For health startups

Branding & Design for Health Startups

For medtech, digital health and healthtech startups: a presence and product design that holds up in the investor pitch, in hospital procurement and in the technical file. Between startup speed and regulatory reality, where most health startups tie themselves in knots.

A health startup lives in two worlds at once that have little to do with each other. On one side the startup world: runway, seed and Series A investors, an MVP that gains new features every week, a pitch deck that sells growth. On the other side the health world: clinical evaluation, notified body, post-market surveillance, a CE mark that decides market access, procurement people in hospitals who are conservative and decide over years. A design presence that serves only one of these worlds loses on the other end.

Most health startups solve this tension the wrong way: either they look like a consumer B2C startup (loud colours, emoji-friendly tone, 'change healthcare forever' in the pitch deck), which immediately puts hospitals off and makes the notified body suspicious when the same language reappears in the instructions for use. Or they slip into a conservative corporate medtech register (a blue-grey palette, a generic stock photo of a doctor with a tablet, LinkedIn language), which makes investors ask why they should invest in a company that looks like a Siemens Healthineers spin-off.

We design for health startups a presence that builds this bridge cleanly: serious enough for hospitals and regulators to take you seriously, ambitious enough for investors to see the growth story, and precise enough that you produce no contradictions in the technical file. In concrete terms: a brand identity that works in the pitch deck in front of VCs, in the IFU (instructions for use) and in the printed hospital dossier.

If you build a medical device, we work MDR-compliant: the EU Medical Device Regulation 2017/745 (MDR) and, for in-vitro diagnostics, the IVDR 2017/746 set the frame. Everything that belongs to the use of your product (user interface, packaging, labeling, IFU, instructions for use, training material) falls under the regulation. We know the relevant MDCG guidance documents, work with IEC 62366-1 (application of usability engineering to medical devices) and IEC 62304 (software lifecycle for medical device software), and deliver design outputs so they can flow directly into your technical documentation, instead of being translated after the fact.

For the Swiss market the framework shifted with the end of the MRA agreement in 2021: Swissmedic registration as a prerequisite for the CH market, an authorised representative (CH-REP) for EU manufacturers, MedDO as the Swiss medical devices ordinance. For digital health products, HIN certification (Health Info Net) for data exchange with the Swiss health system and EPD capability (electronic patient record) come on top, if you want to integrate into the patient record landscape. All of this belongs in your communication towards hospital buyers, otherwise you are not evaluable.

For DACH expansion the German market with DiGA (digital health application, listed in the BfArM directory) and DiPA (digital care application) is the most accessible path to reimbursement by statutory health insurance. For DiGA applicants the BfArM assessment under the fast-track procedure is a communications event in its own right, which we prepare cleanly separated in marketing, investor materials and hospital communication.

For product design itself we work with three user groups in mind: the medical professionals (doctors, nurses, MTRA/MPA), the patients (who often use your product in a stressful state), and the IT and procurement people in hospitals and practices (who decide on integration, security and purchasing). All three need different information about the same product, and all three have to be considered in the design, otherwise you fail at one of the three hurdles.

For investor communication we design pitch-deck systems, one-pagers, data-room layouts and a clean executive-summary PDF that presents the regulatory roadmap so it reads as risk reduction rather than cost burden. A Series A investor with health experience looks for exactly that: a company that knows where it stands regulatorily and presents the milestones as a clear roadmap.

How we help

01

Investor, hospital & notified body at once

A presence that works in the pitch deck in front of VCs, is taken seriously in hospital procurement and produces no contradictions in the technical documentation.

02

MDR/IVDR-compatible design

UI, labeling, IFU and training material along MDCG guidance, IEC 62366-1 and IEC 62304, with design outputs that flow directly into the technical documentation.

03

Switzerland & DACH built in

Swissmedic, MedDO, HIN and EPD for Switzerland, DiGA and DiPA for Germany, cleanly separated in communication and positioning.

Frequently asked

What sets health startup branding apart from regular startup branding?
The consequence. A regular startup can pick its tone freely, a health startup has to hold it in three parallel channels: marketing (campaigns, ads, PR), regulation (IFU, labeling, training material) and hospital communication (procurement dossier, integration whitepaper). A tone that is too loose in marketing will haunt you later in the instructions for use. We design so the three channels speak the same language, without the marketing side becoming sterile.
What do you actually do for MDR conformity?
We deliver design outputs that meet the safety and performance requirements of Annex I MDR: clear symbols per ISO 15223-1, a consistent UI along the IEC 62366-1 usability process, an IFU structure per Annex I §23 MDR, and a labeling system that scales across SKUs and languages. The clinical evaluation, the technical documentation and the conformity assessment itself are handled by your regulatory team or a specialised partner, we feed into that system.
How do you handle usability engineering per IEC 62366-1?
We integrate formative and summative usability studies into the design process, instead of appending them as a check at the end. Task analyses, use-related risk assessment and the link to risk management per ISO 14971 run alongside, and design iterations are documented so they land in the usability engineering file. For the summative study with representative users we work with specialised human-factors studios.
What about ISO 13485 and the design control process?
We work inside your quality management system: design inputs, design outputs, design reviews, design verification and design validation are documented and archived as ISO 13485 §7.3 requires. If you do not have a QMS yet (early seed stage) we recommend partners for the setup and work in parallel so the design history can be transferred into the QMS later.
We are a digital health startup without medical device status, do we need all of this?
Not in full depth, but the classification check comes first: as soon as your software has a medical intended purpose under the MDR (diagnosis, prevention, monitoring, treatment), it falls under the regulation, most often as Class IIa software. The 'we are just a wellness tracker' mistake is one of the most expensive in the industry. We clarify this with you and your regulatory team at the outset and design accordingly.
How do you position us towards investors with health experience?
We design investor materials so the regulatory path reads as a competitive advantage, not a cost block. A Series A investor with digital-health focus (High-Tech Gründerfonds, Sofinnova, MTIP, Redalpine, wingman.vc, Founderful) sees immediately whether a team has its regulatory story under control. A clean regulatory milestone plan in the pitch deck is more credible than any adoption curve.
What about HIN, EPD and integration into Swiss hospital IT?
For digital health products in Switzerland, HIN connectivity for secure data exchange with practices and hospitals is often the door opener. For integration into the electronic patient record you need an EPD certification through a recognised certification body. We prepare these points in your hospital procurement dossier and your materials so hospital IT and procurement can evaluate without follow-up questions.
DiGA for the German market: is it worth it?
If your product falls into one of the DiGA indication categories and you can meet the evidence requirements (positive care effect, CE mark as Class IIa): yes, because you get direct access to reimbursement by the 74 million statutorily insured people in Germany. We design the BfArM application materials, the accompanying investor story and the end-user communication as three separate channels that stay consistent.
Do you also handle the physical product design for medical devices?
Yes, through our industrial design. We take the product from concept to a production-ready 3D model and, for technically demanding products (electronics, actuators, sensors), work with an engineering partner. For regulatorily relevant materials (biocompatible plastics, silicone components, sterilisability) we align with your regulatory and quality side.
How quickly do you have something to show for the next investor meeting?
A first presentable brand and a pitch-deck system typically emerge in health startups within four to eight weeks, timed to your next milestone (fundraising roadshow, DMEA, Bio-Europe, LSX, HIMSS). The full design-system documentation for the technical file emerges in parallel and is roughly synchronised with the CE-mark target.

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