20 Milestones for A Successful Medical Device Startup
Just like any other industry medical device startups also need to follow certain milestones in order to become successful. However, unlike other industries, medical device startups face many challenges. Milestones are much more structured, and you can not bypass them. So let’s get started with the milestones you need to follow if you are creating a medical device startup.
1. Bootstrap:- Arrange for some money to survive for two years(minimum 12 months). Medical device startup is a long journey. You may invest ten years of your life building it. First, make sure that you have at least 12 months’ survival money.
2. Prototype:-Hardware and software development to make a completely functional prototype. The prototype must do the intended things way more easily, at less cost, less time, and with less manpower. If your prototype is not 100x better than the best of the products you intend to replace, then you will make a failed startup.
3. Hackathon:- Win easy cash, validate your prototype, and create interest. Test on judges and other participants in the hackathon. It is a great place to gather free ideas from people. Cash is the king.
4. Prototype testing:- Don’t build a product that doesn’t scale. You have to test the prototype in real-world settings with patients, by the doctors. Remember the rule, if your product is 100x less costly, can save 100x time, and can perform at a more 90% accuracy level than doctors are using, then you have a product that healthcare badly wants.
5. Website:- Search for a .com domain, register the domain and make a basic website. WordPress is great to start with.
6. Workshop Fabrication of Prototype as Early Product:
- Make limited rouged prototypes. Initially, you won’t sell to millions, but to a handful. You can supply them by making the models in your workshop.
- Don’t make fancy stuff. Focus on usability, accuracy, and longevity. Make prototype boxes that are not fancy, but that can work.
- Take Pictures of these products and write a good description with specifications as a brochure.
7. Sell through Website:- Ultimately every medical device has to find a market. If you have built something that the healthcare industry badly wants, then they will be ready to even adopt a shitty prototype and pay you for the same. When you do this, you will be experimenting, and researching and the sale will happen eventually. You will anyways become good at digital narration.
8. Incorporation:- You must incorporate your business not before you have made the first ten online sales. this will be the most important advice that you will receive in your lifetime. An incorporated business has many compliances. You must not get into such time-consuming, resource-draining things.
9. Raise Fund from Friends and Family:- When you run a startup, over a long period of time, you will need to do many fundraising exercises. This is uncomfortable. Asking money from people is very uncomfortable. Certainly, asking them from your own people, putting relationships at stake is very very uncomfortable. When you have an early sell, you can actually inspire people to invest in your startup for a great opportunity. A successful friend and family around will motivate your future investors.
Show them your “hand-made” device. Demo to them how it works. Show them the sales.
10. Rigerous Clinical Use testing: Keep building your product, and test it in real-world medical usage.
11. Publish Observational Study Paper: It is very important to peer review your findings. Take time in writing an initial observation paper about:
- How your device is different.
- How your device is performing in the real world.
- What are the challenges you faced and overcome?
- How your device or solution is making a doctor’s practice better.
- What are the constraints of your device?
- What are the other such devices available in the market?
- Do an initial comparison with a standard device.
12. Design Patent file: Now once you have published your initial paper, file a patent with your design. Because during the pivot, and pilot, you have made several changes in your early prototype to make the prototype better. This innovation must be patented.
12. Grant application:- Go for grants. There are several grants for life science and healthcare companies. Government and authorities know that in order to make a medical device or solution, you have to build technology around a good science. That will need large money. You can’t get investors to support building a product. You have to do it with grant money.
13. Validate Your Product: Compare your product/solution, with as many gold-standard devices you can, for as many different types of patients, in as many different use cases. Publish your papers. This will take 6 months to 1 year. You must set aside this time. Without this validation, you can’t expand your market.
14. Market and Communicate: Remember, you can’t deviate from your discipline of selling. You have to keep improving the robustness of your early product and sell. You have to sell online. This is single-most-important stuff for you.
15. Contract Manufacturing: Now you have to do industry-grade products and get 100-1000 units manufactured by a contract manufacturer. This will now convert your early product to an industrially produced device. You will learn the art of steps of manufacturing. Importantly, you have to do everything you can to get advance orders for your first manufacturing units. If you want to seriously build a company then at all costs avoid
A successful crowdfunding project may bring early revenue, and orders, but that will rarely help a medical business in the long run. You want to do the hard work of getting organic potential customers to the site and give you orders.
16. Standard Clinical Trial: So far all the tests, pilots, and trials you have done are preliminary. Now you want to do a clinical trial, a good clinical trial. Consider hiring a good clinical trial agency and conducting the trial. Following will be your major steps.
- Design Clinical Evaluation Protocol.
- CTRI Registration of trial.
- Ethics committee approval of the protocol.
- Controlled Clinical Study (Observational) Go for compassionate use that allows you immediately be in the market.
- Site Management
- Data Management
- Statistical Analysis
- Technical Writing and Paper Publishing.
17. File Final Patent:- Now you already have proof that your device works, exact data about the functionality, usability, accuracy, and pitfalls. File your patent. This will give investors the confidence that your device works.
18. Raise Investment: You have to be really lucky to get investors without going through the above 17 steps. If you cross the 17 steps, then you already have:
- Your own digital channel to sell.
- Regular orders.
- Clinical Proof.
- Clinical Usability.
- A fair idea about your customers and market.
- Manufacturing partner.
- A research lab.
- Demand, and knowledge about the healthcare industry.
- Early investors.
- Early Revenue.
This checklist is important for any investor to be confident about putting money into your startup. And yes, you have to figure out how to get money before you raise formal funding.
19. Regulatory Approvals: You now need to focus for the next six months on getting the regulatory approvals for market expansion. The following may be your necessary regulatory steps.
- DGCA approval.
- CE certification.
- ISOMED certification.
- STQC for the companion software.
- ISO certification.
20. Scale Your Market:- Now build your marketing engine, and expand the market. A startup is about scaling. Therefore you have to work on the digital channel. You have to build a business where customers come to you. This is the most important teaching and advice that no one gives to a medical device startup founder. You just can not do physical channel sales.
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