Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.

How to Make Your Medical Device Startup Look Less Like a Startup

MedicalDeviceProductLaunch_Novatek2017.jpgIt's MEDTECH season again and, as we do each year, Novatek and Launch Team are taking a close look at the current trends, changes and technologies that are impacting the medical device industry. From product launches to new sales models, we're examining the 2018 outlook and sharing our insights.

Starting a company or launching a new medical device requires a lot of foresight. From lack of funding to heightened risks with digital, a number of factors can delay or derail your route to success, so it is important to be prepared.

While you might not be able to skip the “awkward startup stage” completely, there are steps you can take to reduce risk. Proper technical documentation and training can help prevent product launch failure, protect against threats, and ensure safe and accurate use of your product.

Consider Cyber Security

As the popularity and complexity of connected medical devices continue to grow, so does the need for effective cyber security. If you don’t yet have a cyber security plan for your startup, begin with these four steps:

  1. Assess technology risks and gaps in compliance
  2. Create an incident response plan
  3. Define roles and ownership of needed documentation
  4. Establish a review cycle and timing

Download our full checklist for more guidelines on cyber security best practices.

Download Checklist

Ensure Proper End Use

Great product design without great documentation is like a car without gas. A user-friendly documentation plan ensures that end users can safely and confidently use the product, which in turn:

  • Helps prevent delays and recalls
  • Facilitates product adoption
  • Increases product sales

To ensure a successful medical device product launch, consider instructions for use and other forms of technical documentation in the early stages of product development.

Anticipate Budget Hurdles

Budget constraints are a common problem for newer, smaller companies. Lengthy prototyping, testing, and FDA approval processes all come with significant costs. To reduce risk, it's important to discuss your expectations and gates of entry with potential investors early on in development.

Well-written Instructions for Use can help investors understand the value of your company and product. It can also help you:

  • Meet pre-market notification requirements
  • Ensure accurate product usage and patient safety
  • Reduce service costs
  • Increase buyer satisfaction

Novatek’s customizable Instructions for Use Template can be a cost-effective starting point to becoming LaunchReady. Learn more or request the template today.

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Topics: Process documentation, medical device launch, cyber security