Overview

EMERGE is our unique process for working with partners to transform their ideas for exclusive Class 1 and 2 medical devices into market-ready products – rapidly and efficiently. With EMERGE, we become an extension of our partners in the way they conceive, design and manufacture innovative products. We revolutionize the way our clients think about their business.

The Challenge

A valued client approached MedSource Labs with a unique problem in the medical device industry. The client had identified an opportunity to grow market share with an innovative medical device, but faced barriers to bringing a cost-effective product to market. They lacked access to an experienced design team and a robust quality management system, and did not have the manufacturing capacity to produce the device at scale. In addition, they had a very tight timeframe. To take full advantage of this opportunity, our client needed to move from ideation to market within 12 months.

Our Solution

We are firmly committed to helping our clients find solutions to help them deliver products that meet and exceed customer needs and rigorous regulatory standards.  We moved quickly to apply our four-step EMERGE process to assist our client in bringing their idea to life.

1. PLAN – First, we assessed the project background, objectives and scope, and mobilized a dedicated team of designers, manufacturers and project managers.
2. DESIGN – We consulted our clients on the innovations they wanted to make to the market offerings and navigated intellectual property (IP) questions. Our experienced design team, using state-of-the-art computer modeling equipment, set design specifications and created renderings.
3. VALIDATE– For this project, we identified an overseas manufacturing partner that was well known to us and had a track record of high-quality, innovative work and could deliver at the scale our client required. We rigorously tested our processes, machinery and prototypes to ensure that design specifications were met at the manufacturing plant and with 3^rd party labs in accordance with the Federal Drug Administration. At that stage, our experienced quality team prepared and submitted a comprehensive 510K application to the FDA to ensure the device could be sold in the United States.
4. OPTIMIZE –After validate, MSL’s marketing team then helped design a product launch program with the customers marketing team. Our sales team provided sales, product, and clinical support in the field with the customer’s reps to end users. Throughout the product’s lifecycle, we provide quality and regulatory support with the users and FDA with a dedicated Quality Team. Finally, the Product Development team offers continuous support in product enhancements to meet the changing market needs.

Throughout, we maintained rigorous project management and established transparent and regular communication with our client to ensure priorities remain aligned from start to completion.

Results

Our clients had come to us looking for quality, cost-efficiency and speed. We were able to deliver on all fronts by engaging our unique and adaptable EMERGE process, and by tapping our extensive network of design, manufacturing and quality experts. From start to finish, we were able to deliver finished products in under 10 months – well ahead of our partner’s needs and significantly exceeding industry standards. In this case, our client owns all tangible assets and intellectual property generated by the project.