🎓 MCQs (Multiple Choice Questions) – IOL Launch Plan

Q1: What certification must an IOL manufacturer have before selection?

a) CE or FDA approval only

b) GMP certificate only

✔ c) ISO 13485 + CE/FDA + Sterilization compliance

d) Local trade license only

Q2: What is the ideal number of KOLs to include in a pilot trial?

a) 1 surgeon

✔ b) 3–5 key surgeons across regions

c) 10–15 clinics

d) All major hospitals

Q3: When should Myanmar FDA registration be initiated?

a) After full commercial launch

b) After getting sales orders

✔ c) Before launch and in parallel with training

d) Only when customs clearance is needed

Q4: What type of training should staff receive before launch?

a) Only pricing and promotion

b) Only product placement

c) Soft skills and customer service

✔ d) Technical specs, handling, insertion, competitor comparison

Q5: What is a key message in the product launch marketing theme?

a) Cheapest IOL in the market

✔ b) “Sharper Vision, Safer Surgery — Affordable Innovation in IOLs”

c) Local brand, global quality

d) Fastest surgery turnaround

Q6: Which of the following is a post-launch KPI?

a) Number of factory visits

b) Number of demo kits printed

✔ c) Sales volume by region and month

d) Number of FDA meetings

Q7: Why is staff certification before launch important?

a) For government reporting

b) For marketing campaign claims

✔ c) To ensure confident product handling and surgeon communication

d) For incentive eligibility only

As your Business Development Expert, here's a structured Rollout Plan for Launching Your Intraocular Lens (IOL) Product, with detailed stages, timelines, and strategic focus areas—tailored for Myanmar and ASEAN markets, and designed for regulatory, KOL, and commercial success.

🗺️ IOL Product Launch Master Plan

📅 Total Timeline: 6–9 Months

(Assuming fast-track parallel execution for market entry)

1. Sourcing the Right Manufacturer (Month 1–2)

Objectives:

• Identify OEM/ODM manufacturers compliant with ISO 13485 & CE/FDA.

• Evaluate product specs (material, design, optic types: monofocal, multifocal, toric, etc.).

• Ensure support for private labeling or branding.

Actions:

• Shortlist 3–5 manufacturers (India, China, Europe).

• Conduct virtual/onsite audits (QA systems, sterilization processes, packaging).

• Request samples + compliance documents (CoA, CE, FDA, ISO 13485).

Deliverables:

• Supplier evaluation matrix

• NDA & MOU with selected supplier

2. Staff Training & Internal Capability Building (Start in Month 2–3, Ongoing)

Focus Areas:

• Product Knowledge (Optics, Material, Types)

• Surgical Techniques (Phaco, ECCE, IOL types)

• Sales Training (features vs competitors: Alcon, J&J, ZEISS, etc.)

• Regulatory Compliance (labeling, handling, storage)

Methods:

• Live Zoom trainings with manufacturer

• Internal LMS modules with quizzes

• Video-based training (custom Myanmar subtitles)

• Dry lab workshops for medical team

KPIs:

• 100% field team certified by Week 8

• 80% score avg on post-training assessments

3. Product FDA Registration (Myanmar) (Month 2–5)

Process Steps:

1. Prepare Dossier (Product Specs, IFU, CoA, Sterility Validation, ISO, CE/FDA)

2. Translate IFU/Label into Myanmar

3. Submit to Myanmar FDA (Device Division) via appointed agent

4. Answer technical queries and re-submit if needed

Estimated Time: 3–4 months depending on responsiveness

Deliverables:

• Myanmar FDA Certificate (Import & Sales License)

• MOA with regulatory agent

4. Product Launch Plan (Month 4–6)

Theme:

"Sharper Vision, Safer Surgery — Affordable Innovation in IOLs"

Activities:

• Soft Launch:

  • Initiate with 3–5 KOLs (see #6 below)

  • Feedback loop for quality & usability

• Official Launch Event:

  • CME-certified seminar or hands-on wet lab (partner with ophthalmic society)

  • Invite top surgeons, hospital buyers, procurement units

• Marketing Materials:

  • Printed & digital brochures in EN/MM

  • Launch video (highlight lens design, foldability, insertion)

  • Try-me pack (starter kit: injectors + sample IOLs)

• Channel Activation:

  • Sales incentive schemes

  • Bundle with surgical pack for tenders

  • Online inquiry via website/FB page

5. Post-Launch Follow-up & KPI Tracking (Month 6–9)

Sales & Impact KPIs:

• No. of IOL units sold per region/month

• Conversion rate of demos to bulk orders

• of surgeons converted to regular use

• Complaints or feedback % (within 1st quarter)

Tools:

• CRM dashboard (Odoo/Salesforce/Excel)

• Monthly review meetings with sales & service team

• Hospital feedback form after each delivery

Adjustments:

• Launch new sizes/designs based on market feedback (e.g., yellow-filter, toric)

• Review pricing or bundling models if uptake is slow

6. Pilot Trial with KOLs (Month 3–5)

Purpose:

Clinical feedback & early endorsements to build trust

Target KOLs:

• 3–5 top cataract surgeons in Yangon, Mandalay, and Taunggyi

• Include one government hospital (for credibility)

Approach:

• Provide free IOL sets (3–5 per KOL)

• Collect surgical notes & photos (with consent)

• Ask for testimonial quote/video after trial

Incentives:

• Acknowledgment in launch event

• Honorarium or speaker invitation for CME

KPI:

• 80% of KOLs recommend for broader use

• 1 video + 3 quotes to use in launch materials

📊 Summary Timeline (Gantt-style)

Let me know if you'd like this:

• As a PowerPoint Launch Deck

• In Excel Timeline Format

• Or as a Project Management Board (e.g. Trello/Notion)

I can also help draft the product brochure, KOL invitation letter, or training slide deck next.

Here are FAQs and MCQs based on the IOL Product Launch Plan outlined earlier — covering manufacturer sourcing, training, FDA registration, launch, follow-up KPIs, and KOL trials.

📘 FAQs (Frequently Asked Questions) – IOL Product Launch

(Dual Language – English + Myanmar)

Q1: Why is sourcing the right manufacturer important in an IOL launch?

A1: To ensure product quality, ISO/CE/FDA compliance, and post-market safety.

အကြောင်းအရင်း: ထုတ်လုပ်သူအမှန်ကို ရွေးချယ်ခြင်းသည် ISO/CE/FDA လိုအပ်ချက်များနှင့် အရည်အသွေးကို အာမခံရန် အရေးကြီးသည်။

Q2: What documents are required for Myanmar FDA registration of IOLs?

A2: Product specs, IFU, sterilization report, CoA, ISO 13485, CE/FDA certification.

အကြောင်းအရင်း: မြန်မာ FDA မှတ်ပုံတင်ရန်အတွက် IFU, CoA, Sterile Validation, ISO, CE/FDA စသည်တို့လိုအပ်သည်။

Q3: What training should the sales and clinical team receive before the launch?

A3: Product specs, handling, insertion technique, competitor comparison, safety protocols.

အကြောင်းအရင်း: လက်ဖက်ရည်အဖွဲ့သည် ထုတ်ကုန်အသေးစိတ်၊ ချစ်ခြင်းနည်း၊ ဝေဟင်လျှော့နည်း၊ ယှဉ်ပြိုင်သူများနှင့်ယှဉ်ပြိုင်နည်း၊ လုံခြုံမှု စနစ်များကို လေ့ကျင့်သင့်သည်။

Q4: Why are KOL trials important before the full launch?

A4: To validate usability and build early trust through endorsements.

အကြောင်းအရင်း: အကျိုးသက်ရောက်မှုကို စစ်ဆေးရန်နှင့် အကြို ယုံကြည်မှုတည်ဆောက်ရန် KOL တွေမှ အသုံးပြုမှု ပြုလုပ်ခြင်းသည် အရေးကြီးသည်။

Q5: What are key KPIs to track post-launch?

A5: Sales volume, surgeon adoption rate, complaint rate, and conversion from trials.

အကြောင်းအရင်း: Launch ပြီးနောက် KPIs များမှာ ရောင်းအားပမာဏ၊ ဝန်ထမ်းအသုံးပြုမှု၊ တုံ့ပြန်မှုနှုန်းနှင့် Trial မှ customer ပြောင်းလာမှု ဖြစ်သည်။

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