Commercial Strategy Development
A small public biotech company previously focused on drug discovery and development sought Health Advances' help to develop a strategy to build a more fully integrated organization. We helped prepare a comprehensive plan that included a reprioritized product portfolio, a detailed in-licensing and out-licensing plan, an infrastructure plan, and pro-forma financials to guide our client's transition.
Biotech Transformation Strategy
Working directly with the new CEO, Health Advances led a planning process to lay out a multi-year plan for transforming the company from a platform company into a product company. The plan would completely change the vision and business model, and required an extensive examination of how that company might create a product portfolio and assemble the required organizational skills.
The client team sought a strategy that would dramatically enhance the momentum for the company. By reviewing the technology platform and portfolio, organizational strengths, and opportunities to apply those in new areas, we identified several new strategic directions for the company and developed detailed plans for building internal skills capabilities and driving business development activities.
M&A Strategy and Due Diligence
A Cambridge-based biotech company seeking to complete a major acquisition engaged Health Advances to conduct an extended acquisition-focused project. Over a period of months, and in parallel with due-diligence level review of several possible candidates, Health Advances advised the management team on the criteria that management should use for evaluating the attractiveness and strategic fit.
Drug Out-Licensing Support
Our client, a small public biotech company, engaged Health Advances to assist with the out-licensing of a protein therapeutic for use in wound healing. During our analysis we identified a second possible application, prepared a market analysis, and proposed development steps required to make this new indication a strong component of the licensing package offered to potential partners.
Novel Cardiopulmonary Bypass Oxygenator
Health Advances forecasted the revenues for an oxygenator that appears to reduce the peripheral damage caused by traditional cardiopulmonary bypass circuits during major cardiothoracic procedures. In addition to estimating future penetration of the market, the study forecasted the future procedure volumes in light of demographics and growth of interventional procedures. Health Advances interviewed cardiothoracic surgeons in the EU to assess the new product.
A Respiratory Support Device Strategy
Developed a commercialization strategy for the launch of a respiratory support device in spinal cord injury, ALS, and ICU settings. The strategy included consideration of US markets and prioritization of EU markets. The in-depth primary interview program targeted spinal cord specialists, rehabilitation physicians, intensive care doctors, ALS specialists, payers, executives, and advocacy groups in both the US and EU. Detailed secondary analysis included evaluation of market size, current practices, referral patterns, unmet needs, and costs and charges within each segment.
Percutaneous Coronary Intervention Trends
Assessed the trends in both percutaneous coronary interventions and vascular interventions given recent stent performance data and trends in the use of CT cardio imaging. Numerous dynamics such as reimbursement and technical imaging advancements were evaluated along with clinician feedback to estimate the future percutaneous intervention market.
Vascular Access Market Analysis
The team assessed key trends and the relative importance of various technical product features. The team interviewed US interventional radiologists, cath lab supervisors, materials managers, oncology infusion nurses and vascular access nurses to understand their roles in purchase and utilization decisions and future trends.
Novel Mechanical Thrombus Ablation Technology
Health Advances assessed and prioritized the opportunities for the device. For each potential target indication, Health Advances segmented and sized the relevant market and conducted secondary and primary research to understand the unmet needs, decision-making process and referral patterns in each area. The team also identified hurdles or opportunities for the novel device to be adopted in each area.
Life Science Tools Business Unit Strategy
The team worked with the Bio-discovery division of a large life sciences company to help set the division's strategy for the next 3-7 years. In addition to extensive secondary research, the team interviewed academic, CRO and industry researchers in the US, EU, China, and India across a range of disciplines including mass spec, flow cytometry, genomics, biomarker discovery, HTS, and HCS. The team identified target acquisition candidates and developed an execution strategy for building a business that would address major unmet needs from basic research to translational medicine.
Go-To Market Strategy
For an emerging core lab diagnostics player, the team analyzed the US hospital and reference lab markets to determine the appropriate customer segmentation and key marketing messages for commercialization of a novel hematology analyzer. Adoption potential across customer segments was evaluated through qualitative interviews and a quantitative survey with hematology lab directors and managers and interviews with hospital purchasing managers. Based on primary research feedback and an examination of other diagnostic product analogs, the team created a revenue forecast and profit and loss statement for the novel analyzer. The optimal instrument and per test price points were determined based on an examination of laboratory economics and an evaluation of the trade-offs between revenue, profits, and cash flow at various price points. Ultimately, the work was used to determine the client’s corporate and product strategies and facilitate an acquisition by a global IVD player.
Working with the executive team of a multi-billion dollar diagnostics and life sciences company, our team led a board-mandated review of the strategic positioning and business options for the company. In addition to a thorough assessment of internal strengths and weaknesses, we also examined the competitive environment, trends with customers, our clients’ position and the options for expanding the business internally and through acquisition. Areas of investigation included immunoassay, clinical chemistry, hematology, flow cytometry, molecular testing, and coagulation testing. This strategy was one of multiple projects across the company over several years, including new product launches, reinvigoration of older platform lines, voice of the customer program development, and diligence work.
Life Science Research and Clinical Diagnostic Due Diligence Assessment
Our team worked with an investment group to assess the market outlook for a company with nucleic acid analysis products in both the life science research (LSR) and clinical diagnostics markets. Revenue projections were generated for the LSR business based on market sizing from secondary research, penetration rates from primary interviews, and adoption timelines from analog tool ramps. Revenue projections for the clinical diagnostic were based on market sizing from secondary research, penetration rates from a quantitative physician survey, and adoption timelines from analog tool ramps.
CMO/CDO Expansion Strategy
Our client, a contract manufacturing and design (CMO/CDO) organization for the in vitro diagnostics and device markets with a specialization in equipment rather than disposables, had been experiencing strong revenue growth and margins for several years. On the back of this, the client's parent company, requested a strategy to grow its business from $60MM to $120MM over the next 1-3 years. Our team was tasked with helping the client to determine the most appropriate strategy for accomplishing that goal. Through mediation of several brainstorming sessions with corporate executives and through detailed secondary research a variety of M&A approaches were suggested and potential target companies identified.
M&A Opportunity Prioritization
Our team was engaged to assist in the identification and prioritization of acquisition targets for a mid-sized diagnostics company. After working collaboratively to develop prioritization criteria on which to evaluate potential targets, a small subset of companies were recommended for further evaluation. The team engaged in extensive secondary research as well as primary research to develop detailed company profiles that provided our client with relevant target company details and a preliminary recommendations regarding acquisition strategy priorities.
Liquid Biopsy Opportunity Assessment
A leading genomic diagnostics company enlisted our team to prioritize oncology indications and use cases for a novel circulating, cell-free DNA “liquid biopsy” technology. Our team prioritized oncology use cases according to criteria including market opportunity, development burden, and strategic value. High potential use cases were further divided into near and long-term opportunities.
Budget Impact of Diagnostic
A global core lab diagnostics player engaged our team to develop an interactive budget impact model to demonstrate the economic impact of the implementation of a diagnostic cardiac marker to potential customers. Building from in-depth primary research, key secondary research was performed to populate the model which included deep reviews of clinical and economic literature for the diagnostic marker, clinical and cost effectiveness arguments for the diagnostic work-up, and the cost and reimbursement for the indication. This model was then tested in interviews with payers, laboratorians, and ER department heads to support its validity.
Corporate Strategy for a Molecular Technology
Working with the management team of a small public company, our team assessed the outlook for a novel approach to assessing genomic abnormalities and DNA replication and repair. A number of potential specific applications were assessed for the technology through interviews with a variety of stakeholders including clinicians, pathologists, and researchers. Detailed market sizing, revenues projections, and a full P&L were developed to assess the outlook for various product launch strategies. This work resulted in a switch in corporate strategy from primarily a diagnostics CLIA lab to a life science research product company.
Molecular Test System Economics
Our team developed a system economics model and payer strategy for a molecular diagnostics company developing novel prognostic and predictive tests for cancer. One such test helps physicians determine the optimal treatment strategy for patients with early stage breast cancer. The team developed a system economics model based on the unique aspects of the test’s value proposition which helped differentiate the test from others in the space. We incorporated the system economic justification into a broader payer strategy based on conversations with payers and an analysis of analog diagnostics.
Specialty National Diagnostic Laboratory Diligence
As part of a due diligence effort, our team assessed the outlook for a specialty national diagnostic testing laboratory. The analysis was accomplished through interviews with laboratory directors, physicians, and payers to understand the outlook for specific tests, drivers for selection of specific service providers, and factors that will change the competitive environment in the future. In addition, we conducted secondary research to understand the extent of baseline epidemiology-driven testing growth, the impact of a changing reimbursement landscape on customers ordering the tests, and the laboratory’s current and anticipated positions in the competitive landscape.
Business Plan for Social Robotics Engagement
Health Advances worked with the founding team of a company focused on combining social robotics, artificial intelligence, and adaptive programming to create a mobile device capable of truly personalized medicine. The team evaluated applications across the entire healthcare landscape to identify the best first pragmatic and self-financing product as well as the long-term roadmap of follow-on lucrative applications. Much of the work centered on picking applications where the company's IT capabilities brought unique value beyond typical mobile "apps."
Information Rich Patient Registry Database Development
Designed the strategy for and supervised the development of the largest disease-focused health data exchange in the world that integrates a clinical registry, biobank, clinical trial matching database and web-based patient portal. Leveraged data from an existing disease foundation and relationships with a major online community site to attract and build a leading clinical community with a novel privacy platform.
Comparative Effectiveness Marketing Strategy for Hospital Surveillance
Health Advances performed an extensive literature review to identify and document cost effectiveness data potentially attributable to hospital-based electronic surveillance and computer decision support systems. The HCIT tool was designed to help hospitals, especially pharmacies and infection control departments, to capture, analyze and flag data indicative of an infection outbreak, existence of resistant and susceptible pathogens and/or inappropriate antibiotic use. The findings were summarized to serve as the foundation for future prospective quantification of the cost effectiveness of antibiotic stewardship programs, clinical decision support programs and electronic surveillance enabled by implementation of a hospital-wide clinical intelligence platform.
Health IT M&A Entrance Strategy
Health Advances assisted a medium-sized medical device company in calibrating its M&A and organic growth strategy in light of the growing IT market and healthcare reform. Direct expansion into adjacent IT markets as well as necessary connectivity challenges were reviewed and prioritized based on research with industry experts, hospital stakeholders, and end-users. Ultimately Health Advances reviewed a number of potential expansion paths with senior management and the board of directors.
Health IT Due Diligence
Health Advances has performed multiple due diligence products for strategic buyers looking at Health IT expansion opportunities. One example project evaluated the opportunity for a best of breed hospital workflow optimization tool for a medium sized software and medical device company. The analysis focused on a validation of need, market segmentation, and strategic growth opportunities
Market Assessment for Specialty Medical Device Distributor
Health Advances assisted the management team of a specialty medical device distributor in identifying additional markets in which it could apply its core competencies and accelerate growth. As part of this effort, our team screened over 100 different markets and prioritized them based on criteria of interest to the client to arrive at six key areas for growth. Leveraging secondary and primary research, we provided background information on market size, competitors, and strategies for entering these markets.
Go-to-Market Strategy for Specialty Distributor
Our team assisted in the identification of new markets for a national specialty distributor of anesthesia and surgical supplies. After working collaboratively with the Company’s senior management team to develop prioritization criteria on which to evaluate these markets, three were recommended for further research. We then engaged in extensive secondary research as well as primary research to develop a go-to-market strategy for the Company to successfully acquire customers in each specialty.
Strategic Planning for Specialty Infertility Pharmacy Business
Health Advances assessed the ability of a specialty infertility pharmacy business to maintain market share and profitability in light of current and future competitors, new pharmaceutical, medical device, and procedural advances and greater financial pressures exerted by managed care organizations and/or pharmacy benefit managers (PBMs). Our team anticipated the changing infertility market’s call points and care patterns; the diagnostics and therapeutics used; and the reimbursement climate by state; by interviewing leading private practice reproductive endocrinologists and office managers.
Launch Strategy for Direct-to-Consumer (DTC) Service
Health Advances developed a launch strategy for a specialty pharmacy client interested in providing a DTC service to seniors and their caregivers. Our team analyzed the competitive landscape and conducted an online survey of over 400 customers in order to assess the market potential for the service, identify the most attractive customer segments, and determine the optimal features, value proposition, positioning, pricing, and customer acquisition strategy for the service. Our customer segmentation relied on sophisticated statistical analysis to reveal the connections among purchase intent, psychographic variables, and targetable demographic characteristics.
Strategy Development for Urology Group Practices
Health Advances developed and implemented an economic impact model to demonstrate the impact of a novel prostate cancer prognostic test on large urology group practices’ net income, ancillary service utilization, and allocation of physician and staff time. Our team worked with seven different practices to determine how the impact varied according to individual practice characteristics, demoed the model with individual practice managers and presented the findings to a large group of urologists at an industry conference.
Qualitative Market Assessment of National Infusion Services Business
Health Advances assessed the outlook for a national infusion services company. The analysis relied on interviews with physicians, payers, and executives focused in several therapeutic areas to develop an outlook for the services involved in management of several indications including autoimmune diseases, hemophilia, infectious diseases, and nutrition. In addition, our team conducted secondary research to understand the historical market trends and future impact of likely pipeline entrants.
Commercial Opportunity Assessment of Cell Therapy Services
To evaluate the potential of a cell therapy contract manufacturing and process development service, Health Advances forecasted the commercial opportunity for the cell therapy market and propensity of the biotech industry to outsource production over the next 10 years. The project included a robust analysis of the clinical development pipeline coupled with industry interviews to understand outsourcing dynamics as cell therapy products transition through clinical phases and into commercialization. Through an in-depth analysis of the competitive landscape, the team quantified revenue potential and provided specific recommendations for long-term success.
Offerings Expansion Strategy for Large CRO
A large CRO client historically focused on GLP-level preclinical animal studies was interested in understanding the opportunity to offer non-GLP discovery services. Health Advances conducted an extensive internal research program to understand the Company’s strengths/weaknesses, the current approach to handling such requests, and general organizational opinion of the opportunity. Our team also conducted interviews with customers, key opinion leaders, and competitors to understand the relative demand for discovery services and the types of models that would be relevant and possible for a CRO to offer. We worked closely with the client to develop a document outlining the key investments to make, services/model to offer, and potential acquisition targets to build the business.
Improving Forecasting, Sales and Marketing Effectiveness for Orthopedic CMO
For a leading orthopedic contract manufacturing organization (CMO), Health Advances developed strategic recommendations and tactical action plans for improving sales and marketing effectiveness and organizational design, including roles and skill gaps as well as key customer-facing value propositions. Our team also developed a forecasting roadmap that identified best-in-class inputs and methods in order to improve accuracy. Findings were based on benchmarking interviews with customer and non-customer orthopedic original equipment manufacturers (OEMs), competitive and non-orthopedic CMOs, and industry experts, as well as a thorough review of industry trends to provide the appropriate context for recommendations.
Growth Strategy in Medical Device Sterilization
Health Advances was engaged by a leading supplier of materials used in the terminal sterilization of medical devices and equipment to develop a growth strategy for the business. Our team conducted a thorough strategic review of the client’s business and the market for sterilization services. The assessment included interviews with device manufacturers, third-party contract sterilization providers, sterilization supply providers, hospital purchasing staff, medical device reprocessing companies, and other industry experts. The assessment focused on current use of different sterilization technologies, the decision of OEMs to sterilize internally vs. outsource, and trends in both of these areas.
Potential Acquirer Identification and Business Development Calls
A large healthcare investment firm was considering debt and/or royalty financing agreements with a target company in drug delivery. As part of its diligence of this target, the firm’s royalty team asked Health Advances to assist by identifying and then conducting a series of discussions with companies that may consider entering into a future deal with the target. After debriefing the royalty team, Health Advances targeted a list of 15 prospective partner companies and senior level business development executives. Leveraging Health Advances’ senior level contacts, calls were made directly to decision-makers within these companies to test potential interest level in, and the valuation criteria for, future acquisition of the target company.
Preparing Portfolio Company for Sale
Health Advances initially supported the private equity investment in an emerging core lab diagnostics company. About 3 years later, the investor and company management team enlisted Health Advances to help refine the company’s strategy and ultimately position it for sale. The team analyzed the US hospital and reference lab markets to determine the appropriate customer segmentation and key marketing messages for commercialization of a novel hematology analyzer. Adoption potential across customer segments was evaluated through qualitative interviews and a quantitative survey with hematology lab directors and managers and interviews with hospital purchasing managers. Based on primary research feedback and an examination of other diagnostic product analogs, the team created a revenue forecast and profit and loss statement for the novel analyzer. The optimal instrument and per test price points were determined based on an examination of laboratory economics and an evaluation of the trade-offs between revenue, profits, and cash flow at various price points. This plan and financial forecast was presented by Health Advances to prospective buyers during the sales process which resulted in a very attractive sale price.
Hospital-Based Software Company Diligence
Health Advances evaluated the opportunity for a strategic acquisition of a small start-up software company offering a best-of-breed software system designed to assist hospitals in addressing meaningful use criteria. The core business and growth opportunities were tested with key decision makers within the hospital (CEOs, CFOs, CIOs) as well as the end-users (physicians and nurses) to forecast the market potential with a particular focus on EMR segmentation.
Corporate “White Space” Strategy and Growth Opportunity Identification
Health Advances helped a major international healthcare company define strategic objectives and high priority projects for an executive-level initiative focused on corporate growth. Health Advances conducted a broad scan of the entire health care industry to identify areas of strategic fit and high potential and screened ideas to recommend ten growth areas. The senior management team subsequently gained Board buy-in and is now methodically pursuing acquisitions in these specific areas. As a result of this exercise, the corporate business development function no longer gets distracted by opportunities it receives “over the transom” that do not fit the 10 chosen areas.
Global Biosimilar Acquisition & Strategy Support
Health Advances supported a major biopharma deal by conducting a comprehensive, short-turnaround global diligence on the opportunity for a biosimilar portfolio. The team evaluated clinical and payer strategies to accelerate adoption of the biosimilars in each market and vetted the client’s internal forecast for the assets. Detailed market by market analyses were provided, as were high level strategic recommendations to the client team. The deal was ultimately consummated.