You Need to Ready This Article If…
☑️ You’re in the Life Science industry
☑️ Have expertise in drug development, diseases, and treatment—but not IT
☑️ You manage, influence, or require bespoke softwareIt will ensure you’re asking the right questions to drastically enhance the benefits your organization, patients, HCPs, investigators, and subjects get from bespoke solutions using less of your budget with a more predictable and faster outcome.
The Unnecessary Pain of Fit-for-Purpose Solutions
There are countless use cases in Life Sciences where custom, fit-for-purpose software solutions are required across both clinical and commercial sectors. These solutions are often referred to as Bespoke Software. As you know, they must also cater to a diverse range of stakeholders—patients, healthcare providers, investigators, and internal teams. Traditionally, the IT community has insisted that to meet such diverse needs, each solution must be custom-developed from the ground up.
While this method has long been the norm, it comes with significant drawbacks: it’s time-consuming, increasingly expensive, and often requires the active involvement of biopharma subject matter experts, who should be focused on what matters most—science, treatment, and patient care.
It’s time to look at and apply the proven practices from other industries as the new standard we should expect—and even demand—today.
This article offers up an alternative way—a faster and easier approach to software development— that still supports regulatory requirements like MLR and HIPAA and frees up resources, both in time and money, that can be redirected to benefit patients and other critical stakeholders.
Start with Core Building Blocks — It’s Only Natural
At our core, humans are made up of the same fundamental elements. Carbon-based atoms form complex molecules, which then build our cellular structures, organs, and ultimately, our unique selves. What makes each of us different lies in the “knobs and levers” within our DNA—tiny switches that control our appearance, how we function, and the overall health of our system. It’s your domain—we know, you know.
If the complexity of living things can be distilled into foundational building blocks, the same can be done with software. This approach is already being used in other industries like eCommerce. Take Shopify, for example—a platform built on modular, reusable components that can be configured to suit a wide variety of eCommerce needs. In Life Sciences, we should expect no less from how our bespoke software is built.
Ensure It Has the DNA for Life Sciences
Just as the same biological building blocks combine in unique ways to form distinct species—each contributing differently to the ecosystem—software solutions must be tailored to the specific demands of each industry. Life Sciences face unique challenges and regulatory constraints that cannot be addressed with a generic approach like those used in finance or consumer goods.
That said, not every solution needs to be built from scratch. The key lies in creating building blocks designed specifically for the Life Science industry. These components can then be reused and tailored to fit different use cases, while still addressing the unique needs of each stakeholder involved.
Prep for Quick Assembly
The automotive industry, which predates the IT industry, offers another valuable lesson. By using common parts that are assembled into sub-assemblies, automakers can produce a wide variety of models and styles with efficiency. This concept of reusability is key—pre-engineered components allow for faster production while maintaining quality.
The same principle applies to software, but with even greater flexibility. Unlike physical products, software is more like biology in that its components can be reassembled in countless ways. Pre-assembled software components enable a wide range of combinations, dramatically speeding up development without sacrificing much needed customization. However, this requires thoughtful engineering, not just traditional coding as is often the case today. With the right approach, software for Life Sciences can be assembled quickly, precisely, and with greater agility to meet the needs of patients, HCPs, and other stakeholders.
Customize through Configurability, Not Code
In today’s world, custom solutions should no longer require complex, time-consuming coding from scratch. Enter the WYSIWYG (“what you see is what you get”) approach. Traditionally, the process of creating custom software has involved lengthy wait times—writing up a specification, then waiting weeks or even months to see the first glimpse of the final product. And after that, you might still have to wait longer to actually test and interact with it. This lag should no longer be the norm, thanks to advancements in technology.
However, it’s important to remember that there’s much more to software than the user interface alone. The real magic lies in the underlying logic—how automation, rules, and interactions work behind the scenes. What’s key is not just visualizing the end product, but enabling stakeholders to experience it in real time. A modern approach allows you to see a functional journey—one that represents the entire experience, including workflows and automation—within days, not weeks or months. This rapid configurability lets you adjust on the fly, ensuring the final product is exactly what you need. Say goodbye to last-minute surprises.
Balance Agility and Compliance
In the our industry, compliance is non-negotiable. Regulatory requirements like HIPAA, MLR, and others are critical and must never be compromised. However, when building bespoke software, compliance is often used as a reason for slow or difficult development—or worse, treated as an afterthought. Similarly, minor adjustments shouldn’t result in lengthy change orders or become needlessly complex to implement.
To strike the right balance between agility and compliance, these factors must be thoughtfully engineered into the software from the start. When designed correctly, bespoke software should not only meet compliance standards but also evolve smoothly as users provide feedback or as regulations change. The goal is to ensure that compliance supports—not hinders—the rapid development and deployment of software solutions. Factoring in these requirements from the beginning allows for faster delivery into the hands of patients, HCPs, and other stakeholders, without sacrificing safety or quality.
Fuel Powerful Analytics
While data analytics is a critical part of the Life Science ecosystem, it’s outside the scope of this article—it warrants spotlight as a dedicated topic. However, what is often overlooked—or misunderstood—is the relationship between data capture and the true value of analytics. Without effective data capture, even the most advanced analytics are of little use.
The most successful bespoke software solutions don’t just meet immediate operational needs; they are also designed to capture valuable data throughout the user journey. The more effective the solution, the richer the data it collects. This creates a symbiotic relationship: high-quality software enables better data collection, which in turn drives more powerful analytics. Both are essential to advancing patient care, drug development, and other critical functions in our industry.
Leverage the Right Expertise – Life Science and Engineering
In additional to all mentioned above, having the right expertise involved is crucial for success. Working with a team or vendor that has both industry experience and an engineering mindset brings a significant advantage. Some outsourcing companies have people who have served the industry, but very few have people who have actually worked in a Life Science company.
It’s also important to recognize that IT and engineering are not synonymous. Just as writing a sentence doesn’t make someone a novelist, coding doesn’t mean someone can engineer and develop bespoke software tailored to Life Sciences—especially software that meets the criteria outlined above. Partnering with a team that understands the specific needs and nuances of the industry can accelerate development while ensuring the solution meets both regulatory and practical demands. This also prevents biopharma subject matter experts from being overwhelmed with tasks outside their expertise, allowing them to focus on science, patient care, and healthcare providers.
To Wrap It Up…
Creating bespoke software for Life Sciences doesn’t have to be a slow, complex process. By focusing on core building blocks, leveraging pre-assembled components, balancing agility with compliance, and partnering with the right team, you can develop faster, more efficient solutions. The result? More time and resources dedicated to advancing science, improving patient care, and supporting healthcare providers—all without compromising on quality or regulatory requirements.
The world around us is changing faster than ever, and Life Sciences should be no exception. With thoughtful engineering and the right approach, the complexities of our industry can be addressed more efficiently. We already manage far more intricate biological systems to develop better treatments to support healthier lives. Expecting IT teams, outsourcing vendors, or software providers to deliver predictable, faster, and more cost-effective solutions—without burdening critical resources—is not unreasonable. In fact, it’s what we should demand as we continue to advance science and improve patient outcomes.