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A Digital Transformation Strategy for Your Supply Chain

Global supply chainsThe goal of a supply chain is to deliver the right amount of the right product to the right people using an agile network of partners. The digital supply chain uses data to achieve these goals and overcome today’s challenges and unforeseen disruptions. Transforming your processes to digital gives you and your supply chain partners a competitive advantage in customer satisfaction, cost of goods sold, and sales.

Why a Digital Supply Chain?

  • Improved demand forecasting—the right amount of product for the right people
  • Instant access to the latest released design and manufacturing data—the right product
  • Production through supply chain changes—the agile network
  • Harmonized partners on products and plans
  • Compliance with regulations
  • More efficient path to meet your business goals

Focus on Product First

Many companies start by optimizing logistics as the first step to a digital supply chain. However, making sure the right product design can be sourced, built, and shipped is a better place to start. The digital supply chain uses the latest product data to plan and respond to today’s realities.

The first step of a supply chain digital transformation is to gain control over your engineering and quality processes so every partner can collaborate fast and effectively. You need a flexible and secure way for different types of partners to contribute, based on their unique role in your supply chain and your relationship with them.

Leveraging a digital, cloud-based, product-centric quality management system (QMS) will provide maximum visibility within your supply chain operations throughout new product development and introduction (NPDI). This cloud system forms the foundation of a digital supply chain by controlling your product and quality processes in a single source of truth. This product-centric quality management approach enables you and your partners to collaborate more effectively to improve product quality.

Let’s look at how Ultralite Enterprises Inc. took a product-first approach to transform to a digital supply chain.

Bringing Next-Generation Products to Market

Dave Cummings, VP and COO of Ultralite, shared their digital business transformation experience using product-centric QMS software. Dave’s background is in telecom, continuously bringing next-generation products to market—from research, product development and product management, to business management. He’s usually working on future products to bring to market.

Ultralife’s dedication to providing high-quality, reliable phototherapy equipment has made them the most trusted name in phototherapy systems. The company provides phototherapy systems to treat a range of skin diseases including psoriasis, atopic eczema, vitiligo, and cutaneous T-cell lymphoma (CTCL).

Ultralite introduced the first system that digitally administers phototherapy services based on dosage of light. Before this product, physicians had to calculate treatment time based on device output and a patient’s required dosage. The phototherapy system uses electronic ballasts to control fluorescent lamps and output.

With continued market success in hospitals and clinics, Ultralite expanded to offer products for direct patient usage. Until recently, much of Ultralite’s engineering and manufacturing was done in-house. To support growth and market demand, they are engaging with more partners while maintaining the same focus on quality and reliability.

The Case for Digitizing

There are a few key reasons why Ultralite moved to digitize their supply chain. First, demand for their new products continues to increase. To meet production requirements, they needed to leverage external partners and operations while maintaining the highest level of quality.

Secondly, they needed to simplify compliance. The lack of proper design controls is one of the most cited issues by the FDA. Traceability from design inputs to design output to validation is critical to meet regulatory compliance. With a digital system for all internal and external teams, Ultralite can improve control and traceability, and better address their audits.

Finally, to grow, it was critical to leverage the expertise of partners who are electronic services manufacturers (ESMs). With a cloud-based PLM/QMS system, it was easier to collaborate in real time and design for manufacturing (DFM).

“As we started developing a new generation of products that comply with FDA regulations, managing the paperwork became overwhelming. We did not want compliance management to detract from delivering the high-quality product on time.”

Dave Cummings, VP and COO, Ultralite

Connected Medical Devices5 Steps to Digital Supply Chain Transformation Success

Ultralite is taking an iterative approach to leverage Arena by expanding the system as they meet their top priorities. As each stage is completed, team confidence increases and facilitates buy-in to further optimize how Arena is used.

Step 1. The Basics

Their first step was to manage the complete bills of materials (BOMs) in Arena. They made iterations as they progressed. For example, after the initial part and BOM upload, they expanded the configuration to include RoHS and REACH compliance information to parts. The documentation, including design specifications, is part of the BOM structure and is revision controlled. And Ultralite’s product information is structured to pass easily to partners’ downstream systems.

Step 2. Cross-Functional Collaboration

Once the product record was controlled, Ultralite moved to online design reviews. In milestone review meetings, the product team now uses Arena Scribe to record key observations and points of collaboration, so they’re linked with the product and easy to find later. The approval processes facilitate the collection of electronic signatures (per FDA 21 CFR Part 11 compliance). Each signature is time stamped, building the design history file (DHF). Product team members appreciate being able to conduct real-time reviews and approvals in an automated and streamlined manner.

Step 3. Compliant Product Requirements Management

During new product development (NPD), teams iterate on inputs to track reworked plans, marketing requirements, architecture requirements, and specifications for hardware, software, testing, and packaging. They need to provide access to this information for the entire product team. Spreadsheets and documents containing requirements and specifications were time-consuming to maintain—especially at this phase. With Arena, teams can innovate more rapidly by quickly creating requirements and customer inputs using pre-defined templates and links to parts and reference documents. Arena also helps maintain traceability throughout design validation when test results are linked with requirements.

Step 4. Collaboration With Supply Chain Partners

Another priority is collaborating with their new partners. A benefit of an ESM is the expertise they bring to the OEM. Arena enables communication that helps the ESM add value beyond building the product. For example, an ESM with medical device experience has shared their firsthand knowledge on both compliance and design for manufacturing (DFM). Sharing knowledge improves the partner relationship and eliminates the more transactional, arm’s-length business model.

Step 5. Creation of Audit Confidence

FDA audits can cause anxiety with teams at medical device manufacturers. With Arena, they are more confident in their audit readiness. Answering an auditor’s questions instantly with accurate links to product and quality records, along with a complete design history, is key to meeting audit requirements and to Ultralite’s track record of passing audits without findings.

Key Benefits of Digital Transformation:

  • Creating a single source of product and quality truth
  • Securing access to information for internal teams and external suppliers
  • Streamlining new product development processes
  • Leveraging partner expertise to avoid issues during new product introduction
  • Gaining audit confidence

Undergoing a digital transformation has required a culture change at Ultralite. Arena has helped impacted teams gain confidence as they expand their use of Arena. Dave continues to push for better ways to optimize their NPD processes. With Arena, he knows he can rely on a solid foundation to drive their digital supply chain.

Modern PLM and digital transformation are key to business success. By leveraging cloud-native solutions, AI, and data analytics, companies can optimize product lifecycle management, enhance collaboration, and drive innovation, resulting in improved efficiency, productivity, and competitiveness in the evolving market landscape.

Taking Inventory of Your Supply Chain

If you want to improve accountability, product accuracy, and get innovative products to customers fast, consider whether your supply chain can share information in the digital realm.

If you have trouble tracking product designs, quality issues, and product releases, contact us to learn how we can help.