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Benny Shaviv

FDA Compliance

On-Demand Compliance Software Helps Small Medical Device Makers Compete

Subscription-based quality management and compliance software levels the playing field.

Published: Thursday, December 3, 2009 - 06:30

The rapid pace of technological advancement in the last decade has introduced both significant benefits as well as significant challenges to medical device makers. Companies these days are faced with demands of bringing products to market faster and faster, not only to meet sales and market demands, but also to ensure they are not outpaced by the fierce competition. In the not-so-distant past, competition was limited to companies that were within reach (at least figuratively speaking), or to advancements made by the top companies. Today’s competition is global and medical device makers face competition from upstarts around the globe, as well as large companies that have vast resources at their disposal. Any Minneapolis company could very easily discover that it was just outpaced by a competitor from Denver, Barcelona, or Taipei. In fact, it could discover overnight that the very same Taipei company was just acquired by a very big neighbor from Minneapolis, and now it has a giant sales team pushing its technologically advanced product. Scary thought.

To makes things even tougher, no matter what type of medical device our small Minneapolis company builds, the quality cannot be compromised. This is not just another teenage gadget; this device is responsible for people’s quality of life, or life itself. To ensure that quality remains top notch, compliance standards must be maintained and proven. In effect, this also can limit a company’s ability to move and react quickly.

Small- and medium-size medical device makers are constrained by these challenges and by the fact that they often are contradictory. Getting to market fast requires planning, flexibility, and the ability to react rapidly in the face of newly discovered challenges. Maintaining quality, on the other hand, requires adherence to strict rules and proper management of records. It is traditionally a process that although very beneficial to the company, could be time-consuming if improperly managed. Adding to the difficulty, small and medium-size companies do not have the same access to resources that can be afforded by the large players. The top companies have budgets that allow them to obtain state-of-the-art computer and data systems that help them build a well-oiled machine.

In order to remain competitive, small and medium-size businesses (SMBs) must maintain their technological advantage, both in the product itself and in the internal business processes—allowing them to react fast and stay ahead of the pack. However, SMBs could not traditionally afford a well-oiled machine that gives them that flexibility. Quality management and product life-cycle systems are traditionally expensive, cumbersome to implement, and require extensive training. The end result is that many SMBs implement separate data silos or makeshift solutions to solve niche problems.

We are entering an era where advancement of technology combined with the maturity of organizational mind set will enable SMBs to compete with the big boys—and win. With today’s technology, applications are coming to market that provide small- and medium-size medical device makers with a wide spectrum of capabilities, combined with amazing ease of use, and very affordable prices.

So what has changed recently that is making this a reality? The answer is technology and mind set. To start off, the delivery of on-demand software-as-a-service (SaaS) or cloud-based applications, has become a de facto standard in many application types, and a competitive advantage to its consumers. It’s fast, it’s cheap, and it’s secure. The most exciting part about on-demand applications is that they are becoming very specialized. For instance, there are on-demand quality management systems built specifically for small- and medium-size medical device makers.

Another technological advancement—rich internet applications—are now coming of age. This means that new applications coming to market are flashier, jazzier, and most of all, easier to use. This is not your father’s internet application with only the left mouse button enabled to click a hyperlink; these applications are interactive and rich. The software, if properly constructed, can practically guide the novice user through complex tasks, ensuring proper completion, and much less human errors. This translates into a drastic reduction in training costs and user mistakes.

When it comes to organizational mind set, companies today understand the urgent need to move fast and stay compliant, and it is becoming clear that the only way to move fast, react fast, and win is to stay ahead of the pack in both technology and internal processes and procedures. Systems that enable flexibility and provide value to users are now welcomed inside all companies.

Imagine a case where a small company has a system that provides it with full visibility of not only its quality and compliance status, but also its development processes. In the same system, a company can ensure that it does not get any warning letters, and also gains visibility into its development process. All of this is delivered in an on-demand model, with an application that requires very little investment to get started, and very little organizational training. This translates into the ability to move fast and to have immediate results rather than implementing expensive cumbersome systems—something which small and medium-size companies typically shy away from.

PLMplus, a startup, is developing such a system. The founders say that the idea is to provide a system that not only helps ensure quality and compliance to the Food and Drug Administration’s 21 CFR Part 820 rules, but can also provide true visibility into the product development process and the flexibility to move fast. It is a rich internet application that was designed to be simple—meaning that users require very little training and human errors are kept to a minimum—packaged into a monthly subscription price tag to make the financial decision easy as well.

PLMplus worked with a group of medical device makers to design and build their product. All of the organizations were concerned with quality, but many of them were managing their quality processes in a set of separated systems, or no system at all. Data was spread in different file directories, Excel sheets, documentation databases, and e-mails. The design process on the other hand was being managed in a set of engineering tools and their associated data management systems, or in file folders. Change processes were practically manual (or Excel files that floated around via e-mail).

The result of managing the process in this manner was that each organization had to have their people dedicating a large portion of their time organizing documentation to maintain and prove compliance; and the ironic part is that management of the design control process, from a quality perspective, was actually disconnected from the actual design. The way these customers operate is that to ensure quality and compliance, there are a lot of manual changes and checks all of which are managed in different data silos. Office documents usually reside in file folders or some document management system, product bills of materials were in Excel, processes were in many cases actually conducted in e-mails, and collecting documentation and transactions from all of these was a long and laborious process.

Worse, when the companies needed to move fast and make product changes, the engineering team came into play, with the design changes being relayed to the quality department via e-mails, attached documents, and meetings. It was ad-hoc and very difficult to either track or predict. In many cases, the company management relied entirely on status updates from department managers to gain real visibility into what was going on in development or in quality—quite the opposite situation from the sales department where management uses customer relationship management software to see real-time status.

The PLMplus value proposal to their design customers was to take an encompassing approach to the process. Use a single validated system for quality management and product life-cycle management. The system comes with capabilities and embedded processes for handling design control, corrective and preventive action (CAPA) management, nonconformance, internal audits, change control, and more, but also for development and engineering-related product life-cycle management. This means that the system manages the product bill of material and all its related documents and processes; and the entire team uses it to get true visibility into development and quality control.

Here is a case study that many design customers identified with: A maker of an ambulatory resuscitation device goes through an engineering product change, where improvements are added to the product. The change calls for a redesign of the product body, which is performed by engineering. Changes to the product structure are conducted in the system, with updates to the relevant sections in the system’s view of the product bill of material. Before the change actually occurs, change requests are created and routed to all relevant parties in the online system, each person receiving a task list associated to their role in the workflow. The proper documents are attached to the workflow, and upon change approval, all the right document versions, bill-of-material changes, and any other updates are reflected in the system and visible to everyone. All the actions are automatically tracked by the system, and from a quality perspective, the design actions are an “embedded” part of the design control process. The quality department has real-time visibility of all changes that occur and whether or not quality and compliance demands are met. At the same time, the system also tracks all the other quality related processes (whether they are product related or not) such as CAPA and nonconformance, and it can associate between them; and if they are product related, they are associated back to the relevant product.

This also extends beyond the company wall; any company supplier can participate in the process. The suppliers also have access to the web-delivered system, with the proper role permissions enabled. This means that suppliers can physically participate and take part in the engineering change order process. The system also maintains supplier quality information. In addition, internal audits are maintained in the system, including those related to the suppliers and vendors.

What’s better, company management is provided with development and quality forecasting and analytics dashboards. Since everything happens in the same system, the system is able to provide top management (and everyone else for that matter) with measurements that assist in forecasting their development. For example: the number of change orders still pending, average completion time for change orders last month compared to this month (are we getting better or worse?), bottleneck identification (where are the workflows getting stuck and why?), a list of quality checks that are still outstanding, open CAPAs and nonconformance reports, etc. With this data, management is now able to start predicting how much work it will really take to conduct each change and translate that into a cost/benefit calculation. Department heads are able to see outstanding issues and to handle them immediately, without having to wait for all the information to flow upstream via status meetings. The end result is a company that can be more compliant with less work, and much more flexible. This means taking less risk and moving faster.

Is the age of small and medium-size companies coming back? Can a 50-person company kick the big boys right in the assets? Well, there certainly are a lot of fantastic small companies out there with amazing ideas and technologies, but with strapped resources. At least from their product development perspective, it seems that technology is coming of age and now enabling them to get an advantage. Now both large and small companies have access to systems which are “well-oiled machines,” but the smaller company has fewer internal hoops to jump through and can actually move faster. The technology and on-demand wave is having an impact on everyone, and PLMplus is one provider that is looking to provide small and medium-size companies with a very attractive proposition to ride this wave. The playing field is not fair and the sizes of the research and development armies that the companies employ are not nearly of the same size. However, with a good team and with technology that enables it to move faster and maintain compliance with a lot less work, small companies have an edge that can be turned into an equalizing advantage.


About The Author

Benny Shaviv’s default image

Benny Shaviv

Benny Shaviv is the co-founder of PLMplus, an on-demand subscription based product life-cycle and quality management solution. Prior to co-founding the company, Shaviv spent nearly 20 years providing data management solutions to customers in the manufacturing and software industry.

He has a bachelors and masters degree in computer science.
PLMplus is in currently in private beta and is inviting qualified member to join, more information is available on www.plmplus.com


Hi, Good information about

Hi, Good information about the compliance. Since the market is very competitive & every manufacturer has to follow some rules. So this software will be required. But you should have some compliance related information or knowledge as well.....so more information on compliance just check this website