First and foremost, thank you to all ICE magazine readers for joining us as we chat. The theme of this column will focus on Bill H.R. 2118 Medical Device Servicing Safety and Accountability Act. What is the significance of this proposed legislation? The time of mandated registration with the FDA is now coming upon the independent or alternative service provider (ISO) industry sector. This tide of change has been building for many years and is now ready to come crashing on shore. Its benefits will be many and will drive a new era of healthy competition in both the OEM and ISO service market sectors.

As we “Bridge the Gap” in this edition, we have two very experienced and seasoned professionals. Clinical Radiology Administrative Leader Dina Loughlin and In-House Radiology Engineer Specialist Jack Minter join in a discussion around the theme of ISO and OEM options.

When health care clinical leaders, in their decision process regarding imaging equipment service support, consider options it can be an overwhelming preference toward the original equipment manufacturer (OEM). It is a natural polarization and safe direction for any clinical leader to choose. Is it always the most prudent and financially sound pathway to follow? That is generally where the debate begins. In posing this question to Loughlin, she shared that the main reason for this preference by most clinical imaging leaders is tied to confidence. OEMs are grown and supported organically from the vast research and development resources they possess from the creation and maintenance of products. Training, technical support and escalation processes are a few of the OEM tools available to OEM field engineers in supporting the manufacturer’s product. Minter echoed her comments adding that this is especially true with the “latest and greatest” of imaging technologies that come to market. ISOs and in-house support service capabilities are generally limited because of the “newness” of the technology. He also pointed out that OEMs are reluctant to train ISOs because they view them as competition. Training by the OEMs to in-house teams follows that same suit at least in the first and sometimes second years of a new technology coming to market.

The conversation points and comments from both Loughlin and Minter changed dramatically around clinical confidence when older imaging systems or “legacy equipment” came into play. They concurred that in the “legacy technology” area ISOs and in-house do tend to be an equal, and many times a better, alternative service resource to directly servicing through the OEM. Minter shared the reasoning that skill sets within the OEM workforce can be more focused on the “new product” technologies entering the field. He stated that in most hospital and imaging center settings it is more common to have 5, 10 and 15-year-old imaging technologies deployed in the clinical setting. These older technologies many times are sun-set internally with the OEM, in turn, no longer training staff or the legacy trained engineers are no longer employed with the OEM. Minter also points out that many times these “seasoned” engineers leave the OEM to join ISOs or in-house teams bringing with them a wealth of knowledge and experience regarding legacy technologies. Loughlin said ISOs and in-house teams bring a dynamic the OEMs generally cannot in an ability to provide service across all imaging modality lines including different manufacturers. She says that ability puts the ISO and in-house service model in a top-pole position compared to the OEM’s siloed engineer approach limiting crossover.

This tide of change has been building for many years and is now ready to come crashing on shore. Its benefits will be many and will drive a new era of healthy competition in both the OEM and ISO service market sectors.

When the conversation came around to imaging service training, basic and advanced principle courses through an ISO were deemed an acceptable education path that provides a good foundation in developing service staff. Equipment specific service training was a different story. They expressed an opinion that the OEM is a better resource in this area. ISOs can and do service train in this space, but can be limited as it relates to curriculum, training staff and access to equipment technologies for hands-on laboratory sessions.

Much can be gleaned from the diversity of offerings and options available when sizing up the question, “What is the desired and preferred service support resource?” Along this forked road is an OEM and a ISO/in-house pathway. Each brings varied value propositions and opportunities as well as levels of risk – navigate wisely!