How to Implement Automation in Medical Device Manufacturing

In the medical device manufacturing industry, the prospect of diving into an automation project can be daunting, to say the least. Regulatory requirements, technical details, revalidation batteries and fluid market conditions can give pause. Still, with a little preparation and organization, the benefits of an investment in automation can quickly outshine all hurdles. To help manufacturers reach these ends, we’ve put together the below steps on how to approach and execute automation projects for assured success (a statement we can make because it’s our business).

Define the Need 

Can you refine the pain point being experienced into a concise problem statement? If so, write that out as the guiding basis to work from. A good problem statement provides the “what,” “when” and “why” of the situation. A statement could be: We need to increase weld reliability (what) in our medical device manufacturing line right away (when) in order to cut the high cost of reject parts (why).

Formulate Expectations

For medical device manufacturing (and other regulated industries), this step takes two forms.  

First, you’ll need to define the technical objectives of the project. Including those might change the above statement to: We need to increase weld success rate from 80 to 95 percent, performed on four product profiles using ABS materials at a speed of 20 units per hour. 

Second, you’ll need to define regulatory expectations specific to your industry and application, such as: This upgrade must support our ISO 13485 medical device manufacturing scheme, producing FDA Class III products.

Establish Project Constraints  

To help provide context to the above objectives, we now add more details that serve as constraints or caps on the project. Power specifications, size limitations, device standards, schedule, budget and any other elements that are hard-and-fast limitations on the solution being pursued must be captured in this step.

Seek Market Solutions 

With the challenge, objectives and constraints clearly in mind, you can now turn to external solution providers to seek out a concept and a proposal for solving the need. Of course, we know that often this step may occur in tandem with the above steps, as you might draw on the experience of automation partners to frame the problem, scope and budget to begin with. This is perfectly reasonable, so long as the goal at the proposal stage is still having all of the above points clearly defined and documented (as they need to be captured on scope documents in later steps, cutting risk and bolstering outcomes).

Contract for the Selected Solution 

Once you receive potential solutions from automation partners, take your time comparing, leveling and critiquing each offering. Examine qualifications, references, experience, support, warranty and all other commercial factors that are important to your business. Select a solution and proceed to contract, making sure to document all of the above expectations and requirements into the contract itself. Set clear delivery and performance details, and also make sure all administrative elements are covered (such as sales tax, shipping costs, confidentiality and insurance).

Set Approval Milestones 

Successful projects utilize a very deliberate milestone sequence for approvals, all designed to make sure that a “point of no return” is never passed without your informed agreement. Common milestones include:

• Kickoff, where expectations are locked in at the time of project award. 
• Proof of concept, which includes initial feasibility testing and production to confirm initial concept. 
• 30 percent engineering; an approval step for general fit, form and function of the solution (such as overall size, shape, major component selections and materials of construction). Long lead items are usually ordered at this stage to hold overall schedule.
• 100 percent engineering; an approval step for final design, where all material and components procurement is released and fabrication documents are generated.  This step also produces field-installation requirements that the customer can use internally to start planning the changes needed in their operation. 
• Shop fabrication. Upon completion of fabrication, the customer should visit the fabrication shop and observe testing, debugging and mock production runs, assuring that the solution meets their needs before bringing onsite.

Field Installation 

With the solution assembled and tested, next it’s shipped to the site and installed. This step will be intrusive into your existing operation, so ample planning to accommodate the disruption is needed. A savvy partner experienced with automation in medical solutions will assist in this process on both sides of the table, presenting a detailed plan for installation as well as offering insight into how your operation can best work around the installation work. Pre-building stock, engaging co-pack manufacturing and temporary conversion of other lines to make up production rates are all common options taken.  

Further, the integrity of all critical infrastructure and facility systems must be assured throughout installation. This includes proper protection of sterile utilities, hygienic air handling systems and overall cleanroom classifications. Upon completion of installation, services and areas may need decontamination and revalidation.

Startup and Testing 

After deploying your new automated solution, complete and extensive testing, commissioning and validation must occur. In this step, the overriding goal is to assure that all project controls established at the beginning of the project (and as written into the contract documents) are fully met. For medical devices especially, this should be a very well-documented process, resulting in clear and verifiable paperwork that satisfies performance, compliance, regulatory and financial interests. Handover from the automation provider to the customer occurs in this step as well, including full training on operation and maintenance on all involved systems. Often, a third-party validation company is involved, supervising and confirming all details from a neutral perspective.

Followup 

With the new automated solution up and running, the project is not yet complete.  Followup services should be split between the automation partner and the client, together assuring that all equipment is running within original guidelines, that no budding issues are looming resulting from mis-operation or incorrect maintenance, and that generally the wear-in period is progressing within expectations. Refresher training and coaching for staff is often covered in this step as well, assuring that both equipment operation and regulatory compliance elements are all still up to par.

Questions About Automation in Medical Device Manufacturing?
Launching a major automation project in the medical device manufacturing industry is no small order, but with a clear plan, ample communication and the right partners, the benefits will always outweigh the difficulty. We hope that the above suggestions in formulating an automation project plan are useful. As always, we are happy to provide more information upon request.