December 16, 2014
Dec 16, 2014
LifeScience Alley recently sat down with Randy Barko, CEO of member company Ximedica, to discuss some recent news from the company and to glean some insights from the world of medical technology product design today.
Ximedica, a full-service design firm specializing in medical technology products, is celebrating three years in Minnesota’s Medical Alley and as a member of LifeScience Alley. The company recently announced a recapitalization and is pursuing opportunities for national and international growth. Tell us a little bit about Ximedica - how it started and where the company is today.
Ximedica was started 29 years ago as part of Item New Product Design by co-founders Steve Lane and Aidan Petrie. About 9 years ago a strategic decision to focus solely on the development of regulated medical devices was made and the company formally rebranded as Ximedica.
Given our history with medical technology, we understand the importance of working with FDA and establishing quality management systems early in the process. We’re ISO 13485 certified and FDA registered, so we’re able to guide companies of all sizes at all stages through the entire commercialization process from initial strategy to full-scale manufacturing and launch. We have a proprietary Quality Management System fully integrated in all of our locations, and partnerships across the supply chain to help our clients meet needs from conducting clinical trials to scaling up to volume manufacturing.
What trends are you seeing in industry and how have they impacted your strategy?
I heard recently that “innovation is not innovation unless it provides a better outcome at a lower cost”, and I think this accurately captures the driving forces in our industry today, and helps to explain new dynamics we’re seeing. For example, doctors and healthcare providers are in some ways becoming more of a commodity as administrators and other outside groups are making more purchasing decisions.
Better Outcomes, Lower Cost
In our work, this means that we’re part of the solution in identifying the “better outcomes”. We start engaging in the planning and strategy phases and get involved early with FDA to help manage overall risk in the process. Through user-centered design, development, validation, and launch, we stay focused on providing value and helping to produce a product with better health outcomes. Although we’re basically fee for service, as a partner to our clients, we operate more as a fee for outcome/fee for value because we are focused on commercialization not billable hours.
We also put a lot of thought and time into designing products using human factors methodologies and assessing the usability of those products. For example more technologies are going into the home for remote monitoring and care, so many of today’s healthcare products have to be designed for you and me, who are quickly becoming the caregivers of the future.
In fact, we’ve recently opened a second Usability Lab in our Minneapolis office which serves to provide a research facility for conducting VOC studies and other research associated with the front-end of innovation as well as usability assessments both required by FDA and critical to our process. We decided to expand that space because more and more, we have companies come to us that have been asked by FDA, after submitting their product, to look more deeply into user-friendliness.
You just announced a recapitalization with SV Life Sciences out of Boston. What does this investment mean for Ximedica going forward?
We’re very excited about the deal. It’s a good fit for both parties and will allow us to expand in locations we’re currently in, as well as to new markets worldwide. SV Life Sciences is a global fund with international offices, limited partners, and investments worldwide. They truly understand the global nature of the marketplace.
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