Healthcare start-ups are the lifeblood of the medical device industry. Large MedTech companies depend on medical device start-ups to eliminate some of the risks caused by new technologies.
Grounded in science and regulated by the government, health care is a challenging sector. In the life of any start-up, there are plenty of opportunities for missteps. Knowing the most frequent mistakes which can occur through the start-up medical device development is the first step to avoiding them. With that in mind, here are 5 of the most common problems which can cause a HealthCare start-up to fail.
1. Forgetting the MVP
Building the perfect product right from the start with all imaginable extra functions and optionals seems like a good idea at first, but in fact it is not. You will spend more time, invest more resources, and be under more scrutiny from the regulatory bodies if you try to launch with a fully-developed product.
Instead, you can build a minimum viable product (MVP) and move quickly. First of all you need to focus on the main features and components you want your medical device to have, then get it built as fast as you can without compromising patient safety or product quality. You can limit the scope of your label claim at the beginning and focus on expanding it once you’ve hit the market.
2. Not doing a feasibility study
Another big problem is that if you’re bringing to market something new that hasn’t been done before, you may run into unpredictable problems. The more unprecedented your project is, the longer it’s going to take and the more it’s going to cost. It’s important to understand what is risky and what is not. If the technology is unproven, do a feasibility study, or at least investigate enough to be sure your risk is low.
For med-tech start-ups it’s also important to recognize that challenges will arise and that they must be prepared. That means, when creating timelines and budgets, to always leave wiggle-room for delays or setbacks, and to always anticipate spending more.
3. Waiting to get regulatory advice
Don’t wait to secure regulatory advice. There are hundreds of international MDR/ FDA requirements that your business must join when it is involved in medical device development. And with so many regulations to abide by, it’s easy to miss something.
In this scenario, noncompliance costs medical device start-ups millions per year. As such, it’s recommended seeking advice from an experienced professional who knows the regulations and who has experience working with healthcare start-ups like yours.
4. Not getting the right expertise
Many small health company teams follow a similar pattern: a tech person, a product expert plus a sales and marketing specialist, but that is rarely the right constellation of staff to help the team make it to the finish line and bring the medical device to the market. Find people who know how to build the kind of device you want to build, both Key Opinion Leaders with deep healthcare experience and experts who can help you to design, develop and produce your innovative product.
5. Not preparing to scale
Think about the future of your Medical devices start-up and how your needs are going to change as you grow. Build your processes and systems with scaling in mind. This helps save you from a lot of problems and headaches later on.
Beside the 5 mistakes related to the medical device development, there is another common mistake Med-Tech start-ups make: not having a go-to-market strategy and a solid business model.
Healthcare start-ups often crash and burn before getting their products to the market. Tech-savvy entrepreneurs are rarely great at sales, so while many manage to get their first round of funding, they don’t sell enough, run out of cash and end up in major debt.
To accelerate revenue growth, experts advise identifying a dozen very specific customers and talking to them about their weaknesses before investing months or years in development.
Forbes reports that as many as 98 percent of start-ups funded by that type of investors fail because of a poorly thought-out business marketing strategy.
The best way to solve this issue is by partnering with an industry leader who possesses the necessary business knowledge.
If you are looking for an expert to join your team and support you in design, development and contract manufacturing of your Medical Device, contact us and discover how we support Med-Tech start-ups like yours! [link alla form startup]
Whether you are looking for a design concept or a prototype to raise funds, a POC or an MVP to validate your medical device, or a complete turn-key solution – from R&D development to complete assembly-, Creanova will help you to make it happen at your pace.
Our aim is to empower your internal know-how and reach the best result with a balanced effort, going through the process optimization.
With Lean Start-up methodology and through our iterative process, all the project phases are tailor made on your needs.
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