Medical Device Business Transformation
Many cases, when the medical device organization suffers operational inefficiency, it’s not only because of excellence of products but also it is originated in the organizational issues. It can be based on the organizational structure, flow of process, and/or how the people interact each other. Similarly, how much the organization capitalizes efforts towards medical device business.
The Situation and Issues of Organization
A few years ago, a mid-size medical device company with decent revenue portfolio was suffering financial distress. The product lineups were outdated and product features don’t standout very well. They were desperate to release something that draws attention of customers, hoping to squeeze some revenue. However, the ideas that the senior management was pitching were not able to align with the employees recognition. The organization has lost its sense of unity and it’s coming down to the product quality and competitiveness in the market. The medical device business is highly cross-functional and this is detrimental to to the organization.
This company was experiencing multiple major issues. One of the most notable issues is that there is no PMO function in this organization and it is severely hindering productivity. Since there is no actual “project manager”, the team is not able to balance the priority and workload of their own. Because of this, no realistic program schedule is established. Consequently, the team members work independently rather than collaboratively. As a result, they are doing work as “a favor”. When you think about medical device business, the formation of organization is vital for success. The way of work affects the quality of products and services.
Secondly, this organization does not utilize any sort of business intelligence to process, manage, and track their work. Imagine the traffic without infrastructure. The flow of traffic is severely impeded and the accidents and collisions take place very often. The change request is handled manually and priority is determined by one’s preference. The employees really have to make an effort to process their urgent request.
Ignorance of Management
Furthermore, the management is not aware of these critical issues along with many other issues and all they do is to push employees to do work faster. Also, the redundant hierarchy of organization is slowing down the productivity. For instance, if a project member needs to process a document, she needs to go through multiple approvals of unnecessary managers and directors who could be meaninglessly stubborn to respond.
Missing KPIs Affecting Medical Device Business
Another major issue is that the organization does not have any KPI to track programs, projects, task assignment, and workload of employees. Therefore, only the direct supersedes intuitively know who’s working on what kind of tasks and projects. Similarly, the company does not utilize any business intelligence as well.
Our Approach
In order to address this issue, we worked with senior executives on thorough diagnostics of organization. The company needs a significant change on employees’ recognition towards work. Based on the human psychology, the people tend to perpetuate same behavior regardless of effectiveness of outcome. The goal is to improve the work-capitalization ratio of employees’ time and effort. We focused on these factors that fundamentally address the on going issues.
Absence of PMO: The assignment and training of portfolio manager and program manager were essential
Project Metrics: Evaluated project execution yield, quality and speed
Key performance indicators: discovered lack of KPIs and associated with project productivity metrics
Business Intelligence: The absence of business intelligence is causing delay of change request process
Bottleneck reduction: Pinpointed the multiple sources of bottlenecks
Our Recommendation
After unearthing these critical issues for status quo, we implemented several initiatives.
- Implemented PMO function without heavy organizational change. In this particular case, we kept light PMO structure to meet the time frame and faster transition.
- Incorporation of Project Management Principals: transferring the knowledge of PMBOK: Initiating, Planning, Executing, Monitoring & Controlling and Closing with FDA Design Controls
- Implemented PLM, which governs the revision control and speeds up the change request process
- Introduced Lean Six Sigma methodology 5S principal. Sort, Straighten, Shine, Standardize, and Sustain
- Eliminated major Mura (unevenness) to improve the resource utilization rate
Results
With Alectena’s clear change initiatives, this company swiftly improved the organizational efficiency. The work-capitalization ratio became much higher than before.
As a result, PMO now understands the project KPI and can tell the status of each project. The organization reduced the un-capitalized work of operation. The proper business intelligence reduced the workload of Document Control who was struggle to combat the series of backlogs. The employees reduced time for working on the revision control. They launched new product on time. The customer satisfaction has been improved. Not only the organization revived medical device business, but also it regained the accord of employees.
Kaizen for Medical Device Business
By deploying this short term to long term model, The organization was able to embrace the practice of Kaizen (continuous improvement) to achieve sustainable business model and improvements.