Coming to America: Building a European biomarker brand in just 6 months
Situation
A highly profitable European diagnostic company was looking to enter the U.S. market space with its flagship biomarker. With no U.S. distribution, logistics, brand recognition, or commercial organization, the company required an entire nationwide build-out to meet its strategic objectives.
Challenge
Build a world-class commercial organization in time to capitalize on pending FDA clearance, drive awareness and demand for the biomarker, and support the scientific needs of the clinical customer base.
Ennivate Advantage
The Ennivate team developed and implemented a comprehensive go-to-market program, including:
- Developed a logistics and distribution chain using a network of established, world-class, GMP alliance partnerships.
- Created a branding campaign that instilled confidence in the biomarker's clinical value and improvement in patient outcomes.
- Delivered and promoted remote educational programming to extend evidence-based information to a broader clinical audience.
- Built national direct and distributor sales and client services organizations to directly support and grow demand for this need-based solution.
Results
Within 6 months the European client had an established and recognized brand in the U.S. market, placements in 10 of the top 50 leading hospitals in the country, a cadre of clinical advocates, and a world-class operations team in place to support its growth.
Success in hand: Winning $12 million in orders for a handheld diagnostic device
Situation
A European technology start up with a niche diagnostic marker was developing a handheld, near-patient diagnostic device. With no direct presence in the U.S., Ennivate Launch Partners was engaged to aid in upstream marketing and product development, alliance and business development, and model a U.S. business unit to support FDA submission and product launch in a $250 million market opportunity.
Challenge
Uncover market gaps in product need areas, impact market awareness, and develop corporate alliances to launch this near-patient diagnostic platform to recognized market share.
Ennivate Advantage
The Ennivate team developed growth strategies and tactics for the launch, employing user advisory boards, attribute feedback matrices,
and corporate relationships to:
- Develop a logistics and distribution chain using a network of established, world-class GMP alliance partnership
- Position a branding campaign, instilling confidence in quality and improvement in patient outcomes
- Develop corporate relationships to reach and broaden clinical opportunity
- Build national direct and distributor sales and client services organizations to directly support and grow demand for this need-based solution
Results
Within six months of FDA clearance, the client had commitments exceeding $12 million from corporate alliance clients and a forecast
of $70 million over 3 years.
Exceeding expectations: Redefining market presence for a niche device
Situation
A technology company with a niche diagnostic marker was developing a new near-patient diagnostic device. With only an OEM presence in the U.S., the company wanted to sell this unique product through an organic branded strategy.
Challenge
Establish a corporate presence in the U.S. that would instill confidence in the target market and allow for an accelerated placement rate of the new device; build a U.S. corporate presence to launch the sale, distribution, and client services for the device.
Ennivate Advantage
The Ennivate team developed growth strategies and tactics, employing branding strategies, corporate entity, client services, a direct sales organization, and distributor sales agreements to
- Develop a logistics and distribution chain using a network of established, world-class GMP alliance partnerships
- Position a branding campaign instilling confidence in quality and improvement in patient outcomes
- Develop corporate relationships to reach and broaden clinical opportunity
- Build national direct and distributor sales and client services organizations to directly support and grow demand for this need-based solution
Results
Within 30 days of launch, the client's product sales exceeded business plan forecast with 1500 units under contract and readied for shipment to U.S. clients.
Building the brand: Creating a solid market presence for a urology device
Situation
A technology company with a niche medical device was looking to enter the North American urology market space. Without any market presence outside of Europe, there was no brand, corporate infrastructure, or product recognition in the North American market.
Challenge
Establish a corporate presence in the U.S. that would instill confidence within the target market and allow for an accelerated placement rate of the new device; build a U.S. corporate presence to launch the sale, distribution, and client services for the device.
Ennivate Advantage
The Ennivate team developed growth strategies and tactics, employing branding strategies, corporate entity, client services, a direct sales organization, and distributor sales agreements to:
- Develop a logistics and distribution chain using a network of established world class, GMP alliance partnerships.
- Position branding campaign instilling confidence in quality and improvement in patient outcomes
- Develop corporate relationships to reach and broaden clinical opportunity
- Build national direct and distributor sales and client services organizations to directly support and grow demand for this need-based solution
Results
Within 30 days of engagement, Ennivate coordinated FDA filing, established a U.S. corporate presence, developed reimbursement strategies, initiated corporate alliance technical evaluations, and developed a directed sales effort with a contract manufacturers sales force.
Cardio strength: Creating upstream market presence
Situation
A technology company with a niche medical device was looking to enter the North American cardiology market space. With strong intellectual property, this organization was looking to better understand the market opportunity, needs, entry points, competition, and critical pathways associated with near-patient cardiac care.
Challenge
To network key opinion leaders to best understand cardiac care pathways, caregiver concerns and need areas in improving identification and treatment of cardiac risk patients.
Ennivate Advantage
Ennivate Launch Partners proposed a three-phased solution to provide our client with:
- Immediate access to key opinion leaders through targeted focused cardiology groups using a network of established opinion leaders in key teaching institutions throughout North America
- Remote interviews focused on caregivers throughout the patient contact chain of home-health, long-term care, emergency care, and family practice
- A scientific advisory board to reach and broaden clinical contact and to maintain awareness of shifting trends in the U.S. healthcare market
- Business development opportunities to broaden proprietary offering through corporate alliance programming
Results
Within 30 days, Ennivate Launch Partners was able to collect and present critical market drivers, caregiver needs, and corporate alliance opportunities that were used to develop device platform and alliance offerings. Ennivate also established and maintains a network of U.S.-based opinion leaders that are being used to drive future product development.