Getting Started
Researching existing solutions is a sizable job. However, the steps outlined below can help innovators complete a thorough assessment of the solution landscape for any given disease state.
Develop an Overview of Solutions Options
What to Cover
Create comprehensive descriptions of all relevant solutions in the field.
Where to Look
- Medical References – Refer to Harrison’s Principles of Internal Medicine, Guyton’s Textbook of Medical Physiology, or Schwartz’s Principles of Surgery for credible information regarding established treatments.
- PubMed– A database of the U.S. National Library of Medicine that includes more than 16 million citations from MEDLINE and other life science journals back to the 1950s. PubMed general reviews will be particularly helpful in understanding pathophysiology (locate “Reviews” by selecting this type of article under the “Limits” tab from the main page of the site before beginning a search).
- eMedicine– Clinical knowledge base with more than 10,000 physician authors and editors.
- Up-To-Date– A database of evidence-based clinical information.
Evaluate Clinical Solution Profiles
What to Cover
For each solution assess the clinical rationale for why and when each one is used, including the mechanism of action, indications, efficacy, and safety.
Where to Look
- Medical References
- PubMed (Reviews)
- Up-To-Date
- FDA Website– The U.S. Food and Drug Administration (FDA) posts the label or approval summary for new medical technologies.
- Blue Cross Blue Shield (BCBS) TEC Assessment– The BCBS Technology Evaluation Center (TEC) offers an evidence-based review of clinical solutions.
Analyze Economic Solution Profiles
What to Cover
Consider the financial impact associated with each solution, including the costs of providing it and the potential cost savings for using one particular solution versus another available option.
Where to Look
- PubMed (Reviews)
- Medscape – Database of clinical information targeted to physicians.
- MEPS Data– The Agency for Healthcare Research and Quality (AHRQ) provides data on the health expenditures of 18,000 U.S. households via the Medical Expenditures Panel Survey (MEPS). This data is publicly available for primary analysis.
- Reimbursement Analysis (read ahead to 4.3 Reimbursement Basics).
Explore Utilization Solution Profiles
What to Cover
Provide an overview of how each solution is currently used in clinical practice. Be sure to capture when/why each solution is advocated and the frequency of its use.
Where to Look
- PubMed (Reviews and Guidelines documents)
- Up-To-Date
- BCBS TEC Assessment
- Primary Research – Interviews or direct observations of clinical practitioners.
- Reimbursement Analysis
Investigate Emerging Solution Profiles
What to Cover
Understand emerging solutions that target the given disease state to identify what new areas are being focused on and how quickly new solutions will come to market.
Where to Look
- PubMed– In addition to searching for relevant reviews, watch for information about early trials (e.g., animal trials) and papers presented at conferences to stay current with the most recent developments in a given treatment area.
- ClinicalTrials.gov– A government database that tracks clinical trials with medical technology.
- Controlled-Trials.com– A site for Europe that is comparable to ClinicalTrials.gov in the U.S.
- U.S. Patent Office– A government database that contains all issued and provisional patents and patent applications (see 4.1 Intellectual Property Basics for more information, as well as other sources).
- VentureXpert – The functionality of VentureXpert is now available through Thomson ONE on a subscription basis. This source provides data on mergers and acquisitions, initial public offerings (IPOs), and venture capital funding based on data from Securities Data Corporation. A useful source to get information on emerging companies.
- VentureSource – Another subscription database that contains detailed information about private start-ups including funding, investors, and executives.
- Other – Additional venture capital firm websites.
Summarize the Solution Landscape
What to Cover
Synthesize all of the findings from the first five topics into a comprehensive framework that summarizes the solution landscape. At a minimum, this should include a summary of the solutions, risks and benefits, and a gap analysis in terms of need criteria and patient indications. Validate the need criteria with respect to the outcomes of existing solutions.
Where to Look
Synthesize the information from steps 1 to 5. Bring in information from 1.3 Need Statement Development for the need criteria and 2.1 Disease State Fundamentals for patient information.