product innovation blog

7 Steps to Integrate Medical Device and Lean Product Development


In a previous blog, we covered why medical device companies often don’t use lean product development with their product development.  You’ve thought about it and made the decision to try using lean product development.  The objections from Quality and Regulatory are many.  You know there must be a way, but you just need some help getting started.

Below are some steps to get started implementing lean product development in your organization.  These steps are fairly generic to identify and structure any lean process improvement.  The goal is to identify and remove waste, so work (including product development) can flow through the organization

  1. Build a cross-functional group: Product development includes many functions in your organization. At a minimum, the team should include representation from product development, marketing, operations, quality, and regulatory.  A cross-functional team ensures you don’t miss something important and it helps build buy-in across the organization.
  2. Identify known roadblocks: Ask different functional product development team members where they run into roadblocks. Include support groups, extended team members, and handoff groups.
  3. Review your current process and procedures: The process and procedures are the heart of how you do product development. 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 anything to do with product development.  Walk through the current process (what actually happens) and the procedures.  You may also compare against best practices.
  4. Identify potential changes: Based on the input and review of the process, identify causes of delay, things that don’t add value, and potential changes.
  5. Prioritize the changes: The team should prioritize the proposed changes. A simple grid, as shown in the figure below, is a tool to quickly organize the items.  Medical devices have an additional level of regulation which must be considered as part of evaluating and prioritizing any proposed changes.  Next focus on the items that are easy to do and have the greatest impact (upper right quadrant in the figure).  (Note: You may wish to include some of the “Hard to implement, High waste reduction” projects if there is significant value.)  Combine items that are similar, if appropriate.  As a team, prioritize the proposed changes and assign owners.  Determine potential timeframe to start (e.g., immediate, next quarter, etc.)

7 Steps to Integrate Medical Device and Lean Product Development

  1. Build the plan to implement: For each change which is to start near term, build a project schedule, with the detail needed for the size of the project. A 1 week project may only need a checklist, while a 1 year project probably needs a full timeline.
  2. Communicate and train the right people on the changes: As you work on the changes, communicate to 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, the affected users need to be trained.

Note: Collecting metrics prior to implementing changes is a good idea.  However, often you know where the big problems are and spending a lot of time to collect detailed metrics may delay getting started.

Examples of simple things to implement, which are often of low cost or minimal impact to written or controlled procedures.

  • Use email for business approvals: Some companies require all signatures to be collected in person. That means a big meeting or documents may route sequentially to collect the signatures.  For non-design control approvals, such as a gate approval, you can define alternate forms of valid signatures.  Impact: No cost, no new resources, may be small procedural changes.
  • Frequent, short project meetings: Project delays come from a lack of visibility to what activities are in process, where key tasks have run into roadblocks, and missed handoffs. Communication is often relegated to weekly meetings, which means if a problem occurs on a Monday and the meeting is on Friday, everything has been delayed a week.  Frequent (often daily) short project meetings, including visual workflow management[i], is one of the most effective ways to keep the project focused on keeping work moving and getting the project done.  Impact: No cost, no new resources, no procedure changes.
  • Stagger document submissions: Rather than submit every new product document for review and approval as a large batch, stagger the document submissions over time. The documents can be reviewed as they come in, but they don’t need to be released until everything is ready.  This gives the reviewers time to handle the volume.  Impact: No cost, no new resources, no procedure changes.
  • Build requirements templates or libraries with standardized wording: As a medical device company, you need to define the design inputs. Some of the inputs are common across different products, but you recreate the content for every project, for example biocompatibility.  Work with the affected function to develop standardized wording as the starting point for new projects.  Impact: Limited cost for the time to collect the input and build the template, no new resources, potential procedure change to reference the template.

There are often many things you can do to make changes that minimize waste in the process.  However, you may find it valuable to bring in outside help to drive the process and ensure the focus necessary to drive the changes in the organization.  Internally driven changes may take longer than desired due to other competing internal priorities.

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i.  Mascitelli, Ronald. “Visual Project Management.” Mastering Lean Product Development: A Practical, Event-Driven Process for Maximizing Speed, Profits, and Quality. Northridge: Technology Perspectives, 2011. 82-112. Print

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