By
Creating a new medical device is an enormous undertaking. Having a great idea is just the beginning – you’ve got to get funding, build the right team, comply with regulatory requirements, deal with fierce competition within the healthcare industry – the list of challenges goes on and on. And don’t forget that you also need to find the design, engineering, and manufacturing expertise required to bring your concept to life.
Endolumik, a venture-backed medical device startup, faced all of these challenges. Dr. Nova Szoka, a bariatric surgeon, saw a unique opportunity to improve success rates for weight-loss surgery through a fluorescence-guided gastric calibration system. She partnered with Mara McFadden, Endolumik’s CEO, to create this new device and bring it to market. In addition, the Endolumik team needed to find the right partner to take this device from idea to reality.
This is where DEM Medical stepped in. With expertise in the design, engineering, and manufacturing of innovative products, DEM helped Endolumik meet their challenges, from navigating FDA approval and ongoing documentation requirements to reducing production costs. By working closely with DEM, Endolumik was able to move quickly from prototype to full-scale production and has now helped patients in over 5,000 cases since its launch.
In this case study, we’ll explore the key challenges Endolumik faced and how DEM’s integrated approach enabled them to bring a groundbreaking product to market efficiently and affordably, positioning them for long-term growth.
Challenge #1: Designing & Engineering the Device
Many medical device companies are founded by physicians who see a crucial need to improve something within their own practice. The physician has an idea for a groundbreaking product and knows how the device should work. Once the idea is created, the physician is then looking for a fast and cost effective way to access the design and engineering resources they need without hiring a large team or managing multiple vendors.In Endolumik’s case, their device needed to do three things:
- Evacuate stomach contents: The device needed to ensure the stomach was emptied and prepped for the operation to begin.
- Illuminate the stomach with near-infrared lights: By providing a clear view of the surgical site, the device would help the surgeon make quicker, more accurate decisions about how to shape the patient’s anatomy.
- Post-surgery inflation for leak detection: Once the surgical procedure is completed, the device needs to inflate the stomach slightly, applying pressure to allow the surgeon to check for any leaks in the sutures, reducing potential complications.
While the concept was clear, this device required a blend of mechanical and electrical engineering, which in turn required the expertise of specialized engineers. Adding to the challenge was the fact that Endolumik was a venture-backed startup. This meant that the team needed development to move quickly and to control upfront costs.
Solution: Partnering with DEM Medical
Endolumik found the ideal solution by partnering with DEM Medical. With expertise in both mechanical and electrical engineering, DEM’s team could ensure the product met the technical demands the device required. On top of this, DEM provided everything they needed to manufacture the device in one integrated operation.
This integrated approach allowed DEM to take products from prototype to production much faster and more efficiently than the traditional multi-step, multi-vendor approach where risk and ownership of problems are most often the customer’s burden. Trying to coordinate with multiple vendors while adequately identifying design issues and manufacturing risks is not only difficult, it takes time and resources away from other crucial operations needed to bring a product to market. With all the disciplines of design, engineering, and manufacturing working in tandem, DEM could rapidly identify and address potential issues while also helping Endolumik avoid extended development timelines that could have drained cash reserves.
Challenge #2: Unexpected Production Issues
When developing a unique and innovative device, executing thorough and robust quality validation to identify unforeseen challenges is critical. Endolumik was no exception. As the device entered production, an unexpected challenge arose: completed manufactured units were failing a vacuum test at an unacceptable rate and the cause was not apparent.
The failure rate was unacceptable and the root cause needed to be identified and corrected quickly. DEM experts took action immediately to find the failure mode and an effective solution.
The Solution: Full Failure Mode Analysis & Remediation
DEM Medical halted production at their own expense, conducting a thorough failure analysis to identify the problem. After considerable testing and detailed analysis, they found the issue was caused by too wide of a spring length tolerance on the regulator valve. Once they identified this issue, they worked with their team to establish a tighter tolerance and get production back online in just six weeks.
This situation showcases the benefits of DEM’s integrated approach. Had Endolumik been working with separate entities, the process of fixing this issue could have dragged on for months. They would have needed to hire an external engineer, costing an additional $30,000-$50,000. Then they would have had to coordinate with the manufacturer to identify the issue and implement a fix.
By working with DEM Medical, Endolumik avoided the cost of designing around the problem and was able to get their product back into production quickly, without having to coordinate between several vendors.
Challenge #3: Reducing the Cost of Production
As opposed to making products overseas, manufacturing in the United States offers numerous advantages:- Regional manufacturers can ship products faster
- Regional manufacturers are less vulnerable to global supply chain disruptions
- Regional manufacturers can respond to market changes faster
However, it’s no secret that domestic manufacturing can be more expensive. For a startup like Endolumik, controlling production costs was essential.
In the wake of the COVID-19 pandemic, hospitals have been facing tight budgets, with rising costs shrinking margins across the healthcare sector. To remain competitive and ensure profitability, Endolumik needed to lower manufacturing costs. They turned to DEM for ideas.
Solution: Uncovering Unique Solutions to Cut Production Costs
DEM Medical took a strategic approach to reduce Endolumik’s production costs by 20% in just four months. This was achieved through a series of improvements aimed at bringing more efficiency to the production process:- Bring More Production In-House: Instead of using an outside supplier, DEM produced as many parts in-house as they could, allowing them to cut costs.
- Negotiations with Suppliers - Where it didn’t make sense to produce the part in-house, DEM negotiated with suppliers to bring down per-unit pricing.
- Strategic Sourcing and Supply - To help Endolumik reduce cost and increase supply flexibility to meet the variable product demand from their customers, DEM Medical worked out bulk-order solutions that lowered the price per unit, built product inventory to meet customer demand, and enabled Endolumik to place orders at the time of customer demand with payment due 30 days after shipment.
These three steps helped Endolumik drive down production costs while increasing sales, allowing the company to maintain profitability while maintaining the advantages of working with a US-based manufacturer.
The Results: Projected To Grow 200% Year-Over-Year
By partnering with DEM Medical, Endolumik was able to bring their device to market quickly and at a reduced cost, all while overcoming the numerous technical and regulatory hurdles that can be challenging for startups in the medical device industry. Just as importantly, Endolumik gained a long-term partner that will continue to support the company’s growth and success in the future: the company is projected to grow 200% year-over-year this year.
Today, Endolumik’s device is being used in over 30 hospitals across the United States, including renowned institutions like Cleveland Clinic, Emory Healthcare, and Duke Hospital. With an innovative design and proven effectiveness, this device is positioned to gain widespread adoption in the healthcare industry.
Endolumik also achieved a significant regulatory milestone while working with DEM Medical: they became the first company to have a device authorized under the FDA’s Safer Technologies Program (SteP). This program is reserved for devices that are expected to significantly improve the safety of current treatments or diagnostic methods, underscoring the impact of the Endolumik device.
Partner with DEM Medical
The story of Endolumik is just one example of what DEM Medical can do for medical device companies. Our agile product development process ensures that we solve problems efficiently and get you from concept to production faster, all while delivering innovative solutions tailored to your customers’ needs.Here are a few ways we can assist:
- Design, Engineering & Manufacturing: Whether you’re in the early stages of developing a prototype or ready for full-scale production, DEM can support you every step of the way.
- FDA Approval & Device Validation: Navigating the complex regulatory landscape can be overwhelming, but we’ve got you covered. As we did with Endolumik, we can help your medical device company with FDA approval and device validation, shortening the time it takes to bring your device to market.
- Product Shipping & Fulfillment: DEM Medical can streamline your fulfillment operation and make it easier to sell directly to hospitals and healthcare providers.
If you’re looking for an experienced partner to support you in every phase of creating your new medical device, reach out to us and schedule a consultation.