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Alex Felt

Head of Business Development

Automated bioprocess data management — zero headaches.

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A Guide to Build vs Buy: Biotech Software Edition

Feb 26, 2024

For biotech and synthetic biology companies, there’s always A LOT of work to do. As these companies quickly learn, trying to handle everything in-house–from strain design and high-throughput screening to process development and beyond–can spread funding and resources thinly. This is especially true in difficult funding environments. So, biotech companies must carefully decide what they will take on internally and what they will purchase or outsource.

Software is one of the best examples of this in the biotech sector, mainly because these companies tend to develop core IP and competencies in biology or chemistry, not software engineering. However, biotech software can be essential to the success of these companies, especially during research, development, and biomanufacturing activities. In these scenarios, biotech companies must decide whether to build or buy software.

Given Invert’s focus on developing software for bioprocessing, our team has a lot of experience with this critical decision. Having come from the lab with significant experience deliberating on both options, our product team collected some food for thought and useful questions to help stimulate productive decision-making for biotech companies weighing the choice to build vs buy software.

Getting Started: The Big Picture

Vision & Ambition

First, you have to know the vision and ambition of your company. Though that might sound like a “squishy” line of thought, it’s an essential factor in the calculation.

If you don’t see software as a differentiator for your company, that creates philosophical pressure toward buying because it indicates that software is really a means to an end. If it is part of your differentiation, then there may be more pressure towards building, depending on what resources are at your disposal. Even if you do have a team for the job, remember that if you elect to build one thing, you’re also electing not to build another.

Lastly, don’t forget about your timeline! Buying will probably get you there faster, but implementing purchased software and training users takes time, too.

Focus Questions

  • Do you currently see software as one of your differentiators within the bio space?
  • Do you have developers, engineering managers, and product managers on staff (or plan to soon) to build software?
    • Do you trust your software team to pull it off?
    • Do they have the expertise to build it in a scalable way?
    • What will you be pulling them away from to work on this?
  • How soon do you need a software solution?

Innovation Doesn’t Always Mean Building

In software development, there’s a general sentiment that you “build for advantage and buy for parity.” Though a nice platitude, the decision is usually more complicated than that, especially in the unique circumstances of biotech. According to Michael McCutchen, Product Manager at Invert, “Differentiation comes from good scientific and business processes irrespective of anything digital. The goal is to reflect those in your software.”

To highlight this, let’s consider Moderna. Moderna is regarded as one of the earliest digitally differentiated biopharma companies, describing itself as a “digital-first” company since Day 1. Over the years, Moderna has talked openly about its digital strategy. Importantly, Moderna did not put out a lengthy manifesto about why they built everything from scratch. Instead, they described focusing on buying the best software (where available) and integrating them in a way that best enables the business alongside custom-built components.

Put simply, how software is implemented and integrated often matters a lot more than the sum of its parts.

Evaluate the Market

Do your homework and search around to understand what commercial off-the-shelf (COTS) or software-as-a-service (SaaS) solutions exist, if any. Some companies provide biotech software solutions for strain development, process optimization, and scale-up. As one more unique example, Emerald Cloud Lab provides remotely operated research offerings through a medley of digitally accessible tools. Here at Invert, we offer software for bioprocess data management that enables superior data traceability, live data access, analysis, machine learning-based modeling, and decision-making.

For help determining what’s out there, check out this Life Sciences Software Landscape, which lists existing biotech software providers and their tools.

If the solutions already exist, it’s probably better to buy. It is difficult to gain a competitive advantage by building something your competition can purchase. By buying established software, you can focus on your core competencies, creating greater efficiency and accelerating product development timelines.

Focus Questions

  • Does a software solution already exist in the market?
    • How close are existing software tools to meeting your specific needs?
  • Does it matter to your internal team if the software is cloud-based?

Implementation and On-Going Use

The Costs and Complexity of R&D and Biologic Data

Heavier investment in R&D is a hallmark of biotech compared to many other industries. This difference in resource allocation creates different circumstances.

  • First, biotech companies that must spend a lot of funds on R&D will have less to spend on tools outside of R&D.
  • Second, the high R&D spending means that efficiencies found in R&D have an outsized impact.
  • Third, biology has more complex data sources that factor into decision-making, and you often need to synthesize all of your sources to extract value. In other industries, 80% percent synthesis might be good enough. In biotech, even one missing data source can skew vital decisions and create manual bottlenecks, diminishing benefits.

As a result, you generally want “enabling” software, especially on the R&D side. “Enabling” software provides deeper understanding, insights, and efficiency regarding your data, processes, and applications. Think of enabling software as a tool to more reliably find missing knowledge you are already generating.

Integration

Since research and bioprocess development require many more data sources to make decisions, you must surface data from more groups, connect more variables, and synthesize information from more collaborations and teams. That’s a lot of integration.

You need to have a clear view of your existing hardware, software, and data sources from across teams and understand how a new software fits into the picture. As part of this, look into the interdependence of your current hardware and software.

Getting custom and off-the-shelf software to “play nice” isn’t trivial. If you currently have a lot of custom applications that need to be closely integrated, a built solution might make sense. But, if you’re using other off-the-shelf options, there’s a good chance the provider is aware of common integrations and has already implemented them.

Finally, don’t forget about the human side of integration: training! Given that your team is probably much more versed in biological sciences, they might not have much additional time and energy to decipher and learn convoluted software. Seek out software with an intuitive user interface that requires minimal training.

Focus Questions

  • How much existing software do you use?
  • What existing custom-built software/applications do you have (if any)?
  • What is the interdependence of your current hardware and software?
  • What percent of your existing relevant data sources can be fully integrated with the software?
  • How intuitive is the available software to use?
  • How much training will it require to onboard the team?

Additional Considerations for Buying Software

Pressure Test with an Open Mind

If you’ve moved closer to the decision to buy software, take this opportunity to ask the provider questions and pressure test the most critical functions. You need to ensure the software solves your primary challenge(s). At the same time, keep an open mind about functionalities outside your checklist since the software might have powerful features available that simply aren’t on your radar.

Fitting Your Niche

Since a commercial software solution is designed to meet a range of customers and users, there’s always a possibility that it will have gaps in your specific niche. The more specialized your bioproduct, bioprocess, analyses, or operations are, the more likely this becomes. So, when engaging a biotech software company, talk through the specific details of workflows with the provider to confirm that their offering applies.

Focus Questions For Software Providers

  • Does the tool do what we need and expect of it?
  • What else does it do?
  • What are the support costs for the software?
  • What will it cost to integrate their software with your current infrastructure?
  • What is the cost of ingesting existing data?
  • How long is it expected to train a team to use it?
  • How flexible is the software?
  • What IT certifications do they have?
    • Note: SOC 2 Type II, ISO 27001, and 21 CFR 11 are usually the big three.
  • Ask for a list of compliance details.
  • What audit tracing and other security measures are in place?
  • What fail safes exist?
  • When new features are released, is it optional to control their incorporation without losing functionality? (in the event they are not compliant)

Additional Considerations for Building Software

Manage the Life Cycle

Biotech companies change fast. But, in building a piece of software, you must recognize that it’s never really “done.” Creating a piece requires a lifelong commitment to upkeep it, even as your organization changes rapidly.

So, you must manage the risk associated with company changes and staff turnover, especially if you build your own software. Imagine the headache if the only person on your team who knows how to use a specific important software leaves the company.

Regardless of whether an internal or external team built the software, define who on your team is involved and who “owns” it going forward. In short, you need to know who exactly is responsible for managing upkeep, training new users, and maintaining institutional knowledge of the software.

It is also important to note that even built software is not a permanent solution. “It’s exciting to talk about building a solution. It’s less exciting but equally important to plan how to retire that solution gracefully,” says McCutchen. You will eventually sunset software. So, you may want to focus less on building the perfect solution and instead on building timely solutions that on-/off-board most effectively.

User Experience Matters, Especially with Customers

Software that helps you interface with your customers or partners can significantly impact your bottom line. User-friendly online portals provide a lot of value very quickly, regardless of the rest of your data infrastructure. For example, a CDMO or CMO with an excellent customer interface for tech transfer and client communication is more likely to retain business.

Outsourcing a Build

If you’re trending towards building software, you also can opt to have a custom software development company execute the vision instead of your team. Conceptually, one is not better than the other, but they are different. For outsourcing, you have to have a clear idea of what you want well ahead of time, whereas internally, you can be more agile.

Notably, full outsourcing can create headaches if the service contracts are poorly constructed. Usually, this means you will pay a high management fee or need to find a way to maintain it yourself. Since a software is never really “complete,” outsourcing a build requires you to keep someone on staff or on retain to keep fixing it.

Focus Questions for Building

  • Who is the primary person or team responsible for managing upkeep, training new users, and building institutional knowledge?
  • How do you plan to manage the life cycle of new software?
  • Will your customers ever need to interface with the software?
  • Ask contract custom software development companies…
    • What do their standard service contracts look like?
    • What is the annual cost?
    • What is the expected lifetime of software compared to the length of the service contract?

You Got This!

If you’re not living and breathing biotech software, the decision to build or buy can feel overwhelming. Though it is a complex decision, it becomes easier as you understand the big picture, clarify your organization’s needs, think through implementation, and ask good questions of providers and your team. We hope these considerations help you navigate this decision more confidently so that you can focus on what you care about most: impactful biology.


Otherwise, if you need more help with biotech software or are looking for a better way to manage and analyze bioprocess data, reach out to Invert and request a demo.

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