To be successful, Medical Technology (MedTech) companies must constantly evolve in order to meet patients’ needs. At the same time, external capital pressures are requiring companies to be more efficient with their money. This dynamic puts increased pressure on research and development (R&D) teams to find more efficient, cost-effective paths from development to market while ensuring the safety and efficacy of their products. One approach organizations are taking to optimize operational efficiencies is an outsourced contract research organization (CRO) model.

Understanding the Shift in R&D – Why Companies are Moving to an Outsourced CRO Model

The nature of scientific services is shaped increasingly by the evolving guidelines and requirements set forth by agencies such as the FDA and other global regulatory bodies. This shift necessitates constant vigilance and adaptability from device and drug manufacturers to stay current with regulatory requirements and adjust their practices accordingly.

Simultaneously, the rapid pace of technological innovation requires keeping up with changing scientific methods and approaches. The commercialization of cutting-edge technologies like cell and gene therapies, CRISPR gene editing, and proteomics has pushed the boundaries of what is possible. These advancements have not only opened up new avenues for research but have also created a pressing need for MedTech organizations to update methodologies and capabilities accordingly.

As a result, the modern MedTech R&D landscape operates at a dynamic interplay between compliance and innovation that requires a blend of dedicated support and forward-thinking expertise found in contract research organizations.

Several factors are driving companies to outsource R&D:

• Resource Constraints: Companies lacking a workforce with the experience, expertise, capabilities, or capacity to handle the work need a solution without a significant time or cost investment. In addition, the necessity for specialized facilities is costly and time-consuming to bring online. CROs offer diverse scientific and technical skills and facilities to fill staffing gaps through specialized knowledge and infrastructure.

• Improved Cost Savings: Outsourcing eliminates the need for extensive in-house infrastructure and staff recruitment, potentially leading to significant cost savings. In addition to these savings, CRO pricing models can help enhance budget predictability and reduce overall R&D costs.

• Ability to Focus on Core Competencies: By delegating research tasks to CROs, R&D companies can concentrate on their primary strengths in research and product development, potentially accelerating time-to-market.

• Increased Scalability: Contract research organizations eliminate the cost of hiring full-time employees or specialized teams and laying them off when no longer needed. This greater flexibility in resource allocation enables organizations to scale research efforts up or down.

• Preference: A handful of labs choose not to conduct specific tests, work with certain materials, or complete lab work in-house for specific focuses (such as biology), so many have shifted to a CRO partner who has the ability, team, and facilities to take it on.

• Faster time-to-market: CROs can often execute projects to shorter timelines due to their focused expertise and established processes, enabling R&D teams to take products from lab to market faster. 

However, finding a CRO partner who can answer the call has become increasingly challenging as clinical and preclinical CROs have merged into a handful of large, dominant players in the industry. While this consolidation has led to increased resources and broader service offerings, it has not been without its drawbacks.

These mergers can often result in reduced customer service quality as larger organizations struggle to maintain the personalized attention that smaller firms can provide. Moreover, these giant CROs face mounting pressure to focus on high-volume, standardized “commodity” services to maintain profitability and satisfy shareholders. This creates a need for specialized CRO models equipped to offer tailored, high-touch services and innovative solutions. iFyber can provide that support

Exploring the Benefits of Outsourcing Preclinical Research

Preclinical research and testing are critical stages in the product development process. Outsourcing these activities to CROs can provide numerous advantages, such as:

• Enhanced flexibility and scalability enable companies to swiftly adjust their research efforts and resources to meet project demands, thereby avoiding delays associated with internal scaling.
• Optimized workflows and processes that significantly shorten timelines and accelerate lab-to-market speed while maintaining product safety. Unlike academic labs that operate on semester or yearly schedules, CROs work on timelines measured in weeks and months, potentially accelerating development processes.
• Focused expertise enables experiment designs grounded in solid statistical and scientific principles to deliver data and reliable lab results for informed decision-making.
• Ready-to-go teams who are prepared to start immediately and experienced enough to ramp up quickly, eliminating the months it might take to set up an in-house lab and train personnel.

While there are many benefits to partnering with a contract research organization, there are also several challenges to consider, including communication hurdles, intellectual property concerns, quality control, and potential issues with oversight of outsourced activities. These can create challenges with maintaining consistent standards and potentially impact project outcomes.

Addressing these challenges requires diligence, clear communication, and robust management practices, so selecting the right CRO partner is essential.

The CRO Trifecta: Experience, Expertise, and High-touch Support 

A combination of flexibility, efficiency, regulatory compliance, and specialized support make CROs invaluable partners in the R&D landscape and can help bring your product to market faster while maintaining reliability and safety. However, it all starts with selecting the right partner. 

When selecting a partner, consider these best practices:

1. Services Alignment: Look for CROs that offer the testing or services your company needs, whether that is moving tests involving bacteria, yeasts, and molds out of the lab to avoid contamination or biocompatibility testing for when there are failures. A CRO should bring the knowledge and capability to execute the required tests successfully.
2. Compliant and Quality Standards: An in-depth knowledge of regulatory guidelines and compliance requirements can help minimize the risk of non-compliance and delays. Evaluate CROs who can help simplify the process to create and implement a manageable, tailored, cost-effective plan that makes sense for your specific product and business objectives.  
3. Project Execution and Fit: Communication, transparency, and timeliness build trust and are essential to a successful relationship. Science often has many unknown variables, so choosing a partner who is a fit culturally can help navigate any speedbumps. Plus, transparency and collaboration make it easier to hold the CRO accountable.
4. Focused Involvement: Choosing a partner with the scientific expertise to design experiments based on solid statistical and scientific principles can help ensure your delivered data that informs and reliable results in the laboratory.
5. Track record: Review the CRO history of successful project completions and client satisfaction. Scientific acumen and project completion are important, but how they treat their customers can speak volumes. 

The iFyber Advantage

As companies aim to improve timelines, increase cost-effectiveness, and power scientific breakthroughs, partnering with a trusted and experienced contract research organization can help. 

iFyber strives to create precision in preclinical research through a combination of scientific expertise, cutting-edge facilities, and a high-touch, client-first approach that accelerates R&D efforts and enhances competitive edge. With our team of multidisciplinary scientists and a unique PODS approach, your lab can achieve data-driven insights and reliable results that streamline product development.

Ready to explore how iFyber can enhance your R&D? Contact us today to discuss your needs and discover tailored solutions to drive innovation.