When you just need to have someone on standby for questions that come up, to be a subject matter expert for your engineering team to call, to shepherd small projects that need more focused attention to a finish line, and the list goes on...the advisory assistance is perfect. Offered in hourly segments or as a retainer, this option resolves tight resourcing constraints to move things forward.

You may not think you need it, but you will probably thank me after participating. A valuable tutorial about aligning your understanding with the Medical Device (and other life sciences) Industry. Take this general tour through general expectations and what sets this industry apart. Learn subtleties on how to be successful in it. People using the same words but they mean different things to each person - how could that be confusing? The actual cost of doing business in this industry - how does management or engineering or purchasing or whoever uncover it all? How costly are failures in this industry? All these topics and more are covered in this topic.

Risk management is an objective way to make decisions. It involves how severe some type of harm could be to the user, it involves probability of that harm occurring, and it involves determining when those probable harms need action. Let your engineers, purchasing agents, managers, and technicians use their critical thinking skills to find solutions, and let risk drive decisions on when things are acceptable, unacceptable, needing action, or needing monitored attention. Remove the debates on when work is required, and move into the objective world of risk. Drive decisions in design, development, process, supplier management, CAPAs, non-conforming material, complaints, testing, etc. with risk. In-person assistance is available (in-office or remote).

Whether developing products with outside vendors or trying to manage those products after they enter the market, you need a strong strategy for managing suppliers. Upstream work may include writing user or product specifications, communication (verbal or written) to ensure critical features of the product are not compromised, qualifying those products, components, or sub-components, and ensuring requirements for products are met while the process to manufacture them is being developed. Downstream work may include delivery times, quality of the product being delivered, non-conformances from the supplier and how to address them, changes at the supplier that may require additional work, and continued effective communication. What about purchasing controls? In person assistance is available (in-office or remote).

If change happens, it must be assessed and addressed to ensure product has not changed, safety is not compromised, and the product is still effective. The change could come from suppliers, internal business systems, regulatory agencies, expected or unexpected changes in the manufacturing process, trade wars, etc. But, the product must be the top priority. Making sure the change is invisible to the customer is even more important. Make sure the change management system is robust enough to catch, assess, and potentially re-qualify the change. It need not create contention. It need not cause delays throughout the organization. However, a poor change management system could do just that. In-person assistance is available (in-office or remote).

In the medical device industry, design controls have a very specific meaning. Very specific things are required, but how can they be kept orderly and moving? Design input, requirements, risk management, design output (including specifications, design verification and design validation), design reviews, and design phases just to name some of the work that goes into this process. In-person assistance is available (in-office or remote).

There are many acceptable ways to perform design and development planning. Accommodating large and small projects, pre-launch and post-market continuous improvement projects, high risk and low risk projects, software in a medical device and software as a medical device projects may be important to your organization and culture. Flexibility, scalability, and an attention to detail to ensure all plans and requirements are completed is key. In person assistance is available (in-office or remote).

Ensuring that the manufacturing process stays in control of the organization is key. From product specifications, to supplier controls, to validations, to inspections, to calibration and maintenance, to documentation, and beyond, it is all important. In-person assistance is available (in-office or remote).

Gather input about user needs or problems from various sources, and away we go generating ideas. When do we know that the product idea is good enough and we should start getting it qualified for market use? The answer is it meets the requirement(s) gathered from the design input. But, without the requirements being objective, measurable, and prioritized for trade-offs, the iterative process of freezing the design can go on for far too long. Important safety features in the design can get missed. Overlooking shifting customer desires can go undetected. Thus, generating strong requirements early in the process is fundamental and can be achieved, collated, and traceable. Make life easier with good transformations from general design inputs to requirements so critical thinking and creative juices are not wasted re-doing work. In addition, be careful to avoid calling a "design output" an input so as to make sure proper verification and validation can be completed in as timely a fashion as possible. In-person assistance is available (in-office or remote).

The design output is the actual product along with all the objective evidence in the form of drawings/specifications, design testing, product labeling, product marketing, etc. Testing could include benchtop testing, usability (human factors) studies, other design validation, sterilization testing, biocompatibility testing, packaging and ship testing, potentially animal studies, etc. It's a lot, but it's the whole point of the project. Pass through design output to implement and launch the product into the market. In-person assistance is available (in-office or remote).

Drawings. Component Specifications. Product Specifications. Packaging Specifications. Specification Packages. Regardless of the name, they are the most critical design output element since they define in entirety the product that is being sold. They include the picture or sketch of the product, critical features (either design or manufacturing), material properties, dimensions, workmanship criteria, and so on. They describe the product, and they offer objective definition so manufacturers know what is good and what is bad product. It is imperative they accurate, clear, and reflect reality. There are many tools that can make that happen. In -person assistance is available (in-office or remote).

After gathering design inputs and developing requirements, a product proposal comes together. The decision is made that no further changes will be made to the design. But, before it can go to market, two questions have to be answered: 1) Does the product do what it was designed to do, and 2) Does the product do what the user said it needed to do? Those points said another way: 1) Does testing show that the product was correct when compared to the engineering requirements, and 2) Was the product what the user said it should be? Design verification testing addresses the first question, and design validation addresses the second question. But, how do they work? How can the process be made more efficient and straightforward, how does risk fit in, what about improvements to protocols, when does the testing count? How do you learn when you can take credit for answering either of these two questions. Learn tools for making this process simpler. Improve the overall system or just get it moving. Get help with this aspect of design output. In-person assistance is available (in-office or remote).

CI: Every organization experiences growing pains, inefficiencies, delays for things that seem unnecessary, and the list goes on. Coincidentally, continuous improvement can alleviate those pain points prospectively or retrospectively. Kaisans: no problem. Improved processes: can do. More efficient change control measures: got it. Post market surveillance or management review: great tools to find areas for continuous improvement, as well. When businesses feel the pain, continuous improvement is often the solution.

Perhaps coming from a different industry into the Medical Device world has you feeling behind. Maybe going from one department into plant managment leaves you thinking you are not sure what questions to ask. Perhaps things are behind, and you do not know how to get the answers for when things will improve. Not to worry. When you just need to know the right questions to ask, how to navigate the highly regulated landscape, and learn what people are talking about, this training can cut right through to put you in a position of success.

Make life easier for everyone who uses your product: the user, the production people, the design house…everyone. How? Process Validation. An objective way to show safe, effective, and consistent product. After using this business process to demonstrate that your process does what you said it should do, you can predict exactly how product will behave for years to come...assuming no changes in the process. In person assistance is available (in-office or remote), and the training or live presentation is generally based on the global harmonization standard for process validation and 25 years of actual experience with hundred(s) of validations.

The entire business process to transform a product idea into actual product that is manufactured is called design transfer. From process planning, to developing the process and all of the documentation (work instructions or procedures, specifications, work orders, routers, travelers, inspection sheets, etc.), to reviewing the process, through process validation, and finally to launch, it can be daunting. If not careful, things can be missed (such as translations for foreign locations or approved suppliers). In-person assistance is available (in-office or remote).

While process development is technically part of design transfer, it is such a large topic that it deserves special attention. Understanding where the process inputs are coming from, the risk of the design and how it translates into the risk of the product being manufactured, choosing equipment, suppliers, materials, critical features, processing parameters, cell layout, spare parts, etc. can become overwhelming. But, generally the same basic cycle can be followed to keep it organized and moving to get the process ready for final qualification. In-person assistance is available (in-office or remote).

It seems so simple: does the software do what it is supposed to do. But, protocols can turn into hundreds of pages, each with multiple lines of testing per page. Then, there are the different areas where software comes into both products and company systems: test methods or equipment may be driven by software, manufacturing equipment may be driven by software, there may be embedded software or software as the standalone product, software packages used to help decision making such as a statistics package or labeling software, etc. What about spreadsheets that are used for data collection and analysis? Software validation is all required. In-person assistance is available (in-office or remote).

Whether before or after a product is launched, finding root causes for failure(s) and implementing solutions to ensure they never happen again is critical. This important skill set often determines the difference between business success and failure. A variety of tools can be used to make the process simpler: 5-whys, fishbone diagrams, fault tree analysis, risk assessments, health hazard evaluations, DMAIC problem solving techniques, a variety of charts, analytical methods, etc. This topic, perhaps more than any other, is also benefited by experience...there really is often no substitute for having an experienced problem solver in root cause analysis and investigations.

How does a requirement differ from acceptance criteria? Safety factors. How do I know how to choose the right quality levels or reliability factors? Safety factors embedded in risk management. Although there are very few absolutes on exactly how to do certain things in the product development world, there is one absolute. There must be pre-defined, approved, and objective acceptance criteria prior to the collection of any data. Any data collected before the acceptance criteria is defined, documented, and approved cannot be used for qualification. So, getting the acceptance criteria as early as possible in the process, and ensuring it is tied to objective decision making (risk) is critical. Learn how to create the acceptance criteria, how it differs from requirements, and how to make sure you do not fail the acceptance criteria when you do the actual testing. In-person assistance is available (in-office or remote).

Statistics is just like every other engineering model: each tool was built for a specific purpose or set of purposes, and choosing the right tool gives the ability to powerfully predict outcomes. Hands on statistical analysis available. Create acceptance criteria using valid statistical models. Learn how statistics can be used effectively for your purposes. In-person assistance is available (in-office or remote).

25 years of experience has shown factorials are one of the most powerful tools used during the design development and process development phases. Literally shave months and years off projects with more effective use of this tool. In-person assistance is available (in-office or remote).

One of the most fundamental requirements in engineering is that the test methods used must be valid. How does one prove that? It's all about accuracy and precision. It's all about calibration and measurement system analysis. The data needs to be proven to reflect the part being tested and not the variation found in the test setup, the operators' interpretation while performing the testing, the equipment, or the environment. It can be done. It should also be noted that there are some exceptions when it is not necessary. In-person assistance is available (in-office or remote).

So many project management tools, and so little time to get the project done. Using the tools that make the most sense for your company culture will both speed up the project and make communication far more effective. The project management tools should not be assignments unto themselves...they should be tools that make projects efficient and predictable. If you are tired of never really knowing when a project will be done or what work is left to complete or why work was missed, project management is a good solution. In person assistance is available (in-office or remote).

Non-conformances happen, but they do not have to create chaos and confusion in the organization. Using risk to determine the level of work required and ensuing that the system guides employees through the definition, identification, isolation, boundary, investigation, and corrective actions followed by implementation and verification phases relieves problems with lost time and company resources, poor quality, and confrontational discussions over what to do. Leave the discussion to determine solutions instead of whether or not there is an actionable failure or corrective action. In person assistance is available (in-office or remote).

With over 20 years in the Medical Device Industry, and 25 years in engineering, Mentorneering has extensive experience in developing, launching, and maintaining products in the market. If there is a particular area of assistance you would like to explore further, please reach out. In-person assistance is available (in-office or remote).