Core Competencies

Services

Following is a partial alphabetical listing of the types of Services in which Halteres Associates offers its clients

Business and Financial Modeling
Guiding investment options and returns through creation of customized pro forma financial models and business / partnering scenarios.

Business Development
Identifying and evaluating business, partnering and go to market options to help a client formulate a business development strategy.

Clinical Studies and Regulatory
Helping to develop analytical validation and clinical utility studies in conjunction with corresponding regulatory approval strategies.

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

Impact Modeling and Value Creation
Helping clients derive maximum value for their products, services and technologies by evaluating medical and economic impact and by developing appropriate pricing strategies.

Intellectual Property
Helping clients consider and assess their intellectual property options.

Investor Presentations
Helping clients to clearly and concisely present their company, technology and value proposition in ways that will immediately resonate with investors, strategic partners and other stakeholders.

Market and Technology Assessments
Determining market opportunities, commercial attractiveness and technical likelihood of success for our clients’ products, services and technologies.

Medical Practice
Assessing current medical practices and how those practices might be impacted through the adoption of new products and services.

Portfolio Planning
Identifying lead indications and menu expansion strategies to help clients optimize their development resources while maximizing their commercial opportunities.

Product and Process Development
Helping clients to plan for and to conduct efficient product and process development programs, including such disciplines as design of experiments, six sigma and design for manufacturing.

Strategic and Tactical Planning
Developing and implementing strategic planning processes to help clients clarify their strategic goals and objectives and create a framework to help guide better informed execution decisions.

Technologies

Following is a partial alphabetical listing of the Technology Areas in which Halteres’ team members of deep current expertise.

Algorithms / Informatics / Health IT
Understanding the role of interpretive algorithms and the need for information and communication technology (ICT) solutions in product design.

Biomarker Discovery and Validation
Helping clients understand the options and requirements for identifying, sourcing and validating biomarkers for their applications.

Biostatistics
Working with clients to design statistically significant studies and to select comparator products or predicate devices to best demonstrate the clinical and analytical performance of their products.

Companion Diagnostics (CDx)
Understanding what companion diagnostics are and the opportunities and risks inherent with CDx co-development programs.Is it time to consider companion therapeutics?

Digital Health and Wellness
Understanding the drivers in consumer health and wellness and when the new generation of digital devices might be considered to be medical diagnostics/devices.

Histology / Anatomic and Clinical Pathology
Understanding new technology developments driving advances in histology and anatomic and clinical pathology including automated systems, specialty stains and digital methodologies.

Immunodiagnostics
Helping clients understand the need for immunodiagnostics and what is required to develop and commercialize competitive immunodiagnostic product solutions .

Instrument Systems
Understanding the requirements for instrument system design, including hardware, software, consumables, information and communication technologies, assays, user interfaces and overall systems integration approaches.

Life Science Research Tools
Assisting clients in understanding the landscape, drivers and emerging opportunities for new tools supporting life science research.

Medical Devices
Helping clients understand whether a conceived product is actually a medical device and how to effectively and efficiently navigate the development, clinical and regulatory approval process.

Molecular Diagnostics
Helping clients understand the need for molecular diagnostics and what is required to develop and commercialize competitive molecular diagnostic products.

Next Generation Sequencing
Understanding the competing technologies, approaches and diagnostic opportunities for next generation sequencing applications and the need for gating or supporting technologies.

Markets

Following is a partial alphabetical listing of the Market Segments in which Halteres Associates has participated.

Blood Screening
Understanding technologies, opportunities, requirements and competition in the global volunteer blood donor and transplant screening markets.

Chronic Diseases
Determining the screening, diagnostic, prognostic, staging, monitoring and confirmatory testing needs for all chronic diseases.

Clinical Laboratory Services
Helping clients understand the requirements for building, staffing, licensing and maintaining a CLIA-certified clinical diagnostic laboratory and evaluating the pros and cons of deploying products and technologies through clinical laboratory services or directly to consumers.

Global Health
Understanding the policies, environment, stakeholders, opportunities, and unmet needs in global health and the requirements for developing and delivering products to address those needs.

Infectious Diseases
Determining the screening, diagnostic, resistance monitoring and surveillance testing needs for all infectious diseases.

Life Science Research
Helping clients understand product opportunities and trends in life science research.

Oncology
Understanding, evaluating and positioning in vivo and in vitro diagnostic methodologies and the requirements for informatics and reporting to enable physicians, patients, payers and families to offer better treatment and care decisions.

“Omics” applications - Proteomics, Genomics, Metabolomics, Microbiomics, Economics
Understanding the markets for “omics” applications and the pros, cons, utilities, interrelationships and applications of established and cutting edge testing methodologies.

Parasitology
Developing appropriate diagnostic solutions for the detection of parasites and pathogens in global markets.

Pathology
Understanding new technology developments driving advances in histology and anatomic and clinical pathology including automated systems, specialty stains and digital methodologies.

Point of Care (POC) Testing
Understanding local policies, health care delivery and infrastructure demands, and the needs and desires of patients and medical practitioners in low and high resource settings around the world and how advancements in POC testing technologies, applications, and business practices are driving uptake of testing in both developing and developed markets.