Health & Wellness design for founders.

We take health and wellness founders from concept to production. Comfort tested on real bodies, claims and standards planned early, and the electronics, materials and tooling settled before you commit to a factory.

Book a free 30-minute callSee our health and wellness work

Free 30-minute call · NDA before you share the idea · You own every sketch

The Sleepmaxxer sleep mask with nasal dilator and chin strap, designed by Analogy
7+

health and wellness products designed

150+

shipped and selling in the real world, across all our industries

8 months

from concept to a Kickstarter-ready sleep mask for Sleepmaxxer

What health and wellness teams say

Unedited, from the founders behind the health and wellness products on this page.

  • Shard
The Sleepmaxxer sleep mask with its integrated nasal dilator
Akhil Krishna, Founder & CEO, Geniyes Health and lifestyle LLCFounder of the Sleepmaxxer sleep maskAkhil KrishnaFounder & CEO, Geniyes Health and lifestyle LLC
“Analogy's dedication to craft, and their uncompromising focus on actually launching products, is unparalleled in India. Most teams drift toward feature lists or feel-good claims. Analogy built for the symptom our users actually had, and our health span habits philosophy stayed intact throughout, never diluted, never compromised. They were always a helping hand rather than the driver, but that conviction wouldn't have crystallized into something real without their team's craft and hard work behind it. Grateful for the partnership.”

Read the Sleepmaxxer case study

Our health and wellness work

Straps, eye cups, LEDs, compressors and sensors: the details that decide whether a product is worn, used and kept. Hover or tap to open a project.

SleepMeditationDentalFitnessAirBack care
The Sleepmaxxer sleep mask with nasal dilator and chin strapSleepmaxxer sleep maskKickstarter-ready in 8 monthsThe iDiya smart wellness deviceiDiya meditation deviceCrowdfunding-ready for the US and EuropeThe Mobident portable dental clinicMobident dental clinicHalf the parts, half the internal volumeThe Shard smart exercise bikeShard smart exercise bikeAmbient light replaces screens and numbersThe EUME ergonomic backpack with a built-in massagerEUME back-care backpackA massager built into the strapsErgonomic toothbrush designed for PepsodentErgonomic toothbrushDesigned for Pepsodent

Details from the bench

Eye cups, straps, light and airflow: the small parts that decide whether people come back to a product.

Contoured memory-foam eye cups on the Sleepmaxxer sleep mask
Sleepmaxxer · contoured eye cups
Shard exercise bike with customisable ambient lighting
Shard · ambient light replaces screens and numbers
EUME backpack button-activated back massager
EUME · button-activated back massager
iDiya light, speaker and scent module in one palm-sized body
iDiya · light, sound and scent
Mobident two-part system separating personal tools from the compressor
Mobident · two-part system

Where founders get stuck

Most health and wellness founders arrive stuck at one of three points. Here’s how each one played out.

Adjustable Sleepmaxxer sleep mask strap01 · Fit on the body

It has to feel right on the body. Customers drop products that press, slip, run hot or can’t be cleaned.

We test fit and pressure on real bodies across positions, and pick materials that survive washing.

Kickstarter-ready in 8 months

Sleepmaxxer case study
The Mobident portable dental clinic02 · Decide the claim

Your claim decides your rules. One word on the box can turn a wellness product into a regulated device.

We agree the claim and risk level with you before the design is fixed, so materials, enclosure and testing fit the path.

One system rebuilt from eight years of fragments

Mobident case study
The iDiya smart wellness device03 · Prepare for production

Too much electronics for a small body. Light, sound, sensors and batteries are hard to cool, charge and build.

We keep the architecture modular and remove electronics the product does not need.

Mobident: half the parts. iDiya: crowdfunding-ready hardware

iDiya case study

What it takes to bring a health and wellness product to market.

Your claim, skin contact, batteries and tooling decide the budget. No hourly billing: each phase is scoped and priced before it starts.

THE HARD PARTWHAT MOVES THE NUMBERTYPICAL COST

Fit on the body comes first

Comfort, pressure and cleaning decide whether people keep using it.

How many people you design for

More body sizes and sleep or wear positions mean more fit testing and more prototypes.

$15k–$75k

You pay Analogy

Phase 1, industrial design and concept. A simple consumer product sits at $15k–$25k, a medical device at $50k–$75k

Safety and claims are designed in

Batteries, radios and skin contact each bring their own tests.

Your claim and the markets you sell in

A wellness claim and a medical claim follow different rules. Decide early, and plan each market together.

$10k–$50k

You pay the labs

Certification (FCC, CE, UL, BIS and others), quoted separately for your markets. Billed directly by the lab, no commission. A medical-device path adds $30k–$80k and 6–12 months

Tooling commits you early

Once steel is cut, changes are slow and expensive.

Number of moulded parts

Housings, soft-touch parts and seals each need their own tool. Fewer, smarter parts cost less.

$15k–$100k

You pay the factory

Per mould, billed directly by the factory, separate from development. Fewer, smarter parts cost less

Unit cost sets the shelf price

Electronics, materials and assembly decide your margin.

Electronics and connectivity

Sensors, light, sound, an app or a battery add firmware, testing and cost per unit.

$25k–$150k

You pay Analogy

Phase 2 engineering. Off-the-shelf modules about $25k, custom connected devices past $100k

Get a number for your product

Bring a sketch or a sample to a free 30-minute call and leave with a rough budget and timeline.

STAGE 01Concept & StrategyExplore ideas and directions before a single path is drawn.
PRODUCT PATH

From sketch to shelf, one stage at a time.

Concept & Strategy

Explore ideas and directions.

Engineering & Prototyping

Refine form, use and details.

Manufacturing & Scaling

Resolve parts, materials and tolerances.

Launch Support

Build and test the real thing.

Explore the Product Path

Which standards and certifications does a health and wellness product need?

Health and wellness products touch skin, carry batteries and often make health claims, so several sets of rules can apply at once. Standards shape the materials, parts and test time, so plan them early; labs and regulators do the certifying.

Standards and certifications for health and wellness products by requirement
RequirementApplies whenWhat to plan for
Wellness or medical claimAny product with a health claimIn the US, FDA’s general wellness policy covers only low-risk products meant for general wellness. Claims to diagnose, treat or prevent disease typically make it a medical device, in the US and in other markets.
Medical device registrationMedical claims, such as dental equipmentTypically FDA classification in the US, CE marking under the EU MDR and an ISO 13485 quality system. India: CDSCO classes A to D, licence valid five years. Confirm your route with a regulatory specialist.
Battery safety and transportLithium cellsUN 38.3 for shipping, IEC 62133-2 for cell and pack safety, and UL 1642 or UL 2054 for North America.
Radio and EMCBluetooth, Wi-Fi or any other radioFCC in the US, CE in the EU and UKCA in the UK, with radio and EMC testing for each.
Skin contactAnything worn on the skinISO 10993 tests for cytotoxicity, sensitisation and irritation. OEKO-TEX Standard 100 for fabrics.
Restricted substancesElectronics, plastics and textilesRoHS and REACH for the EU and UK, and California Prop 65 for the US.
Electrical safety, consumer productsPowered products without a medical claimIEC 62368-1 typically, in its regional versions for North America and the EU.
Electrical safety, medical equipmentPowered clinical devicesIEC 60601-1 is the usual standard. Scope to confirm with a lab.
Connected-device securityAn app, Bluetooth or Wi-FiETSI EN 303 645 is the common baseline for consumer connected devices, and the US Cyber Trust Mark is a voluntary label for the US.

Requirements depend on the product's intended use, technical configuration and target markets. This information is intended as a starting point for planning and should be validated with an accredited testing laboratory or qualified compliance specialist before finalising the design.

If the product is regulated as a medical device, budget a $30k–$80k regulated add-on and 6–12 months on top.

Battery

UN38.3 and IEC 62133-2 testing for lithium cells

$10k–$50k certification, paid to the labs

Radio

FCC and CE testing if the product has Bluetooth or Wi-Fi

$10k–$50k certification, paid to the labs

10–15 days

per skin-contact test once a sample is in the lab

$8k–$25k design-validation prototypes

Phase 3

when your test map should be written

$10k–$50k prototyping and testing

Six decisions that make or break a health and wellness product

The details customers notice in their first week and reviewers write about. Each one is cheaper to settle in CAD than on the production line.

Human factors and fit

Test across body sizes and positions, not one fit model. Sleepmaxxer was built for side, back and stomach sleepers.

Skin-contact materials and safety

Foams, silicones, fabrics and plastics that are skin-safe and survive washing. Sleepmaxxer’s fabrics were chosen for repeated machine washes.

Hygiene and cleaning

Detachable parts, open corners, no trapped moisture. Mobident’s exposed tubing and hard-to-clean surfaces were redesigned.

Battery and electronics integration

Cell, charge port and enclosure set safety tests, shipping rules and weight. Keep only the electronics users feel: iDiya uses an energy-efficient LED system.

Regulatory classification and claims

Decide the words before the design: they set the regulatory path. A late switch from wellness to medical can mean new materials, tests and paperwork.

Usability validation and reliability

Test with real users over repeated wear, washing and charging, not just a first try. Faults found on real bodies are cheaper to fix before tooling.

Where should your product start?

It depends on what you already have. Find the line closest to where you are today.

A wellness or health idea and a few sketchesConcept designA white-label or existing product you want to make comfortable and your ownConcept and industrial designA prototype that needs to pass battery, radio or skin-contact testingProduct engineeringA design that needs tooling quotes and a factoryDesign for manufacturingA product in production with returns, complaints or rising costsManufacturing optimization

What working with us on a health or wellness product looks like

The people who sketch it engineer it

Every concept is checked against fit, safety standards and tooling by the engineers who will build it.

A team of four in Shenzhen

They stay at your factory through tooling, first samples and the first production runs.

Your idea stays yours

NDA signed before you share anything. Every sketch, render and CAD file is yours.

Fixed price per phase

Scope and price are agreed before each phase starts. No hourly billing, no surprises.

Health and wellness design questions, answered

Not here? Ask us on a free call.

How much does a health and wellness product cost to develop?

Full development, concept to market-ready, runs $125,000–$250,000 for wearable and fitness-style products and $75,000–$125,000 for a simple wellness product with no electronics. A product regulated as a medical device runs $250,000–$400,000+, so confirm your path with a regulatory specialist. Phase 1, industrial design and concept, is $15,000–$75,000. Tooling and certification are paid separately, to the factory and the labs, and we suggest holding 10–20% above the core estimate for iteration and redesign.

How long does it take?

It depends on the product. Sleepmaxxer reached Kickstarter-ready hardware in 8 months. A product regulated as a medical device adds 6–12 months for the regulatory path.

Is my product a wellness product or a medical device?

It depends on your claims and the risk. Claims to diagnose, treat or prevent disease make it a device. Confirm with a regulatory specialist before you fix the claims on the box.

How do you design for comfort, fit and skin contact?

We start from the body: fit is tested across sizes and positions with prototypes, and we choose materials with skin contact and washing in mind. Sleepmaxxer was built for side, back and stomach sleepers. A lab then tests the materials against ISO 10993. We do not promise a test result.

What does a battery-powered product need to ship?

Transport testing (UN38.3) and cell safety testing (IEC 62133-2), plus FCC and CE if it has a radio. Certification across your markets typically runs $10,000–$50,000, paid to the labs.

Do you build prototypes?

Yes. Phase 2 delivers a working prototype, test reports, a first bill of materials and a cost model.

Can you help with manufacturing and tooling?

Phase 3 covers design for manufacturing, a vetted vendor shortlist with quotes, tooling recommendations, QC protocols and certification mapping.

Do I keep the IP?

Yes. An NDA is signed before you share anything, and every sketch, render and CAD file is yours.

Your guide to building better health and wellness products.

Practical reading on fit, skin-contact materials, certification, cost and manufacturing for health and wellness founders. Leave your details and we’ll send the guide PDF to your email. Tick the box to also get our newsletter.

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Bring us the idea before you fix the claim.

A sketch, a white-label sample or a prototype that needs testing. In 30 minutes we’ll tell you what it takes to get it tested, built and on the shelf, and roughly what that costs.

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