No More Delays for Supply Chain Postponement in Life Sciences Life sciences companies with postponed supply chains are reducing working capital and lead times by as much as 35 percent, and obsolescence expenses by up to 15 percent. No More Delays for Supply Chain Postponement in Life Sciences 1 Introduction Supply chain postponement has been around for decades, pioneered by companies in the automotive, electronics, and consumer goods industries. Some other sectors have lagged behind—and only recently has the life sciences sector begun to show interest. We asked senior supply chain executives from more than 20 leading pharmaceutical, biotechnology, and medical devices firms what they think about postponement, what they are doing about it, and why. According to our findings, four out of ten companies have already deployed some elements of postponement, and nearly all the others are actively examining its potential. The implication is clear: if you are not already thinking about supply chain postponement, you certainly ought to be. Many of the interested parties are still struggling to build the business case for postponement, and then with the commitment to the changes required to achieve the benefits. Others, however, are already reaping the rewards, with measurable benefits of as much as a 35 percent reduction in lead time for finished goods, a similar reduction in working capital, a 15 percent decline in obsolescence expenses, and up to 5 percent revenue growth. The companies raking in the benefits of postponement do four things well. Namely, they: • Segment their supply chain strategies and product portfolio by looking from the market in, rather than from the supply chain out • Adopt technologies and invest targeted capital to make the production line more responsive and minimize changeover time, while working to drastically reduce quality release times • Accelerate planning cycles to respond nimbly to market demand signals directly from the consumer, with deliberate make-to-order strategies and decoupling points aligned to the flow of information • Train their people (and adjust their processes and incentives) to encourage cross-functional cooperation and end-to-end thinking From Field of Dreams to Minefield In the hit U.S. film Field of Dreams, a voice repeatedly tells Kevin Costner, “If you build it, he will come.” For decades, that tagline could also have been the slogan for the life sciences sector. Nearly any product that made it through the R&D pipeline was sure to find a market— and a highly profitable one at that—bolstered by strong brand reputations, robust patent protections, and an insatiable hunger for medical innovation. Business success was driven by product availability and serial launches of new protected products. It’s not surprising, in this context, that operational considerations were an afterthought. Although reliable service levels were expected, they were not a source of differentiation. And hefty margins, coupled with strict regulatory and quality control requirements, made it simpler to meet service demands by holding high inventories rather than by making production itself more flexible. Postponement A.T. Kearney defines postponement as the deliberate choice to hold a particular type of semifinished goods inventory, selecting where to decouple and where to site adjacent activities—and using information flows directly from the market to select when to perform these activities. But the “field of dreams” in life sciences has become a minefield. Budget-constrained payers are making it increasingly difficult to position minor innovations at high price levels. Most markets are tending to commoditize in generics, biosimilars, and, increasingly, entire therapeutic areas of patented medicines. Prescriptions by active pharmaceutical ingredient (INN prescriptions) and tenders are forcing off-patent product marketers to compete on price and service levels.1 At the same time, labeling requirements have grown more complex and continue to change regularly, while marketing departments have sought to differentiate through secondary packaging formats. Consequently, the number of stock-keeping units (SKUs) has skyrocketed, creating increasingly large inventories of finished goods, a potential source of obsolescence, and further reducing net margins due to packaging and rework costs. With a proliferation of products and formats, and with changes to markets, unpredictable demand follows, making the problems worse. In some geographies (notably Europe), the complexity can become acute, exacerbated by the free market movement of goods in distribution. In this new reality of tighter margins and greater complexity, companies can no longer afford to offset a rigid operational setup with higher stocks of finished goods. Today, a more flexible, responsive supply chain is crucial to expand the customer base while managing both working capital and margins. Some life sciences companies are now rising to the challenge of becoming more responsive by holding inventory in a semifinished state, waiting for market signals (such as customer orders or the publication of impending regulations) before they complete final steps such as packaging and labeling. The elements of this practice, commonly called postponement, have long been employed in other industries. Although there are many definitions for postponement, ours refers to the deliberate choice to hold a particular type of semifinished goods inventory, selecting where to decouple and where to site adjacent activities—and using information flows from the market (meaning actual demand, rather than forecasts or buffer stock levels) to select when to perform these activities. One industry where postponement is prevalent is fast-moving consumer goods (FMCG), where margins can be low, demand is often unpredictable, and the product frequently has a common base form. In addition, the historical shift to low-cost country (LCC) sourcing has made FMCG supply chains long and cumbersome, further advancing the need for postponement. INN stands for international non-proprietary name. 1 No More Delays for Supply Chain Postponement in Life Sciences 1 About the 2015 A.T. Kearney Postponement in Life Sciences Study We surveyed more than 20 senior supply chain executives from the life sciences sector. Participants account for six of the world’s top 10 pharma companies. More than one-half work for companies with revenues of more than $12 billion, and 90 percent of the participants’ companies have a turnover of at least $1 billion. Small and large molecule manufacturers comprise 45 and 48 percent of the total revenue of each sector, with smaller representations from medical devices and OTC firms. In addition to the survey, we also held in-depth discussions to delve into select topics, including: • How companies define postponement and how they apply it in their supply chains (for example, by decoupling point, galenical form, packaging technology, production concept, or region) • What benefits postponement contributes • How roadblocks to implementation can be overcome The study was conducted in the first quarter of 2015. • Why companies postpone • Which product types are best suited to postponement No Longer Postponed Many of these same drivers of FMCG postponement have now arrived in life sciences, but perhaps 20 years later. When we surveyed a representative sample of more than 20 senior supply chain executives from pharmaceutical, biotechnology, and medical devices firms (see sidebar: About the 2015 A.T. Kearney Postponement in Life Sciences Study), we found that 38 percent have implemented full late-stage customization within the past three years.2 While this group already reports material benefits, many continue to track the effectiveness of late-stage customization and explore how to further increase its business impact. Another 48 percent of the executives surveyed are incrementally applying some aspects of postponement but have not yet embraced a full supply chain postponement strategy. Ten percent have completed their assessment and decided not to proceed, and just 5 percent have not considered postponement at all (see figure 1 on page 3). Geographically, among the companies using postponement, just 38 percent apply them in all locations. The rest employ them exclusively in Europe, the Middle East, and Africa (23 percent); Asia Pacific (20 percent); Latin America (17 percent); or the United States and Canada (3 percent). This geographic distribution reflects the relative complexity and homogeneity of market dynamics and requirements in the different regions, as well those geographies where higher growth is expected. Interestingly, many of the companies’ reported late-stage customization activities are not true postponement. For example, some companies in Asia Pacific are pasting new labels on top of old ones rather than leaving goods unlabeled until assigned for delivery; strictly speaking, they are performing rework rather than postponement. Certain other companies simply delay the physical deployment of inventory, while still maintaining a finished good stock and push strategy for replenishment—without addressing the underlying processes and information flows needed for true postponed fulfillment. Late stage is defined as the assembly, labeling, and packaging stages of manufacturing. 2 No More Delays for Supply Chain Postponement in Life Sciences 2 Figure 1 More than 80 percent of life sciences executives surveyed are applying elements of supply chain postponement Have not considered 5% Supply chain postponement ruled out 10% Some postponement aspects already applied Full late-stage customization implemented 38% 48% Note: Late stage is defined as the assembly, labeling, and packaging stages of manufacturing. Source: 2015 A.T. Kearney Postponement in Life Sciences Study Figure 2 Postponement enables a more responsive supply chain Select benefits of supply chain postponement • Availability of business continuity inventory • Rapid resupply capability • Increased reliability • Sales uplift of up to 5% • Lead time reduction of 20–35% for finished goods • Reduction in obsolescence expenses of 10–15% Resiliency Costs Service enhancement Working capital • Decreased exposure to regulatory changes • Working capital reduction of 10–35% • Reduced fraud exposure Source: 2015 A.T. Kearney Postponement in Life Sciences Study A Winning Proposition Participants in the 2015 A.T. Kearney Postponement in Life Sciences Study that engage in late-stage customization say that it has made their supply chains more responsive (see figure 2). First, they report that their supply chain is more resilient and that customer service has improved. For instance, semifinished inventory can be rapidly mobilized to guarantee business continuity in the event of unforeseen disruptions elsewhere along the supply chain. Similarly, increased flexibility makes it easier to quickly resupply markets and otherwise respond to large fluctuations No More Delays for Supply Chain Postponement in Life Sciences 3 in demand—for example permitting the business to confidently reply to (and indeed win) new tender opportunities: • Participants attribute sales uplifts of as much as 5 percent to postponement. • Service levels are reported to improve, which is especially important for large molecules and medical devices, where customers expect service levels of close to 100 percent. • Respondents say that lead times for finished goods in postponed supply chains have dropped by between 20 and 35 percent. • There is a 10 to 15 percent reduction in obsolescence costs, thanks to smaller lot sizes that decrease exposure to regulatory changes. • A top benefit cited across all life sciences subsectors is a reduction in working capital— anywhere from 10 to 35 percent—as a result of lower inventory levels. Four Pillars of Successful Postponement Supply chain postponement in the life sciences sector is far from easy. First, the sector covers an extraordinarily diverse range of products—medical devices, such as prosthetics; smallmolecule chemical drugs, such as antibiotics; and large-molecule biotechnology drugs, such as vaccines and anticancer treatments—and some product classes are easier to postpone than others. Secondly, efficient and adaptable quality and production processes are essential, triggered by good planning and effective information flows—yet for the reasons discussed earlier, life sciences firms have tended to de-emphasize certain capabilities in operations. Finally, postponement requires flexibility at manufacturing facilities; often, however, the current asset base is not adequately configured and may require new investment. Furthermore, many companies outsource their production to third parties, and the need to handle variable demand can challenge conventional contracts and relationships. Based on our analysis of survey responses and a number of follow-up interviews with supply chain executives, we have discerned four key enablers of successful postponement (see figure 3 on page 5): 1. Clearly segmented supply chain and portfolio strategies 2. Swift replenishment technologies 3.Fast planning cycles 4.Right-skilled staff 1. Segment supply chains and portfolios by looking from the market in Increasingly, the ability to customize route-to-market strategies at the product market level is becoming critical to maximize market access and achieve commercial potential. In many markets, direct-to-customer distribution models (whether to the patient, the hospital, or the pharmacy) are one avenue life sciences companies are pursuing to better understand— and deliver on—what their customers need and value. These models offer the advantages of greater security, customer centricity, and, potentially, efficiency (through disintermediation), but they also require much more agile and responsive supply chains that postponement can help enable. No More Delays for Supply Chain Postponement in Life Sciences 4 Figure 3 Enablers of successful postponement Enabler Clearly segmented supply chain and portfolio strategies Description • Postponement models tailored to portfolio complexity, sales volume, and demand volatility • Smart automation Swift replenishment technologies • Fewer or faster changeovers • Shorter quality release times • Real-time view of supply and demand Fast planning cycles • Smaller batches and frequent changeovers • Agile planning and distribution processes • Cross-functional cooperation Right-skilled staff • End-to-end mindset Source: 2015 A.T. Kearney Postponement in Life Sciences Study To determine where it makes the most sense to postpone, successful companies look at three dimensions (see figure 4 on page 6): • Portfolio complexity: Postponement makes most sense for products that diverge exponentially from a common core, late in the production process. For many medical devices, complexity builds progressively along the supply chain—so although postponement makes sense in many cases, case-by-case evaluation and careful placement of the decoupling point are vital. By contrast, for small- and large-molecule pharmaceuticals, the myriad of labeling and packaging requirements (some of them marketing-driven) means that variants tend to proliferate at the very end, making them excellent candidates for postponement. • Volume: Postponement is most heavily indicated for finished goods with low volume but whose semifinished precursor presents much higher aggregate demand. This characteristic is very common in large-molecule pharmaceuticals, which tend to be used in low-volume, high-value, specialist-prescribed products. Additionally, the short shelf lives and high value of large-molecule pharmaceuticals place finished goods stock at elevated risk of obsolescence—as opposed to intermediate (postponed) stock, for which the product rotation is much higher (reducing this exposure). Again, medical devices vary case by case, though often the final product is provided to individual physicians and matched to specific patients; in these cases, postponement is a valuable strategy. By contrast, while some small-molecule products do exhibit these characteristics, frequently the volume of sales and widespread distribution leads to high volumes, even at finished-goods SKU level. No More Delays for Supply Chain Postponement in Life Sciences 5 Figure 4 Large molecule manufacturers stand to benefit the most from supply chain postponement Postponement favorability Less Dimension Portfolio complexity Volume Demand volatility More 1 Key questions 2 3 4 • Where are the natural break points in the supply chain? • What is the typical order size? • What is the tender environment? • How volatile is demand? • What is driving volatility? Large molecule Small molecule Medical device Source: A.T. Kearney analysis • Demand volatility: The third dimension for postponement is volatility, and in particular the likelihood that a product will see unpredictable changes in demand, coupled with the importance of quickly meeting that demand to adequately serve customers and achieve revenue and distribution growth. Again, this matches well to large-molecule products. For example, an unexpected outbreak of infectious disease can create a sudden flood of urgent tenders for tens of millions of vaccines. Furthermore, tender-based procurement is increasingly frequent in this sector, following a trend also seen for both medical devices and small molecules. Indeed, some countries are even extending them to entire therapy areas, offering a “feast” for the companies that win and “famine” for those that do not. Products in the earlier stages of their life cycle also generally present higher demand volatility than mature products. Postponement can be a useful technique to maintain the flexibility to swiftly meet the demand that arises from a winning tender, a brilliantly successful product launch, or unanticipated market opportunities. Interestingly, although postponement is best suited to large molecules or complex small molecules, postponed supply chains are more common in simple small molecules, where the primary and secondary packaging steps are often decoupled. That said, large-molecule manufacturers are more advanced than their small-molecule counterparts in one aspect of postponement: that is, the former are more likely to deliberately hold inventory in a semifinished state, whereas the latter tend to push products through the supply chain in a more continuous process. We saw this in Europe at a rapidly growing biotech company that was grappling with high demand volatility and write-offs. In a bid to improve its working capital and security of supply, the company decided to hold drug products before the labeling and packing processes. No More Delays for Supply Chain Postponement in Life Sciences 6 Supported by rapid production, the company was able to configure products only when actual orders were received. This allowed write-offs to be reduced to just a small fraction of pre-postponement figures, while reducing overall working capital. 2. Adopt technologies for a more responsive production line Given the traditionally limited need for lean processes in life sciences manufacturing, the use of internal capital assets is normally scheduled far in advance. But in a postponed world, greater responsiveness is essential; highly adaptive scheduling, flexible materials management, and near real-time quality clearance are imperative. Some companies that successfully use postponement establish dedicated packaging and labeling lines for their low-volume products. This way, they keep changeovers to a minimum, and lines can quickly respond to changing demand. Also, the layout is often altered (for example, changing straight production lines into a U-shaped formation) to consider operator movements for a greater variety of products in order to speed up small-batch manufacturing and reconfiguration. And small-scale, modular shop-floor setups make it easier to introduce dedicated robotic technologies to ramp up production and assemble multiple products (such as syringes) that demand high quality and precision. Other thriving companies retain the traditional straight-line setup, but they apply new technologies such as digital position sensors combined with servo, stepper, and direct current (DC) motors to fully automate changeovers. Another very recent enabler is white-line production, where country-specific information is only added to lidding films, boxes, and inserts later— when they are in the packaging line—reducing changeover times to less than 10 minutes. These strategies are especially effective for lower-value, high-volume products such as simple small molecules. Electronic batch records, shared in real time, and release-by-exception policies are used to slash quality release times, especially where contract manufacturing organizations are involved. Life sciences companies also apply continuous improvement methodologies to significantly reduce quality assurance lead times, while adapting their quality control protocols to enable bright stock manufacturing and distribution without losing lot control and sub-lot traceability. One pharmaceutical manufacturer slashed production and quality approval lead times by more than 50 percent to enable a postponement strategy. The company achieved this feat by tackling the problem from the bottom up and the top down. Working methods were thoroughly reexamined and challenged, at the same time that the latest technologies were brought into play. Leadership and front-line staff worked collaboratively throughout the effort in a series of high-intensity workshops where new approaches were rapidly tested and buy-in for the changes promoted. 3. Accelerate planning cycles to react to market signals Postponement, by its very nature, means smaller batch sizes, as manufacturing transitions from a make-to-forecast to a make-to-order (or market replenishment) model. But few life sciences firms have planning and information flow processes that are configured to recognize and react quickly to pull signals from the market. A make-to-order configuration model requires nimble and robust IT systems, as well as planning and distribution processes that can turn on a dime. No More Delays for Supply Chain Postponement in Life Sciences 7 Yet despite the difficulties, some companies manage to pull this off. Take the case, for example, of a leading pharmaceutical firm that established stronger, more formalized planning linkages with its country affiliates to increase its ability to detect market demand signals. The company achieved not only nearly instant notification of new orders, but also had near real-time transparency of local pipelines, sales activity, and on-hand reservable inventory—allowing it to greatly improve market anticipation and planning for demand. Although IT played a role in bringing about this change, most of the benefits resulted from strengthened processes and protocols. Such adaptable planning cycles and variations in production output are especially challenging to third-party provider relationships, where prices often depend on periodic volume commitments and production schedules communicated weeks, if not months, in advance. In a postponed world, sometimes companies must consider how they combine their products to fully utilize their partners’ manufacturing assets, or alternatively buy blocks of time in a contract manufacturer’s production line, coupled with the labor availability to allow for changes to output. Despite the challenges and potential inefficiencies, our survey respondents find that postponement still pays off. 4.Train staff in cross-functional cooperation and end-to-end thinking Postponement is built on cross-functional cooperation and end-to-end thinking. Collaboration is much closer between the supply chain and commercial functions. Design considers not only how to make a product stand out from its competitors, but also how to balance the marketing advantages of differentiation with the supply chain benefits of commonality. Operationally, some industry leaders are taking a page from the playbook of the automotive industry, where team leaders responsible for connected parts of the production value chain meet at the beginning of each shift to jointly resolve quality or manufacturing problems, and share accountability for end-to-end order delivery. IT plays a crucial role in enabling end-to-end thinking. Leading companies make extensive use of visual management tools, for example so that manufacturing teams can react immediately to issues that might affect production, and so that planners become immediately aware of inventory and demand signals. The importance of high-performing teams to successful postponement cannot be understated. Managers at leading firms can attest that teams need to complement the hard, technical skills with what Katzenbach and Smith, in their seminal 1993 Harvard Business Review article “The Discipline of Teams,” described as mutually reinforcing capabilities and a commitment to “a common purpose, set of performance goals, and approach for which they hold themselves mutually accountable.” In this regard, the human resources construct, metrics, and incentive schemes will typically need to be changed to encourage agile delivery, doing away with conventional metrics that often value level loading, absorption, and finished goods availability. No More Delays for Supply Chain Postponement in Life Sciences 8 Getting Started For the nearly 50 percent of life sciences executives who are still just dipping their toes in the supply chain postponement waters, we can offer three pieces of advice: • The business case is unlikely to be built around a single benefit. Executives should develop a comprehensive value case, including estimates of savings (such as reduced obsolescence, greater resilience, and lower working capital) alongside the benefits to revenue (for example, from service level improvements, access to new markets, and tender responsiveness). Full cases invariably demonstrate step changes in performance and are vital tools for investment discussions. • Once suitable pilots are conducted, commit to implementing postponement quickly, at scale, and across geographies. The risks of implementing such changes to the operating model can be mitigated; on the other hand, risk tends to increase under a “go-slow” approach, which creates confusion in operations and serves only to delay the benefits. • Engage front-line workers to develop solutions that are truly applicable to operations. While new technologies will deliver a major part of the benefits, ways of working will need to be challenged and rewritten. While top-down approaches can work, a bottom-up approach is usually better. The potential benefits of postponement can be huge, so it is never too soon to get started. Authors Bill Tribe, partner, Chicago [email protected] Oliver Eitelwein, principal, Düsseldorf [email protected] Michael Wise, partner, New York [email protected] The extended postponement team includes Claire Jarvis and Jim O'Keefe, who also contributed to this study. No More Delays for Supply Chain Postponement in Life Sciences 9 A.T. Kearney is a leading global management consulting firm with offices in more than 40 countries. Since 1926, we have been trusted advisors to the world's foremost organizations. A.T. Kearney is a partner-owned firm, committed to helping clients achieve immediate impact and growing advantage on their most mission-critical issues. For more information, visit www.atkearney.com. Americas Atlanta Bogotá Calgary Chicago Dallas Detroit Houston Mexico City New York Palo Alto San Francisco São Paulo Toronto Washington, D.C. 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Kearney Limited (Branch Office), a branch office of A.T. Kearney Limited, a company organized under the laws of England and Wales. © 2015, A.T. Kearney, Inc. All rights reserved.
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