The emergent is unlike its components insofar as these are incommensurable, and it cannot be

reduced to their sum or their di�erence.

G. H. Lewes

2013 YEAR IN REVIEW

Easier said than done. For all the progress (innovation and investment) seen in medical device in 2013, the process of commercialization is no more linear or streamlined than the year prior. In fact, new wrinkles seem to appear on a daily basis that conspire against e�ciency, and companies that succeed do so through a combination of brute force, perseverance, and a roster of very patient investors.

Company principals must continue to manage around limiting factors that have become all too common in the device business. Pricing strategy, cost of sales and cost of goods for new medical technology still confound and often invalidate the best-researched business models. Delivery dates, sales cycles and receivables are now running on geologic time (not unlike other evangelistic pursuits). QA/RA - acting as a friendly extension of the FDA and your Notified Body - seems to create enough paralysis and risk aversion to haunt the waking minds of every employee, supplier and distributor in the company’s sphere.

The good news is that together, these constraints constitute “knowns” in the model: assumptions that will eventually be validated; risks that can be mitigated. More menacing to operators, perhaps, are the benign daily nuisances that grow to become existential threats to the business.

EmergeIP illuminates and neutralizes hidden risk. We take on those “special projects” that protract schedules and impede execution. We remove hurdles, open doors to better partners, help you articulate your value story, and get folks really excited about your work. Most of all, we help you to focus on what you are really good at: improving clinical outcomes.

MOVE FASTER

www.emergeip.com

www.emergeip.com

CLIENTS & SERVICES

The Innovation Paradox. For hospitals and 3rd party payors, mandates for better outcomes compete directly with cost containment initiatives and institutionalized conformance. Underwriters, procurement managers, and new product committees must find a way to lower the cost of care and improve clinical e�cacy and safety, all while fulfilling the hospital’s need for continued modernization through the acquisition of unproven yet “substantially equivalent” technology (Class II) or experimental therapies.

For medical innovators, particularly those on the FDA 510(k) path, the sales process is long and very expensive. If access is gained to a specifier or purchaser, the company rep must quickly make the case for economic and clinical value while simultaneously avoiding unsubstantiated claims, blunted di�erentiators and a dearth of actionable clinical data. They also must take care of any training and post-market surveillance on the spot.

Whether planning a rollout or in the midst of a worldwide launch, EmergeIP works to make your go-to-market activities more e�cient, productive, and compliant. For principals and investors in early-stage companies, we help you understand current market conditions and competition specific to your platform technology so your financial projections are more accurate and defensible.

EmergeIP is a marketing company. We work with medical technology innovators at all stages of development and commercialization.

For the bioscience researcher or physician inventor, we help to make your early-stage opportunity more appealing to strategic partners and prospective investors. We identify, quantify, and prioritize specific market opportunities and sales targets to add depth to your financial pro forma, and we examine the regulatory, clinical, and payment factors that may influence your design and development e�orts.

For the growth stage company seeking funding, we add deeper layers of detail to your value story to make investor due diligence more e�cient and productive. We help you secure key strategic partnerships to enhance pre-money valuation, and we sharpen your marketing collateral and training materials to shorten sales cycles and drive adoption.

For the mature enterprise we are a strategic resource for very specific project needs. We provide localized market characterization - including VOC, competitive analysis and pricing strategy - to enhance the positioning of new products. We also complement technology acquisition and corporate venturing initiatives by generating actionable market intelligence around emerging product categories.

2013 PROJECTS

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Project: Commercialization of Surgical Ligation Clip and Applier

Client: Urologic Surgeon Group (private practice)

Scope: EmergeIP was hired to provide business development support for the commercialization of a new ligation clip. Scope items included the development of a mature value case (economic, clinical and market) and supporting documentation for the new device. Additional tasks included regulatory and business feasibility assessment for a new clinical indication, preparation of desired agreement terms, and partner ID for product out-licensing and/or acquisition.

Results: Upon completion of analysis, documentation, and partner ID tasks, potential acquirers were ranked and systematically engaged to discuss the opportunity. EmergeIP handled lead engagement through the process.

Status: Term sheets under consideration by project principals.

Project: Acquisition Management of Enteral Nutrition Device

Client: Medical Device Manufacturer - Pueblo, CO

Scope: EmergeIP was retained to find acquirer for a patented and FDA-cleared enteral feeding device. Market conditions and funding constraints led to slow rollout and adoption of the product. Our scope included creating an entirely new value case for the product with strategic acquisition as the endpoint.

Results: New collateral and value materials were developed for the device, supported by empirical clinical and economic field data. COGS, gross margins, reimbursement, pricing and market positioning were analyzed anew to bolster the pitch, as were IP strength and regulatory flexibility. EmergeIP handled partner ID and selection, as well as negotiations of acquisition terms.

Status: Project under consideration by several leading manufacturers in enteral nutrition. A non-confidential pitch deck can be viewed at www.emergeip.com.

www.emergeip.com

Project: Product Realization: Ozone Therapy for Diabetic Ulcers

Client: Physician Group (private practice)

Scope: Engaged to provide early stage enterprise and product development for novel ozone-based wound treatment technology. Scope included: aggregation and in-licensing of complementary IP, preparation of corporate foundation documentation, business plan (w/PPM), financial pro forma, project plan with funding requirements, and supplier ID for proof-of-concept and prototype development. Prepared commercialization plan for SBIR submission.

Results: Company was created and a portion of the requisite IP has been secured. Limited POC work is underway, constrained somewhat by resources (time and $) available through practicing physician owners.

Status: Principals are currently seeking investment to continue development work.

Project: Enteral Nutrition Delivery Monitoring System

Clients: Pediatric Gastroenterologist (private practice) & Large Manufacturer

Scope: EmergeIP is working with a private practice gastroenterologist and leading international device manufacturer to create a new monitoring system for patients with gastrostomy tubes.

Results: As an early-stage venture, EmergeIP is leading all tasks for product realization, development and commercialization, including IP strategy, team and supplier management, product design, mobile UI/UX specifications, business model creation, financing, and product monetization.

Status: The new entity has been selected for corporate strategic venture funding from a major enteral nutrition company. Work is ongoing to secure the financing and push toward POC and additional patent filings in Q2 2014.

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Project: Bedside iOS Application for MSK Ultrasound Training

Client: Private Physician Group, Boulder, CO

Scope: EmergeIP was retained to help a group of pain management doctors and physiatrists to develop a MSK ultrasound training program for mobile devices. The software enables early market entry and product monetization to support the exploitation of more comprehensive patents in the domain.

Results: EmergeIP directed interface design and creation of product features based on comprehensive competitive and market analyses. Developed detailed project budgets and schedules facilitating investment. Selected illustrators and software development team: conducted interviews and negotiated agreements.

Status: iOS platform completed. Product in beta testing. Distribution via Apple store set to begin in Q2 2014.

Project: Strategic Growth Consulting

Client: Software Development Company (mobile ERP for med device), Denver

Scope: Retained by CEO of software development company to provide a range of business advisory services to fuel enterprise growth. Created comprehensive due diligence package for prospective investors including pitch deck, business plan, financial pro forma, cap table, PPM, market analysis, and corporate governance documentation. Also served as interim member of Board of Directors to support development of new strategic growth plan and creation of a permanent senior management team.

Results: The due diligence materials prepared by EmergeIP were used to facilitate significant equity investment (growth round) in the company, and helped to attract new CEO and other strategic partners to the opportunity. EmergeIP also helped client negotiate a significant enterprise-level reseller agreement in the mobile payments space, and created a JV for mobile ERP software development specific to FDA-regulated businesses. Developed an entirely new corporate growth model for the client, leading to strategic realignment around the growing mobile ERP vertical.

Status: Continuing active business development role in the company.

www.emergeip.com

2013 STRATEGIC PARTNERS

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Strategic partnerships are vital to medical technology companies at all levels. For the seed-stage manufacturer, potential future acquirers can provide insight about strategic direction in their portfolio as it relates to your product category, and will often make you aware of enabling technologies in the market that could significantly a�ect your product requirements documentation. Potential acquirers may also provide insight on standards for design and document control that can a�ect future integration and will steer an early-stage company toward approved suppliers and vendors before their design verification and validation (V&V) activities commence. The thinking goes that early attention to any quality, compliance, supply chain and/or operating shortcomings will significantly de-risk a potential acquisition in the future.

The companies below represent a selection of the manufacturing partners that EmergeIP has cultivated for its clients, primarily to facilitate business development and corporate venturing (financing) discussions around new technology.

www.emergeip.com

FEES & ENGAGEMENT

TEAM

CONTACT

EmergeIP is led by Bill Arnold, CEO. Mr. Arnold has extensive background in product development and commercialization, with focus in the life sciences and emerging technologies. He has had considerable success as a marketing director, product designer and entrepreneur, and has founded several technology and consumer products companies.

EmergeIP works with a team of accomplished professionals with background specific to medical technology development and commercialization.

Team Expertise includes:

• Corporate Formation and Intellectual Property Law • Quality Assurance and Regulatory Affairs • International Pricing and Reimbursement Strategy• Translations (localization) of Product Labeling and Marketing Collateral• Anatomical Illustration and Video Production• Specialized Manufacturing Engineering and Rapid Prototyping• Microelectromechanical Systems Design and Manufacturing

EmergeIP is very flexible about client engagement and professional fees. For early stage clients, a monthly retainer arrangement (unlimited correspondence) is preferred. For growth stage companies with multiple deadlines on critical path, a project scope and fee based on 3 or 6 months of work (via renewing 30-day contracts) is usually best. For mature concerns with very specific project needs, EmergeIP can be retained at reasonable hourly rates.

303.514.5148info@emergeip.com