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USA 502 Mace Blvd, Suite 15 Davis, CA 95618 United States Tele: (+1) 530-792-8400 BACKGROUND CHALLENGE IMPACT The Client is an international pharmaceutical company that was developing a therapeutic medical device for treating Inflammatory Bowel Disease (IBD) patients in the U.S. In preparation for the product launch, the Company needed a clearer understanding of the user environment and market space. This technology was already approved and in use in both Europe and Japan. The product was in the pivotal clinical trials stage for FDA approval. As part of the process, the Client was obligated to gather user requirements and to evaluate the product offering within this context. Some of the primary benchmarks were the device’s user interface, impact on patient safety, and related training/support needs. The potential use environ- ments investigated included apheresis centers, infusion therapy centers, and large gastrointestinal physician practices. The end goal was to determine the best way to promote the product and how to motivate the practitioners and hospital department offering apheresis therapy to support the adoption of this technology. SOLUTION The solution was designed around a 3-phase approach. In Phase I, The MarkeTech Group (TMTG) conducted a preliminary, qualitative, environmental review through In-Depth Interviews (IDIs) of treatment center managers to capture characteristics that best define the market, and assess critical market segment differences. In Phase II, field case studies provided a means to view clinical and operational practices at representative sites and to interact with practitioners in their own environment. Furthermore, this helped in building a functional purchase model of decision makers and influencers. Phase III, a series of focus groups allowed TMTG to test product design features, obtain consensus feedback, and determine how to best position the product to facilitate adoption. The study results provided the Client’s commercialization team with critical user-level information to use both in the FDA approval process, and also to guide the internal product development and sales and marketing planning leading up to the U.S. product launch. This research also set the stage for a follow-up study in Puerto Rico with focus groups who had completed clinical trials with the product. EUROPE / FRANCE 3 rue Emile Péhant 44000 Nantes France Tel: +33 (0)2 72 01 00 80 www.themarketechgroup.com MARKET METHODOLOGY MIX South America Europe Qualitative Research Strategic Consulting Quantitative Asia PROFILE CLIENT TYPE PROJECT CATEGORY PRODUCT CREATION LAUNCH PREPARATION Medical Device Medical Imaging Medical Diagnostics Medical IT/eHealth Biotechnologies Pharmaceuticals Technology Assessment Opportunity Analysis Customer and Product Requirements Product Concept Testing Segmentation Analysis Brand Positioning Packaging and Materials Testing Go to Market Planning Pricing PRODUCT MONITORING Customer Satisfaction and Loyalty Post Launch Acceptance MARKET RESEARCH AND PLANNING Custom Market Analysis Opportunity Analysis Collecting and Analyzing User Requirements for a New Therapeutic Device TECHNOLOGY GO / NO GO North America

Case Study: Collecting and Analyzing User Requirements for a New Therapeutic Device

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Visit us on the web: http://www.themarketechgroup.com/?utm_source=SlideShare&utm_medium=Social+Media&utm_campaign=Case+Studies About Us: With offices in North America and Europe, The MarkeTech Group provides a unique combination of extensive marketing research methodology expertise, deep medical technology domain knowledge and value-added strategic marketing consulting to medical technology companies who seek high quality marketing research studies and professional marketing strategy consulting. The MarkeTech Group's team of marketing research and strategy experts take pride in integrating their leading voice of customer (VOC) research expertise and strategic consulting into their clients' marketing and R&D departments to help successfully launch and maintain profitable products in healthcare. The MarkeTech Group, LLC 502 Mace Blvd, Suite 15 Davis, CA 95618 Tele: (+1) 530-792-8400 Fax: (+1) 530-792-8447 The MarkeTech Group, SARL 3, Rue Emile Péhant 44 000 Nantes Tele: +33 (0)2 72 01 00 80 Fax: +33 (0)2 40 48 29 40 Contact Us: http://www.themarketechgroup.com/index.php?page=Contact_TMTG&utm_source=SlideShare&utm_medium=Social+Media&utm_campaign=Case+Studies

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Page 1: Case Study: Collecting and Analyzing User Requirements for a New Therapeutic Device

USA502 Mace Blvd, Suite 15Davis, CA 95618United StatesTele: (+1) 530-792-8400

BACKGROUND

CHALLENGE

IMPACT

The Client is an international pharmaceutical company that was developing a therapeutic medical device for treating Inflammatory Bowel Disease (IBD) patients in the U.S. In preparation for the product launch, the Company needed a clearer understanding of the user environment and market space. This technology was already approved and in use in both Europe and Japan.

The product was in the pivotal clinical trials stage for FDA approval. As part of the process, the Client was obligated to gather user requirements and to evaluate the product offering within this context. Some of the primary benchmarks were the device’s user interface, impact on patient safety, and related training/support needs. The potential use environ-ments investigated included apheresis centers, infusion therapy centers, and large gastrointestinal physician practices. The end goal was to determine the best way to promote the product and how to motivate the practitioners and hospital department offering apheresis therapy to support the adoption of this technology.

SOLUTIONThe solution was designed around a 3-phase approach. In Phase I, The MarkeTech Group (TMTG) conducted a preliminary, qualitative, environmental review through In-Depth Interviews (IDIs) of treatment center managers to capture characteristics that best define the market, and assess critical market segment differences. In Phase II, field case studies provided a means to view clinical and operational practices at representative sites and to interact with practitioners in their own environment. Furthermore, this helped in building a functional purchase model of decision makers and influencers. Phase III, a series of focus groups allowed TMTG to test product design features, obtain consensus feedback, and determine how to best position the product to facilitate adoption.

The study results provided the Client’s commercialization team with critical user-level information to use both in the FDA approval process, and also to guide the internal product development and sales and marketing planning leading up to the U.S. product launch. This research also set the stage for a follow-up study in Puerto Rico with focus groups who had completed clinical trials with the product.

EUROPE / FRANCE3 rue Emile Péhant

44000 NantesFrance

Tel: +33 (0)2 72 01 00 80www.themarketechgroup.com

MARKET

METHODOLOGY MIX

South AmericaEurope

Qualitative ResearchStrategic Consulting

Quantitative

Asia

PROFILECLIENT TYPE

PROJECT CATEGORY

PRODUCT CREATION

LAUNCH PREPARATION

Medical DeviceMedical Imaging

Medical DiagnosticsMedical IT/eHealth

BiotechnologiesPharmaceuticals

Technology AssessmentOpportunity Analysis

Customer and Product RequirementsProduct Concept Testing

Segmentation AnalysisBrand Positioning

Packaging and Materials Testing

Go to Market PlanningPricing

PRODUCT MONITORINGCustomer Satisfaction and Loyalty

Post Launch Acceptance

MARKET RESEARCH AND PLANNINGCustom Market Analysis

Opportunity Analysis

Collecting and Analyzing User Requirements for a New Therapeutic Device

TECHNOLOGY GO / NO GO

North America