Entrepreneurs can be quite sceptical of medical device startups because of the sheer complexity involved. Many of the hurdles are technical and regulatory, making it a minefield for anyone wanting to make money.
However, things aren’t necessarily as challenging as conventional wisdom would suggest. While device manufacturers struggled to gain traction in the past, the same isn’t necessarily true today.
But why is that? Here’s some of the answers we’ve come up with.
Support Networks Are Growing
Perhaps the biggest reason things aren’t as hard as they used to be for medical device startups is the fact that support networks are growing. Entrepreneurs aren’t left to their own devices in the wilderness anymore.
You can see this trend in the sheer number of accelerators and incubators that larger companies now offer. These provide spaces for founders to perfect their devices and work on bringing their businesses to scale.
MedTech is a good example of a program that’s helped dozens of founders make progress in their respective industries. This option makes the journey less isolating and gives founders the feeling that they have real support around them.
Digital Tools Are Making Market Entry Easier
At the same time, digital tools are making getting your foot in the door easier as a new market player. Multiple platforms reduce the complexity of the launch process and streamline everything for you.
For example, tools like QMS software make managing compliance more straightforward. These automate much of the process and ensure that your company doesn’t fall outside of acceptable bounds.
At the same time, you can now get software that will launch targeted online campaigns for you. These will often reach healthcare providers and patients so you have a ready market, waiting for you as soon as you’re in a position to start distributing products.
Partnerships Reduce Manufacturing Complexity
Another perk is the fact that partnerships are massively simplifying manufacturing complexity. Today, it is easier than ever to outsource the process, as long as you provide the proper specifications.
Historically, this step was more challenging because there were fewer providers. Startups often had to do a lot of the grunt work on their end before their medical devices could be made by their partners, including parts sourcing and planning. But now, many manufacturers have integrated supply chains and specialize in the creation of new medical devices. The more options they have, the better they can meet your requirements.
These setups mean all you need to do is focus on innovation. Once you have the design, outsource partners should be able to complete it for you at scale.
Cybersecurity Compliance Is A Breeze
Another reason launching a new medical device is easier than ever these days is because of automated cybersecurity compliance. Various companies can do this part for you, reducing the effort required on your part.
Medical device cybersecurity is a growing concern for many brands in light of HIPAA requirements, and getting it wrong can lead to substantial fines. However, agencies operating in this space can deal with regulatory approval issues for you, so you no longer need to develop specific expertise in this area. For example, third parties can take care of things like penetration testing and SPDF development to keep you safe from regulators and ensure your business thrives long-term.
Clinical Trials Can Be Minimal
Most medical device manufacturers are required to perform clinical trials for safety and if they want to make any claims about what their devices do. However, the requirements for RCTs are considerably lower than many people think, making the launch of devices easier than many entrepreneurs imagine.
If the device is broadly considered safe, the testing requirements are minimal. You may be able to run a lean randomized controlled trial or none at all, depending on what it does. If you want to make medical claims, you may need to do more testing with a suitable sample size. However, as before, you can get other third parties to do all of this for you so it doesn’t get in the way of what you want to do.
We’d suggest using a contract research organization. These specialize in lowering the cost of randomized controlled trials so you don’t have to manage them yourself.
Prototyping Is Faster And Cheaper
Prototyping is also faster and cheaper these days, lowering the cost of medical device release even further. Advances in things like CAD software and 3D printing mean that you can get multiple mockups for a fraction of the cost of previous systems (which required you to submit a custom order to a manufacturer and get them to perform a limited run).
3D printing is arguably the breakthrough technology in this regard. It allows rapid prototyping at a fraction of the cost of conventional systems, allowing for faster design iteration than ever before. You can potentially test dozens of options before finally settling on one you like without running up your development costs to extreme levels.
Regulatory Pathways Are Clearer
Finally, you might find launching a new medical device less painful than you think because regulatory pathways are becoming clearer. Given the explosion of digital technology and patients’ needs, the FDA has streamlined the process of generating medical devices from scratch, giving them a new pathway forward to make your life more bearable. This standardized procedure has structured guidelines to follow, which you can check off one at a time during the development phase to ensure you meet all requirements.
This clarity reduces the guesswork and uncertainty that used to dog the process. Previously, entrepreneurs had to jump through hoops and find solutions to issues that the FDA raised, which sometimes arose unpredictably.
However, the new guidelines means that that’s now changing. Regulatory pathways are becoming clearer and many entrepreneurs can now see their path forward, six to twelve months ahead.
In conclusion, launching medical devices is becoming less painful and more lucrative. Cultural forces mean that it remains an untapped market, but there is potential here for anyone who thinks they have an idea for a new device.
