The life sciences and diagnostics industries are evolving rapidly, bringing both exciting opportunities and complex challenges. As software development is at the heart of what we do at BioSistemika, we wanted to gain deeper insights into the key hurdles organizations face and how emerging trends and technologies can help overcome them.
To do so, we reached out to industry professionals and asked them to share their perspectives. What are the biggest challenges in software development holding organizations back? And how can innovation transform these obstacles into opportunities?
Let’s dive into the insights we uncovered.
Survey respondents
We gathered insights from various industry professionals to ensure a well-rounded perspective on software development in the life sciences and IVD industries. The survey engaged key decision-makers and stakeholders, including:
- CEOs and CTOs – Offering strategic insights on how software development aligns with long-term business objectives and industry trends.
- Product and Project Managers – Sharing hands-on experience managing software development lifecycles, from ideation to deployment, while balancing innovation and compliance.
- Software Architects – Providing technical expertise on system design, integration challenges, and scalability considerations.
- Sales Managers – Highlighting the commercial implications of software development decisions, customer demands, and market trends.
With professionals from pharmaceutical companies, medical diagnostics, life sciences, and healthcare sectors participating, the survey captures industry-wide challenges and opportunities that influence the trends in software development.
Key challenges in software development
When asked about the main challenges in software development in their projects, 50% of respondents highlighted regulatory compliance as their primary concern—a sentiment echoed in many of our other industry conversations.
Integration with existing systems ranked second, with 43.2% of respondents identifying this as a hurdle, followed by data security (36.4%) and a lack of software engineers (31.8%). These challenges underscore the complexities of developing innovative yet compliant software solutions in a competitive market.
The figure below illustrates these challenges and provides a clear snapshot of the hurdles faced by the industry.
Figure 1: Key challenges in software development across the industry
Regulatory compliance remains a significant challenge, particularly with the growing emphasis on adhering to standards such as FDA 21 CFR Part 11:
- One-quarter of the companies identifying this as a challenge plan to implement FDA 21 CFR Part 11 features, such as user management, electronic signatures, and audit trails, within 6 to 12 months.
- Additionally, 27.3% of respondents indicated that they have already incorporated these regulatory requirements into their devices, signaling progress but also highlighting the varying stages of readiness across the industry.
How can these challenges be addressed? Let’s explore how emerging trends in software development provide solutions and opportunities to overcome these obstacles.
Trends in software development in life sciences and IVD
In the life sciences and IVD sectors, the rapid technological evolution is transforming how software development is approached. IT professionals recognize that their roles and responsibilities are shifting in response to these advancements, particularly in an increasingly digital and contactless world.
When asked which trends will dominate laboratory software development in the next five years, respondents highlighted several transformative forces:
- Artificial intelligence (AI) and machine learning (ML): 77% of participants identified them as pivotal to driving diagnostics, automation, and data analytics.
- Robotics and laboratory automation: Recognized by 70% as essential for enhancing operational efficiency.
- Cloud-based solutions: Emphasized by 50% as crucial for scalability and integration.
- Blockchain technology: Still nascent, with only 13.6% of respondents acknowledging its current use.
Figure 2: Emerging trends shaping the future of laboratory software development
AI and ML are particularly dominant in the pharmaceutical industry, with 83% of respondents identifying them as key trends in software development. Meanwhile, robotics and laboratory automation are highly prioritized in the life sciences sector, where 79% of respondents highlighted them as important trends.
To capitalize on these trends, organizations should consider the following strategies:
- Invest in talent and training: Developing expertise in AI, machine learning, and robotics is crucial. This can be achieved by providing ongoing training to existing staff and collaborating with external experts.
- Adopt scalable cloud infrastructure: Transitioning to cloud-based solutions can enhance flexibility and scalability. Selecting platforms that integrate with existing systems and support future growth is essential.
- Foster a culture of innovation: Encouraging a forward-thinking mindset within the organization can facilitate the adoption of new technologies and processes, ensuring the business remains agile in a rapidly evolving landscape.
Many companies already explore these trends by staying updated through conferences, webinars, industry journals, and partnerships with external consultants. 61.4% of respondents highlighted events and webinars as key resources for staying informed.
Figure 3: Key strategies for staying updated on industry trends and best practices
Emerging technologies
Some emerging technologies are already steadily becoming integral to the workflows of life sciences companies.
Here’s what the survey revealed:
- AI and ML: 65.9% of respondents reported integrating or planning to integrate these technologies. They are transforming the industry, from enhancing diagnostic accuracy to optimizing laboratory workflows. For instance, AI-powered tools are being used to analyze large datasets in genomics, while ML algorithms help automate routine tasks in laboratory settings.
- Telemetry: The second most explored technology, with 52.3% of respondents indicating its adoption. Telemetry’s ability to provide real-time performance monitoring and usability data makes it a valuable asset for both pre-market validation and post-market surveillance.
- Other technologies: Cloud computing, Lab IoT, and chatbots are gaining traction, while blockchain remains underutilized, with only 2.3% of respondents considering it.
Figure 4: Emerging technologies organizations are exploring or planning to integrate
When considering readiness, the responses suggest that while many organizations are eager to adopt emerging technologies, barriers such as expertise gaps, regulatory concerns, and integration challenges persist. To address these obstacles, respondents noted their reliance on strategies like investing in employee training, collaborating with external experts, and leveraging professional networks to gain expertise when adopting new technologies, as mentioned earlier.
Machine learning
Machine learning (ML) emerged as the top technology currently being explored or planned for integration. According to the survey, 31.8% of respondents plan to integrate ML within the next year, while 29.5% have no immediate plans. Meanwhile, 25% of respondents are already in the process of integrating ML into their software development projects, reflecting its growing significance in driving innovation and efficiency.
Figure 5: Approaches to integrating machine learning in software solutions
Respondents who identified ML and AI as emerging technologies they are already implementing or planning to integrate, face three primary challenges:
- 55% encounter regulatory compliance challenges, slightly above the survey average.
- 45% struggle with integrating these technologies into existing systems, also slightly higher than the average.
- 45% face data security challenges, which is notably higher than the survey average.
Telemetry
The integration of telemetry varies significantly across organizations. Some adopt modular approaches tailored to specific use cases, while others implement comprehensive systems that monitor entire device ecosystems. These strategies range from basic performance tracking to advanced predictive analytics, enabling organizations to align telemetry adoption with their specific goals and resources.
Telemetry’s ability to provide actionable insights and maintain regulatory compliance positions as an essential tool for driving innovation and operational excellence in life sciences software solutions.
The telemetry adoption is gaining momentum, driven by its transformative potential in life sciences and IVD software development. According to our survey:
- 84% of respondents view telemetry as an effective method for device performance and usability monitoring.
- 2% are actively integrating telemetry into their products.
- An additional 15% plan to adopt it within the next year.
Figure 6: Approaches to integrating telemetry in software solutions
Post-market surveillance
Post-market surveillance remains a largely manual process for many organizations, with 36.4% of respondents relying on employees to call customers and gather feedback. While direct communication with end-users is valuable for understanding their needs and challenges, manual methods can be time-consuming and prone to inconsistencies. By modernizing these processes, organizations can capture more comprehensive and actionable insights.
Collecting end-user feedback is crucial for improving product quality, identifying potential issues, and prioritizing new features that add value to customers. Effective post-market surveillance also ensures compliance with regulatory standards and enhances customer satisfaction, both of which are critical for maintaining a competitive edge.
According to our survey:
- 36.4% of respondents collect data manually, with employees directly calling customers to gather feedback.
- 22.7% of respondents use in-house developed monitoring tools, enabling tailored solutions for post-market needs.
- 11.4% rely on commercial off-the-shelf solutions, which offer faster implementation and standardized capabilities.
- However, 15.9% of respondents have no technology implemented, and 6.8% indicated they have no plans to adopt post-market surveillance practices.
Figure 7: Methods for managing post-market surveillance of software products
Surprisingly, 15% of respondents who manually manage post-market surveillance are not interested in adopting telemetry at all. One respondent commented, “It would be interesting to integrate, but it’s not easy to convince customers of it.”
External partners
Our survey reveals that most respondents recognize the value of collaborating with external partners for software development projects.
Only 2% of all participants mentioned they would never consider such collaborations, while the rest expressed varying levels of enthusiasm:
- 6.8% of respondents shared that they always rely on external partnerships for their projects.
- 25.0% of respondents indicated they often work with external collaborators.
- 67.3% of respondents stated they sometimes collaborate with external partners.
There are several compelling reasons why organizations choose to partner with external experts:
- Access to specialized skills and expertise: 36.4% of respondents identified this as the primary advantage. External partners bring niche knowledge and cutting-edge capabilities, which can elevate project outcomes.
- Faster time-to-market: 32.1% of respondents noted that external partners help accelerate development timelines, a crucial benefit in highly competitive and rapidly evolving industries.
- Enhanced team capacity: For 13.6% of respondents, external partnerships (such as Employer of Record) enable organizations to effectively scale their resources and hire talent in the U.S. or internationally, ensuring project milestones are achieved without overburdening internal teams.
- Cost-effectiveness: 11.4% of respondents highlighted financial benefits, demonstrating how strategic collaborations can provide high-quality outcomes while staying within budget.
Our results indicate that cost-effectiveness is a key priority for Heads of Software Development, while faster time-to-market for new products is most important to Project Managers, Product Managers, and CEOs. Enhancing the performance and capacity of internal development teams is particularly relevant for developers. Meanwhile, access to specialized skills and expertise is valued across various roles, including Sales Managers.
Summary
The survey highlights both challenges and opportunities in life sciences and IVD software development. Regulatory compliance emerged as the most pressing obstacle, with integration issues, data security, and talent shortages also creating significant hurdles.
Despite these challenges, the industry is poised for transformation, driven by trends such as artificial intelligence, machine learning, robotics, and cloud-based solutions. Telemetry and other emerging technologies are rapidly gaining traction, offering innovative ways to enhance efficiency, improve compliance, and deliver better outcomes.
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