## The Diagnostic Innovation Dilemma Diagnostics businesses face a critical transition when scaling from startup to sustainable growth. These organizations—typically with fewer than a couple hundred employees—often struggle with a fundamental disconnect between scientific advancement and practical application in clinical settings. ## Core Scaling Challenges ### Scientific Value vs. Medical Utility Many small teams want to disrupt an existing diagnostics market but operate under the assumption that scientific breakthroughs naturally translate to clinical value. In reality, clinicians and laboratories prioritize technologies that address clear, actionable diagnostic endpoints that help them provide a confident answer to patients. Niche, high-complexity testing services—regardless of their scientific merit—struggle to gain traction when they don't align with established clinical workflows or address recognized medical needs. While there will always be some clinicians who are at the cutting edge, the vast majority of patients are treated by clinicians who [[On Working|work]] to established standards of care within health systems that do not give much latitude for deviation. ### The Inventor's Blind Spot Founders and R&D leaders in these startups typically emerge from research backgrounds with deep technical knowledge but limited experience in commercialization of tools for life sciences and diagnostics. These passionate inventors are driven by [[On Curiosity|curiosity]] and technical exploration rather than market fit. They often develop complex, highly specialized products that assume a level of end-user engagement that doesn't align with the practical realities of busy clinical environments. ### Workflow Integration Failures New solutions must operate seamlessly within established [[On Laboratory|laboratory]] processes. Many companies overlook these practical considerations, focusing instead on the capabilities of their technology rather than how it fits into the broader environment of a clinical [[On Laboratory|lab]]. This oversight creates friction for adoption, as laboratories resist technologies that disrupt rather than enhance their existing operations. ### Regulatory Pathway Confusion Determining early whether a product is intended for Research Use Only (RUO) or as an In Vitro Diagnostic (IVD) has significant implications on the [[New Product Development]] strategy. Companies often underestimate the level of rigor required in documentation, compliance measures, and testing protocols. Instead, companies often adopt a costly 'middle ground' approach—more rigorous than needed for RUO but insufficient for IVD—resulting in regulatory limbo, development inefficiencies, and delayed market entry. ### Feedback Implementation Gaps Despite recognizing the importance of user feedback, many diagnostics companies struggle to effectively collect and translate this information into meaningful product improvements. In many cases, this as a direct result of confusion about the regulatory path the product will take because of a faulty understanding of product-market fit. They may collect input but fail to integrate it into their development process in ways that meaningfully enhance usability and workflow integration. ## Applying Liminal Thinking to Bridge the Gap [[Liminal thinking]] offers a powerful framework for diagnostics companies navigating the threshold between scientific innovation and clinical implementation. The concept of liminal thinking, explored by Dave Gray in his book of the same name, provides a powerful framework for navigating these transitions. > [!What is liminal thinking?] > Liminal is a word that means boundary, doorway, portal. Not this or that, not the old way or the new way, but neither and both. A state of ambiguity or disorientation that precedes a breakthrough to a new kind of thinking. The space between. Liminal thinking is a kind of psychological agility that enables you to successfully navigate these times of transition. It involves the ability to read your own beliefs and needs; the ability to read others’ beliefs and needs; and the habit of continually evaluating, validating, and changing beliefs in order to better meet needs. The book is an outstanding read, with a lot of great advice on how to reframe one's personal view on the world. While these concepts might initially seem distant from diagnostics development, they provide invaluable tools for bridging the gap between innovation and implementation. However, it is a great way to understand the 'voice of customer' and bring those ideas back to an organization in actionable ways. There are six things you need to know to apply liminal thinking and help steer better strategic product outcomes. ### 1. Beliefs Are Models, Not Reality **Liminal Approach**: Understand that your conception of any diagnostic product is simply one perspective—an imperfect representation of a complex, multidimensional reality. Stay with me here: in this space, all perspectives become valid pieces of a larger truth rather than competing claims. This perspective requires temporarily suspending 'ownership' of ideas and being open to multiple interpretations of value. **Gathering Customer Perspective**: It is essential to conduct immersive studies where you observe the end-user's actual laboratory workflows without interruption or guidance. What does their current process look like? What if any workarounds and adaptations have they've created? Capture their language and mental models without translation. **Bringing Insights Back**: Facilitate a 'model-making' workshop, where you encourage stakeholders to explicitly articulate their current beliefs about a product's value, then label these as 'models'. Create visual representations of both the [[On Teamwork|team]]'s approach and the customers' approach. It helps make these models more abstract out of up-cycled materials (cardboard boxes, papertowel rolls, cans, bottles, bottlecaps, etc). Based on the crude prototype models, highlight areas of alignment and disconnect. Use this visualization to help teams recognize how their selective perception shapes product decisions. ### 2. Beliefs Are Created **Liminal Approach**: Recognize that beliefs are constructed hierarchically from selected facts, subjective experiences, and theories. Customers and internal stakeholders all have beliefs, and it can be instructive to trace the origins of our beliefs. **Gathering Customer Perspective**: Develop journey-mapping sessions with laboratory personnel where they reconstruct their decision-making process for adopting or rejecting new technologies. Focus on identifying which facts they select as relevant, which experiences shape their judgments, and which theories they use to make sense of diagnostic tools. Document the hierarchy of considerations that ultimately drives their adoption decisions. **Bringing Insights Back**: Map the customer's decision process against the internal process for product development decisions. Create parallel visualizations showing how customer beliefs are constructed versus how internal beliefs are formed. Help teams identify instances where they've built elaborate theories on limited or biased facts. ### 3. Beliefs Create a Shared World **Liminal Approach**: Position yourself at the threshold where you can see how different belief systems create different 'worlds' for scientists, clinicians, and laboratory technicians. **Gathering Customer Perspective**: Organize multi-stakeholder dialogues that bring together different roles within the clinical environment—laboratory directors, technicians, pathologists, and clinicians who order tests. Use facilitated discussions to reveal how each stakeholder's world is constructed and what they value most in diagnostic technologies. Document the language and metaphors each group uses to describe their ideal diagnostic solution. **Bringing Insights Back**: Develop a 'Parallel Worlds Workshop' where internal stakeholders are divided into groups, each tasked with designing a product or feature exclusively for one stakeholder perspective (e.g., for the lab technician's, for the pathologist's). After presenting these single-perspective concepts, challenge the teams to consider where the worlds converge without compromising what matters to each group. This exercise makes visible the trade-offs and potential synergies of different belief systems on the product/feature. ### 4. Beliefs Create Blind Spots **Liminal Approach**: Step into a space where you can recognize the artificial constraints and blind spots created by current beliefs about your diagnostic technology. Possibilities that were previously invisible or presumed impractical become apparent when viewed from multiple perspectives. **Gathering Customer Perspective**: Design 'Day-in-the-Life' shadowing experiences where your team observes not just how your technology is used, but the complete context in which it operates. Pay special attention to constraints, workarounds, and adaptations that users have developed. Document moments of friction or hesitation that might indicate where your technology conflicts with established workflows or mental models. **Bringing Insights Back**: Conduct possibility expansion exercises where teams deliberately question assumptions that limit thinking by continuously asking 'why?' Create a 'blind spot inventory' by listing beliefs that have gone unexamined. Come prepared with a list of customer observations to challenge assumptions and reveal new possibilities for product development that current belief systems render invisible. ### 5. Beliefs Defend Themselves **Liminal Approach**: Realize that beliefs have a tendency to defend themselves, like a null hypothesis defends the status quo. Just as a null hypothesis assumes "nothing special is happening" until proven otherwise, our existing beliefs resist change by requiring strong evidence to overturn them. Both create a natural barrier that makes us stick with our current understanding unless compelling evidence forces us to consider a new perspective. **Gathering Customer Perspective**: Implement structured feedback sessions where users can safely express criticisms and challenges without fear of being 'corrected' or 'educated.' Record not just what they say, but also their emotional responses and non-verbal cues. Create mechanisms for anonymous feedback that bypass the social pressure to be polite or accommodating to technology developers. **Bringing Insights Back**: Create a 'Belief Defense Inventory' by documenting common responses to critical feedback within your organization. Phrases like "they just don't understand the [[On Science|science]]" or "they haven't been properly trained" often indicate self-sealing logic at work. Develop protocols for feedback review that require teams to first acknowledge defensive reactions before evaluating the feedback itself. ### 6. Beliefs Are Tied to Identity **Liminal Approach**: Know that the most difficult beliefs to change are those tied to identity—particularly for scientific founders who define themselves through their innovations. **Gathering Customer Perspective**: Conduct narrative interviews with clinical users focused on their professional identities and how they see themselves contributing to patient care. Document the stories they tell about meaningful work experiences and how various technologies have either enhanced or diminished their sense of professional competence and purpose. Identify the values and aspirations that drive their career choices. **Bringing Insights Back**: Create user personas based on clinician feedback that capture customer identities and values. Equally important, recognize that internal stakeholders have beliefs tied to their professional identities. It can be useful to host workshops that guide discussions about the difference between "being a scientist who created a valuable technology" and "being a creator of a technology that delivers value to healthcare." ## The Path Forward For diagnostics companies navigating the growth threshold, success requires more than technical excellence—it demands the ability to operate in the liminal space between scientific innovation and clinical utility. By applying the concepts core to liminal thinking, organizations can overcome the type of myopic thinking that hinders the business' success. What distinguishes successful diagnostics companies is their ability to hold diverse perspectives simultaneously—honoring both scientific excellence and clinical practicality as complementary rather than competing values. This ability to think liminally subverts the typical growing pains that small companies encounter, enabling team members to focus on the customer and deliver products that are so good that they can't be ignored. > [!Question] Interested to learn more? > [Get access to a preview of my Product Toolkit](https://services.cwagner.co/#toolkit), with full coverage of how to build a usability program as a part of the New Product Development (NPD) process. #### Related to: - [[Liminal Thinking]] - [[Beliefs ≠ Facts]] - [[On Science]] - [[On Product Management]]