Did you know that seven new startups will launch in the time that it takes you to read this blog post? Unfortunately, four of those startups will fail in the first year.

Recently, one pharmaceutical company was forced to file for bankruptcy. The company borrowed millions of dollars to fund research and product development. Unfortunately, the company seriously struggled to gain FDA approval and never made it to market. In the blink of an eye, all of those funds were wasted.

So what does this mean for your medical device startup?

As the leading eQMS provider for medical device startups and scale-ups, we've seen some of the common mistakes companies make during the growth stage. Follow the medical device startup process advice here, and your company will have a better chance of becoming one of the medical device startup success stories.

7 Medical Device Startup Process Mistakes to Avoid

For many medical device startups, creating a quality assurance plan is the crucial first step towards securing high-value processes, systems, and cultures.

To help you get started, our experts have created a free guide to help you craft your first quality assurance plan. As you build, plan, and prepare, be sure to avoid these medical device startup process mistakes.

1. Skipping Market Validation

What is market validation? In short, it's the process that helps determine whether or not consumers actually want to buy your product. Unfortunately, many startups make the mistake of assuming that their product will skyrocket right from the outset.

The fact is, you need to validate your product before committing to development.

Many medical device companies conduct surveys to secure market validation. Use this survey to uncover any flaws that you might have overlooked. Based on survey results, you can tailor your product to meet consumer preferences and demands.

2. Waiting to Get Regulatory Advice

Don't wait to secure regulatory advice. There are hundreds of international and FDA requirements that your business must adhere to when developing a new medical device. And with so many regulations to abide by, it's easy to miss something.

In this scenario, noncompliance costs medical device startups millions of dollars per year. As such, we recommend seeking advice from an experienced professional who knows the regulations and has experience working with startups like yours.

The sooner you get guidance, the better.

RELATED READING: How Much Does Medical Device Regulatory Consulting Cost in 2020?

3. Forgetting the MVP

Building the perfect prototype with all the bells and whistles seems like a good idea at first, but it's not. You will spend more time, invest more resources, and be under more scrutiny from the FDA if you try to launch with a fully-developed product.

Instead, build a minimum viable product (MVP) and move quickly. You need to focus on the main features and components you want your medical device to have. 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.

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4. Getting Too Specific on Patents

Don’t make the mistake of getting specific on your patent application. Your medical device could end up having broader applications that you originally designed it for, and you don’t want to lock yourself out of potential markets.

However, you also don’t want to make your patent application too broad. When you put in too many details, competitors can swoop in and find workarounds for making their own versions of your product without violating the patent.

You should include any vital information about the device and how it works, as well as other possible uses for your device that you’re aware of, but leave out details like the exact materials it’s made of.

5. Not Preparing to Scale

Think about the future of your company 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 hassle and headaches later on.

For example, changing your QMS (quality management system) can be an extremely daunting and time-consuming task. However, the longer you wait to invest in a better solution, the harder it’s going to be to change systems.

With Qualio, you can grow your company from 5-500 employees effortlessly and never need to change to another QMS software as you scale.

RELATED READING: 6 Signs Your Quality Management Process is Failing

6. Focusing Too Much on Compliance

As mentioned above, compliance is an important part of operating a medical device company, but don’t become so focused on compliance that you don’t focus on quality. Because you’re a startup, you have the unique advantage of setting up the company culture upfront.

Ask yourself these questions to determine if you’re focusing enough on quality vs. compliance:

  • Can we make our device easier to use?
  • Are we using the best suppliers?
  • How can we win back unhappy customers?
  • How can we keep our employees motivated?
  • How can we build our company, so it thrives for a long time?

7. Neglecting Documentation

Documentation is crucial to your product development and FDA approval. It's not something that can be skipped over or dealt with later. If you fail to properly document every step of product development, you will find yourself in trouble with the FDA or other international organizations that regulate medical devices.

You should consider implementing an eQMS that helps make documentation simple. This is the first step you can take to avoid noncompliance issues. Qualio makes creating documents a breeze and even has built-in features to help you maintain FDA 21 CFR Part 820 & 21, CFR Part 11, and ISO 13485 & 14971 compliance.

You’ll be ready for FDA and ISO audits in no time after creating an account and setting up Qualio for your eQMS.

Are you ready to look for a quality eQMS that will suit your needs?

Buyer's remorse is expensive and can be very painful. Let us help you make the right decision with our free guide: 12 Questions to Ask Before You Buy an eQMS.

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Published by Robert Fenton April 1, 2020
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