How to Make Quality the Focus of Your Medical Device Startup

With the life expectancy of the Australian population increasing year upon year, it's no surprise that you've chosen to enter the medical market. So many new companies are taking advantage of the ageing population that you may be eager to get started with the production process. However, you and your startup team must remember to avoid making speed the focus of your endeavour. While it's important to launch as quickly as possible, quality always needs to be at the forefront of your business. After all, the last thing you want is to end up losing money on a product that's flawed. Here are the 3 steps you need to follow to ensure your startup is producing quality medical devices from the get-go.

Step 1: Hire a Quality Manager

You're an entrepreneur, not an auditor. In order to succeed in this field, your business will need to be us to date on all the details of quality compliance, laws and regulations, certifications, registrations, and everything in between. However, to learn this would be a waste of your time and talents as a businessperson. That's why your first step should be employing a quality manager with an education and track record in producing compliant medical devices. This person will already know about state-wide and national requirements, saving you time and money both in the present (by saving you the hassle of educating yourself) and in the future (by preventing any costly mistakes). It's best to hire a quality manager as an employee rather than a consultant; you want someone who can advise you every step of the way to avoid missing anything important.

Step 2: Consider User Experience

In a world where technology is rapidly advancing, it's easy for new medical device startups to get caught up making their device as advanced as possible. While wireless operation and complex inner workings can give you the edge, the main thing you need to think about is user experience. Quality is about more than just function—it's also about ease, risk, lifespan, and many other factors that those using your device will care about. Whether your device is intended to be internally fitted by a doctor or externally used by a patient, you need to make sure it's designed to make the user's job as painless as possible. When you're finalising your design, ask yourself these 4 questions:

  • Is the device easy to use or install?
  • Does the device pose any risk to the patient?
  • How long will the device last?
  • Will this device cause less hassle to patients or doctors than existing products on the market?

Step 3: Work with Quality Materials

Design is a big part of the picture, but manufacturing is equally important. To make a quality design come to life, you need to use quality materials. Many device manufacturers use high performance plastics for this reason. The right polymers will be, above all, durable and resistant, hygienic, and cost-effective. High-performance plastics also offer many other benefits. For example, they're usually lightweight, able to withstand moderate to high temperatures, recyclable, and easy to fabricate in a variety of forms.