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Companion Diagnostics: Uncertainties for Approval and Reimbursement SWOT Analysis / TOWS Matrix / Weighted SWOT Analysis

Case Study SWOT Analysis Solution

Case Study Description of Companion Diagnostics: Uncertainties for Approval and Reimbursement


The FDA approvals of novel therapeutics were seen as signs in the personalized medicine community of real progress in the growth of personalized medicine; The FDA's approval of such drugs, along with companion diagnostics, suggested a shift in thinking and regulatory practices at the agency. Beyond the regulatory questions, many considered the reimbursement system archaic, dispersed, unpredictable, and unnecessarily time consuming. Many questioned whether the traditional models of reimbursement were relevant in the era of personalized medicine, and who should be covering the cost of tests needed to identify the sometimes small number of patients who could benefit from expensive targeted drugs. This case focuses on the array of possibilities and the ambiguity surrounding these regulatory and reimbursement issues.

Authors :: Richard G. Hamermesh, Norman C Selby, Phillip Andrews

Topics :: Innovation & Entrepreneurship

Tags :: Entrepreneurship, Health, SWOT Analysis, SWOT Matrix, TOWS, Weighted SWOT Analysis

Swot Analysis of "Companion Diagnostics: Uncertainties for Approval and Reimbursement" written by Richard G. Hamermesh, Norman C Selby, Phillip Andrews includes – strengths weakness that are internal strategic factors of the organization, and opportunities and threats that Reimbursement Personalized facing as an external strategic factors. Some of the topics covered in Companion Diagnostics: Uncertainties for Approval and Reimbursement case study are - Strategic Management Strategies, Entrepreneurship, Health and Innovation & Entrepreneurship.


Some of the macro environment factors that can be used to understand the Companion Diagnostics: Uncertainties for Approval and Reimbursement casestudy better are - – customer relationship management is fast transforming because of increasing concerns over data privacy, technology disruption, increasing transportation and logistics costs, banking and financial system is disrupted by Bitcoin and other crypto currencies, wage bills are increasing, competitive advantages are harder to sustain because of technology dispersion, increasing inequality as vast percentage of new income is going to the top 1%, cloud computing is disrupting traditional business models, there is backlash against globalization, etc



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Introduction to SWOT Analysis of Companion Diagnostics: Uncertainties for Approval and Reimbursement


SWOT stands for an organization’s Strengths, Weaknesses, Opportunities and Threats . At Oak Spring University , we believe that protagonist in Companion Diagnostics: Uncertainties for Approval and Reimbursement case study can use SWOT analysis as a strategic management tool to assess the current internal strengths and weaknesses of the Reimbursement Personalized, and to figure out the opportunities and threats in the macro environment – technological, environmental, political, economic, social, demographic, etc in which Reimbursement Personalized operates in.

According to Harvard Business Review, 75% of the managers use SWOT analysis for various purposes such as – evaluating current scenario, strategic planning, new venture feasibility, personal growth goals, new market entry, Go To market strategies, portfolio management and strategic trade-off assessment, organizational restructuring, etc.




SWOT Objectives / Importance of SWOT Analysis and SWOT Matrix


SWOT analysis of Companion Diagnostics: Uncertainties for Approval and Reimbursement can be done for the following purposes –
1. Strategic planning using facts provided in Companion Diagnostics: Uncertainties for Approval and Reimbursement case study
2. Improving business portfolio management of Reimbursement Personalized
3. Assessing feasibility of the new initiative in Innovation & Entrepreneurship field.
4. Making a Innovation & Entrepreneurship topic specific business decision
5. Set goals for the organization
6. Organizational restructuring of Reimbursement Personalized




Strengths Companion Diagnostics: Uncertainties for Approval and Reimbursement | Internal Strategic Factors
What are Strengths in SWOT Analysis / TOWS Matrix / Weighted SWOT Analysis

The strengths of Reimbursement Personalized in Companion Diagnostics: Uncertainties for Approval and Reimbursement Harvard Business Review case study are -

Successful track record of launching new products

– Reimbursement Personalized has launched numerous new products in last few years, keeping in mind evolving customer preferences and competitive pressures. Reimbursement Personalized has effective processes in place that helps in exploring new product needs, doing quick pilot testing, and then launching the products quickly using its extensive distribution network.

Strong track record of project management

– Reimbursement Personalized is known for sticking to its project targets. This enables the firm to manage – time, project costs, and have sustainable margins on the projects.

Operational resilience

– The operational resilience strategy in the Companion Diagnostics: Uncertainties for Approval and Reimbursement Harvard Business Review case study comprises – understanding the underlying the factors in the industry, building diversified operations across different geographies so that disruption in one part of the world doesn’t impact the overall performance of the firm, and integrating the various business operations and processes through its digital transformation drive.

Low bargaining power of suppliers

– Suppliers of Reimbursement Personalized in the sector have low bargaining power. Companion Diagnostics: Uncertainties for Approval and Reimbursement has further diversified its suppliers portfolio by building a robust supply chain across various countries. This helps Reimbursement Personalized to manage not only supply disruptions but also source products at highly competitive prices.

Highly skilled collaborators

– Reimbursement Personalized has highly efficient outsourcing and offshoring strategy. It has resulted in greater operational flexibility and bringing down the costs in highly price sensitive segment. Secondly the value chain collaborators of the firm in Companion Diagnostics: Uncertainties for Approval and Reimbursement HBR case study have helped the firm to develop new products and bring them quickly to the marketplace.

Superior customer experience

– The customer experience strategy of Reimbursement Personalized in the segment is based on four key concepts – personalization, simplification of complex needs, prompt response, and continuous engagement.

Diverse revenue streams

– Reimbursement Personalized is present in almost all the verticals within the industry. This has provided firm in Companion Diagnostics: Uncertainties for Approval and Reimbursement case study a diverse revenue stream that has helped it to survive disruptions such as global pandemic in Covid-19, financial disruption of 2008, and supply chain disruption of 2021.

Learning organization

- Reimbursement Personalized is a learning organization. It has inculcated three key characters of learning organization in its processes and operations – exploration, creativity, and expansiveness. The work place at Reimbursement Personalized is open place that encourages instructiveness, ideation, open minded discussions, and creativity. Employees and leaders in Companion Diagnostics: Uncertainties for Approval and Reimbursement Harvard Business Review case study emphasize – knowledge, initiative, and innovation.

Innovation driven organization

– Reimbursement Personalized is one of the most innovative firm in sector. Manager in Companion Diagnostics: Uncertainties for Approval and Reimbursement Harvard Business Review case study can use Clayton Christensen Disruptive Innovation strategies to further increase the scale of innovtions in the organization.

High brand equity

– Reimbursement Personalized has strong brand awareness and brand recognition among both - the exiting customers and potential new customers. Strong brand equity has enabled Reimbursement Personalized to keep acquiring new customers and building profitable relationship with both the new and loyal customers.

High switching costs

– The high switching costs that Reimbursement Personalized has built up over years in its products and services combo offer has resulted in high retention of customers, lower marketing costs, and greater ability of the firm to focus on its customers.

Ability to recruit top talent

– Reimbursement Personalized is one of the leading recruiters in the industry. Managers in the Companion Diagnostics: Uncertainties for Approval and Reimbursement are in a position to attract the best talent available. The firm has a robust talent identification program that helps in identifying the brightest.






Weaknesses Companion Diagnostics: Uncertainties for Approval and Reimbursement | Internal Strategic Factors
What are Weaknesses in SWOT Analysis / TOWS Matrix / Weighted SWOT Analysis

The weaknesses of Companion Diagnostics: Uncertainties for Approval and Reimbursement are -

Lack of clear differentiation of Reimbursement Personalized products

– To increase the profitability and margins on the products, Reimbursement Personalized needs to provide more differentiated products than what it is currently offering in the marketplace.

Employees’ incomplete understanding of strategy

– From the instances in the HBR case study Companion Diagnostics: Uncertainties for Approval and Reimbursement, it seems that the employees of Reimbursement Personalized don’t have comprehensive understanding of the firm’s strategy. This is reflected in number of promotional campaigns over the last few years that had mixed messaging and competing priorities. Some of the strategic activities and services promoted in the promotional campaigns were not consistent with the organization’s strategy.

High operating costs

– Compare to the competitors, firm in the HBR case study Companion Diagnostics: Uncertainties for Approval and Reimbursement has high operating costs in the. This can be harder to sustain given the new emerging competition from nimble players who are using technology to attract Reimbursement Personalized 's lucrative customers.

High dependence on existing supply chain

– The disruption in the global supply chains because of the Covid-19 pandemic and blockage of the Suez Canal illustrated the fragile nature of Reimbursement Personalized supply chain. Even after few cautionary changes mentioned in the HBR case study - Companion Diagnostics: Uncertainties for Approval and Reimbursement, it is still heavily dependent upon the existing supply chain. The existing supply chain though brings in cost efficiencies but it has left Reimbursement Personalized vulnerable to further global disruptions in South East Asia.

Workers concerns about automation

– As automation is fast increasing in the segment, Reimbursement Personalized needs to come up with a strategy to reduce the workers concern regarding automation. Without a clear strategy, it could lead to disruption and uncertainty within the organization.

Skills based hiring

– The stress on hiring functional specialists at Reimbursement Personalized has created an environment where the organization is dominated by functional specialists rather than management generalist. This has resulted into product oriented approach rather than marketing oriented approach or consumers oriented approach.

Slow to strategic competitive environment developments

– As Companion Diagnostics: Uncertainties for Approval and Reimbursement HBR case study mentions - Reimbursement Personalized takes time to assess the upcoming competitions. This has led to missing out on atleast 2-3 big opportunities in the industry in last five years.

Ability to respond to the competition

– As the decision making is very deliberative, highlighted in the case study Companion Diagnostics: Uncertainties for Approval and Reimbursement, in the dynamic environment Reimbursement Personalized has struggled to respond to the nimble upstart competition. Reimbursement Personalized has reasonably good record with similar level competitors but it has struggled with new entrants taking away niches of its business.

Slow decision making process

– As mentioned earlier in the report, Reimbursement Personalized has a very deliberative decision making approach. This approach has resulted in prudent decisions, but it has also resulted in missing opportunities in the industry over the last five years. Reimbursement Personalized even though has strong showing on digital transformation primary two stages, it has struggled to capitalize the power of digital transformation in marketing efforts and new venture efforts.

Slow to harness new channels of communication

– Even though competitors are using new communication channels such as Instagram, Tiktok, and Snap, Reimbursement Personalized is slow explore the new channels of communication. These new channels of communication mentioned in marketing section of case study Companion Diagnostics: Uncertainties for Approval and Reimbursement can help to provide better information regarding products and services. It can also build an online community to further reach out to potential customers.

Capital Spending Reduction

– Even during the low interest decade, Reimbursement Personalized has not been able to do capital spending to the tune of the competition. This has resulted into fewer innovations and company facing stiff competition from both existing competitors and new entrants who are disrupting the industry using digital technology.




Opportunities Companion Diagnostics: Uncertainties for Approval and Reimbursement | External Strategic Factors
What are Opportunities in the SWOT Analysis / TOWS Matrix / Weighted SWOT Analysis


The opportunities highlighted in the Harvard Business Review case study Companion Diagnostics: Uncertainties for Approval and Reimbursement are -

Learning at scale

– Online learning technologies has now opened space for Reimbursement Personalized to conduct training and development for its employees across the world. This will result in not only reducing the cost of training but also help employees in different part of the world to integrate with the headquarter work culture, ethos, and standards.

Increase in government spending

– As the United States and other governments are increasing social spending and infrastructure spending to build economies post Covid-19, Reimbursement Personalized can use these opportunities to build new business models that can help the communities that Reimbursement Personalized operates in. Secondly it can use opportunities from government spending in Innovation & Entrepreneurship sector.

Loyalty marketing

– Reimbursement Personalized has focused on building a highly responsive customer relationship management platform. This platform is built on in-house data and driven by analytics and artificial intelligence. The customer analytics can help the organization to fine tune its loyalty marketing efforts, increase the wallet share of the organization, reduce wastage on mainstream advertising spending, build better pricing strategies using personalization, etc.

Leveraging digital technologies

– Reimbursement Personalized can leverage digital technologies such as artificial intelligence and machine learning to automate the production process, customer analytics to get better insights into consumer behavior, realtime digital dashboards to get better sales tracking, logistics and transportation, product tracking, etc.

Using analytics as competitive advantage

– Reimbursement Personalized has spent a significant amount of money and effort to integrate analytics and machine learning into its operations in the sector. This continuous investment in analytics has enabled, as illustrated in the Harvard case study Companion Diagnostics: Uncertainties for Approval and Reimbursement - to build a competitive advantage using analytics. The analytics driven competitive advantage can help Reimbursement Personalized to build faster Go To Market strategies, better consumer insights, developing relevant product features, and building a highly efficient supply chain.

Buying journey improvements

– Reimbursement Personalized can improve the customer journey of consumers in the industry by using analytics and artificial intelligence. Companion Diagnostics: Uncertainties for Approval and Reimbursement suggest that firm can provide automated chats to help consumers solve their own problems, provide online suggestions to get maximum out of the products and services, and help consumers to build a community where they can interact with each other to develop new features and uses.

Changes in consumer behavior post Covid-19

– Consumer behavior has changed in the Innovation & Entrepreneurship industry because of Covid-19 restrictions. Some of this behavior will stay once things get back to normal. Reimbursement Personalized can take advantage of these changes in consumer behavior to build a far more efficient business model. For example consumer regular ordering of products can reduce both last mile delivery costs and market penetration costs. Reimbursement Personalized can further use this consumer data to build better customer loyalty, provide better products and service collection, and improve the value proposition in inflationary times.

Finding new ways to collaborate

– Covid-19 has not only transformed business models of companies in Innovation & Entrepreneurship industry, but it has also influenced the consumer preferences. Reimbursement Personalized can tie-up with other value chain partners to explore new opportunities regarding meeting customer demands and building a rewarding and engaging relationship.

Reconfiguring business model

– The expansion of digital payment system, the bringing down of international transactions costs using Bitcoin and other blockchain based currencies, etc can help Reimbursement Personalized to reconfigure its entire business model. For example it can used blockchain based technologies to reduce piracy of its products in the big markets such as China. Secondly it can use the popularity of e-commerce in various developing markets to build a Direct to Customer business model rather than the current Channel Heavy distribution network.

Identify volunteer opportunities

– Covid-19 has impacted working population in two ways – it has led to people soul searching about their professional choices, resulting in mass resignation. Secondly it has encouraged people to do things that they are passionate about. This has opened opportunities for businesses to build volunteer oriented socially driven projects. Reimbursement Personalized can explore opportunities that can attract volunteers and are consistent with its mission and vision.

Developing new processes and practices

– Reimbursement Personalized can develop new processes and procedures in Innovation & Entrepreneurship industry using technology such as automation using artificial intelligence, real time transportation and products tracking, 3D modeling for concept development and new products pilot testing etc.

Lowering marketing communication costs

– 5G expansion will open new opportunities for Reimbursement Personalized in the field of marketing communication. It will bring down the cost of doing business, provide technology platform to build new products in the Innovation & Entrepreneurship segment, and it will provide faster access to the consumers.

Low interest rates

– Even though inflation is raising its head in most developed economies, Reimbursement Personalized can still utilize the low interest rates to borrow money for capital investment. Secondly it can also use the increase of government spending in infrastructure projects to get new business.




Threats Companion Diagnostics: Uncertainties for Approval and Reimbursement External Strategic Factors
What are Threats in the SWOT Analysis / TOWS Matrix / Weighted SWOT Analysis


The threats mentioned in the HBR case study Companion Diagnostics: Uncertainties for Approval and Reimbursement are -

Increasing international competition and downward pressure on margins

– Apart from technology driven competitive advantage dilution, Reimbursement Personalized can face downward pressure on margins from increasing competition from international players. The international players have stable revenue in their home market and can use those resources to penetrate prominent markets illustrated in HBR case study Companion Diagnostics: Uncertainties for Approval and Reimbursement .

Learning curve for new practices

– As the technology based on artificial intelligence and machine learning platform is getting complex, as highlighted in case study Companion Diagnostics: Uncertainties for Approval and Reimbursement, Reimbursement Personalized may face longer learning curve for training and development of existing employees. This can open space for more nimble competitors in the field of Innovation & Entrepreneurship .

Technology disruption because of hacks, piracy etc

– The colonial pipeline illustrated, how vulnerable modern organization are to international hackers, miscreants, and disruptors. The cyber security interruption, data leaks, etc can seriously jeopardize the future growth of the organization.

Aging population

– As the populations of most advanced economies are aging, it will lead to high social security costs, higher savings among population, and lower demand for goods and services in the economy. The household savings in US, France, UK, Germany, and Japan are growing faster than predicted because of uncertainty caused by pandemic.

Trade war between China and United States

– The trade war between two of the biggest economies can hugely impact the opportunities for Reimbursement Personalized in the Innovation & Entrepreneurship industry. The Innovation & Entrepreneurship industry is already at various protected from local competition in China, with the rise of trade war the protection levels may go up. This presents a clear threat of current business model in Chinese market.

High level of anxiety and lack of motivation

– the Great Resignation in United States is the sign of broader dissatisfaction among the workforce in United States. Reimbursement Personalized needs to understand the core reasons impacting the Innovation & Entrepreneurship industry. This will help it in building a better workplace.

Instability in the European markets

– European Union markets are facing three big challenges post Covid – expanded balance sheets, Brexit related business disruption, and aggressive Russia looking to distract the existing security mechanism. Reimbursement Personalized will face different problems in different parts of Europe. For example it will face inflationary pressures in UK, France, and Germany, balance sheet expansion and demand challenges in Southern European countries, and geopolitical instability in the Eastern Europe.

Easy access to finance

– Easy access to finance in Innovation & Entrepreneurship field will also reduce the barriers to entry in the industry, thus putting downward pressure on the prices because of increasing competition. Reimbursement Personalized can utilize it by borrowing at lower rates and invest it into research and development, capital expenditure to fortify its core competitive advantage.

Barriers of entry lowering

– As technology is more democratized, the barriers to entry in the industry are lowering. It can presents Reimbursement Personalized with greater competitive threats in the near to medium future. Secondly it will also put downward pressure on pricing throughout the sector.

High dependence on third party suppliers

– Reimbursement Personalized high dependence on third party suppliers can disrupt its processes and delivery mechanism. For example -the current troubles of car makers because of chip shortage is because the chip companies started producing chips for electronic companies rather than car manufacturers.

Consumer confidence and its impact on Reimbursement Personalized demand

– There is a high probability of declining consumer confidence, given – high inflammation rate, rise of gig economy, lower job stability, increasing cost of living, higher interest rates, and aging demography. All the factors contribute to people saving higher rate of their income, resulting in lower consumer demand in the industry and other sectors.

Capital market disruption

– During the Covid-19, Dow Jones has touched record high. The valuations of a number of companies are way beyond their existing business model potential. This can lead to capital market correction which can put a number of suppliers, collaborators, value chain partners in great financial difficulty. It will directly impact the business of Reimbursement Personalized.

Technology acceleration in Forth Industrial Revolution

– Reimbursement Personalized has witnessed rapid integration of technology during Covid-19 in the Innovation & Entrepreneurship industry. As one of the leading players in the industry, Reimbursement Personalized needs to keep up with the evolution of technology in the Innovation & Entrepreneurship sector. According to Mckinsey study top managers believe that the adoption of technology in operations, communications is 20-25 times faster than what they planned in the beginning of 2019.




Weighted SWOT Analysis of Companion Diagnostics: Uncertainties for Approval and Reimbursement Template, Example


Not all factors mentioned under the Strengths, Weakness, Opportunities, and Threats quadrants in the SWOT Analysis are equal. Managers in the HBR case study Companion Diagnostics: Uncertainties for Approval and Reimbursement needs to zero down on the relative importance of each factor mentioned in the Strengths, Weakness, Opportunities, and Threats quadrants. We can provide the relative importance to each factor by assigning relative weights. Weighted SWOT analysis process is a three stage process –

First stage for doing weighted SWOT analysis of the case study Companion Diagnostics: Uncertainties for Approval and Reimbursement is to rank the strengths and weaknesses of the organization. This will help you to assess the most important strengths and weaknesses of the firm and which one of the strengths and weaknesses mentioned in the initial lists are marginal and can be left out.

Second stage for conducting weighted SWOT analysis of the Harvard case study Companion Diagnostics: Uncertainties for Approval and Reimbursement is to give probabilities to the external strategic factors thus better understanding the opportunities and threats arising out of macro environment changes and developments.

Third stage of constructing weighted SWOT analysis of Companion Diagnostics: Uncertainties for Approval and Reimbursement is to provide strategic recommendations includes – joining likelihood of external strategic factors such as opportunities and threats to the internal strategic factors – strengths and weaknesses. You should start with external factors as they will provide the direction of the overall industry. Secondly by joining probabilities with internal strategic factors can help the company not only strategic fit but also the most probably strategic trade-off that Reimbursement Personalized needs to make to build a sustainable competitive advantage.



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