Case Study: Apical Instruments achieves rapid ECO turnaround from months to days and improved regulatory compliance with Arena Solutions

Why Quality Execs Prefer an all-in-One Product Development Platform

Apical Instruments, a Redwood City–based medical device design and manufacturing partner, faced mounting quality and compliance risks from outdated, paper‑based processes and disconnected systems. With Director of Regulatory Affairs & Quality Assurance Kim Khoe leading audits and regulatory submissions, the company struggled with lack of lifecycle visibility, siloed PLM and QMS tools, long ECO cycles, and exposure to FDA and other regulatory penalties.

Apical adopted Arena’s unified product development platform with an embedded QMS and connected component databases to manage BOMs, documents, DHF/DMR, ECOs, CAPA and compliance records. The change cut ECO cycles from months to days, eliminated costly manual file sharing (saving over $10,000), removed expensive IT overhead (recouping ~$100,000), improved audit readiness and compliance approvals, and delivered faster access to traceability and component compliance (e.g., RoHS documentation that would have cost ~$20,000).

Apical Instruments

Bruno Strul

Chief Executive Officer