First In Human: a Medtech Hallmark

Starting a medtech company has one simple objective for each founder: bring the value of their innovative product to patients.

Getting to that point is far from simple. Before receiving approval for commercialization, some clinical evidence is needed to demonstrate safety and efficacy. 

Taking the first step in this direction involves conducting a First in Human (FIH) study, namely a study in which a device for a specific indication is evaluated for the first time in human subjects (definition from MTAA). This is usually one of the key milestones most startups have to achieve.

Why is it important for you?

When joining a startup you will need to align your work to the view and objectives of the founder and hence striving towards a FIH study might be a fundamental part of your work, either directly or indirectly. Moreover, contributing to achieving that milestone will be very satisfying.

But what is required to get there and how much time will it take?

The short answer is it depends. Let's dig into common metrics that help understand what comes within a FIH and what other companies have done.

Key milestones (before FIH)

A lot of work goes into a device even before getting into humans. Medical manufacturers that want to achieve the FIH milestone must primarily verify and validate the product.

Following the design control procedure and being rigorous in the risk management processes are the bare minimum activities to support an FIH. Even though an FIH is a requirement to demonstrate safety and efficacy where it is impossible to do so through bench testing, medical manufacturers must ensure its safety before getting into humans.

Generally speaking, if a product is mature (aka efficacious and safe) enough to get to humans, it must be a functional production unit, which means the following (source EIT Health MEDTECH MILESTONES FRAMEWORK):

• GMP manufacturing is in place

• Key suppliers are committed at least through a MOU (Memorandum of Understanding)

• IP source report is written

• It has demonstrated key technical functionality through experiments

• Essential Requirements Checklist to support regulatory submission is in place 

• Application Form submitted to competent authority

• Approval for clinical investigation has been achieved

Both regulatory and technical endpoints support the beginning of such a study, and having those boxes checked helps derisk the study outcome as much as possible.

Capital raised

Managing clinical investigation is a financial burden, even if the required capital may differ considerably across regions.

For this reason, companies have to secure large investments to cover operations expenses and conduct the study successfully. One example comes from the NeuroTech industry where its 5 largest players are in the race to get to humans and raised between $50M and $300M in the US at very different stages of clinical investigation.

The need for such high capital investments adds up to the reasons why getting to the FIH study has become more and more the hallmark of medtech startups which is nicely summarised by the quote below:

Timeline

The usual timeline to get into humans starting from an early prototype may vary due to different concomitant factors, including technology complexity and resources accessible.

However, Med Tech companies require on average 5.6 years for a 510(k) clearance and 5.3 years for a CE mark. As FIH is needed for approval, this means getting to first humans will take slightly less time in Europe (CE mark) compared to the US (510k clearance).

What comes after FIH?

As we said a few times already, the First in Human is just a milestone.

If the FIH study is successful, Pilot Trials (Phase I) are meant to demonstrate the clinical feasibility of the new medical device and can involve from a few units to a few tens of patients.

The primary objective from a clinical standpoint, is to have enough evidence to inform the Phase II Trials and move towards regulatory approval, involving a few hundred patients.

Only after these steps are successfully completed, the product is clinically validated and ready to be launched. There is still an ultimate Phase III Trial, also called Post Market Surveillance when the product is monitored while being used in clinical practice along with its long-term effectiveness and safety on a larger group of patients (>1000).

Hence one might say getting there is definitely a marathon rather than a sprint: discipline, grit and competence will be essential to guide you and the company to this initial accomplishment, which will surely pay you back.

If you enjoyed this issue, share it with someone who loves medtech innovation!

This week's top scientific reads

1. Harmful Chemicals in Everyday Foods (Consumer Reports)

2. Long Covid Study for Hospitalized Patients (Nature Medicine)

3. Proteins Change Structure at Body Temperature (Nature)

4. Epidurals Reduce Childbirth Risks by 35% (British Journal of Medicine)

5. Cell Therapy Shows Promise to Cure Diabetes (Nature Cell Discovery)

Read the highlights of these articles here.

Latest European funding rounds in health & bio

• Lighthouse Tech raised a 500k seed round to develop their assistive smart glasses for blind and visually impaired people 🇨🇭

• Expression Edits raised €12M for their AI platform that enhances protein expression using proprietary gene editing technology 🇬🇧

• Adcendo raised €16M to develop new antibody-drug conjugate therapies for cancer patients 🇩🇰

• ifeel raised €18M for their mental health platform for companies and insurers 🇪🇸

• Iris AI raised €7.6M to improve data extraction from large scientific research datasets using AI and natural language processing 🇳🇴

• Novobiom closed a €2M seed round to leverage their fungal technology to turn waste into biogas and reusable materials 🇧🇪

• Natural Cycles raised €50M for its fertility tracking app 🇸🇪

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