No other branch of science has stirred up more excitement in the past century than nanotechnology. Nanotechnology is touted as THE revolutionary technology that could obliterate current business models, and restructure vast parts of the economy. Currently, nanotechnology is the largest US government funded science initiative since the Space Race (even larger than the Human Genome Project). With all these grandiose visions of massive disruption in virtually all sectors of the economy, nanotechnology is also a subject of discussion and debate in the executive board rooms of most large market leading corporations. Perhaps the number one question on the topic of nanotechnology is: "Exactly what IS nanotechnology?"

The c-level executive staff of a large multi-national healthcare company approached SI with the following interesting problem statement: define for us what nanotechnology is, and what opportunities and threats does it pose for the myriad of our medical device, pharmaceutical and consumer products? SI methodically researched through the large volume of information published on nanotechnology, interviewed foremost experts on the topic of nanotechnology at leading government agencies, public and private corporations, and academia, to evaluate and analyze the current status of nanotechnology and its relevance to the various businesses of SI's client. The final assessment represented a comprehensive technology and market focused overview of nanotechnology, with key specific recommendations on how best to address the challenges posed by the emergence of this new field, and how to best capitalize on the vast opportunities created due to advances in nanotechnology.

Screening and diagnostic technologies have among the most complex commercialization issues among medical device opportunities. Many of these technology platforms need extensive clinical and regulatory development to establish their utility in screening or providing valuable diagnosis of a clinical condition and in the end, the main benefit to the patients, the overall value proposition, and the economics surrounding the adoption of the new screening or diagnostic modality may lead to modest adoption in the marketplace.

A large multi-national healthcare company approached SI with a novel breast cancer screening technology that would have enabled routine screening of women for evidence of breast pre-cancer, similar to pap-smear screening for evidence of cervical intraepithelial neoplasia. In the absence of any other technique to screen and detect breast pre-cancers, and in the presence of a 7000 patient clinical trial validating the strong correlation between the market used in the proposed assay, and the presence of breast pre-cancerous tissue, the value proposition seemed eminently obvious and intuitive.

SI was asked by the client company to carefully evaluate the current clinical evidence, and the potential commercial viability of such a new screening technology. SI conducted a thorough secondary research reviewing the most current clinical literature on the details of the clinical research conducted to date, and the status of similar screening technologies. Furthermore, SI identified key opinion leaders in oncology and interviewed a significant number of these experts regarding the value proposition of the new technology and the viability of such device to be used in routine screening of women. The results, surprisingly, led to highly counter-intuitive conclusions and ultimately led to a recommendation for SI's client to pass on the new screening technology.

The US is the largest healthcare market in the world, and an enormous consumer of new health and wellness products and services. Despite its stringent regulatory and healthcare economics environment, the size of the market opportunity is of a scale that few international developers of new healthcare technologies can ignore the US market as a key strategic target. Geographical separation and lack of familiarity with the US regulatory, reimbursement processes, along with a lack of access to corporate development resources to forge corporate alliances and distribution partnerships, however, could pose significant challenges to international companies.

SI has been approached by multiple European and Australian companies that used SI as a 'one stop shop' for expertise in strategy, market research, technology assessment, the FDA regulatory process, the all important reimbursement process, and business development expertise to establish relevant corporate partnerships for penetrating the US healthcare market. Most such engagements have led to continued involvement of SI with the client company through multiple generations of existing products, and also the introduction of new products into the US marketplace.

Convergence is one of the most exciting trends in the medical device industry. Convergence of drug and device technologies has led to enormous and ground breaking opportunities such as the drug eluting stent, arguably one of the most successful medical device in the history of the industry. Drug device combinations, however, are only an example of the myriad of convergence opportunities; other examples include wireless-lifescience, and semiconductor-lifescience convergence opportunities. Despite the intriguing new possibilities that convergence offers, it is also uncharted territory with respect to some of the key issues that impact the successful adoption of new medical device platforms, such as regulatory and reimbursement policy issues.

A large non-medical company set out to converge their core technical expertise to solve key life science issues; however, in the absence of any significant experience in the life science industry, the FDA regulatory path and reimbursement strategies posed significant uncertainties (and risk) to their development plans. SI was engaged to conduct a detailed analysis of product platforms that had gone before the FDA with relevant functionality and intended use, and crafted a comprehensive analysis and strategy for FDA approval of the newly conceived convergent platform technology. Insiders within the FDA were interviewed for an informal confirmation and validation of the key conclusions and recommendations of SI's strategy. A similar process was followed to map out the key coding, coverage, and payment issues pertaining to the reimbursement strategy. SI's thorough analysis provided the executive management of the client company a strong sense of confidence around the feasibility, cost, and timeline of obtaining regulatory approval, and the most likely reimbursement scenario for their new convergent life science product platform.

Many new ventures in the biotechnology and medical device sector are founded by a team of technologists that are highly competent and specialized in their respective fields, but do not necessarily have an extensive experience in building significant enterprises around their core inventions.

A client company in the biotechnology field had assembled a highly capable executive management team and had secured multiple rounds of financing, but no significant analysis had been carried out regarding the full commercial potential of the lead product, and viable strategies for commercialization. At the request of the Board of Directors, SI was engaged to critically analyze the market opportunity surrounding the company's lead product, and develop one or more recommendations on viable commercialization strategies. SI systematically conducted a market and industry analysis, along with an internal analysis of the core strengths and weaknesses of the company to develop a detailed set of strategic options for the executive management. From that point forward, SI's analysis was used for presentations to a wide range of audience, from investors, to Board of Directors, to potential corporate partners, as an objective and thorough analysis of the market landscape for the client company's lead product and the company's detailed commercialization strategy.

A new $200M fund had identified healthcare as a key strategic area of interest, and they had an interest in identifying high potential investment opportunities that represented a right balance of large market opportunity and low overall business and technical risk. SI methodically reviewed over 300 early stage opportunities in medical device and biotech sectors, and conducted a thorough due diligence on the overall market opportunity, key technical, clinical and business risks, evaluation of the defensive and offensive strengths and weaknesses of the intellectual property, and a review of the regulatory strategy, reimbursement strategy, and competitive landscape for each proposed investment opportunity. All of the above analyses were integrated to provide a comprehensive evaluation of the key opportunities that represented the finalist target opportunities for our client's investment portfolio.

In the landscape of new startups in the life sciences, there generally are multiple opportunities that are competing for the same sources of capital. In some rare cases, however, the new venture opportunity is so compelling and so strong that several sources of capital compete for a 'seat at the table' to participate as equity partners to the new venture.

SI was approached by a private equity fund regarding an opportunity that was highly sought after by multiple funds and the client engaged SI to develop a strong case for making the client a key investor in the new venture. The executive management of the company had the luxury of interviewing a wide range of funds to select the top few that would be allowed into a syndicate of investors to serve as equity partners to the new venture. SI methodically evaluated the core strengths and weaknesses of the client, and aligned the client's value added offerings with the key strategic interests and objectives of the new venture. SI also actively managed the negotiations and the relationship between the client and the executive management of the new venture. Despite the relative weak brand equity of SI's client relative to the competing investors, the proposed value added contributions of SI's client helped differentiate this fund from the majority of other investing organizations, and in the end, SI's client took a lead position in the syndicate for this very significant and high potential new venture.

Despite all the challenges of developing a novel technology, and the arduous process to protect it through the patenting process, and finally to secure full rights to these patents through negotiation with all stake holder, unfortunately, it is only the beginning of all that is required to make a business out of an invention.

SI's client had developed a novel technology with a unique value proposition for applications in urology and had just negotiated an exclusive license to the associated patent. At the point in time that the client approached SI, the inventor had know-how and a single document at hand, which was the signed exclusive license to the patent. SI was then asked to develop a detailed business plan around this technology, define the market opportunity, develop the product development and commercialization plan, recruit executive management to the company, lead the fund raising and financing activities of the company, and manage the entire process of engineering, preclinical, clinical and regulatory development of the product. SI engaged its venture development resources and staffing to build a viable start up company out of a licensed patent in exchange for taking a significant equity position in the company. The company was successfully launched and it is currently going through its multiple stages of development.

Many academic institutions, non-profit research organizations, or large corporate R&D organizations have a peculiar problem - while the scientists are constantly challenged to invent and innovate, the financial resources available to protect the intellectual property created falls significantly short of what is required to protect all that is generated by the scientists and engineers. As such, with mounting legal costs for patent filing and prosecution, and ongoing maintenance of the patent portfolio generated, it is critically important to devise patent strategies that align each patent filing, and each claim under prosecution, with the underlying business rationale and market opportunities of relevance to the organization.

SI has advised multiple research organizations (in academia or in industry) in developing a targeted IP strategy that extracts the most value and benefit from the scarce resources allocated to IP filing and prosecution. SI's market focused approach is an important complement to the efforts of in-house or outside patent counsel. Typically, SI's process involves: a) assessment of the business interests and strategies, as well as a new technology's unique features and capabilities, to guide patent portfolio development, b) review and validation of the market opportunity associated with each technology offering to assist in making go/no-go decisions around patent filings and continued prosecution, c) supporting commercial development and improvements in technology by developing patent strategies that support out-licensing and commercial opportunities in established and/or emerging markets, d) improving value of IP by aligning patent prosecution with business goals, and e) defining a competitive business landscape using IP analysis, allowing for a clear definition of an early technology's competitive position in the market and evaluation of key freedom to operate issues. These efforts have resulted in 30-50% cost reduction in IP related expenditures, and significant increase in the value derived from an organization's existing IP portfolio, following SI's engagement to oversee and manage the client organization's patenting strategy.