By Michael S. Slocum

Systematic innovation is being applied to many industries with great results. Unique approaches are producing important resolutions and solving difficult problems. Two healthcare case studies address the wide fields of applicability for strategic and systematic innovation – the first focuses on problem solving for a biotech company and the second addresses emergency room delays in a hospital.

Contamination in a Biotech Company
A biotech company manufactures amino acids and other solutions for delivery to pharmaceutical companies, which use these inputs in larger drug-manufacturing operations. The problem for this biotech company was substantial contamination rates at the end of long-lead production batches, each of which was unrecoverable at a cost of $150,000 per batch.

The company performed several failure analyses, including a standard root cause analysis and corrective action procedure and the Kepner-Tregoe method, but no assignable causes were identified. The manufacturer then turned to the Theory of Inventive Problem Solving (TRIZ), specifically to its predictive nature within the structure of the classic plan-do-study-act quality framework:

Plan: Define the problem statement.
The company was growing amino acids in a multi-step reactor process for ultimate delivery to their pharmaceutical customers. Contaminates were frequently found in the batch at the end of the manufacturing process.

Do: Identify necessary and sufficient conditions for the mode of failure.
Using substance field modeling (SFM), several possible contamination “entry ports” were identified (e.g., valve pumps for adding amino acids, nutrients or stabilizers). Since the reactor system is closed (or controlled), these entry ports were determined to be the only possible pathway for contaminants to enter the system.

Study: Study the system to identify conditions present during failure and eliminate potential causes until mode is verified.
Each condition for contamination was evaluated during the processing of many amino acid batches. Only normal trace quantities of bacteria were identified – no introduction of assignable contamination was verified. But batches were still failing due to measured contamination levels at the end of the process.

With all the entry points in the closed system ruled out as contamination pathways, the company had no choice but to suppose that employees could be responsible for sabotaging the batches. Because their FDA-approved quality system and other failure detection methods did not reveal the cause of contamination, the company considered installing cameras to monitor employee behavior.

Prior to this, however, the cumulative effects of the system were analyzed using substance field modeling. This is a natural progression in TRIZ of first considering the additive (independent) dynamics of a system first, then considering the cumulative (interdependent) dynamics.

Act: Assign cause and create cause and corrective action.
In biological terms, the previous work pointed to the idea of a “bacterial quorum,” whereby trace contaminants from different parts of a system can combine and interact to create an overall contamination level that is greater than the sum of its parts. After further testing and evaluation using SFM, trace contaminants were discovered interacting to produce a quorum adequate enough to destabilize the batch.

Bacterial counts were taken before introduction for each component entry point and a continuous bacterial monitoring system was established in real-time for the entire process. After two or three low-bacteria count components were added, the bacterial level escalated rapidly to the point of failure. While each step of the process functioned without flaw, interaction inside the reactor was causing the failure. Corrective actions were tested and installed. The problem was solved.

Slow Emergency Room Triage
Visiting an emergency room (ER) can be highly stressful from the patient’s perspective. A single patient is rarely alone in an ER – others are there with their own injuries and illnesses. The hospital is obligated to see each and every one of them – even those who might end up referred out are seen and evaluated.

The process of checking patients into the ER is called triage and it exists for a number of reasons:

It determines the nature and severity of a injuries/illnesses as soon as possible after a patient’s arrival.
It determines the insurance status of patient and/or their abilities to pay.
It helps determine the order in which patients are treated, considering their needs and available resources.
A triage system for a major hospital network in the Boston area was analyzed. The network had determined triage problems and inefficiencies were compromising the quality of patient care, as well as one hospital’s ability to cost-effectively meet its own business needs. The front end of the triage process is typically bottlenecked by a lot of paperwork and fact checking – patient name and address, phone number, insurance card, emergency contacts, a description of injury/illness and other information. This Boston facility was not unlike others in that processing paperwork took time, while patients waited with their serious needs. Nevertheless, there is legal documentation that must occur – a connection with an insurance company has to be made. A hospital has to do what it has to do before treating a suffering patient.

Problems to Solve
Initially, this hospital felt it could improve patient wait time and also help itself by automating the patient sign-in and insurance-verification process. Doing so, managers thought, would make the process faster and more error-free. After implementing an automated system, the process did run faster – but errors were not improved. In the new automated system, initial data was only entered (and checked) once, whereas before it was checked multiple times by virtue of different people handling the same set of physical papers.

The hospital still had a problem on its hands. “Paperwork” errors still existed and patients still had to wait for medical triage. “We found out faster whose insurance pays for what, but many of our patients still had to wait in long queues,” said the ER director.

Solving a Technical Contradiction
There was a second problem to solve: patient waiting time. The system had a technical contradiction that could benefit from the use of TRIZ – triage needed to happen faster, but speeding up triage left a system full of errors. The improving feature this technical contradiction corresponded to TRIZ inventive parameter 39, productivity. The degrading feature of the contradiction corresponded to inventive parameter 27, reliability. Using the contradiction matrix, the meeting point of these two parameters led to the suggestion of the following inventive principles: 1, weight of a moving object; 35, parameter changes; 10, preliminary anti-action; and 38, strong oxidants. Principle number 35, parameter changes, led the project team to a solution.

The project team learned that parameter changes can mean changes in the flexibility of a system, material, part or person. While staff doctors and nurses have little flexibility in their schedules, interns do. They are available before and after their rounds to assist in the logistics of processing patients and to perform certain triage functions.

After a little bending and stretching of the intern’s schedule and commitments, a new triage process was installed that took a major step toward increased patient satisfaction. The formerly serial activities of administrative and medical triage were now simultaneous and patient wait times dropped. In addition, diagnostic reliability rose as a result of the intern’s involvement.

Conclusion
Systematic innovation methods and tools can lead to breakthrough innovations. But systematic innovation methods, such as TRIZ, can also lead to inventive solutions to problems – resulting in breakthrough, albeit incremental, progress.

About the Author:
Michael S. Slocum, Ph.D., is the principal and chief executive officer of The Inventioneering Company. Contact Michael S. Slocum at michael (at) inventioneeringco.com or visit http://www.inventioneeringco.com.