Since most manufacturers do not staff experts in every area of technology they may need to create a finished medical device, collaborating with professionals who are can be the ideal formula for success. This article examines Total System Design Collaboration, a design method that promotes this approach when designing a new product.

By Chris Oleksy

Collaboration at the design stage with experts in the various technologies incorporated into a medical device can make the difference between an average product launch and an exceptional one.
At a Glance
  • Collaboration is key
  • Defining the method
  • Understanding the system
  • Real world example

  • In today’s healthcare environment, there has never been a more important time than now to invent and launch new technologies. As the baby boomers head into retirement, there will be an unprecedented need for the most effective therapies being delivered via innovative technologies. In addition, the volume of treatments needed for this population will test the responsiveness of our healthcare system like never before, requiring not only new therapies and more precise technologies, but delivery mechanisms that help health care professionals to quickly and easily diagnose and provide treatment.

    Convergence of differing, but supportive, technologies and disciplines is becoming the norm. As an example, major medical device providers are seeing a need to link biotechnology with information technology. An example of this is a closed loop, glucose monitoring and treatment system for diabetes patients. In this example, implanted sensors determine the need for insulin and communicate that to the delivery device, such as an insulin pump. Another example is telemetry used in conjunction with heart pacing devices to allow remote monitoring of patients with heart disease. The healthcare provider gathers information about the patient and data from the device from remote locations and adjusts the device/treatment accordingly.

    We are all familiar with the saying “the right hand needs to know what the left hand is doing.” The previous examples could not possibly achieve their results without very close integration of these technologies. Furthermore, the ‘total system’ is getting more and more complex. The system may require pharmacology, delivered via a disposable device, and being driven by an electronic box of some type. The three components of this total system will all need to work as one cohesive delivery mechanism. Another common example is where an electronic device drives the utilization of a single-use disposable device.

    In order to respond to the future of converging technologies, an era of design collaboration is required like never before. This collaboration is very difficult for many providers to adjust to. Some original equipment manufacturers (OEM) have taken steps to vertically integrate their organizations over the years. The investment needed to vertically integrate the capabilities needed across the total system continuum is cost-prohibitive; this is especially true in a healthcare environment that is becoming very cost-sensitive. Acquiring staff with expertise in everything from Bluetooth technology to sensors to pharmacology is no small undertaking. Because of this, OEMs often make due with what they have and the result is a sub-optimum solution.

    Total System Design Collaboration (TSDC) is an approach that will become commonplace in the medical device industry. The key will be to understand where your organization’s or your personal skill sets are best used within this impending method of providing services to the healthcare industry and utilizing those skill strengths properly.
    Configure . . . Then Manage
    TSDC is a mindset change for many organizations and individuals within those organizations. All solutions begin by determining an outcome configuration and then managing it properly. As mentioned previously, this will be difficult for some organizations. They generally error and switch these around. In other words, they manage a configuration of internal resources only, and fail to utilize world-class capabilities existing in other organizations within the industry. Or, they only fund projects their internal teams can take on due to resource constraints. A better approach is to leverage internal resources to manage external collaborations, which could result in a dramatic throughput increase in project completions. Everything from the creation of the intellectual property (IP) to the manufacturing of the products needs to be configured.

    TSDC begins with recognizing that the product being designed is part of a treatment “system.” Upon understanding that system, the proper configuration can be put into place. For example, an organization has a new disposable device IP for the treatment of tumors. It is an extension of technology already provided by the same company’s current device. This device delivers a pharmaceutical directly to the location of an isolated tumor. The device is connected directly to an electronic box commonly utilized in an operating room. This device is similar to previous devices that the organization has delivered before and therefore, there is synergy in utilizing the same components. In fact, the manufacturing organization in-house can utilize secondary operations to fill the disposable with the pharmaceutical. Therefore, the product is internally designed and delivered similarly to those the organization has delivered previously. The product sells 10,000 units per year and management is actually quite pleased. However, research showed that the market penetration could have been as much as 40,000 units per year, leaving the project team puzzled.

    They begin to look into why the product has not performed better. During market penetration research, it is discovered that a competitor is launching a breakthrough therapy/technology. They configured a Total System Design Collaboration of a world class pharmaceutical company + world class global electronics provider + world class disposable manufacturer + world class freight company and created a breakthrough treatment system. A system that is wireless; opens up the market to treat patients in out-patient clinics, instead of operating rooms; the disposable device was automated to include the pharmaceutical in-line at the manufacturer of the disposable; is shipped anywhere in the U.S. within 24 hours resulting in the end customer not having to carry any inventory or worry about obsolescence; and due to collaborative synergies, is 25% cheaper than this organization’s device. In addition, due to its use in outpatient clinics, not operating rooms, it appears that the market penetration will exceed 100,000. There is little doubt who “won” in this competitive challenge.
    It is imperative that when designing a new device, the total system is considered to see where a TSDC can be configured. Examples of collaborations within the healthcare world are evolving daily. The results are powerful. The experience base comprised of the companies within this example is exponential due to the wealth of knowledge they can draw upon within the industries they represent. While the example illustrated in this article is fictitious, the outcomes seen with regard to this type of problem are factual. Medical device manufacturers must challenge themselves with regard to what they are doing to become a leading class embracer of collaborative execution and the Total System Design Collaboration mentality.
    For additional information on the technologies and products discussed in this article, visit ATEK Medical Manufacturing at

    Chris Oleksy is president of ATEK Medical Manufacturing, 620 Watson St. SW, Grand Rapids, MI 49504. The company, headquartered in Minneapolis, specializes in Total System Design Collaboration and is an outsourcing partner for the medical device and biotechnology industry, offering product design, product launch, production, packaging, labeling, microbiology services, sterilization management, distribution, supply chain services, and overall project management services. Oleksy can be reached at 763-392-5882 or