5 Warning Signs Your Lateral Flow CDMO Partnership May Be Failing

1. Timeline Extensions Have Become Routine
2. Quality Issues Keep Emerging, Even After “Final” Designs
3. Regulatory Expertise Seems Superficial or Absent
4. Communication Becomes Difficult or Defensive
5. Cost Surprises Keep Appearing
When to Consider a Change
Selecting a Partner With Confidence
Moving Forward

Chris Yates, co-founder and CCO of Abingdon Health plc outlines early warning signs to help you identify whether your lateral flow CDMO relationship may not lead to successful commercialisation – and what to do about it.

Selecting a development and manufacturing partner for your lateral flow diagnostic represents one of the most consequential decisions your company will make. The right partnership accelerates your path to market, reduces technical and regulatory risk, and positions you for commercial success. The wrong partnership leads to extended timelines, escalating costs, and in worst cases, projects that never reach commercialisation despite years of effort and millions in investment.

At Abingdon Health, we’ve worked with numerous companies recovering from problematic CDMO relationships, and certain patterns emerge consistently. While no partnership will be perfect, some warning signs indicate fundamental problems that rarely resolve on their own. Recognising these signals early – and addressing them directly – can save months of frustration and substantial resources.

1. Timeline Extensions Have Become Routine

Every development project encounters unexpected technical challenges. Complex lateral flow assay development sometimes requires additional optimisation cycles; and occasional delays are normal and should be expected in any sophisticated development program.

However, if timeline extensions have shifted from occasional occurrences to routine expectations, deeper issues may be at play. When “just a few more weeks” becomes a monthly refrain, and original six-month development timelines stretch into year-plus odysseys, the problem often isn’t technical complexity – it’s fundamental capability gaps or resource prioritisation issues.

What to watch for:

• Milestone dates that consistently slip with minimal advance notice.
• Explanations for delays that focus on generic technical challenges rather than specific root causes and remediation plans.
• Lack of proactive communication about emerging risks before they become full-blown delays.
• Timeline projections that seem increasingly disconnected from reality.

The underlying issue:
Your partner may lack the technical expertise to solve the problems your project presents, may be spreading limited resources too thin across too many projects, or may not have robust project management processes to identify and address emerging risks early.

What to do:
Schedule a direct conversation with senior technical leadership (not just your project manager) to understand root causes and realistic timelines. Ask for a detailed project plan with specific technical milestones, not just vague “development continues” placeholders. If the response is defensive or continues to be vague, that in itself is additional data worth considering.

2. Quality Issues Keep Emerging, Even After “Final” Designs

In early development, it’s completely normal to iterate through multiple design cycles as you optimise performance. But once your partner declares a design “finalised” or “frozen,” quality issues should become increasingly rare as you move toward validation and manufacturing.

If quality problems continue emerging after immunoassay Design Freeze – test failures in supposedly validated batches, inconsistent performance between production lots, or recurring issues with specific components – this suggests fundamental problems with design controls or manufacturing processes.

What to watch for:

• Batch-to-batch variability that exceeds expected statistical ranges.
• Recurring failures of the same test components or process steps.
• Post-Design Freeze discoveries that require going back to earlier development stages.
• Quality issues attributed to “one-off” problems that somehow keep occurring.

The underlying issue:
Your partner may not have robust design control processes that thoroughly validate designs before declaring them complete, may lack manufacturing process controls necessary for consistent production, or may not have adequate quality systems to identify and correct root causes of quality deviations.

What to do:
Request a comprehensive quality review meeting that examines failure modes, root cause analyses, and corrective actions. Ask to see validation data demonstrating that their manufacturing processes are capable of consistently producing your assay at specification. If they’re reluctant to share this data or the data reveals concerning patterns, take that seriously.

3. Regulatory Expertise Seems Superficial or Absent

Not every CDMO needs deep regulatory expertise for every project. If you’re handling regulatory strategy in-house or through consultants, your lateral flow CDMO development partner primarily needs to execute to your specifications and generate appropriate documentation.

However, if you’re relying on your IVD CDMO partner for regulatory guidance, superficial expertise becomes a major liability. Regulatory requirements for diagnostic devices – particularly for FDA 510(k) or PMA submissions – are highly specific. General familiarity with “FDA requirements” is fundamentally different from proven experience successfully navigating actual submissions.

What to watch for:

• Generic answers to specific regulatory questions, e.g. “FDA requires validation studies”.
• Inability to discuss specific regulatory pathways relevant to your device type and intended use.
• Lack of familiarity with FDA guidance documents applicable to your project.
• No documented history of supporting successful FDA submissions for similar products.

The underlying issue:
Many CDMOs focus primarily on technical lateral flow development and manufacturing, treating regulatory requirements as an afterthought, or assuming customers will handle those complexities independently. If you’re counting on regulatory support that doesn’t exist in sufficient depth, you may not discover the gap until you’re preparing submissions and realise critical validation data is missing or inadequate, or development reworking is required.

What to do:
Request detailed discussion at the outset of the specific regulatory pathway your product will require, including validation studies, documentation requirements, and timeline expectations. Ask each prospective lateral flow assay development services provider about their experience with similar submissions and whether they have regulatory specialists on staff or rely on external consultants. And lastly, verify that their quality systems generate the type of documentation FDA will expect to see.

4. Communication Becomes Difficult or Defensive

Strong immunoassay development partnerships operate on a foundation of transparent, proactive communication. You should receive regular updates on project progress, early warnings about emerging technical challenges, and honest assessments of timelines and costs. Questions should be welcomed and answered thoroughly.

When communication becomes difficult – emails go unanswered for days, meetings get repeatedly rescheduled, or questions receive vague or defensive responses – these are serious warning signs about the health of your partnership and possibly about problems your in vitro diagnostics (IVD) development partner would rather not discuss directly.

What to watch for:

• Difficulty getting timely responses to straightforward questions.
• Defensiveness when you raise concerns about timelines or quality.
• Reluctance to provide detailed project updates or technical data.
• Feeling like you’re being “managed” rather than informed.

The underlying issue:
Poor communication often indicates that your partner is struggling with aspects of your project they’re reluctant to acknowledge, is overwhelmed with competing priorities and can’t give your project adequate attention, or lacks sufficient project management discipline to keep stakeholders appropriately informed.

What to do:
Address communication concerns directly and explicitly. Request establishment of regular project review meetings with documented action items and responsibilities. If communication patterns don’t improve rapidly or if defensiveness intensifies, seriously consider whether this partnership can succeed.

5. Cost Surprises Keep Appearing

Lateral flow development projects sometimes encounter unforeseen technical challenges that require additional work beyond initial scopes and budgets. Occasional change orders for genuinely unexpected situations are reasonable; this is scientific discovery after all.

However, if cost surprises have become frequent, if initial quotes bear little resemblance to actual costs, or if you feel like you’re being incrementally charged for work that should have been included in original scopes, these patterns suggest either inadequate project planning or problematic business practices.

What to watch for:

• Frequent change orders for work that reasonably should have been anticipated in initial planning.
• Vague initial quotes that don’t break down specific deliverables and associated costs.
• Surprise charges for “necessary” additional work that wasn’t discussed proactively.
• Difficulty getting clear answers about total project costs and remaining budget.

The underlying issue:
Cost surprises often indicate that your IVD CDMO partner didn’t thoroughly understand project requirements before quoting, underestimated work to win your business with plans to recover costs through change orders or lacks project management discipline to control scope and budget.

What to do:
Request a comprehensive meeting to review total project costs to date against original budgets, understand specifically what additional costs should be anticipated, and establish clearer change order processes going forward. If your partner is unwilling to provide this transparency, that is also quite revealing.

When to Consider a Change

The best partnerships challenge you in good ways, and collaboration accelerates innovation – no single warning sign necessarily means you need to change partners. Communication occasionally breaks down. Timelines sometimes need adjustment for legitimate reasons. Technical challenges happen and situations sometimes necessitate additional experimental work to achieve the desired performance specifications – a normal part of pushing the boundaries of immunoassay technology.

However, if you’re seeing multiple warning signs simultaneously, if problems persist despite direct conversations about concerns, or if you’ve lost confidence that your lateral flow CDMO partner can successfully take your project to commercialisation, it may be time to seriously evaluate alternatives.

Making a change is never simple. Technical transfers take time and resources and you may have already invested significant sums with your current partner. The unknown risks of a new partnership might seem daunting compared to the known problems of your current situation.

But here’s the reality we’ve observed repeatedly: companies that recognise a failing partnership early and make decisive changes often reach commercialisation faster and at lower total cost than companies that remain in problematic relationships hoping things will improve. Every month you continue with a partner who can’t deliver is a month your competitors gain ground and your funding depletes without corresponding progress.

Selecting a Partner With Confidence

If you’re fortunate enough to be reading this before selecting your initial CDMO partner, use these warning signs as a framework for evaluation questions. Don’t just ask whether a potential partner has relevant experience – ask for specific examples, like ISO 13485 certification, with verifiable details. Don’t accept generic claims about quality systems – ask to understand their design control and validation processes in depth.

Strong partners will welcome this and provide substantive, specific answers. Service providers who respond with generic marketing claims or resistance to detailed discussion may not be equipped to support your success.

Moving Forward

Whether you’re selecting your first lateral flow CDMO partner or evaluating your current relationship, remember that successful diagnostic development requires more than technical capability – it demands project management discipline, regulatory expertise, manufacturing scalability, and transparent communication throughout the journey from concept to commercial launch.

At Abingdon Health, we’ve supported numerous companies through both initial development programs and recoveries from problematic previous partnerships. We understand the challenges you’re navigating and the confidence you need in your development partner.

If you’re concerned about your current partnership or want to discuss how to evaluate potential partners effectively, we’re happy to share perspective based on direct experience. No sales pressure – just straightforward conversation about what successful partnerships actually require.

As a fully integrated CDMO and CRO with ISO 13485 and ISO 9001 certifications and dual UK & USA lateral flow development and manufacturing capabilities, our team brings extensive experience in analytical performance studies, clinical trial management, and regulatory strategy.

Get in touch with Abingdon Health to explore how our integrated approach can accelerate your path to market access.