Case Study
Building a New Strategic Business Unit: 2.5 Yr Transformation
Transforming Breakthrough Technology into Strategic New Business Line. Led a 15-person cross-functional team over 2.5 years to build capital equipment business from proof-of-concept to commercial launch
The Challenge
After five years developing breakthrough bioprocessing technology, the company faced the classic “valley of death” between proof-of-concept and commercial readiness. The technology worked, but commercialization required capabilities beyond R&D excellence: program management, manufacturing infrastructure, validation protocols, strategic sourcing, and market positioning.
What started as commercial viability assessment evolved into comprehensive business transformation—building not just products, but an entirely new capital equipment business line while maintaining focus on core consumables operations.
- Industry: Bioprocessing / Biopharma Manufacturing
- Services: Commercial Viability Assessment, Program Management, Strategic Sourcing, NPD Leadership, Manufacturing Infrastructure, Validation Strategy, Brand Development, Pricing Strategy
- Timeline: 2.5 years (October 2019 – March 2022)
- Company Type: Established bioprocessing consumables supplier expanding into capital equipment
Company Background
The client was a successful bioprocessing consumables supplier with strong brand equity, deep customer relationships, and reputation for quality. Their R&D team had developed breakthrough technology addressing media preparation challenges in biopharma manufacturing—reducing contamination risk, improving mixing consistency, and enabling efficient workflows.
After five years proving technical feasibility, leadership faced critical strategic decisions about commercialization path.
The Strategic Context
Two fundamental questions needed answering: Was there sufficient market demand to justify building commercial business around this technology? Should they build their own capital equipment business or partner through OEM arrangements?
The OEM path offered faster market access through established infrastructure and lower risk. However, as market leaders in bioprocessing consumables with existing brand equity and customer relationships, they had advantages that OEM partnerships might not fully leverage. Their sales teams already called on accounts who would use this equipment.
Leadership commissioned independent commercial viability assessment to inform the strategic decision before committing to either path.
The Challenge
Like many innovative companies, they faced the “valley of death” between proof-of-concept and commercial launch. Taking breakthrough technology from lab validation to market requires different capabilities than R&D excellence including dedicated program management bandwidth that R&D teams don’t have while managing core development work, capital equipment commercialization expertise that differs from consumables operations, and new business line capabilities the company hadn’t yet developed—pricing strategies, service models, sales infrastructure, manufacturing partnerships.
Leadership recognized they needed specialized program management expertise to orchestrate the moving pieces, build missing capabilities, and drive initiatives from concept to commercial launch while maintaining focus on core operations. This wasn’t about R&D failure—it was recognizing that commercializing innovation requires different expertise than creating it.
Our Approach
01 | Commercial Viability Assessment & Strategic Direction
We conducted comprehensive commercial viability assessment examining market demand, competitive dynamics, customer needs, and economic feasibility. The analysis confirmed significant market opportunity existed—biopharma manufacturers actively sought solutions improving media preparation workflows.
More importantly, our assessment revealed that building their own capital equipment business would capture substantially more strategic value than OEM partnerships. The company’s existing brand equity, customer relationships, and market position made them ideally suited for direct commercialization.
We presented strategic recommendation: build your own capital equipment business line. This fundamentally changed project scope from product launch to new business venture creation, positioning the company to capture full innovation value rather than sharing with OEM partners. This strategic foundation shaped everything that followed over the next 2.5 years.
02 | Cross-Functional Program Leadership Through Complex Transformation
MKA assumed program management leadership, providing dedicated capacity that enabled the client’s team to maintain core operations focus while building new business infrastructure. Over 2.5 years, we led a 15-person cross-functional team across 6 interdependent workstreams: sourcing, quality, manufacturing and engineering, technical R&D, sales, and marketing.
We established program management infrastructure including dashboards, trackers, and regular status updates. We conducted weekly team meetings plus up to 8 additional coordination meetings weekly to align workstreams, resolve bottlenecks, and maintain momentum. This hands-on leadership navigated organizational complexity of building new business within existing company—especially during COVID when the company’s primary focus shifted to producing media for vaccine manufacturing. MKA maintained strategic initiative momentum through consistent leadership, managing cross-functional complexity, and ensuring progress even when internal resources were constrained.
03 | Building Complete Business Infrastructure & Operational Capability
Beyond program coordination, MKA led or directly executed work establishing functioning capital equipment business. Strategic sourcing leadership included 14-18 months negotiating with contract manufacturers and component suppliers to establish production partnerships. NPD management advanced 9 products through formal stage-gate processes with 400+ pages of technical documentation. Validation strategy defined IQ/OQ/PQ protocols proving manufacturing process control. Facilities planning conducted 2-month assessment of space, workflows, storage, and kitting requirements.
Manufacturing optimization led product design improvements reducing SKU count 30-40% while eliminating operational constraints. Pricing strategy built complex models incorporating 30+ cost components using cost-plus and value-based approaches. Commercial development included voice of customer research validating technical needs, beta testing frameworks de-risking launch, brand development creating naming and positioning, and financial modeling supporting investment decisions.
This comprehensive scope reflected reality that creating new business line required building every functional capability from scratch—MKA provided expertise, leadership, and execution capacity making it happen.
The Impact
Strategic Business Line Established with Full Value Capture
MKA’s commercial viability assessment and strategic recommendation enabled the company to build their own capital equipment business rather than pursuing OEM partnerships. This positioned them to capture full market value from breakthrough technology, establish new revenue stream beyond core consumables, and leverage existing brand equity and customer relationships—transforming what could have been contract manufacturing relationship into strategic business asset.
The company established formal business unit, hired 8-10 dedicated personnel supporting capital equipment operations, and created organizational capabilities positioning them for long-term growth. This infrastructure enables operation in fundamentally different market (capital equipment versus consumables) and captures recurring revenue from both equipment sales and associated consumables—creating entirely new growth vector for the organization.
Program Advancement from Concept to Commercial Readiness
MKA drove 2.5 years of sustained progress, advancing the initiative from proof-of-concept to validation-ready status despite navigating COVID-19 pandemic. While the company’s primary focus necessarily shifted to producing media for vaccine manufacturing and supporting global pandemic supply demands, MKA maintained program momentum through consistent leadership and cross-functional coordination.
When MKA rolled off engagement in March 2022, the project had complete technical documentation (400+ pages including DHF, validation requirements, equipment specifications, software design files, and customer installation guidelines), User Requirements Specifications (URS) for capital equipment, defined IQ/OQ/PQ validation strategy, and 9 products developed through formal stage-gate NPD process. This documentation and regulatory readiness positioned the client to complete final validations and pursue customer installations—which eventually materialized with 3 major biopharma customers expressing purchase interest. While formal product launch occurred 2 years after MKA’s engagement concluded (4.5 years from project start to launch), the infrastructure, processes, documentation, and organizational capability built during engagement created foundation enabling eventual commercialization.
Complete Business Infrastructure & Go-to-Market Readiness
MKA established all business infrastructure required for market entry including strategic sourcing partnerships with contract manufacturers, manufacturing process design and facilities planning, validation protocols and quality systems, brand naming and market positioning, pricing models balancing cost-plus and value-based approaches, customer voice research validating unmet needs, and go-to-market financial projections.
This commercial foundation meant the company could pursue direct sales under their own brand with confidence in pricing strategy, market positioning, revenue projections, and operational capability to fulfill customer commitments. The comprehensive infrastructure prevented common pitfalls where companies rush to market without proper foundation—then struggle with supply chain issues, pricing mistakes, or operational constraints limiting growth.
Organizational Transformation: From “Can We?” to “How Do We Scale?”
The most profound impact was fundamental transformation in how the organization approached complex strategic initiatives. When MKA began, the question was “Can we even do this? Should we?” By engagement’s end, the conversation had shifted to “How do we do this faster and more impactfully for our next innovation?”
MKA didn’t just deliver project outputs—we transferred comprehensive methodologies through facilitated learning embedded in real execution. The 2.5 years of hands-on collaboration built organizational muscle memory for complex commercialization, establishing systems and processes the company now applies to other initiatives. The volume and breadth of work—spanning commercial strategy, sourcing, manufacturing, validation, pricing, and brand development—created living playbook that internal teams witnessed, participated in, and ultimately owned.
The company gained practical frameworks for evaluating market opportunities and making strategic build-versus-partner decisions, conducting rigorous commercial viability assessments before committing resources, managing complex cross-functional programs with interdependent workstreams, establishing strategic supplier partnerships rather than transactional vendor relationships, navigating regulatory requirements and validation protocols for new product categories, and balancing innovation investment with core business priorities during crisis conditions.
More importantly, they developed organizational confidence to tackle ambitious initiatives. The engagement proved they could successfully enter new markets, build new business lines, and transform breakthrough technology into commercial reality. This confidence shift was transformational—moving from risk-averse hesitation to strategic boldness backed by proven methodologies.
The systems MKA established—program management dashboards, decision frameworks, stage-gate discipline, validation planning approaches, pricing model structures—became permanent organizational assets. These tools now enable the company to pursue future innovations more efficiently, having learned not just what to do, but how to think strategically about commercialization challenges.
Perhaps most valuable was the cultural shift toward structured problem-solving and data-driven decision-making. The organization learned to ask better questions, gather appropriate evidence, evaluate trade-offs systematically, and make informed strategic choices. They moved from instinct-based decisions to methodology-driven approaches that can be replicated, refined, and taught to new team members.
This transformation represents the difference between hiring consultants who deliver reports versus partnering with advisors who build lasting organizational capability. The company didn’t just get a new business line—they gained repeatable processes, decision frameworks, and strategic confidence that positions them for continued innovation and growth long after MKA’s engagement concluded.
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