The Life Sciences industry is under increasing pressure from governments, healthcare authorities and private insurers seeking to reduce costs and increase value of healthcare providers. Markets for healthcare products have become more strictly regulated, approvals of innovative products are increasingly hard won, and competition from generics and the East is fierce. These market conditions are impacting all aspects of Life Sciences businesses. Tefen provides strategic consulting and works with Life Sciences companies across their value chains to transform sales, marketing, supply chain, manufacturing, quality and R&D. We help medical device, pharmaceutical and biomedical companies to define new commercial and operational strategies, then work closely with them to deliver major performance improvements. Our recent work in the industry focuses on topics including pre-launch, pricing and positioning, customer segmentation, key account management, lean six sigma manufacturing, supply chain optimization and risk management, QC efficiency, tech transfer and transforming R&D operations.
The continuous introduction of new technologies and drugs, aging populations, increased awareness of healthcare issues, attention to care and quality of life and a new focus on effectiveness of treatment across all national health care systems have all been contributing to an ever increasing cost pressure from payers around the developed world. These pressures have been materializing in numerous ways such as increased centralization of purchasing processes, consolidated buying groups, and an overall sensitivity to healthcare economics-related value propositions.
Under these conditions, competitive pressure on prices is growing, which makes product price a key factor when a customer is considering options. The impacts on the Life Science and pharmaceuticals industries are significant: generics become ever more attractive, decision making is done more and more at the administrative and the financial side and unprepared vendors are finding themselves in a difficult position trying to justify their products’ value adding properties. All of this puts a renewed focus on optimizing the competitive bids and tender management process.
Over the last several years it has been shown that a proactive, structured approach to tender management can yield high-level results, even when challenged with fierce competition. Tefen’s own approach to tender management in such situations is based on three pillars:
1 - Develop and implement tools to support tender execution
Using a number of structured tools can significantly increase the effectiveness of the tender process. These tools include:
2 - Perform business intelligence activities, supported by specific tools, within a regular process
Business intelligence is a regular and critical process for gathering information and defining commercial strategy. The process aims to answer questions such as:
Using the tools described above, these questions can be answered and can support account managers in forecasting the issuance of new tenders, understanding intra-organizational influences within a client, optimizing the product/price mix offered to each account and ensuring actual sales fall in line with established tenders.
3 - Develop and implement commercial structured approach
Matching the right set of activities at each of the tender phases – pre-tender, the tender itself and post-tender – is key for execution and to maximize winning chances. For example, planning and ensuring resources are available to support and coach physicians at the post-tender phase is crucial to mainlining long-term relationships that will improve the odds of securing the next tender.
A lack of cohesion between supply and demand can manifest into significant costs for companies as out-of-stocks, excess inventory and over discounting multiply. With the addition of complexities such as new product introductions, promotions, packaging changes or demand variances, the need to align Sales and Operations Planning (S&OP) is vital to sustaining profitability. Companies that are proactive with S&OP gain visibility and the agility to improve delivery performance and pricing management, while streamlining inventory and increasing revenue forecasts.
The value of S&OP may be deciphered by considering whether your company experiences the following problems:
Tefen’s approach to S&OP is to create harmony between our clients’ sales and manufacturing functions. This process differs from traditional planning methods, moving away from daily or weekly planning reviews. Instead, planning reviews are arranged on a monthly or annual basis, and involve higher level management. This arrangement includes critical knowledge of demand and operations, allowing for a well-rounded horizon to create a planning strategy. Input from higher level management also ensures that the formulated plan will remain in line with the business strategy, be profitable, productive, and realistic with lead times, among other things.
Our S&OP process also involves a thorough redesign and the implementation of a demand and supply review process, each of which is handled independently.
For the demand review, the primary objective is to forecast the sales of each product line. This forecast is a collective agreement between stakeholders from marketing, sales and even product development. Consideration of factors such as new or deleted products, competitors or market conditions ensure the best possible forecast accuracy.
Given a reliable demand plan, a supply review may be planned accordingly. The objectives of this review are to consider the potential for temporary capacity bottlenecks or under-utilization; ensure staff planning is aptly distributed; and deliver a high level capacity plan. This review is also capable of producing a procurement plan. Essentially the goal here is to ensure optimal resource utilization.
Finally, an S&OP review will address any disparity between the demand and supply plans. The output is a single published plan that examines forecasted demand revenue and the associated planned production cost, stock levels, purchasing projections, financials (budget versus actual) and productivity and performance utilization.
It is more important than ever to streamline supply and operation processes to gain competitive advantage. An effective S&OP process can provide improved visibility across the supply chain; leading to increased control of product and inventory management, better targeted promotional planning and enhanced revenue forecasts.
Manufacturing effectiveness is of significant importance in the Life Sciences sector because it fundamentally dictates both quality and delivery performance. The term embodies a vast scope of methodologies, which are primarily designed to streamline processes that add value to the customer and remove processes that lack customer value. The importance of this subject matter is heighted as internal drivers and competition increase the pressure for improved performance. Subsequently, industry-wide, manufacturing effectiveness is always a subject for improvement.
The advancement of manufacturing effectiveness requires a comprehensive understanding of the current state performance, as well as a tangible vehicle to deliver the needed change. High performance requires the removal of complexities and the clarification of root causes of issues and the subsequent design of focused change solutions. Specificity is what facilitates perpetual manufacturing effectiveness, because the most significant process inhibitors are not always apparent. These inhibitors may be the subject for improvement for immediate benefit.
Given our depth of experience in this field, Tefen has established a proven success record in providing services such as:
Alongside decades of experience within the Life Science sector, our Tefen experts may draw upon a bank of additional methodologies to advise clients on how to gain increased customer value, greater flexibility for growth, cost reduction or better operational reliability.
At the same time, Tefen recognizes that at its pinnacle, manufacturing effectiveness ought to be a self- driven mechanism, where improvement may be recognized and leveraged at any level within an enterprise. When change for self-improvement is instigated both at a physical and cultural level, true manufacturing effectiveness is achieved. Our methodologies facilitate this end by implementing a paradigm shift so that all available resources are aligned to deliver a manufacturing excellence focused on adding sustained customer value.
A common hurdle in the Life Sciences industry is the optimization of laboratory processes. One misconception is that it is impossible to gain the same benefits from applying Lean approaches in lab environments as in manufacturing environments. QC departments in labs are often perceived as having numerous steps along their value streams and acting like a brake; whereas in manufacturing QC is seen as the accelerator. This QC perception in labs makes it difficult to achieve the balance between reducing lead-times and boosting reliability and product quality.
Quality Control is certainly vital in any Life-Sciences company in order to ensure that raw materials are suitable for use and the end product meets the highest quality standards required. QC typically is involved throughout the entire product life-cycle development process and focuses on testing products and materials to deliver results in the most efficient way in terms of cost and speed.
Our diagnostic benchmarking includes assessing a site’s priorities, practices and performance and allows for customized recommendations for the specific objectives and constraints of each company. In addition, Tefen has gathered detailed benchmark data from practices and performances in more than 60 labs (pharmaceuticals, biotech, biopharma, and more). The data covers 120 metrics that help drive performance improvements. This type of experience and data can be a valuable tool, not only in short-circuiting errors made by others, but also in building a viable, compelling and less risky case for change.
Tefen’s Lean quality programs utilize elements of Lean and Six Sigma to streamline processes within labs, e.g., resource planning and scheduling, layout design, and others. We help QC operations synchronize their organizations and operations with production; pull product right through the entire value chain; minimize setup times and process queues; eliminate waste through streamlined processes; and change layout. We also design organizational structures to encourage continuous improvement by developing standard management routines, clear accountability for improvement, visible leadership on the lab floor, and clear KPIs, etc.
All in all, the main objective is to optimize “flow” and “pull” to suit the needs of the organization by eliminating delays caused by bottlenecks, and to respond immediately to triggers from the subsequent process in order to produce results only when needed.
There are numerous benefits of Lean labs, such as improved productivity with reduced costs and lead times; minimized rework and unnecessary tests; a culture of continuous improvement to sustain business benefits and many others. All of these directly impact the bottom line and advance the joint efforts in quality, productivity, and effectiveness.
Strict regulatory requirements and the challenges of staying competitive in a fast-changing environment are not only raising the demands on sales, production and administrative functions, but also on Quality Assurance departments. QA teams are now expected to maintain control of quality, costs, reliability and speed, while also complying with regulations. In order to achieve this, Quality Assurance must become a proactive process that ensures product manufacturers adhere to specific standards and strive for continuous improvement and the elimination of errors. The goal is to create products that are “fit for purpose” and “right first time" through prompt and effective operational performance while still observing all statutory requirements.
In fact, many in the industry struggle with this challenge, because support functions, such as Quality Assurance, are increasingly tied up with administrative activities, which reduces the time spent on the shop floor to prevent issues and directly add value to the end customer. However, this trend also provides us with opportunities for optimizing and better organizing QA activities.
Quality is now frequently included in Operational Excellence transformations. To ensure the sustainability of QA success, optimization of process reliability and efficiency is required. We advise our clients to acknowledge the need to streamline their operations to improve flow and operational speed, while minimizing unnecessary tasks that waste time and resources.
Organizations should structure themselves around key processes that add value to patients and users. Tefen’s methodology and experience of QA process optimization can create a quality culture across a Life Science organization and help overcome challenges. Tefen can show how Lean practices should be applied in an organization’s structure and introduce processes to encourage continuous improvement.
Tefen's holistic approach starts with a diagnostic benchmarking stage that assesses three key factors: a site’s strategic priorities, performance and practices. The results allow us to formulate customized recommendations for a company's specific objectives and constraints and give valuable insight into what other organizations with the same issues have done to improve their areas of low performance.
1 - Strategic Priorities
Before any structural changes are made, it is crucial to specify the priorities of each site. Conducting specially designed interviews gives us an understanding of the drivers, constraints and overall site philosophy, with its principles and trade-offs. This then enables us to define high-level targets for cost, quality and delivery metrics. Once site priorities have been set, a process/function matrix is used to prioritize the key business processes within the scope. Processes are then prioritized according to their impact on quality and drivers, such as workload per department, cost, lead-time, customer value, etc.
2 - Current State: Performance and Practices
An analysis of current practices at the site and their impact on performance is the foundation for any change and is crucial to the success of the program. Workshops are used to identify the process steps, inputs and outputs, and to clarify accountabilities. These processes are mapped, with the most critical QA processes as the focus. Customers, inputs, outputs, and suppliers are specified for each of the processes and subsequently, each of the process steps are categorized as either value adding, non-value adding or required for sustainable business. The aim of all this is to establish the impact of practices on quality and to quantify performance in terms of lead-time, FTEs or other costs. This allows for benchmarking performance levels with other sites in the industry. At this stage it is essential to invest time on site to uncover root causes and agree on action plans with the teams.
3 - Future State
For an organization to be successful it should have a clear vision designed to maximize customer value. At this stage, each of the mapped processes is analyzed, in close cooperation with the teams performing these activities. This analysis is used to determine the optimum measures for process streamlining and the removal of any waste and NVA activities.
Benchmarks and best practices are brought in, assessed and incorporated to improve QA activities. Once the processes have been streamlined, a structure can be designed to enhance their output. Roles, responsibilities, accountability and interfaces are redesigned while taking into account existing knowledge and skill levels. A training plan is designed to enable a speedy and effective transition. When the projected benefits of the improved processes have been quantified, new performance targets are set and KPIs are introduced to monitor and promote the effectiveness and reliability of each process.
4 - Implementation Roadmap
A roadmap will be designed to translate all these recommendations into a tangible and explicit work plan to enable a complete, timely and successful implementation. This includes detailed work streams, responsibilities, timescales, and resource requirements. The roadmap should clearly illustrate the exact route to be followed by the organization, in order to achieve the desired future state. It is imperative that the quality leadership and management teams agree and sign off on the roadmap to guarantee a successful implementation phase.
Sourcing and managing suppliers is crucial for sustaining profitability because suppliers essentially dictate a major proportion of an organization’s variable costs. A supplier becomes part of the foundation upon which a product is built; therefore it is essential that suppliers share similar business objectives / strategy. When selecting a supplier, one must consider attributes such as:
Price should not always be the leading attribute while choosing a supplier.
Selecting the ‘best fit’ supplier can be difficult to justify; and this process must undergo continuous inspection. This can require substantial resources. Meanwhile, managing suppliers is also crucial; forging mutually beneficial relations with suppliers will help minimize costs and ensure good service.
Traditional procurement methods are passive, and the response to requisitions and unexpected requirements is reactive. Tefen's strategic sourcing methodology differs from the norm in that it causes sourcing teams to conduct analysis of the supplier market and only recommend suppliers that can deliver solutions which meet pre-defined and agreed upon business needs. We also use roadmaps for supplier technologies, so that full knowledge of forthcoming opportunities is absorbed, allowing clients to capitalize as early as possible.
Leverage with suppliers is pivotal when it comes to deal making, meaning that the ability to create leverage is key to gaining competitive advantage. Tefen moves away from fragmented supply orders and instead uses a holistic approach to supplier sourcing and management. This allows us to ask the question: are X products from supplier A more advantageous than Y products from supplier B? Leveraging bulk buying value or reducing logistics cost all add up to significant cost savings.
Management of suppliers is also a continual process, which should be subject to continuous review. Tefen uses contracts with contingencies as tools to mitigate the risks that suppliers may pose. Suppliers for stable products are usually governed by long term agreements, while suppliers for products that are more volatile or in development are governed by short term, flexible deals. We also provide sustainable strategies to follow-up with supplier performance and to prevent supplier relation losses.
The current, reactive nature of supplier sourcing and management is changing. A more thorough understanding of supplier markets and associated technological advancements is required. With our experience in this field, Tefen can implement and inject the necessary pace into this function to ensure that the best suppliers are selected to reflect your specific business needs.
A firm’s supply chain is the vehicle through which materials and products are moved from the source to the customer. A good supply chain design can become an effective strategic weapon for competitive advantage. On the other hand, lacking an optimized supply chain network design can place a structural stranglehold on costs as well as cause a reduced agility to react to changing market demands. In addition, given the variance of products, customers and facilities, it thus becomes vital to continuously review the network design for potential savings.
A network design covers a vast scope of business and may be manipulated to solve any one of the following business problems:
A conventional method to design a network focuses mainly around operations and geographical layout. Tefen’s approach expands on this methodology and presents a more strategic outlook for capturing any opportunity between distinct operational units, while ensuring that customer demand is fulfilled. By analyzing up to date labor cost, legislative and tax policy, logistical costs and inventory requirements, Tefen can help companies design efficient networks, ensuring potential savings are not missed.
Tefen recognizes that there is no satisfactory one-size-fits-all solution. Our methodology systematically models the network design exercise on four tiers: suppliers, factories, warehouses and customers. We consider multiple ‘what if’ parameters and iterate different scenarios and designs to ensure the optimum design is chosen. While we do use tested mathematical models to assist with network design, it is the combination of our experience with the client’s input that delivers a tailor-made network design tool for your specific needs.
As companies consider a reconstruction of their network design, they have the opportunity to reconsider the various benefits and trade-offs associated with alternate constructs. This heavily quantitative and qualitative exercise—addressing the number and locations of these facilities—is a critical factor in the success of any supply chain. Essentially, Tefen not only provides the first design solution, but also implements a vehicle which is self-sustaining and can provide ongoing benefit, itself.
A shifting landscape forces Life Sciences and Pharmaceutical R&D organizations to embrace change. Tefen segments this change into five main external points:
Internal issues are also hampering performance in R&D, causing problems such as schedule delays, quality issues and unplanned costs. Many companies are able to define a strategy, but struggle with implementation due to a lack of productivity within R&D. The tight schedule and the demanding environment create a series of quality problems and also impact the overall performance of the R&D flow. As for the lack of use of tools such as Design to Cost, Quality Function Deployment and Value Engineering, products end up costing more than originally planned.
Customer commitments are often broken due to the complexity of managing several projects with varying knowledge gaps, making it difficult to predict when a project will be completed satisfactorily. Products end up in the field with components that do not meet specifications or with specifications that were not fully investigated, leading to high service and maintenance costs. When design reviews and gates are not carefully managed, the development team is faced with many changes that delay the R&D process.
Tefen’s methodology relies on five important steps that start with building a coherent product strategy in order to fulfill unmet medical needs. The product strategy includes ensuring a steady, balanced revenue stream for the company and a technology roadmap that exploits current and emerging technologies to deliver products that the market needs.
The second step is outlining the optimal IP licensing strategy. It can be too expensive to conduct all development in-house, yet risky to allow external partners to own intellectual property. A clear strategy and well managed partnerships are critical.
The third step is the implementation of excellent development processes. Complexity in organizations, processes and legislation can extend time-to-market, jeopardize launch dates and exceed budgets.
Since as much as 80% of a product’s cost is set at the development stage and there is little ability to reduce this cost during commercial life, Tefen's fourth step is to integrate a "Design-for-X" philosophy. This means making specifications meet the needs of all internal customers, not just the end customers. It also encourages a culture of innovation to drive towards practicality and manufacturability.
Finally, managing the R&D project portfolio is important to ensure investment decisions are made systematically and are strategically aligned with existing development initiatives.
Overall, Tefen’s approach involves developing structured processes and Key Performance Indicators that facilitate effective portfolio and pipeline evaluation decisions, and establish accurate and comparable data-based information to ensure fact-based decision-making and resource allocation.
The trend for changing organizational culture and design to improve customer focus and effectiveness of the value chain is still on-going across the Life Sciences industry. Meanwhile, organizations are still trying to figure out how to create this desired “Lean” culture across their sites and determine which organization design would suit their needs best. At Tefen, the notion of organizational structure and culture are two of the most important pillars of our business excellence solutions, along with operational improvement, transformation capability and strategy of operations for the Life Sciences industry.
With help from the deep and broad knowledge of our industry experts and close partner engagements, we provide our clients with a fresh perspective as well as both hard and soft benchmark data from more than 80 Life Sciences sites worldwide. Using our proven diagnostic methodologies and best practice data we not only aid our clients with understanding the attributes of different structures and finding the best one for them, but also run focused projects to implement cultural and organizational change and drive tangible performance improvements straight from the shop floor.
One of Tefen’s most common recommendations for Life Sciences sites is the implementation of a PCO – Process-Centric Organization. Our industry experience shows that a traditional functional organization is a root cause of poor on-time delivery, confusion and low morale. A PCO is split along the value streams (by product or product group) with value stream leaders being accountable for end-to-end delivery to the customer and with access (where possible through line reporting) to all resources required to achieve the delivery. At the same time, activities detached from day-to-day activities sit in functional centers of excellence (such as Finance, Procurement and others).
A PCO structure allows the site benefit from the following: 1) streamlined processes eliminating duplication and waste; 2) organizational alignment with the customer, enabling consistent on-time delivery; 3) empowered employees making decisions at the closest level to the actual operation, resulting in quicker problem solving; and, finally 4) improved flexibility thanks to value stream leaders owning end-to-end resources, ensuring they meet ever changing customer needs. Therefore, a Process-Centric Organization serves customers better, adds more value, increases employee satisfaction, and reduces costs.