"The thing about regulation is that it tells you what the end goal needs to be but not how to get there. It’s really up to you to figure out what that means for your company,” says George Thomas, chief product officer at fertility startup Béa Fertility.
The company provides women wanting to conceive with the equipment to carry out a fertility treatment called Intracervical Insemination (ICI) at home. It involves placing a small cervical cap containing semen at the cervix using an applicator, which is left in for an hour. Users can test for pregnancy two weeks after the treatment.
Béa had to jump through many regulatory hoops before it could bring its product — a medical-grade device — to the UK market. And it’s now taking steps to expand to the US in the next few years.
In our Startup Life newsletter, George gave us his top tips for launching a D2C product in a regulated market.
Do your research
Firstly, you need to understand the regulations that apply to your product, your industry and your target market. For example, we needed to figure out:
- Is our product classed as a medical device?
- If so, which specific type of medical device?
- What kind of legislation applies to us?
- What is our route to market? (ie, what kind of accreditation schemes will we need to go through?)
Aside from the product, there are also requirements you have to meet as a company. In Europe and the UK, there’s a standard called ISO 13485 which covers how as a medical device company you design and manufacture your products, as well as all the operations of your business. Requirements might be recording any major safety problems your users encounter with your device and reporting them to public bodies, or setting up a customer support team.
Get the help of regulatory experts
This could be a consultant or an in-house expert with experience in navigating regulation in your specific sector. The key is to hire someone who has knowledge of how to comply with all the regulations and a deep understanding of what your product is and what you are trying to achieve as a business.
Use a specialist recruitment company suited to your industry (we used Capu, which has experience hiring for medtech companies) to help you find the right profile. Recruiters can also help you assess whether you need a full-time person on the job (and whether that person should be hired internally or externally), or whether you need someone on a temporary short-term or longer-term contract.
Start to work out your go-to-market timeline
If you’re in a category where you need to have auditors come in and check your final product or assess how your company is working, book those in good time, as otherwise, it could be a long wait. You don’t want to get your product ready and then realise you’ve got an eight-month wait to have it assessed before it can hit the shelves.
Give yourself buffer room
Being a regulated company is much different to being a classic software product: you can’t throw something out into the world and see what happens, especially if you’re dealing with hardware. In the process of getting regulated, things will inevitably change or get delayed. For example, if your hardware changes, you may have to redo some of your regulatory testing to check it is still compliant.
When planning out when your device will be launched, figure out the worst case and best case in terms of date and aim to be somewhere in the middle. Give yourself as much buffer room as you can to factor in delays, problems with supply chains, or any other issues.
Do user testing
In and amongst navigating regulation, you need to make sure that what you’re building suits the needs and expectations of your target market — so get your product out in front of real people as early as possible. (You don’t want to spend time and money building a prototype and figure out later down the road that it’s not what customers want.)
For us, as a medical device designed for people to use at home, there’s a really high bar in terms of ensuring that people can read and understand the instructions and use the device without supervision. We did lots of testing and studies which helped us understand how consumers interact with our product and what could be better.
If you’re planning to launch in a new market in the next one to two years, it’s a good idea to start figuring out your regulatory pathway now. Every market is unique and will have different rules. Again, you don’t want to start trying to roll out your product in another market and then realise that you need to choose a different manufacturing method or material to be compliant, or that you’ve missed a critical bit of testing. It will be more time-consuming and costly to have to start from scratch a few years later, so do your homework ahead of time.
On the subject of... launching a product in a regulated market
🗺️ Have a strategy. Start by mapping out the areas where regulation will have real business impact, such as product, go to market, finance, and operations, and identify two to three key issues to prioritise above others.
🧱 Launching in a regulated market 101. This interactive LinkedIn article breaks it down into six key steps, using advice from product managers around the world.
📣 Attention, PR professionals. You should also be paying attention to regulatory issues in your clients’ markets.