§1What this business is

An incentive spirometer is a hand-held lung exerciser: the patient breathes in through a tube and lifts colour-coded balls marked for 600, 900 and 1,200 cc. It helps patients after surgery and people with COPD. The unit moulds the body, makes corrugated breathing tubes, adds the mouthpiece, connector and balls, and packs it. The report plans 120 units a day.

Capacity: 120 units a day (10-hour shift); 40% use in year 1.

§2Is it right for you?

Who it is for

Someone from medical disposables or plastics moulding with hospital-supply contacts.

Who it is not for

Someone not ready for medical-device rules and quality systems.

Advantages

  • Hospitals use them after surgery — repeat demand
  • Simple plastic product, low unit cost
  • Growing home-care and respiratory-health market (report: USD 799.5 million in 2019)
  • Same moulding set-up can make other disposables

Drawbacks

  • Needs a medical device licence before selling
  • Hospitals and distributors demand quality certificates
  • Cheap imports compete
  • High machinery cost (₹18.75 L) for a simple product

Skills you need

  • Injection moulding
  • Clean assembly and packing
  • Medical-device documentation
  • Hospital and distributor sales

Why difficulty 4/5: Medical-device licensing and hospital sales take time and paperwork.

§3Market

Who buys

  • Hospitals and nursing homes
  • Patients after surgery and COPD patients (home care)
  • Physiotherapy clinics

How it sells

  • Surgical and medical-supply distributors
  • Chemists and online pharmacies
  • Hospital tenders

Good to know

  • The report quotes the spirometer market at USD 799.5 million in 2019, growing 9.7% a year to 2027.

§4Raw material & machinery

ItemQtyCost
Vertical mixer1₹1,25,000
Injection moulding machine1₹5,50,000
Automatic corrugated pipe making machine1₹6,00,000
Planetary saw1₹4,00,000
Paper printing machine1₹1,00,000
Industrial cooling unit1₹1,00,000

From: PMEGP sample project report — Spirometer (prepared by Udyami/Samadhan)

  • Medical-grade thermoplasticfor the body; raw material ₹34.56 L in year 1 (report)
  • EVA corrugated medical breathing tubesmade in-house on the pipe machine
  • Mouthpiece and 12 mm OD pneumatic air-line connectorbought-in parts
  • Coloured polyethylene balls, 1–6 gthree per unit, colour-coded

From: PMEGP sample project report — Spirometer (prepared by Udyami/Samadhan)

§5Licences & registration

  1. Udyam registration
  2. GST registration
  3. Medical device manufacturing licence under the Medical Devices Rules, 2017 (applied for on the CDSCO online portal)
  4. ISO 13485 quality system (buyers usually ask)
  5. State Pollution Control Board consent to establish and operate

We can do this registration for you

§6Schemes & subsidies

PMEGP (the report is a PMEGP sample), CGTMSE and Stand-Up India for SC/ST or women founders. Above MUDRA's ₹20 lakh limit.

§7Money

How the investment is worked out: Samadhan report: plant & machinery ₹18.75 L, furniture ₹1.00 L, working capital ₹4.25 L = ₹24.00 L (term loan ₹17.78 L, working capital ₹3.82 L, own money ₹2.40 L); land own or rented.

Working capital: Working capital ₹4.25 L (bank ₹3.82 L); 10 days of stock and 10 days' credit.

Year not printed on the report — check current machinery and material prices.

How to prepare a loan file

§8Export potential

Get an Import Export Code (IEC) from DGFT before exporting.

§9Risks — where people fail

  • Licence delays
  • Product recalls or complaints
  • Price pressure from imports
  • Plastic resin price swings

§1030 / 60 / 90-day plan

A general plan that applies to any business. A plan for this business will be added after research.

  1. Days 1–30: Visit a working incentive spirometer manufacturing unit, ask 10 buyers about price and quantity, and get quotations from 3 suppliers.
  2. Days 31–60: Udyam and the licences you need (Udyam registration, GST registration), a project report (DPR), and the scheme or loan file.
  3. Days 61–90: Space and machines, trial production, and first deliveries to 10 customers.

§11Who to connect with

Not verified yet

Associations, clusters and training institutes — the directory is being built. Connect

§12Watch

There is no episode on this business yet. Shows are coming soon on the Podcast page.

Want to start Incentive Spirometer Manufacturing?

DPR, loan file or registration — ask us on WhatsApp.

Get a DPR / loan file made

Sources

  1. PMEGP sample project report — Spirometer (prepared by Udyami/Samadhan)

Data review: 6 October 2026. Spotted a mistake? Report it. For information only — not legal or financial advice.