Success Stories

🏥 Healthcare – Faster FDA Approval for a Medical Device

Challenge: Regulatory submission delays for a liquid-based cytology system
Solution: Expert FDA-compliant documentation.  We structured and wrote acceptable documentation 
Result: Approval four months early, saving $4.5M in time to market and added expense for a product that could not be marketed

This Company’s experience with the FDA had been a long string of requests for more information or outright rejections of their paperwork.  At one time or another, the FDA had noted deficiencies incomplete or inconsistent documentation, poor-quality clinical evidence on their PMAs (Premarket Approval) application. The FDA issued notices detailing the deficiencies, and the Company believed they could not progress further without outside help.  That is when we were engaged.  Their IFUs (Instructions for Use) were likewise unacceptable and we created new ones.  Lack of familiarity with FDA requirements for acceptable documentation was one of the primary reasons for the notices of deficiency they received. We ensured their resubmission included valid scientific evidence demonstrating a reasonable assurance of the safety and effectiveness of the medical device for its intended use. Still, they were cited for minor, easily remediable documentation deficiencies.  They had received an approvable letter for their deficiencies, and received a decision in 60 days.  They estimated that an approval in less than 180 days saved them $4.5M. 

🏭 Manufacturing – Cost Savings from improved processes and documentation

Challenge: Outdated manuals and inadequate preparation for knowledge transition that would occur with one-third of the staff retiring within the next two years
Solution: Streamlined technical documentation and training; a knowledge transition program, based on adaptive continuity.
Result: Training time reduced down time by 40%, knowledge transition program anticipated to save at least $1.2M over three years

This precision aircraft parts manufacturer had experienced an increasing number of production delays, safety incidents, and quality control failures. They had struggled with incomplete technical documentation and inconsistent manufacturing procedures.  They were also facting a critical knowledge loss due to retiring employees that could impact their ability to meet stringent aerospace quality standards and maintain their certifications. Their existing documentation was fragmented, with critical manufacturing processes undocumented or documented in formats that were difficult for newer employees to follow. That is when we were engaged. We created comprehensive technical manuals with visual workflows, online gamified training modules, and step-by-step instructions. We developed an adaptive continuity program that captured institutional knowledge through structured interviews, process mapping, and mentorship protocols. They estimated that preventing just one week of production downtime through adequate training and our knowledge transition program would save them over $40,000, making the three-year projected savings of $1.2M conservative.

💼 SaaS Provider – 340% Lead Increase

Challenge: No qualified leads from technical white papers
Solution: Audience-focused content, new business case library
Result: Leads up 340%, $1.8M new revenue

This SaaS provider’s experience with content marketing had been disappointing campaigns, low engagement rates, and virtually zero qualified leads despite significant investment in technical white papers. They had published dense, feature-heavy documents that failed to resonate with decision-makers–content that was too technical for C-suite executives and too generic for technical evaluators. Readers abandoned them after the first page, and those who did complete them rarely converted into sales leads. The Company’s marketing team was under increasing pressure to produce results. That is when we were engaged. We created audience-specific white papers that addressed real business challenges.  We also developed compelling business case studies and restructured their content to follow a problem-solution-results framework that resonated with different stakeholder personas. We implemented a strategic content funnel that guided prospects from awareness through consideration to decision-making. They had been generating fewer than 12 qualified leads per month from their content efforts. Within four months they were consistently producing over 50 high-quality leads monthly. They estimated that the 340% increase in qualified leads directly contributed to $1.8M in new revenue within the first year.