Company: Confidential pre-IPO medical-device manufacturer
Board base: Surat, Gujarat
Sector: Surgical implants, disposables and procedure-enabling devices
Appointment: Independent Director, Non-Executive
Intended committees: Audit Committee Chair; Risk, Quality & Product Safety Committee
Time commitment: 30–36 days annually through the IPO and first reporting year
Application deadline: 2 October 2026
Expected appointment: December 2026
Company context
The company designs and manufactures implantable and single-use medical devices for orthopaedic, trauma, surgical and hospital applications. It sells through domestic distributors and institutional tenders while expanding registrations and channel partnerships in regulated export markets. A new manufacturing block, clean-room capacity and automated lines form part of the pre-IPO investment case.
Market hint: A western India manufacturing base, surgeon-led product development, growing implant exports and a mix of owned brands and contract manufacture may resemble several Indian device companies. Product families and destination markets are deliberately broad.
Board mandate
The director will chair the transition from entrepreneurial quality management to public-company product stewardship. The Board must understand not only whether a device can be sold, but whether design history, clinical evidence, process capability, traceability and post-market surveillance support every claim throughout the product life.
Strategic priorities
- Establish design-control gates from user need and risk analysis through verification, validation, clinical evidence, transfer, change control and post-market review.
- Separate regulatory registration from commercial readiness; no geography should launch without distributor capability, complaint handling, vigilance, recall and liability arrangements.
- Require product-family dashboards for nonconformance, sterilisation, bioburden, yield, rework, supplier defects, complaints, adverse events and field corrective action.
- Govern implant traceability from raw material and machining lot through finishing, cleaning, sterilisation, packaging, hospital and patient record.
- Examine surgeon consultancy, training, evaluation units, travel support and distributor incentives for genuine clinical need, documentation and anti-bribery controls.
- Review imported equipment, critical materials, sterilisation capacity, test laboratories and single-source suppliers through qualified alternatives and recovery-time scenarios.
- Stage-gate clean-room and automation capex by process validation, demand qualification, trained personnel, utilisation, cash ramp and downside return.
- Challenge offer-document claims on market size, registrations, capacity, R&D, product pipeline, clinical differentiation, exports and use of proceeds.
- Strengthen revenue recognition, distributor stock, returns, consignment inventory, warranties, tender receivables, capitalised development and regulatory provisions.
- Build direct Board access for quality, regulatory, internal audit and product-safety leadership.
Decisions expected at Board level
- Whether an export launch may proceed when registration is complete but distributor vigilance capability is immature.
- Whether a recurring complaint requires voluntary field action before causality is fully established.
- Whether a surgeon relationship creates unacceptable influence over procurement or reported product performance.
- Whether IPO-funded capacity should be delayed because validation and customer qualification lag equipment installation.
- Whether product-development cost and acquired technology remain recoverable under a changed regulatory pathway.
Candidate profile
Essential: Former medical-device, medtech, diagnostics, pharmaceutical-quality or safety-critical manufacturing CEO, COO, CFO, quality/regulatory executive or regulator; experience with Board/Audit oversight, global quality systems, recalls or field action; fluency in capex, validation, product liability and public disclosure.
Preferred: implantable devices, sterile products, US/EU registrations, surgeon engagement, IPO or first-year listing experience, international product-liability governance.
Eligibility and conflicts
Active IICA Databank inclusion and verified proficiency-test or exemption status are mandatory. Candidates must satisfy all independence and committee requirements and disclose interests involving surgeons, hospitals, distributors, tender authorities, test laboratories, notified or certification bodies, equipment vendors, suppliers, auditors and competitors.
First-year outcomes
- A Board-approved product-safety case and change-control discipline for every material product family.
- Full implant and complaint traceability with a tested recall simulation.
- Capex release tied to validation, qualified demand and cash evidence.
- Offer-document claims supported by controlled source records.
- Independent escalation from quality and regulatory leaders to the committee chair.