Why Your MVP And Its Evolution Matters To Manufacturing

By Irwin Hirsh, Q-Specialists AB

Most companies already invest serious time and energy in defining a minimum viable product (MVP). Teams debate who the product is for, how it will be used, which features matter most, and what it will take to convince payers, prescribers, and patients. This thinking lives in slide decks, strategy documents, and investor pitches, and is rightly seen as central to clinical and commercial success.

What is less recognized is that the same MVP is one of the most important inputs to designing and developing the manufacturing process. Inside it are the essentials that matter to those who must make the product: how it is given, in what strength, how long it must last, how it is stored and handled, how easy it is to use, and — implicitly — what we expect it to cost and how reliably we must supply it. A choice such as a prefilled syringe instead of a vial and syringe, for example, immediately drives different requirements for filling, assembly, packaging, and capital investment and sets early expectations for cost of goods (COGS) and supply options. If these expectations are vague, poorly shared with CMC, or not updated as thinking evolves, the manufacturing side of the organization is effectively asked to design in the dark.

An MVP is not a one-off milestone; it should evolve as we learn. Clinical data may change who the product is really for, what dose is needed, or which outcomes matter most. Market and competitive insight may reshape which features are essential, which are optional, and whether the device or presentation needs to change. Each turn of learning shifts constraints and options for process design, equipment, and COGS. When the MVP does not track these shifts, we freeze fragile assumptions into the process and control strategy, locking in avoidable cost and complexity and inviting late surprises.

Used as a living, shared reference point, the MVP stops being a buried slide in a pitch deck and becomes a working tool for CMC and process development. It can align clinical plans, development work, COGS expectations, and long-term supply around the same set of trade-offs. The goal is not more paperwork but more value from work already being done by making sure the evolving MVP actively guides how we design and scale the manufacturing process. Making that real depends on an ongoing dialogue with CMC and manufacturing about process capabilities — what the process can reliably deliver today, what it could deliver with focused development, and what that means for your timelines and MVP — so gaps are surfaced early and closed together rather than discovered as late surprises.

What Manufacturing Needs To Know About Your MVP

If we strip the MVP back to basics, it is an answer to a simple question: “What exactly are we trying to put into the world?” For product and commercial teams, that answer focuses on patients, prescribers, payers, and the competitive landscape. For those who must design and run the manufacturing process, the same MVP has a different role: it is the starting point for deciding how the product can realistically be made, at what cost, and with what level of quality risk.

To do that job, the MVP cannot remain a high-level story. Certain elements of the product definition need to be clear, shared, and easy to update so that manufacturing and development can translate them into process and technology choices. At a minimum, CMC and manufacturing need to be in dialogue about:

• How the product is used in real life: who administers it (self vs. healthcare professional), where it is used (home, clinic, hospital), and how often. These choices drive batch sizes, packaging formats, labeling, and distribution models — long before any equipment is bought.
• What “good enough” means for quality and safety: not the full specification but the nonnegotiable aspects: what must not go wrong for patients, what levels of stability and reliability are expected, and which product characteristics are mission-critical. These expectations later become the critical product attributes that development, QC, and regulators will scrutinize.
• How the product is presented and delivered: vial, prefilled syringe, auto-injector, pen, blister pack, multi-dose bottle — each option may look like “the same product” in a pitch deck, but each implies a different filling process, assembly flow, inspection regime, and validation burden. These choices also influence which sites and partners are even viable.
• What is assumed about cost and supply: even when no one writes down a target COGS, there is always an implicit range and access ambition: premium niche vs. broad access, steady low volume vs. large, predictable demand. These assumptions quietly shape process complexity, yield expectations, and the level of redundancy built into the supply chain.

When these aspects of the MVP are made explicit and shared early, they give manufacturing and development something solid to work with. A decision like “prefilled syringe for self-administration at home” stops being just a line in a slide; it becomes a concrete driver for process design, equipment selection, COGS modeling, and even CMO choice. Just as importantly, as CMC and manufacturing teams explore what is and is not feasible, they can feed that learning back into the MVP: clarifying trade-offs, flagging hidden risks, and suggesting alternative device or presentation options that still meet the clinical and business goals.

Seen this way, the MVP is not only a description of the product for the outside world. It is a core internal business asset: a shared definition that allows product, clinical, CMC, and manufacturing teams to talk about the same thing from different angles and adjust it together as evidence accumulates. The clearer and more openly these MVP details are communicated, the stronger the foundation for development and manufacturing decisions across the life of the product.

Understanding CMC Process Capabilities And What They Mean For Your Timelines And MVP

A well-defined MVP is only as real as the process that can deliver it. On paper, the product may look ready for the clinic and the market; in practice, your timelines and risk profile are driven by what the CMC team can actually make work in a lab, at a CMO, and eventually at commercial scale. That is what we mean by CMC process capability — and it has direct consequences for both the project plan and how ambitious your MVP can be.

At a business level, you can think of CMC process capability in three simple questions:

• Can we make it reliably?
  How robust is the process today? Does it produce consistent material, or does every batch feel like an experiment?
• Can we scale it and transfer it?
  Can the process move from development scale to manufacturing scale, and between sites or CMOs, without a complete redesign?
• Can it cope with change?
  If clinical data or the MVP shift — dose, regimen, device, shelf-life — can the process adapt without resetting timelines?

Under the hood, CMC teams describe this in more technical terms. They define a handful of product characteristics that must be right (critical quality attributes) and the process settings that must be right to protect them (critical process parameters). When those product ranges are extremely tight, or the process can only hit them in a narrow operating window, capability is low: the process is sensitive to variation, hard to scale, and vulnerable to surprises. When the same outcomes can be achieved across a wider, well-understood range of settings, capability is higher: development moves faster, scale-up is easier, and change is less risky.

This is where your timelines start to bend. A process built around exotic raw materials, fragile unit operations, or highly specialized equipment may technically deliver the MVP, but it will take longer to develop, longer to qualify, and longer to transfer. Lead times for unique equipment, extended optimization work on a tricky step, or repeated engineering batches to get a marginal process under control all add weeks or months. The same is true if yields are low: large numbers of batches to supply trials or validation can quietly stretch a project’s calendar.

The opposite is also true. When CMC can show that the MVP can be met using a platform process, proven technologies, or a more forgiving operating space, your options change. A slightly simpler presentation (for example, delaying a move from vial to auto-injector), a modestly wider specification that is still clinically sound, or a different dose strength can open the door to existing equipment, established CMOs, and shorter validation campaigns. In other words, good process capability is a schedule and COGS asset, not just a quality comfort blanket.

For the people defining the MVP, the key is to treat CMC feedback on process capability as input to decision-making, not as an unwelcome constraint. When CMC says, “We can do this, but it will be slow, fragile, and expensive,” the underlying message is about risk to timelines and sustainability. The constructive questions to ask together are:

• Which MVP expectations are driving the most development time, complexity, and delay risk?
• Which elements are truly nonnegotiable for patients, payers, and regulators — and which could be staged, simplified, or adjusted?
• Are there alternative formats, devices, or dosing strategies that keep the value proposition but sit better with what the process can realistically support?

Seen through this lens, understanding CMC process capabilities is not about lowering ambition. It is about making ambition executable. By bringing process capability explicitly into the conversation about timelines and MVP requirements, teams can choose where to hold the line, where to bend, and where to sequence their ambitions over time — reducing the risk of late surprises while still building a product that delivers on its promise.

The MVP As A Conversation, Not A Document

Most organizations already do the visible part of the work defining an MVP that makes sense for patients, prescribers, payers, and investors. The real question is what happens next. Does that definition sit in a slide deck, or does it become the starting point for an ongoing conversation with the people who have to make the product real?

When key elements of the MVP are clearly described and shared — how the product is used, what “good enough” means for quality and safety, how it is presented, and what is assumed about cost and access — they give development and manufacturing a concrete basis for design. When those same elements are updated as clinical evidence, market insight and process knowledge accumulate, and the MVP stops being a static milestone and becomes a coordination tool: a way for product, clinical, CMC, and manufacturing teams to stay aligned on what they are trying to build.

Understanding and communicating CMC process capabilities is central to that coordination. A capable, well-understood process is not only a quality asset; it is a schedule and COGS asset. When CMC can say, “We can do this quickly and robustly,” or “We can do this, but it will be fragile, expensive, and slow,” they are commenting on the viability of the current MVP, not just on technical details. Used well, that feedback helps teams decide where to hold the line, where to adjust the MVP, and where to sequence ambitions over time so the project remains executable.

In the end, “viable” in minimum viable product has to mean viable for the whole business: for patients and prescribers, for payers, and for the factory. That only happens when the MVP is treated as a shared conversation rather than a one-way announcement — when the people defining the product and the people designing the process use it as their common reference point. Making that conversation explicit is one of the simplest and most powerful ways to reduce late surprises, protect timelines, and bring better products to market with confidence.

Conclusion

Just as a good metric hierarchy turns abstract strategy into concrete, aligned action, a living MVP shared with CMC and manufacturing turns a product story into an executable plan. Both are, at heart, tools for making thinking easier and decisions better across the organization.

About The Author:

Irwin Hirsh has 30 years of pharma experience with a background in CMC encompassing discovery, development, manufacturing, quality systems, QRM, and process validation. In 2008, Irwin joined Novo Nordisk, focusing on quality roles and spearheading initiatives related to QRM and life cycle approaches to validation. Subsequently, he transitioned to the Merck (DE) Healthcare division, where he held director roles within the biosimilars and biopharma business units. In 2018, he became a consultant concentrating on enhancing business efficiency and effectiveness. His primary focus involves building process-oriented systems within CMC and quality departments along with implementing digital tools for knowledge management and sharing.