Medical Device Startups: An Entrepreneur’s Guide

From smart implants and AI-assisted patient diagnosis to surgery directed by augmented reality, health tech is set to improve the lives of patients and medical professionals by delivering better health outcomes.

With COVID-19 increasing focus on human health as a whole, innovations in the medical device industry are happening at a rapid pace. Specifically, medical device startups are adapting technology and processes in order to solve the problems we are currently facing.

If you are part of the medical device industry and are looking to establish your own startup, here are a few tips to keep in mind:

1. Research Your Market:

In order to create a viable product in a niche market, like medical devices, research is your closest ally. Have a comprehensive knowledge of the market demands, cost of healthcare systems, and your client base. Use medical journals, published articles, client questionnaires, and online databases as useful tools for your research.

If you can invest in hiring professionals to ensure your medical device will be compliant with regulations, do it early in your creation process. Actuarial consultants may also be useful in helping you analyze your data and make forecasts based on available information.

2. Create a Design History File:

Design history files are legally mandatory as part of your firm’s quality system. A design history file contains all of the documentation that you create regarding the design of your product. The following documents should be present:

  • Design controls- Documented procedures that define your company’s development process.
  • Product user needs- Details of how your product will be used, what problems it solves, and what features it needs.
  • Design plan- Defined responsibilities and milestones for your design procedure.
  • Design inputs- A document describing all of the product necessities for your medical device, including physical, functional, and performance requirements.

3. Establish A Risk Management File:

All regulatory bodies for medical devices are concerned with risk management, and you should be too. Establish risk management procedures, define, and document a risk management plan for your product’s entire life cycle, even the development. Recognize any hazards associated with your device, and start a risk assessment by identifying any possible harm it could cause, the likelihood of occurrence, and what the severity could be. Document all of this information in your risk management file.

4. Build Relationships with Suppliers:

Figure out what materials you’ll require for your new device and establish a system for choosing suppliers. Base it on price requirements as well as quality. Make a list of approved suppliers for the materials you need, and keep files on suppliers you may wish to work with in the future. It’s vital that you fully understand the materials used in your products, and that you trust the companies that sell them to you.

5. Establish Document Controls:

Document controls may belong at the top of this list. As you create your product, you’ll create plenty of records, and it’s important to have a system for organizing and maintaining these records. They will be reviewed by the FDA, ISO, and possibly other governing entities to establish your compliance with medical device regulations.

The best way to guarantee smooth audits and get to market quickly is to maintain great document controls from the outset.

What to Avoid for a Successful Medical Device Startup:

For medical device validation, we’ve repeatedly seen common mistakes companies make during the growth stage. Follow the medical device startup advice below, and your company will have a better chance of becoming a medical device success story.

  • Skipping market validation: You need to validate your product before committing to development. Does anybody need it or want it, and will any healthcare agencies actually use it?

  • Waiting to get regulatory advice: Seek advice from an experienced professional who knows the regulations and has experience working with startups like yours.

  • Forgetting the MVP: 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.

  • Getting too specific on patents: Don’t make the mistake of getting extremely specific on your patent application.

  • Not preparing to scale: Build your processes and systems with scaling in mind. This helps save you from a lot of hassle and headaches later on.

  • Focusing too much on compliance: Ask yourself these questions to determine if you’re focusing too much on compliance and not enough on quality and company health:
    • Can we make our devices 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?

  • Neglecting Documentation: 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.

From devices to the cloud, Dash Technologies focuses on the development of custom software for medical device development. Our purpose is to create software that helps improve lives, a core tenant of the healthcare industry.

If you would like to learn more about our capabilities or would like to chat about our healthcare software solutions, please get in touch with us.

We’re technology experts with a passion for bringing concepts to life. By leveraging a unique, consultative process and an agile development approach, we translate business challenges into technology solutions.

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