Instrument Development Trends Among IVD & Life Science Manufacturers

Recent industry discussions have pointed to increased utilization of agile methodologies for in vitro diagnostics (IVD) instrument development, with a number of IVD product developers indicating that they were in the early stages of transitioning from traditional product development methods to more of an agile approach. However, there had not been a formalized study exploring the degree to which this was the case.

Having adopted agile methodologies for IVD instrument development projects and seeing positive results, Invetech was interested in assessing the degree to which the IVD industry as a whole has begun to embrace agile beyond the software team.

Working with Hanover Research, a global research and analytics firm, a blinded survey was administered to diagnostics and life science instrument developers to investigate the adoption and usage of agile methodologies at these companies, as well as some of the associated challenges and benefits. The survey was distributed by the American Association for Clinical Chemistry (AACC), generating a total of 90 qualified industry responses.

Below is an executive summary of the key findings from the survey to serve as a reference for IVD manufacturers to benchmark agile adoption.

Download the full benchmarking report for a compilation of all the survey findings.

Agile is gradually making inroads in IVD

Though more than a third of respondents (37 percent) reported using more traditional sequential development approaches for instrument development (e.g., stage-gate or waterfall methods), agile is making inroads with 40 percent of the survey participants using iterative development approaches (e.g., agile, speed design review (SDR) or concurrent engineering) either exclusively or in some hybrid form along with sequential development. Hybrid development processes (22 percent) slightly exceeded dedicated use (18 percent) of agile processes.

Interestingly, 19 percent of the survey participants reported currently having no formal process for product development, while four percent cited using other methodologies.

Agile methodologies being utilized

Rapid prototyping and customer-centered design were the two most commonly reported agile practices adopted, noted by 54 percent and 50 percent of respondents currently using agile, respectively. Visual management and short development cycles were also reported as being utilized, each cited by 38 percent of those agile users. Co-location of all team members had only been incorporated as part of agile methodology adoption by 31 percent of participants currently using agile.

Benefits of agile adoption for IVD

The top benefits reported among respondents using agile included: increased project transparency and visibility for management and within the team, improved team collaboration and communication, increased ability to manage changing priorities, and improved team productivity. Those benefits were mostly aligned with the anticipated benefits for those considering agile adoption with the exception of improved product quality. Given the length of IVD product development cycles and that the adoption of agile was cited as a fairly recent initiative for most respondents (50 percent reported using agile for less than two years), more time may be required for realization of this particular benefit.

Key success factors in agile introduction

Ensuring Stakeholder InclusionBy far the most significant contributing factor in successful agile adoption was ensuring stakeholder inclusion from the very start of the process, cited by 54 percent of respondents currently using agile methods. The second most frequently cited key success factor was co-locating team members (31 percent). Identifying a leader, using visual management, and starting with smaller projects were also noted as contributing to agile success, each cited by 19 percent.

Overcoming barriers to adoption

Of the respondents having gone through the transition and currently using agile methods, general organizational resistance to change (38 percent) and lack of internal agile expertise (35 percent) were the two most frequently cited barriers to overcome. Those same barriers were also among the top reasons cited by those not considering an alternative instrument development process at this time.

Measuring agile success for IVD

On-time delivery (58 percent) and product quality (54 percent) were the two most frequently cited metrics used by respondents to measure the success of instrument development programs using agile methodologies. Team productivity and business value were also considered important success metrics, each cited by 35 percent of survey participants.