Few Steps to Integrate Medical Deviceby Derrick Corea Technosoft Innovations, Inc
Create an inter-functional group: product development includes many functions in your organization. At a minimum, the team must include representation of product development, marketing, operations, quality and regulation. An inter-functional team ensures that something important is not lost and helps generate acceptance throughout the organization.
Identify known obstacles: Ask the different functional members of the product development team where they encounter obstacles. Include support groups, extended team members and transfer groups.
Review your current process and procedures: the process and procedures are the heart of how you develop products. It is not unusual for the product development process to become "heavier" over time as things are added to the process because it is a convenient place to make sure things happen, whether or not they have something to do with the development of products. Go through the current process (what really happens) and the procedures. You can also compare with best practices.
Identify possible changes: based on comments and review of the process, identify the causes of the delay, things that do not add value and possible changes.
Prioritize changes: the team must prioritize the proposed changes. A simple grid, as shown in the figure below, is a tool to quickly organize the elements. Medical devices have an additional level of regulation that should be considered as part of the evaluation and prioritization of the proposed changes. Then, focus on the elements that are easy to make and have the greatest impact (upper right quadrant in the figure). (Note: You may want to include some of the “Hard to implement, high waste reduction” projects if there is significant value). Combine elements that are similar, if applicable. As a team, prioritize the proposed changes and assign owners. Determine the potential timeframe to begin (e.g., Immediate, next quarter, etc.)
7 Steps to Integrate Medical Device and Lean Product Development
Create the plan to implement: for each change that will begin in the short term, create a project schedule, with the necessary details for the size of the project. A 1-week project may only need a checklist, while a 1-year project probably needs a complete timeline.
Communicate and train the right people about the changes: while working on the changes, contact the affected organizations. Be sure to include why you are changing and the general process you are using, as well as what is changing. Like any change, affected users must be trained.
Note: collecting metrics before implementing changes is a good idea. However, you often know where the big problems are and spending a lot of time to collect detailed metrics can delay the start.
Examples of simple things to implement, which often have a low cost or minimal impact on written or controlled procedures.
Use email for business approvals: some companies require that all signatures be collected in person. That means that a large meeting or documents can be routed sequentially to collect signatures. For non-design control approvals, such as a door approval, you can define alternative forms of valid signatures. Impact: no cost, no new resources, can be small procedural changes.
Brief and frequent meetings of the project: delays in the project come from the lack of visibility of ongoing activities, where key tasks have run into obstacles and transfers have been lost. Communication is often relegated to weekly meetings, which means that if a problem occurs on a Monday and the meeting is Friday, everything has been delayed for a week. Frequent (often daily) project meetings, including visual workflow management [i], is one of the most effective ways to keep the project focused on keeping work moving and carrying it out. Impact: no cost, no new resources, no procedural changes.
Alternate document shipments: Instead of sending each new product document for review and approval as a large batch, stagger the document shipments over time. Documents can be reviewed as they enter, but they do not need to be published until everything is ready. This gives reviewers time to handle the volume. Impact: no cost, no new resources, no procedural changes.Create templates of requirements or libraries with a standardized wording: as a medical device company, you must define the design entries. Some of the entries are common in different products, but you recreate the content of each project, for example, biocompatibility. Work with the affected function to develop a standardized wording as a starting point for new projects. Impact: Cost limited by the time required to collect the entry and create the template, without new resources, possible change of procedure to refer to the template.
Created on Mar 12th 2020 06:23. Viewed 263 times.