Cost, quality, regulatory challenges, safety and usability were the major near-term challenges identified in a recent survey of more than 300 engineers and business managers who work for life science instrument makers and users. Although engineers tended to have different priorities than managers, both groups identified many of the same challenges they face on a daily basis:
- The trend toward smaller reimbursements to the laboratory makes the need to reduce costs the number-one challenge. Cost pressure is forcing cost reductions down to the OEM and the component suppliers. Users are looking at the cost model from per-test and floor-space-per-test perspectives, while OEMs are looking at their bill of material and engineering costs. Many respondents pointed to the concept of total cost of ownership as the critical measure, with a relatively even split looking at it through the eyes of the end user in terms of instrument performance compared to looking at the internal costs of the instrument.
- Quality and regulatory challenges highlight the need for “bullet-proof” and “robust” designs, with much discussion about the move away from strictly internal quality measurements like returned parts per million (RPPM) or mean time between failure (MTBF) and looking at more end-user-centric measurements like laboratory uptime. MTBF was seen as a “killer variable.”
- Instrument safety and usability are related to the increase in instrument complexity and difficulty among laboratories that don’t have engineers or maintenance staff to deal with downtime or troubleshooting. With advances in cellular research, multiple instruments are being configured together, with lab robots taking care of loading and unloading. This change makes user safety paramount, whether achieved through the use of collaborative robots or simply with machine guarding. Sample safety is another aspect of user safety, and here again, guarding and closed-loop control are needed to keep users safe from in-process samples and to protect samples from possible user interference or tampering.
- Accuracy also weighs heavily on the quality scale, requiring new levels of performance for motion control systems. Trends toward new technologies like DNA sequencing, digital pathology, cell inspection and manipulation, and molecular diagnostics require precision and repeatability outside of the normal liquid handling or robotic handling applications—thanks primarily to smaller sample sizes.
- Lack of engineering manpower and training is forcing many instrument makers to find ways to do more with fewer people. Since the recession of 2008–2009, staffs have been kept relatively trim, causing teams to extend project timeliness, outsource design elements, or find subsystem level suppliers that can provide more completely engineered system solutions. More complex, automated instruments are being introduced into laboratory settings where the staff does not have the expertise or bandwidth to troubleshoot. This makes good user training more difficult and therefore less likely.
- Regulatory concerns ranged from the trend away from releasing instruments outside the United States to synchronizing the instrument revenue stream with gaining FDA approvals.
Read our earlier blog, which looked at the emerging technologies in Life Sciences identified by survey respondents.
Watch for our next blog, which will look at the key “takeways” from our survey and subsequent interviews.
Article contributed by Brian Handerhan, Business Development Manager for Electromechanical Division North America, Automation Group, Parker Hannifin Corporation.