Our Work: Fractional Support

Digital Health Startup Uses TRCG for Fractional and Flex Quality Support

Background

A digital health startup, having recently received clearance for its initial solution, was developing a second innovative complement solution. Operating with a minimalistic Quality Management System (QMS) appropriate for the early stage of the company, the startup needed its QMS to mature along with their products. Typical of startups, they faced constraints due to limited funding and a growing list of needs for the organization. With most of their budget allocated towards development, the organization ran a lean operational structure. Recognizing the need for growth and increased regulatory scrutiny, the startup searched for an experienced quality leadership and flexible capacity solution to meet these demands.

Client Challenge

With their changing business circumstances, and increased market exposure, this startup client had several challenges they hoped to address, including:

  • Audit Support: Recognizing their new regulatory exposure, and lack of experience in audit scenarios, the client needed an experienced leader to guide the organization and Subject Matter Experts (SMEs) through interfaces during external audits from both regulators and clients.

  • Independence: Due to the limited size of their existing QA team, the company had trouble maintaining independence in both Approval and Audit activities.

  • Budget Constraints: With a new product on the market, and a complement in development; the startup’s competing budget allocations constrained staffing commitments.

  • Fluctuating Workload: Reflecting the unpredictable nature of their dynamic environment, the Quality team experienced fluctuating work demands. These ebbs and flows, combined with the complexities of their AI solution made it challenging to find a flexible staffing solution without significant ramp-up time.

  • Digital Domain Expertise: Their product portfolio made it necessary for any staffing solution to include deep expertise in Artificial Intelligence (AI), Clinical/Care Decision Support (CDS) and Software as a Medical Device (SaMD) to guide their projects.

  • Quality System Evolution: With their growing and maturing business, the client needed a Quality System to mature along with them, without maturing too quickly and outgrowing the company.

TRCG Approach

TRCG addressed these challenges with a tailored approach:

  • Fractional VP of Quality: Meeting the need for deep domain expertise, TRCG provided a fractional Vice President of Quality with over 10 years of AI, CDS, and SaMD experience to lead the in-house quality team and manage high-risk topics.

  • Audit Support: TRCG provided peace of mind by ensuring the availability of personnel experienced in both front and back room leadership, with extensive knowledge of FDA and Notified Body procedures.

  • Quality System Evolution: Our associates worked to revise the existing quality system to better support the development of the new AI-enabled regulated Medical Device solutions.

  • Flexible Resource Allocation: TRCG offered a support framework with additional resources familiar with the organization added (or removed) as needed, adapting to the ebbs and flows of the business.

Results

The fractional (retainer) support approach yielded broad results for our client:

  • Cost Efficiency: TRCG's support provided the client with top-tier digital solution and regulatory compliance experts. The combined support provided clarity, capacity, independence, and experience at a fraction of the cost of maintaining a full-time headcount.

  • Flexible Capacity: TRCG maintained a team of associates familiar with the clients products and processes, enabling the ability to scale independent resources up or down as needed. This framework helped the client manage projects and incidents without having to maintain long-term staffing commitments, resulting in a more responsive organization while maintaining a favorable cost position and avoiding employee dissatisfaction associated with potential layoffs or burnout.

  • Optimized Quality System: Throughout the engagement. our associates revised the quality system, optimizing it for Good Machine Learning Practices, and to produce regulatory necessary and helpful design artifacts through normal operation. This right-sized QMS supports successful regulatory submissions while keeping non-value-added overhead to a minimum. Thus minimizing the need for future regulatory submissions and systemically driving the development of higher-performing solutions.

  • Audit Readiness: Using TRCG audit experience, an external audit preparedness kit was developed. Developing the kit ensured the organization knew what to do in the event of an inspection (including front and backroom set-up and contacts), identified a set of Subject Matter Experts (SMEs) for a number of key topic areas, and catalogued the most helpful information.

Why TRCG

TRCG's associates are a team of seasoned Quality and Regulatory professionals with decades of industry experience. The Group’s deep Quality Management and Audit experience and history with both industry giants and agile startups, makes TRCG the ideal fractional support partner. We have successfully designed, maintained and ultimately defended quality systems with regulatory authorities. Our comprehensive approach provides not only compliance assurance, but makes strategies for building a value-added quality system a priority; driving better product performance and customer satisfaction.

With over a decade of Artificial Intelligence and Machine Learning (AI/ML), Clinical/Care Decision Support Systems, and Software as a Medical Device (SaMD) experience, TRCG has the “Digital DNA” to unlock the insights necessary to help you address quality issues and prepare for regulatory inspections. Our expertise in assessing risk and evaluating quality system capabilities ensures that your organization can promptly identify and correct underlying problems, securing regulatory compliance and enhancing overall effectiveness for you Digital Health and MedTech solutions.