Medical Device Company
What is a medical device company?
A medical device company is a commercial organisation that develops medical devices, medical software, medical accessories and surgical instruments to diagnose, treat, or prevent medical conditions. Some examples of medical devices include brain PET scanners, artificial joints, portable health-monitoring devices (e.g. watches, fitness monitors), gastric monitoring systems, proton therapy systems, and pacemakers.
What do medical device companies do?
Many medical device companies start their life as startups, and most evolve from their initial idea of a novel medical solution. The mission of medical device companies is often to develop devices that provide a novel solution in a niche medical market or an innovation that surpasses current methods, services or products.
How to start a medical device company?
Having a good idea for a medical device is only the first step to starting a medical device company and there are many unique challenges that MedTech entrepreneurs face.
This topic is however quite extensive and so we give you a summary of the things you need to consider:
Strength of your idea: Is your idea truly novel? What are similar products already on the market?
Market: Research the size of the market. Who are your customers? Who are your competitors?
Regulations and quality: Understand what regulations apply to your device and what development and quality processes you will need to implement for compliance.
Funding: Investigate options for funding and prepare a solid pitch.
Partnerships: form partnerships and outsource work that you cannot handle in-house.
For more information, watch our webinar on the unique challenges that you may face on your way to market.
Where can you find funding for your Medical Device?
There are many funding options available, for example:
However, whatever funding route you choose, you have to make sure that you have a solid pitch. Read our article on Do’s and Don’ts when Pitching to MedTech Investors for some insight.
Who are the most common partners for medical device companies?
If you’re a start-up, you most likely have a small staff complement, which may not contain all the skills that you need to develop your medical device. Even if you are an established medical device company, there comes a time when you just need extra support. In these cases, partnerships help.
Consider forming partnerships with physicians, regulatory consultants, VCs, and medical device engineering companies. They will be able to provide valuable input into the development of your medical devices.
What are the main challenges for medical device companies?
Medical devices are notorious for being one of the most difficult products to get to market. They are not easy to develop, manufacture and launch and are surrounded by layers of regulations. You also have to know well in advance who your customers are and how they shall pay for your product.
In addition, medical devices are subject to clinical trials and approval processes with regulatory bodies in, potentially, Europe, Asia, USA and the rest of the world.
Medical devices are strongly regulated products and must be approved by medical regulators such as the EU Commission agencies under the Medical Device Regulation (MDR), or by the FDA in the USA – before you can place them on the market.
Which are big medical device companies?
Some of the biggest medical device companies are:
Johnson & Johnson
Can we help you develop a Medical Device?
Yes, we can! Don’t hesitate to contact us, and we will work out how you can leverage our skills to speed up getting your medical device to market.