Medical devices is a fast growth segment in the health care industry. The demand for devices is accelerating from two particular areas, emerging foreign markets where the devices are relatively new, and in the U.S. with its aging population.
Medical devices manufacturers face unique challenges when compared to other equipment manufacturers. Not only do they face the product complexity, the demand for more variety by customers, the competitive pressures, and the downward price pressures; they also face the following unique complexities.
New technologies, new standards, and new regulations are continuously being introduced into the medical device market. Staying on top of these changes can make the difference between success and failure. Collaborating with doctors, medical experts, engineers, regulators and suppliers of technology must be quick and pervasive. Medical device manufacturers can also suffer when these changes cause time-to-market issues for new or modified products.
The medical device industry is subject to a long list of regulations, standards and compliance items. These include FDA, ISO, Federal hazardous substance and other local or international mandates. These regulations can differ slightly within geographies and sometimes have particular nuances. A manufacturer must comply with these regulations or risk penalties or malpractice lawsuits. These same regulatory items can also contribute to expensive redesigns in some of the products.
With medical malpractice, competitive challenges, and customer demands for more features and functions, maintaining quality standards has become even harder. Medical device manufacturers must be more exacting and persistent with their quality and documentation efforts. Recalls can be expensive for the cost of product replacement, but can be even more damaging to company image, and future product reputation.
Another challenge for medical equipment manufacturers is access to low-cost, on-call 24/7 technical support. Medical devices are used around the clock across the globe, and require timely support to avoid costly problems.
Supply Chain Weaknesses
Regulations / Quality
Product Life Cycle Management
After Market Sales and Support
Finance and Accounting
All aspects of our company are now running through our ERP software. Having everyone work out of the same system and not have multiple programs that you have to jump back and forth through, has allowed us to get more done in less time.
One of the main benefits we’ve experienced using WorkWise ERP is being able to get meaningful information we can use, versus getting data that requires more work to get the answers you’re looking for. The data is integrated and streamlined for efficient use which keeps our fixed costs lower and allows us to invest our capital into building better products.
It doesn’t take all day to do our schedule anymore. Also, the Performance Management WorkBench lets us see what information we want to see, and what time we want to see it, in a nice visual way. Item Planning is also great. It’s so easy to look up specific information related to whatever we need to see.
American Metal Fab
What’s really nice is having everything in one package. My financials are in the same package as manufacturing and customer orders. Everything integrates seamlessly. Bringing in inventory management has been a huge benefit for us. Being able to jump between workbenches and different points of data has been really nice.
Chief Financial Officer
I would highly recommend WorkWise to other companies. It’s cost competitive, the Cloud ERP implementation has been great, the people have been great. WorkWise bends over backwards to help us. We feel that they’re on our side.
President and CEO
The Industrial Controls Company
WorkWise has been a true leader in our ability to drive process change and productivity enhancement, and to assist us in our lean capabilities.
I would definitely recommend WorkWise ERP to anyone looking to improve their manufacturing processes. We’ve been utilizing the software for 20 years and have never regretted our decision.
WorkWise spent a lot of time with us in order to understand our manufacturing process. We’re fairly unique, and there’s not that many companies in the world that do what we do. WorkWise really made us feel like they understood what we were doing and where we were going.
Business Process Improvement Director
The team at WorkWise is phenomenal. I highly recommend WorkWise ERP to any company looking to improve their processes, improve their efficiency, become more productive and work with a company who really gets to know them and understands what they’re going through.
IT Systems Specialist