Complete Solutions: New Milestones.
From Executive Vision to Worldwide Market Access for a Consumer Healthcare Multinational
As a worldwide leader in their category of health-related consumer products, our Client had manufacturing and commercial operations in all the major world markets.
Although their product innovations had been studied and published in numerous investigator-initiated postmarket studies, their experience and capabilities in regulated premarket clinical development was limited. Also, their breakthrough product line under development included embedded systems, proprietary software, self-learning user interfaces, and electromechanical components- all of which were new territory for their global R&D team.
Having delivered success in prior complex engagements, we were invited by our Client’s executive leadership to present our approach at their US headquarters. At the outset of the meeting, our Client CEO expressed frustration with the piecemeal projects and overly complex study designs proposed by competing firms. We presented our integrated, technology-enabled approach, plan, and qualifications, and our firm was engaged in writing before the meeting ended.
As usual, we launched a secure, collaborative team portal for sharing project status, milestones, documentation, and alerts. And to properly design the Clinical Development and Global Market Clearance Plans, we reviewed all the key program documentation. We shared our experience in medical device embedded systems, software, electromechanical components, and consumer products, and our recommendations were integrated into the risk analyses and risk management plans. We also configured a full set of our internally-developed clinical operations procedures for release within our Client’s quality management systems.
The breakthrough product line included both consumer and professional (hospital) product lines, so we designed an integrated, parallel-process Clinical Development Plan that eliminated any duplicative efforts in the evaluation and validation of product performance, safety, usability, labeling comprehension, training, reliability, security, and other endpoints. We addressed all the development requirements with a small number of straightforward, short-term, well-focused studies, and we designed a parallel-process Global Market Clearance Plan that enabled simultaneous regulatory submissions.
Based on our experience with consumer medical devices, we targeted and qualified clinical study sites to achieve appropriate demographic and multilingual representation. Our recommendation to reposition the previously-targeted, oversubscribed key opinion leader academic sites out of the critical market clearance path and into postmarket investigator-initiated roles was adopted. And the enthusiastic and appreciative investigators from the high-volume regional sites we identified energized the Client’s development and commercial teams.
Based on our experience with embedded systems, software, and electromechanical components, we designed and drafted clinical study protocols to include initial, brief study pilot periods, after which both clinical data and electronic product data would be simultaneously reviewed and analyzed. And we designed the studies to be adaptive, so that important learning could properly make the clinical study operations run with high efficiency. Study protocols included product evaluations in hospital, outpatient, and home settings. Prior to final release, we achieved US FDA concurrence on our plans and protocols.
We rapidly executed all site qualification, contracting, preparation, and training, we designed all patient recruiting materials and advertising, and we led all IRB submissions, support, and reviews. And we configured, validated, and released clinivation ClinicalSuite EDC, CDM, and CTMS applications for each study protocol. Because our Client had not anticipated the need for consumer-design, multilingual Quick Reference Guides, we designed and produced them using lessons-learned and benchmarks from our previous experience in consumer medical devices.
We initiated study enrollment and, as anticipated, a number of unexpected issues surfaced during the review and analysis of the study pilot periods. Because the pilot periods had been previously discussed with the investigators, they did not lose confidence when the clinical study operations were briefly suspended. And the IRBs were not surprised when some minor protocols amendments were submitted, and their subsequent reviews were completed quickly.
We rapidly identified probable root causes for the issues, and we determined that the product’s DFMEA, systems verification, electromechanical component testing, and other core processes and documentation needed important revisions. Communicating our findings with diplomacy, we immediately dispatched two of our specialists to our Client’s international R&D and production headquarters. There they worked day and night with our Client team to correct the component defects, revise the software, processes, and documentation, and release a validated, pre-production run of new investigational product.
Upon restart, the clinical study operations, data and study monitoring, and data management advanced rapidly to data lock. Within days, we completed the statistical analysis and released the clinical study reports. Working in parallel, we drafted and assembled the US FDA submissions, and developed base-case and upside-case product claims.
For several months our Client’s international marketing team had worked with an outside agency to develop very creative product packaging, user guides, and advertising materials which, unfortunately, had no chance of success with US FDA reviewers. Communicating our findings with diplomacy, and providing educational materials, we requested certain revisions to the product labeling. Avoiding lengthy debate, and with the support of our Client CEO, we redrafted the product labeling from the electronic files and completed the US FDA submissions without delay.
We achieved simultaneous US FDA market clearances of the consumer and professional product lines in fewer than 70 days of regulatory review, and most of our upside-case product claims were allowed. Despite the product revisions, we advanced from initial engagement to US FDA approvals in fewer than 11 months. International market clearances followed quickly, and positive study results were published and presented.
IMPACT: BUSINESS GROWTH AND INNOVATION
The breakthrough product lines now lead their categories worldwide.