other avenues of financial assistance such as seeking venture capital as it will not only help to lighten the load financially, but it will also put you in connection with the venture capitalist's network they have forged. Granting you access to other legal, logistical, scientific, and business resources that will help to bridge your company together a lot quicker. That being said, you would also have to consider the fact that since you will have investors the final decision regarding what your company does will not be entirely up to you anymore. I too am trying to start my own business within the next year, and I had to reevaluate my initial projections, expectations, and plans to establish a smaller version of what I want in order to work up to something bigger in the future.

You definitely have a big dream! But nothing worth having comes easy. All the big corporations and successful businesses out here now, all started the same way, with someone sitting here wondering how to make it come to pass. Yes, it will be a lot of work, but it will be worth it! Tackle one thing at a time, and NEVER give up! I haven’t encountered this personally, but I more so just wanted to take the time to encourage you!  Keep pushing! I wish you and your family the best!

I know this post is old, and there is a good chance that you will never see this, but I am commenting on it because I hear stories like this daily. I am a biotech venture capitalist and spend my days helping fund start-ups in the medical device, therapeutics, and diagnostic space. I don’t know much about your company, but I would like to say that you should continue to dream big and never give up hope. I see success stories like yours all the time. My advice would be to align yourself with those in the areas where you are a bit less experienced. Reach out to your LinkedIn networks and send some cold messages. You will be surprised by the results and the number of people willing to help you along this journey. Stay encouraged.

This discussion really stood out to me in comparison with the others for this weeks forum. I really enjoyed reading all the posts in this topic because they show that even though engineers (or any professionals for that matter) who may not know each other or have never met each other, still provide positive guidance and input. I think that professionals like this who share their encouragement and experiences with others make it possible for new aspiring entrepreneurs to keep pushing forward and stay motivated. As you mentioned, your spouse and you are the only investors in your business but this shouldn't discourage you at all, there are a countless amount of businesses that run successfully from 2 or less partners, especially start ups that have the potential to turn into something big. I really had to share my thoughts because I enjoyed the positivity in this post and wanted to wish you the best of luck in your future investments, hope you see this some day! 

Speaking from experience working in (not owning) a small startup as well as a large corporation, I think your idea of starting a company may work but has a couple of very difficult challenges to overcome before you make money. Those challenges include, in no particular order:

1. Clinical trials if the device is Class 1 or 2. This will prevent a lot of VCs from looking at your company, unless you have overwhelmingly compelling preclinical data.
2. Facilities and capital to scale production and pay people
3. Handling challenges to your soft skills (managing personnel and leading) and challenges to your technical skills (troubleshooting problems associated with the device).
4. Accepting risk of business failure, which can strain your personal life since you mentioned your spouse would be involved in the venture.

This is probably too much for me to handle alone, which is why I would be more interested in a LLC or S-Corp vs. a partnership or sole proprietorship.

Yes, I have experienced those emotions before. I own my own business as an LLC for my fitness brand: KKfitness LLC! The business that you want to open seems way more intense but starting a business if not easy. It is great that you are saving up money, but I would not be afraid of taking out a loan and then paying it back because you are helping to build business credit which is important. I believe having a partner is a really good idea if you feel it is too much. That way, you can still have your business while having the support or someone else to work on the load of it with you since being an entrepreneur is not easy. Just remember to set goals and keep going!