It is not easy to build a Medical Device. And we all know that every beginning is hard. Therefore, for startups, it’s quite a challenge. But fear not. More you know, easier it is.
Since the 2000s, MedDev startups have become more important in the global economy and the business environment is changing accordingly. To survive in a rapidly changing business environment, MedDev startups need the capacity for supportable growth as well as competence in the market.
These few tips that you are going to read below will give a clearer image of what you should be aware of.
- First of all, a good idea is the root of success. Think of a medical device that will be truly useful to humanity in the 21st-century.
- As a medical device startup, you must be able to design, build and launch a new product while managing costs and quality.
- Making a decision where you plan to sell your medical device is crucial – keep in mind: Different countries different regulations
- You’ll need to think about outsourcing product design and development and prototyping services – that is one of the biggest decisions you will have to make, but more about it you can find it here...
- Another early consideration is where to pursue approval first. The relative ease of obtaining a CE Mark in Europe compared with the FDA’s more stringent requirements? Things are changing, follow up is a must!
- You should plan, implement and keep-up-to date your QMS carefully as you will be one step closer to the regulatory approval.
- Not less important to establishing a quality management system that suits your company size and expected growth - Implementing and maintaining a QMS is a crucial part of regulatory compliance. The medical device quality system is primarily concerned with production and post-production. FDA 21 CFR Part 820 defines the quality regulations for the U.S. market. Otherwise, ISO 13485 can be used to build a quality system for global markets.
- As a Medical Device Startup, you should begin building quality and compliance programs during the development phase, by focusing on design controls, risk management, document control and record management, and supplier management.
Design controls, essential for your QMS, help with the design process by capturing key aspects of development to prove your product meets user needs and is safe and effective. Risk management works with design controls to create documents and records throughout product development, to demonstrate that you’ve considered the risks and are doing something about them. Document management is the process that helps those pieces of the puzzle stay together.
- And – Maintenance of Design History Files (DHF) and Technical Files (TF) are peace of cake with right QMS software
- Last but not least important is to be aware that it’s not only a challenge to place your medical device to market but to sustain it – Auditors are always here to keep you straight!
Few “don’t forget” tips
- Teamwork is the most important factor for success
- Don’t underestimate the power of good eQMS software
- Nothing is impossible