4 challenges in bringing medical devices to market (and how to avoid them)

With a new medical device, you can literally improve or even save lives. But it’s also one of the most difficult sectors to enter. Only 1 in 50 MedTech devices ultimately reaches the market. And in the Netherlands, just 29% of a relatively large group of healthtech start-ups become scale-ups. Those are hard numbers.
ResearchManager works with medical device start-ups in innovation hubs and academic hospitals. We keep seeing the same challenges again and again, but the good news is: they can be solved if you know how. That’s why in this article, we’re sharing 4 common challenges and how to tackle them.

Challenge 1: Market validation – when should you do it?

A classic. You have a brilliant idea for a medical device and want to get started right away. Understandable. But bringing a medical device to market as quickly as possible also means that you need to know early on whether there’s actual demand for what you’re building. Some entrepreneurs fall so in love with their idea that they forget to check whether the world actually needs it. And that can be costly.
A smart go-to-market strategy starts by determining whether there is real demand for your product, not by asking whether it’s technically possible.

Why market validation is hard

• You want to start developing your medical device right away

• Feedback from potential users can be disappointing

• Dutch start-ups often struggle to connect with healthcare providers for patient feedback

How to approach it successfully

Start with curiosity.
Talk to real users before you begin developing your medical device. Don’t ask, “Would you buy this?”—ask, “How are you solving this problem now?” and “What would you be willing to invest in a better solution?”
These early conversations also help you build a network for later, which is useful for the pilot phase.

Tip
ResearchManager can help you find the right contacts through our network of academic hospitals.

Challenge 2: The regulatory landscape is a bureaucratic jungle

Welcome to the paperwork… It’s easy to lose motivation when faced with the complex regulations in the MedTech sector. Developing, approving, and marketing a medical device involves a mountain of processes and rules.

Why regulations are hard

• Regulations are boring, complex, and time-consuming

• Every region has its own (additional) rules

• If you skip a step in the approval process, you may have to redo a lot later

How to approach it successfully

1. Classify your medical device immediately
   Find out whether your product qualifies as a medical device and which risk class it falls into. That determines which rules you need to follow.
2. Start complying with regulations right away
   Begin early with meeting standards and requirements of quality systems like ISO 13485 (Europe and UK) and QSR 21 CFR Part 820 (USA) to obtain FDA Clearance. That’ll save you a lot of stress later.

Tip
Use a checklist to determine which laws and requirements apply to your product.

Europe

• Regulation: Medical Device Regulation (MDR)
• Authority: Notified Bodies/EU
• Classification: I, IIa, IIb, III 
• Pre-market procedure: CE marking  
• Quality Management: ISO 13485

United Kingdom

• Regulation: UK Medical Devices Regulations (UK MDR)
• Authority: MHRA
• Classification: I, IIa, IIb, III 
• Pre-market procedure: UKCA marking 
• Quality Management: ISO 13485

United States

• Regulation: Food and Drug Administration (FDA)
• Authority: FDA
• Classification: I, II, III 
• Pre-market procedure: 510(k), PMA, De Novo
• Quality Management: QSR (21 CFR Part 820) aligned with ISO 13485:2016

Challenge 3: Clinical validation – how many patients do you need?

Many MedTech start-ups get stuck here. How many people do you need to test your medical device on to prove it works? It’s not as simple as “a few” or “a lot”, there’s statistics behind it.
Reliable clinical validation is essential for accelerating clinical research and your innovation. If you don’t meet statistical requirements, you’ll have to redo the trial, costing time and money. If your sample size is too small, regulators won’t accept it. If it’s too large, you’re wasting budget. It’s a delicate balance.

Why clinical validation is hard

• Statistics aren’t everyone’s strong suit

• A sample that’s too small will be rejected

• Failing to follow protocol leads to rejection. This is the most expensive phase in your go-to-market process. Most start-ups need investors for this stage, but those investors often require clinical validation proof before they commit.

How to approach it successfully

Bring in a statistician or epidemiologist
This will save you a lot of headaches and provide a reliable calculation of how many participants you need to statistically demonstrate that your medical device is a sound innovation.
They take into account the expected effect size and the required level of certainty. Hiring one may seem costly, but it’s much cheaper than having to redo your clinical validation due to unmet requirements.

Tip
ResearchManager’s Professional Services team helps you create research proposals and perform statistical calculations for clinical validation, so you get it right the first time.

Challenge 4: Budget – how much does it cost to bring a medical device to market?

If you’re developing a medical device for the first time, you probably don’t yet know what the full process entails, or what it costs. Some think it’s unaffordable, others underestimate it. Some start-ups think they can do everything in three months. If only it were that simple.

Why budgeting is hard

• Costs vary widely depending on the device type and clinical validation complexity

• You want to be thorough, but not overspend

• Hidden costs can pop up everywhere: ethics committees, monitoring, data management, statistics, regulatory support

• Investors are cautious about early-stage MedTech because many start-ups have failed

How to approach it successfully

Work in phases

You don’t have to fund everything at once:

• Start with a proof-of-concept

• Use existing infrastructure such as universities and hospitals instead of building everything from scratch

• Don’t try to do everything yourself unless you truly have a multidisciplinary team, you’ll need experts in statistics, data management, regulation, and monitoring

Tip
ResearchManager offers software you need for clinical validation, made available on demand without license costs for smaller projects. Because our pricing is per project (not per user), clinical validation becomes far more affordable for start-ups.

How ResearchManager helps accelerate clinical research

The above challenges aren’t unique. Every MedTech start-up faces them. The difference between success and failure often comes down to how well you understand the clinical validation process.
That knowledge prevents you from charging ahead in development only to get bogged down later in regulations, causing delays and additional costs.
That’s why ResearchManager supports Dutch MedTech start-ups by helping them:

• Secure their first funding round

• Get through clinical validation faster

• Obtain approval without expensive do-overs

How we can help

1. Professional services
   We help with solid study design, well-structured study processes, regulatory compliance, data management, monitoring, and statistics. In short: everything needed to achieve clinical validation for your medical innovation.
2. EDC system (Electronic Data Capture)
   For clinical validation of medical devices, you need a validated database. Optimize and streamline your data collection process, gain insights quickly, and ensure data security at the highest level.
3. ePRO system
   A simple system for collecting feedback from trial subjects and patients. They can fill out questionnaires on their own devices, laptop, mobile phone, or tablet.

Ready to take the next step with your (idea for a) medical device?

Get in touch with ResearchManager. We are happy to help you find the right approach for clinical validation of your innovative medical device.