Question 1

What sets health startup branding apart from regular startup branding?

Accepted Answer

The consequence. A regular startup can pick its tone freely, a health startup has to hold it in three parallel channels: marketing (website, ads, PR), regulation (IFU, labeling, training material) and hospital communication (procurement dossier, integration whitepaper). A tone that is too loose on the website 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.

Question 2

What do you actually do for MDR conformity?

Accepted Answer

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.

Question 3

How do you handle usability engineering per IEC 62366-1?

Accepted Answer

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.

Question 4

What about ISO 13485 and the design control process?

Accepted Answer

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.

Question 5

We are a digital health startup without medical device status, do we need all of this?

Accepted Answer

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.

Question 6

How do you position us towards investors with health experience?

Accepted Answer

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.

Question 7

What about HIN, EPD and integration into Swiss hospital IT?

Accepted Answer

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 on the website so hospital IT and procurement can evaluate without follow-up questions.

Question 8

DiGA for the German market: is it worth it?

Accepted Answer

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.

Question 9

Do you also handle the physical product design for medical devices?

Accepted Answer

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.

Question 10

How quickly do you have something to show for the next investor meeting?

Accepted Answer

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.

Branding & Design for Health Startups