Medical Device News Magazine

How Applied Research is Transforming Medical Device Startups | By Hannah Eherenfeldt, Co-founder & CEO of ReSuture

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Medical device startups face numerous barriers when trying to penetrate the crowded startup landscape. Fundraising is highly competitive, and many products fail to reach the market due to insufficient funding for research, validation, and testing.

The applied research model provides a solution. This model leverages public-private partnerships to help startups accelerate their journey to commercialization. By following a specific formula, applied research supports startups in navigating the complexities of product development.

Our surgical training technology startup, ReSuture, has significantly benefited from the applied research model. My colleague, Ben Knapp, and I founded ReSuture in 2019 to offer surgeons a way to practice complex surgeries on models that accurately replicate human tissue.

As biomedical engineers, we have collaborated closely with medical device professionals to understand the industry’s needs. During our efforts to develop various training models for medical students and surgical residents, we identified a glaring need for improved hands-on training options.

Traditionally, surgical training occurs during live procedures in operating rooms. Our proprietary manufacturing technique allows us to produce realistic replicas of vascular structures, such as veins and arteries, incorporating disease-like conditions. This innovation offers a new method for creating synthetic vasculature, enabling surgeons to practice on the most life-like alternatives before performing on humans to test new devices or refine surgical techniques. Our technology is primarily utilized by medical device companies, which drive over 90% of ongoing surgical training.

For ReSuture, applied research has provided access to non-dilutive funding and a network of experts through partnerships with public and private sectors. Support from university researchers and local health systems has allowed our team to concentrate on testing and validating our technology, propelling us towards commercialization. Understanding and leveraging the applied research model can help both existing medical device companies and startups overcome entry barriers, accelerate commercialization, and drive innovation.

ReSuture and the Applied Research Model in Arizona

ReSuture is headquartered in Phoenix, AZ, and was inducted into the Partnership for Economic Innovation’s Arizona WearTech Center Applied Research Center as part of its third cohort in 2023. The WearTech Center has been instrumental in our early success, significantly expediting our development timeline.

Arizona’s biomedical, semiconductor, and technology industries have grown rapidly over the past decade. Industry leaders have established a robust foundation to help startups bring transformative ideas to market. Originally launched in New Orleans as Tulane University graduates, we recognized the financial opportunities in Arizona’s bioscience sector and vibrant research ecosystem, prompting our strategic relocation.

Support in research and development, prototyping, and validation has been pivotal to ReSuture’s success. Recently, we secured a patent for our novel manufacturing method, underscoring the uniqueness of our synthetic vascular tissue and bolstering our credibility. The applied research framework has fostered critical collaborations with leading university research teams and health systems while streamlining access to both private and public funding sources through strategic partnerships.

Public-Private Partnerships

Developing technology to address complex challenges necessitates substantial financial, technical, and strategic support. As a startup, ReSuture has had to cultivate this support from the ground up. We have navigated the competitive startup landscape with the aid of both public and private investments, leveraging state and national government funding streams to focus on bringing our products to market.

A pivotal factor in our success has been the support from local Arizona programs funded by the Arizona Commerce Authority, including the WearTech Center and Venture Ready Accelerator. These initiatives have provided invaluable assistance in refining our business plans, enhancing our go-to-market strategies, and increasing our investor pitch readiness.

The Arizona Commerce Authority has also connected us with a network of business and financial mentors, high-level executives, and subject-matter experts, further aiding our growth and fundraising efforts.

Additionally, ReSuture has received substantial support from the National Science Foundation (NSF) in the form of two Small Business Innovation Research (SBIR) awards, totaling over $1.2 million. Our most recent Phase II SBIR grant has enabled us to integrate cutting-edge sensing technologies into our models, allowing us to capture critical data on surgical tool movement and the forces applied during procedures. This advancement significantly furthers our mission to improve surgical training.

Leveraging Local Health Systems

Validation is one of the most significant hurdles in research and development. The applied research model offers a strategy to streamline and expedite this lengthy and cost-intensive process. Building relationships with industry experts can be the missing link to achieving validation, and for us, the applied research model has been instrumental in bridging complex and segmented systems.

ReSuture’s robust research partnerships with local health systems, including St. Joseph’s Hospital and Medical Center and the Mayo Clinic, have been crucial. These collaborations allow us to understand and address the challenges medical professionals encounter in their daily environments. Relying on these partnerships has also been essential in overcoming internal obstacles, such as the lack of infrastructure needed to bring our products to market.

As surgeons use our models to learn and practice new techniques, we collect data to establish objective and well-defined performance metrics for surgical procedures. This data is invaluable as we develop sensing technology and machine learning algorithms to measure and differentiate surgical skills effectively. Additionally, it provides critical insights into the performance of medical devices and surgeons during simulated operations, which can be applied to real surgeries.

Collaborating with University Researchers to Respond to Market Needs

ReSuture’s partnerships with researchers at Arizona State University’s School of Computing and Augmented Intelligence have been pivotal in advancing our data analytics capabilities, an experimental platform that aims to enhance both medical device performance and surgical skills.

Arizona State University, a globally recognized research institution, has been a critical partner in transforming our ideas into impactful solutions. Collaborating with ASU faculty and staff has provided us with access to a vast network of experts and state-of-the-art lab technology. This partnership has been especially beneficial in our efforts to develop the machine-learning algorithms that power our surgical data analytics platform.

This collaboration significantly boosts ReSuture’s credibility, making potential customers and stakeholders more inclined to trust and support our future growth initiatives. Partnering with a prestigious research institution not only strengthens our reputation but also aligns us with renowned experts and the latest advancements in medical research.

Conclusion

Arizona, as an emerging innovation hub, offers businesses and startups numerous opportunities to transform ideas into tangible solutions that enhance patient care.

With the support of the WearTech Center and a commitment to interdisciplinary partnerships, ReSuture is expanding its network both within Arizona and across the nation. We are currently experiencing a remarkable period of growth and development, highlighted by the recent acquisition of our first patent. We are proud of the significant progress we have made toward our ultimate goal: providing the medical device industry and surgeons with objective metrics for surgical performance.


Editor’s Note:  Hannah Eherenfeldt, CEO and Co-Founder of ReSuture: Hannah Eherenfeldt leads ReSuture with a background in engineering and entrepreneurship. Before founding ReSuture, she worked with early-stage biotechnology startups as part of the commercialization team at the New Orleans Bioinnovation Center. With a strong affinity for design and product development, Hannah leverages her expertise to drive innovation and growth. She holds a Bachelor of Science in Engineering (BSE) in Biomedical Engineering from Tulane University.

 

 

 

 

 

 

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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