Case Studies
- Thermal Ablation Device
- An Entire Line of Polypectomy Forceps
- Wound Treatment System
- Bipolar RF Ablation Device
- Blood Collection System
- Heart Stabilization Device
- Implantable Pacing Leads
- High Flow Micro Infusion Catheter
- Esophageal Dilator Development
- Development of a Laparoscopic Anti-Adhesive Sprayer
- Development of Laparoscopic Vesico-Urethral Anastomosis Device
- Aortic Cutter Improvement Program
- Torque Wrench
- Colonoscope Guidewire
- Product Transfer
Thermal Ablation Device
The Challenge
Accellent was tasked with transferring the entire production of a USFDA Class III PMA product used in the treatment of prostate cancer. The customer needed a complete supply chain solution, including design, assembly, and packaging, for a highly sophisticated device.
The Accellent Advantage
Accellent transferred all assembly for the product to its plant in Juarez, Mexico. Throughout the process, numerous challenges arose, not least of which the fact that no English documentation existed for the product.
The execution of the product transfer was enormously complex. The device features complicated fiber optic sensors and electro-mechanical design. There were also significant regulatory issues present.
The Result
In spite of the enormous obstacles, Accellent was able to successfully transfer the product on schedule. As a result, production increased 42%, while capacity increased 125%, all while producing a measurably higher-quality product.
The Testimonial
The customer was ecstatic about the results. "Accellent took production across the Atlantic Ocean, and still managed to substantially increase our ROI for a highly complicated product line. We weren't even sure that was possible."
An Entire Line of Polypectomy Forceps
The Challenge
To transfer an entire line of polypectomy forceps from in-house manufacture at the customer's facility, assuming responsibility for the entire supply chain, including assembly, manufacturing and warehousing. Further, Accellent was tasked with improving costs and increasing ROI.
The Accellent Advantage
Accellent immediately set to work improving production efficiency by working to reduce lead times, while improving quality and customer service responsiveness.
Accellent transferred more than 14 assembly lines, representing 6.5 million products per year to our Juarez, Mexico site. Our complete supply chain solution encompassed 275 separate validations.
The Result
Accellent was able to handle the entire supply chain solution, while reducing lead times by 90% and improving production efficiency by 125%. At the same time, Accellent improved customer service satisfaction to 99.7% and improved overall quality by 25%.
The Testimonial
In the end the customer generated more than $1 million in additional revenue per year. Perhaps that is why they were quick to note that "Accellent's complete solution not only improves turnaround, but provides a higher quality product than we could produce in house."
Wound Treatment System
The Challenge
Accellent was asked to design and develop a new therapy for the treatment of chronic wounds and severe burns within 18 months, at 80% of the targeted cost. Accellent was to create new devices for the harvesting and preparation of autologous skin grafts.
The Accellent Advantage
Skin grafts present some of the most difficult tissue-handling issues. Accellent set to work creating two disposable devices, one battery powered, for single use. Due to the nature of the trauma involved, the customer needed a device that was intuitive and required less end user training.
Accellent provided a complete device design solution. Utilizing two parallel development teams, and a specialized design control process, Accellent controlled the entire supply chain with an eye toward reducing overall costs.
The Result
In 18 months, Accellent was able manage the process from a blank sheet of paper to human clinicals. Most importantly, the devices proved to be highly reliable and easy to use. Accellent met its targeted goal, beating the target price by 20%.
The Testimonial
The customer was ecstatic about the results. "We came to Accellent with a very specialized project, an aggressive timeline, and an ambitious target," said the customer. "They met every criteria imaginable for quality, and improved our ROI by leveraging experience no other company provides."
Bipolar RF Ablation Device
The Challenge
The customer charged Accellent with developing an ablation device used in the treatment of Gastroesophageal Reflux Disease (GERD). There were no devices yet on the market that had the required level of ablation control, and the customer needed the product to reach the clinical trial stage within ten months.
The Accellent Advantage
Utilizing the "Accellent Process Excellence Toolset", Accellent immediately set to work crafting a concept design for the device. Accellent engineers reduced the size of the design, and also included a timer circuit that is compatible with three major brands of RF generators.
The Result
Accellent created a fast-moving pilot manufacturing environment. By increasing efficiency, Accellent was able to produce 1,000 units for clinical trials within 10 months.
The Testimonial
The customer was impressed with Accellent's ability to meet a demanding timeline. "To create a product from scratch, and bring it to clinical trial within ten months is more than I have seen from any other potential outsourcing partner."
Blood Collection System
The Challenge
The customer needed to reduce costs on a point-of-collection blood aphaeresis system by 20%, so they enlisted Accellent to accomplish the task with one caveat: Accellent could not modify the design in any way that would impact 510k clearance, tooling decisions, or the launch date.
The Accellent Advantage
Accellent immediately got to work crafting the 39 components of the device by leveraging its considerable DFMA process and materials experience. Accellent was able to reduce the amount of process steps utilizing its Design for Process Excellence program geared toward eliminating efficiencies and improving turnaround.
The Result
Accellent was able to achieve a 26% cost reduction without postponing any major benchmarks. As a result, the customer saved $500,000, representing two months' return on investment on engineering fees.
The Testimonial
The customer was more than pleased. "Accellent not only met, but drastically exceeded its performance goals for our blood collection system. Even with very specific parameters, they found leeway to greatly improve our ROI, and we would certainly utilize their solution in the future."
Heart Stabilization Device
The Challenge
Accellent was asked to reduce the cost of producing a heart stabilizing device indicated for use during "off pump" coronary artery bypass graft surgery with the end goal of bringing the device to market within six months.
The Accellent Advantage
Utilizing our extensive design expertise, Accellent crafted a two-month timeline for crafting completing the 38 process steps necessary to create the 61 components of the device.
The Result
Accellent reduced costs by 16% ($11.61 per unit), resulting in $2,000,000 in savings throughout the life of the product. This represents a 2,500% return on investment in engineering fees.
The Testimonial
Naturally, the customer was ecstatic about the results. "Partnering with Accellent's unique solution made our product substantially more profitable. Their expertise allows us to focus on what we do best."
Implantable Pacing Leads
The Challenge
The customer challenged Accellent to design and produce 1,500 minimally invasive placements of pacing leads. The project represented a unique challenge, since proof of concept models had not yet been.
The Accellent Advantage
Accellent immediately assigned a multidisciplinary project team to handle all elements of the supply chain. The design team worked with Accellent project managers to craft a supply chain solution leveraging its extensive internal component capabilities. The pilot assembly team worked to streamline the transfer of pilot production.
The Result
In spite of the obstacles, Accellent was able to reduce the time from concept to market by 50%, from 12 months to 6 months. Accellent met every deadline, creating enormous savings for the customer on a particularly difficult project.
The Testimonial
The customer had this to say about Accellent's impressive turnaround. "Without Accellent's broad, comprehensive solution, we never could have turned this project around with this level of efficiency. They will certain be our partner for supply chain solutions in the future."
High Flow Micro Infusion Catheter
The Challenge
The customer presented Accellent with a specific challenge: Design a 2.8F High Flow/Selective peripheral catheter capable of withstanding dynamic pressure of up to 1000 psi at contrast fluid flow rates of 3cc per second.
The Accellent Advantage
Using Accellent's proprietary Virtual Tubing Model© , designers were able to achieve a working prototype in fewer attempts. Process experts worked with catheter specialists to create an innovative design and our process team ensured the seamless transfer from prototype to manufacture.
The Result
Accellent's micro catheter not only met, but exceeded both technical and clinical requirements. Better yet, the project was completed in ten weeks, well ahead of schedule and well under budget.
The Testimonial
"Accellent went above and beyond the call of duty on this project," said the customer. "They created an outstanding product from scratch, and were able to turn it around faster than we could have anticipated. Rest assured, we'll be partnering with Accellent in the future."
Esophageal Dilator Development
The Challenge
Accellent was tasked with developing a second-generation esophageal dilator for the customer, with enough volume to introduce to the market within 12 months. The customer also wanted a visually clear device, which would require weld process development.
The Accellent Advantage
Accellent assigned a multidisciplinary team with the goal of optimizing the design of the dilator while creating a more efficient process in order to assure quick delivery to market. From concepting to manufacturing, Accellent handled each step under budget and on time.
The Result
Accellent successfully transferred all manufacturing, and the customer introduced to market within 12 months with sufficient quantities for a successful launch.
The Testimonial
"Without Accellent's extensive product development experience, we simply could not have gotten our esophageal dilator to market within our desired timeframe," Said the customer. "Partnering with Accellent brought our innovations to market while we focused on the things we do best."
Development of a Laparoscopic Anti-Adhesive Sprayer
The Challenge
The customer came to Accellent with a need for an anti-adhesive dispenser for open and laparoscopic procedures. The project demanded a uniform and accurate product, and the customer requested special ergonomic futures.
The Accellent Advantage
Accellent imposed strict quality standards and set parameters for uniformity, spray pattern, and accuracy, and assigned a cross-functional team to achieve those standards while meeting the customer's ergonomic specifications.
Accellent established a cross-functional team to handle industrial design from all angles, including concepting, detail design, packaging and production.
The Results
Accellent met and exceed customer expectations by creating a highly ergonomic device that was consistent with the customer's reputation for quality and accuracy.
The Testimonial
The customer has this to say about Accellent's outstanding work. "Our name is synonymous with high quality, so we are always leery about outsourcing our work. Accellent allayed our fears by creating a tremendous product, and we will certainly have the confidence to use them again."
Development of Laparoscopic Vesico-Urethral Anastomosis Device
The Challenge
Accellent was asked to assist the customer with the design, prototyping, testing and production of laparoscopic vesico-urethral anastomosis device for post radical prostectomy.
The Accellent Advantage
The anastomosis device features a highly complex mechanism packaged in a 26 Fr device, and the customer established an aggressive timetable to bring the product to market.
Working side-by-side with the customer's development team, Accellent utilized decades of design expertise in mechanisms, cams, and injection molded components.
The Result
Accellent was able to form an extremely cohesive, efficient team with the customer. The team easily met all design challenges and schedule dates.
The Testimonial
"Accellent exhibited outstanding professionalism and service throughout the process," said the customer. "We look forward to partnering with them for future projects."
Aortic Cutter Improvement Program
The Challenge
Accellent was challenged with transferring a product line for a prime supplier for a major medical technology company. One major component of the project was to increase production while identifying quality-related issues that were in need of immediate improvement. In particular, Accellent was tasked with addressing the problem of particle residue and damage during assembly.
Particulate was discovered on a number of aortic cutters. FTIR analysis determined that the root cause was the winding feature, such that the winding wheel transferred brown particulate to the instrument itself.
The Process
Improving quality and improving turnaround go hand-in-hand for Accellent. Accellent applied lean technologies to define systemic flaws and produce a higher quality product more quickly. Accellent immediately went to work identifying the root causes of particular flaws, and correcting processes to eliminate those flaws.
Accellent engineers built a non-contact winding feature, which would eliminate the particulate for future components. Using Lean Improvement methodology, Accellent reconfigured the inefficient batch-processing flow to a streamlined, single-piece flow in an effort to dramatically decrease turnaround time.
The Result
Accellent reduced the square footage necessary to produce the aortic cutter by 340 square feet, and cut the scrap rate by more than half. More importantly, Accellent increased baseline production by more than 500%, while reducing the rejection rate from 34% to 29%.
The Testimonial
The customer's parent company perhaps put it best, honoring Accellent's "commitment to ensuring the uninterrupted supply of the Aortic Cutter device to our Cardiac Surgery Division for use in beating heart coronary artery by-pass surgical procedures."
Torque Wrench
The Challenge
Accellent was asked to redesign an existing, stand-alone Torque Wrench, used in Revision Knee systems. The original product was purchased off the shelf, and Accellent was tasked with incorporating a new design for the existing Impactor Handle that featured a quick connect/disconnect for other attachments in the instrument set.
The Accellent Advantage
Accellent leveraged strong customer communication to ensure quality production from a small, efficient team. Accellent crafted a well-defined scope, consisting of a single part Torque Wrench to execute a quality, finished product within an aggressive time frame.
The Result
Accellent was able to take an existing model, and adapt it to produce an entirely new tool. Accellent was able to generate a quality, compliant product well ahead of schedule. The end result yielded a higher-than-expected profit margin and ROI for the customer.
The Testimonial
The customer was elated with Accellent's fast turnaround, noting that "Accellent made this entire process quicker, less expensive, and more efficient. We would certainly turn to them for future projects."
Colonoscope Guidewire
The Challenge
Accellent took part in a unique, device brainstorming session with the EES team and their key thought-leadership, with an eye toward crafting prototype devices as a result of that brainstorming. The ultimate goal was to introduce a specific design and build devices for limited clinical use, all on a very aggressive timeline.
The Accellent Advantage
The tight timeline meant that the brainstorming and ideation sessions could only take weeks out of the nearly yearlong project. Accellent offered several subject matter experts to take part in the brainstorming session. The experts then worked with the Accellent team to produce expedited prototypes for animal testing and, ultimately, clinical use.
The Result
Accellent was able to leverage compelling thought leadership to produce high quality prototypes with an extraordinarily tight turnaround. The end result was a disruptive technology that established the customer as a thought leader in the market place. This is the model of Accellent's strong ideation capacity reaching the market in record time.
The Testimonial
The customer was impressed with "Accellent's ability to produce great ideas on a quick turnaround, without sacrificing innovation. We look forward to working with them in the future."
Product Transfer
The Challenge
An endoscopy customer announced that they were closing a major facility, which was responsible for producing RF, Disposable and Visualization devices. Accellent was tasked with producing RF devices with 54 different SKUs.
The Accellent Advantage
Accellent transferred the entire production line to their Juarez, Mexico facility. Accellent was able to produce all 60+ devices within 18 months, and met the customer's non-negotiable deadline.
The Result
The different RF lines represent $6.5 million dollars in annual sales to the customer. Not only did Accellent take over a major production line, but they saved the customer $1 million in the process. Accellent was able to take an existing product line, improve efficiency, quality and turnaround, and provide a superior service to the customer.
The Testimonial
The customer was relieved that Accellent was able to facilitate the entire product transfer. "Accellent was easy to work with, and provided a seamless transfer of our product line. We would certainly work with Accellent again.
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