US MedTech Startup
Sector: Medical Devices / Healthcare
Region: United States Engagement
Type: PoC Program – 2 days/week (Builder Plan)
Duration: 12 weeks
The Challenge
A US-based MedTech startup developing a novel diagnostic device wanted to expand into Japan – a key market for advanced healthcare technologies. However, they faced a complex regulatory environment, unclear PMDA (Pharmaceuticals and Medical Devices Agency) processes, and a lack of local knowledge. Without Japanese- language support or in-house expertise, navigating compliance and clinical readiness risked months of delay.
Our Approach
Inspanzo matched the startup with a bilingual expert – a former regulatory director at a global healthcare firm with experience navigating the PMDA approval process. The expert quickly reviewed the client’s product category, identified relevant regulatory pathways, and created a roadmap for clinical trial preparation. Work was split into three phases:
• Weeks 1-4: Regulatory landscape review, stakeholder identification, and PMDA mapping
• Weeks 5-8: Localisation of documentation, preparation of submission materials
• Weeks 9-12: Pre-review of documents, consultation readiness, and risk mitigation planning
The Outcome
• Regulatory pathway mapped in just 4 weeks
• Full localisation of submission materials completed
• $120K+ in cost savings by avoiding a 3-4 month delay in trial timelines
• Internal team fully briefed and confident in next-stage regulatory steps
“Inspanzo helped us demystify the PMDA process. Their expert didn’t just advise – he executed. This was the fastest and most focused 12 weeks of regulatory work we’ve done.”
