Core Competencies

Services

Below is a partial alphabetical listing of the services Halteres Associates offers:

Business and Financial Modeling
Creating customized pro forma financial and market models and business/partnering scenarios to guide investment decisions and forecast returns.

Business Development
Identifying and evaluating business, partnering, and go-to-market strategies to help clients shape their business development plans.

Clinical Studies and Regulatory
Supporting the development of analytical validation and clinical utility studies, along with corresponding regulatory approval strategies.

Global Sales and Marketing
Crafting customer channel and access strategies for global sales and marketing teams, including market development, commercialization, and post-entry follow-up.

Impact Modeling and Value Creation
Helping clients maximize product, service, and technology value by assessing medical and economic impact and developing pricing and reimbursement strategies.

Intellectual Property
Assisting clients in evaluating and navigating their intellectual property options.

Investor Presentations
Helping clients present their company, technology, and value proposition clearly and compellingly to investors, strategic partners, and stakeholders.

Market and Technology Assessments
Evaluating market opportunities, utilizing Halteres’ proprietary commercial attractiveness and technical likelihood of success process to assess our clients’ products, services and technologies.

Medical Practice
Analyzing current medical practices and assessing how new products and services may influence them.

Portfolio Planning
Identifying lead indications and menu expansion strategies to help clients optimize development resources and maximize commercial potential.

Product and Process Development
Facilitating client planning and  execution of  efficient product and process development programs using methodologies such as design of experiments, design for manufacturing, and future proofing.

Strategic and Tactical Planning
Designing and implementing strategic planning processes to help clients define goals and objectives and create frameworks for informed decision-making.

Technologies

Below is a partial alphabetical listing of technology areas where Halteres team members have deep expertise:

Algorithms and Information and Communications Technologies
Exploring the role of interpretive algorithms and ICT solutions in product design.

Biomarker Discovery and Validation
Advising on strategy for the identification, sourcing, and validation of biomarkers for client applications.

Biostatistics
Designing statistically significant studies and selecting comparator products and predicate devices to demonstrate the clinical and analytical performance of their products.

Companion Diagnostics (CDx)
Evaluating opportunities and risks in CDx co-development programs—and considering companion therapeutics.

Digital Health and Wellness
Understanding consumer health and wellness trends and when the newest digital devices may be considered as medical diagnostics/devices.

Histology / Anatomic and Clinical Pathology
Assessing technological advances in histology and anatomic and clinical pathology, including automated systems, specialty stains, and digital methods.

Immunodiagnostics
Guiding clients through the development and commercialization of competitive immunodiagnostic solutions.

Instrument Systems
Advising on instrument system design, including hardware, software, consumables, ICT, assays, user interfaces, and systems integration.

Life Science Research Tools
Helping clients navigate emerging opportunities in tools supporting life science research.

Medical Devices
Determining whether a potential product is considered a medical device and guiding its development and regulatory approval.

Molecular Diagnostics
Supporting the development and commercialization of competitive molecular diagnostic products employing a diversity of assay technology approaches.

Next Generation Sequencing
Evaluating competing technologies and diagnostic opportunities, including supporting or gating technologies.

Markets

Below is a partial alphabetical listing of market segments where Halteres Associates has been active:

Blood Screening
Understanding technologies, market dynamics, and competition in global volunteer blood donor screening and typing, transplant screening, and source plasma markets.

Chronic Diseases
Identifying testing needs across the full patient pathway, including screening, diagnosis, prognosis, staging, monitoring, and confirmatory testing.

Clinical Laboratory Services
Advising on building, staffing, licensing and maintaining a CLIA-certified clinical diagnostic laboratory and evaluating deployment strategies for products and technologies.

Global Health
Navigating policies, environment, stakeholders, opportunities, and unmet needs to develop and deliver impactful global health solutions.

Infectious Diseases
Assessing infectious disease testing needs for screening, diagnosis, resistance monitoring, and surveillance, including assessing the potential and emerging risks of “spillover” events.

Life Science Research
Identifying product opportunities and trends in life science research.

Oncology
Evaluating diagnostic methodologies and informatics requirements to support better treatment decisions.

“Omics” applications
Understanding the markets and methodologies for proteomics, genomics, metabolomics, microbiomics, environmentalomics, and economics.

Parasitology
Developing diagnostic solutions for detecting parasites and pathogens in global markets.

Pathology
Exploring technological advances in histology and anatomic and clinical pathology, including automated systems, specialty stains and digital methods.

Point of Care (POC) Testing
Understanding healthcare delivery needs and how innovations in POC testing are driving adoption globally.