Writing for Results

Our Work In Action: Three Core Technical Writing Case Studies

REGULATORY WRITING CASE STUDY

510(k) Resubmission: From Deficiency Letter to FDA Clearance in 60 Days

A mid-sized medical device manufacturer’s initial 510(k) submission received an FDA deficiency letter citing insufficient clinical data and unclear substantial equivalence arguments. The company faced a six-month delay costing $300K+ in lost early-market revenue.

The Challenge:
The manufacturer had 60 days to respond comprehensively while the window of opportunity was closing. Standard regulatory experience wasn’t enough—they needed strategic positioning that would turn the reviewer’s concerns into an approval pathway.

What We Did:
We analyzed the specific deficiency letter language to identify reviewer concerns, restructured the clinical evaluation section with additional peer-reviewed literature support, strengthened the substantial equivalence argument with head-to-head comparison data, and refined the Instructions for Use to address labeling questions. The result was a comprehensive response strategy that made the company’s argument compelling to FDA reviewers.

The Results:

• FDA clearance achieved in 60 days

• Company entered market on original timeline, capturing first-mover advantage

• Estimated revenue impact: $2.5M+ over 18 months

• Regulatory timeline accelerated by 6 months vs. standard deficiency letter resubmission

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RFP/PROPOSAL CASE STUDY

RFP Win: Engineering Firm Increases Proposal Win Rate from 18% to 42%

An architecture and engineering (A&E) firm was winning fewer than one in five government proposals despite strong technical qualifications and relevant past performance. The firm had experienced writers, but proposals were losing at the evaluation stage—not on technical merit, but on strategic positioning and compliance.

The Challenge:
The firm needed to understand why technically sound proposals were losing to competitors. The issue wasn’t the content; it was the strategy. Proposals weren’t directly addressing evaluation criteria, weren’t highlighting past performance advantages, and weren’t telling a compelling story about capability to execute.

What We Did:
We implemented a SARRM-based strategy (Situation, Action, Result, Relevance, Measurable): every proposal section directly mapped to evaluation criteria. We developed compliance matrices ensuring no criterion was missed. We created past performance narratives that demonstrated relevant experience without burying the message. We reframed technical descriptions to emphasize capability and risk mitigation, not just features.

The Results:

• Win rate improved from 18% to 42% (more than doubled)

• Average contract value increased due to better targeting of opportunities

• Proposal development time decreased (clearer process)

• Improved team confidence in competitive bidding strategy

• Estimated revenue impact: $3M+ over two years from increased contract awards

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TECHNICAL MANUALS CASE STUDY

Service Manual Revision: 35% Reduction in Support Calls, Eliminated Liability Risk

A manufacturing company’s service manual—written years earlier by internal staff—generated constant customer support calls, field service complaints, and unresolved warranty issues. The company faced potential liability exposure: customers couldn’t follow procedures, service technicians improvised solutions, and equipment failures could result in injury claims.

The Challenge:
The existing manual covered procedures but wasn’t actually usable. Technical language was dense, steps were incomplete, diagrams were unclear, and safety warnings were buried in paragraph text rather than highlighted. Customers and technicians couldn’t follow instructions, leading to increased support costs, customer frustration, and liability risk.

What We Did:
We completely restructured the manual using Simplified Technical English (STE) standards: shorter sentences, active voice, numbered steps with visual callouts, safety warnings in highlighted sections, and clear troubleshooting guidance. We added diagrams and flow charts to supplement text. We tested procedures with both experienced technicians (who could catch gaps) and less experienced users (who could identify unclear language). The result was documentation that actually guided users through procedures correctly.

The Results:

• Support calls decreased 35% (fewer “how do I?” inquiries)

• Field service time decreased (technicians could follow procedures without workarounds)

• Warranty claims decreased (correct procedures prevented failures)

• Liability exposure reduced (clear safety instructions, documented procedures)

• Customer satisfaction improved (documentation actually helped)

• Estimated cost savings: $150K+ annually in support and warranty costs