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Author Archives: Omnica Corporation

  1. Biotoxin E.coli Detection Device

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    Innovative magnetic detection technology brings quicker assays to the laboratory bench.

    Our entire Electronics and Advanced Services departments were involved in the software development, circuitry design, troubleshooting, and the problem-solving challenges that occurred during development. For this article we interviewed Paul Gleason, a member of that group.

    Projects that are a technical challenge, and solve real-world problems are a great fit for us. Do you recall the news about illness arising because of eating undercooked hamburger, and raw milk? E. coli 0157, a bacterium that normally lives in the intestines of mammals is the microbe responsible for most of these recalls. In 2002 a major U.S. supplier had to recall 19 million pounds of beef because of E. coli contamination!

    Companies that process food need a rapid and accurate method to test their products before they are sold to the public. We have developed such a testing device for Centrus International, a subsidiary of Eastman Chemical. It is a desktop instrument and assay test cassette that uses para-magnetic microparticles, which bind to the target microbes during the test. The results are displayed and printed. Until now the food industry has not had access to a system with this combination of accuracy, speed, and sensitivity.

    The system has its own built-in CPU and printer, and calibrates itself each time it is turned on.

    But how does it work? 1) The sample in question is mixed in enrichment broth, a growth media for E. coli. 2) After an incubation period the broth is filtered. Magnetic particles that later attach to the target bacteria are added. 3) A small amount is placed in the assay cassette. 4) Capillary action pulls the magnetic particles, with or without their E. coli hitchhikers, along the assay membrane strip to a detection zone, and then into a control zone. 5) A magnetic detector module reads the strip and identifies minute concentrations of the magnetic-bound bacteria. Results of the test are displayed on the instrument, and printed with its internal printer.

    Development of the Envisio® instrument (shown at right) was an example of an integrated team effort.

    Paul Gleason, Omnica’s Vice President, was chosen to head the development team because the system requirements were similar to those found in the clinical diagnostics market, his field of expertise. “There’s an assay consumable, a detection methodology, software, user interface, and instrument hardware. It’s a different market, but it is laboratory instrumentation,” explains Paul. “Originally we worked for MagnaBioSciences® to develop the technology of their assay cassette (shown below left) and the magnetic detector module. Eastman® licensed the patented magnetic detection technology, and we were hired to implement it in their new instrument.”
    The Envisio device is aimed toward high-volume test sites, so it was designed to be easy to operate. The assay results are interpreted in less than 30 seconds. There are only two buttons, one for the printer paper feed and the other to cancel the process. “Basically the user opens the door and inserts the cassette, and that’s all they have to do,” states Paul.

    The instrument incorporates the cutting edge of electronics and software design. “There’s a lot going on in that box. In most lateral-flow assays, concentrations of the target molecules are high, as is true with a pregnancy test.” comments Paul, “To achieve the sensitivity our client wanted, we had to develop special algorithms to detect very low concentrations in test samples. This part of the software and firmware development was particularly intense and rigorous.”

    They said “develop the product, and get the appropriate approvals for marketing on three continents.”

    The Omnica team faced significant challenges combining just-perfected technology from one company with reagent chemistries from another into an innovative, sleek, and distinctive package. Our client made it clear that the instrument development should not be a hold-up to production (not a unique circumstance for us). Paul describes other unique requirements, which could have slowed the process. “We had to develop a custom miniature barcode reader, which may be the world’s tiniest, and we had to design, tool and mold the cassette. The production processes and components we chose were tailored specifically to their projected production volumes. From Eastman’s point-of-view, the process was turnkey. They said ‘develop the product, and get the appropriate approvals for marketing on three continents’, and we did that.” Transfer to the contract manufacturer was another big part of the process. Paul clarifies by saying, “Eastman chose the manufacturer, and we tailored elements like the documentation, control drawings, preliminary release prints, and inspection according to that manufacturer’s quality system.”

    Near the end of the program, one ranking member of the client’s development team commented that the large medical OEM he previously worked for could not have done this job in the short amount of time Omnica completed it. Later, another member added that Omnica has successfully pushed the envelope to the state-of-the-art limit for this parallel project effort.

  2. POC Drug Monitoring System

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    Learn about Omnica

    The PaperSpray Ambient Ionization system™ can rapidly analyze complex samples including whole blood in 3 to 5 minutes with no sample preparation. The automated system was developed by Purdue University and Omnica for use in the clinical laboratory and other research applications.

    The platform was developed to analyze minimal sample volumes of whole blood, urine, saliva, and fresh tissue samples (biopsy and tissue homogenate) to determine drug levels within minutes sample collection. It is particularly useful for oncology patients who have been administered small-molecule chemotherapeutic agents.

    The Omnica team developed the entire system, including cassette, reagent injectors, high-voltage system, automated magazine, status display, and the Graphical User Interface software (for protocol parameter setting and remote diagnostic capability) – in 12 months.

    PaperSpray Cassette

    • Custom injection-molded thermoplastic cassette
    • Preserves electrical field characteristics for use in mass spectrometry
    • Uses minimal sample volume of whole blood
    • Design ensures safe and reliable introduction of solvents and high voltage
    • required to generate the paper spray ionization.

    Ion Source Instrument

    • Automated sample introduction system for the mass spectrometer.
    • Holds 40 test cassettes in a magazine
    • Quantitated spectral analysis with minimal hands-on time.
    • Barcode for sample tracking
    • Capability to configure system for running custom assay protocols
    • Therapuetic Drug Monitoring

    The PaperSpray / Ion Source Instrument, when combined with a miniature mass spectrometer, has resulted in a Point-of-Care Therapeutic Drug Monitoring (POC-TDM) device that can revolutionize cancer treatment by solving a major problem in oncology.

    When administering small-molecule chemotherapeutic agents, health care professionals should strive to optimize the dose to therapeutic efficacy, but below toxic levels.

    Within minutes, POC-TDM provides clinicians real-time feedback on the patient’s drug levels. It offers the possibility of an improved clinical outcome by personalizing drug levels over a period of time.

    As stated by a leading oncologist:
    “The use of POC-TDM will create a paradigm shift, replacing Dose to Toxicity with Intelligent Dosing”.

  3. The Organizational Model of Omnica is Different

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    Over 38 years, Omnica has continued to satisfy its customers and employees because our founder Earl Robinson has spent a career learning about how to manage creative teams.    He learned early on that creatives are different from most people and thus require a unique environment to use their talents and thrive.    The result is a peer-based culture that does not conform to the typical structure of most companies.

    We are all familiar with org charts.  We have seen them a million times.  They cannot however communicate the structure of Omnica.    Each person can be involved in many roles and in Omnica that is especially true.

    Just as an example,  my roles are many,  I am responsible for all Marketing activities,  I manage the IT environment, I manage all sales opportunities,  I find new hires,  I do project management,  I build cable assemblies.  I could probably think of a few more things.

    I challenge you to write a job description for me that would make any sense.  Job descriptions are demeaning,  why would you not want to maximize the talent of the individual rather than put them in a confined box and limiting what they are capable of?  This is the traditional method of management that we believe has reached the end of its usefulness.  It was designed in the early days of the industrial revolution but is not relevant to the knowledge and creative work of today.

    The Omnica culture has evolved through the years to become what it is, and is not well documented or formalized.  There are elements of a variety of management paradigms but there is not one overarching “system of management”  the management has certain principles:

    1. Integrity
    2. Logic and Common Sense
    3. Orbiting the Giant Hairball
    4. Teamwork
    5. Encourage Continuing Education
    6. Economic Responsibility
    7. Profit Sharing


    “Integrity is the essence of everything successful”  Buckminster Fuller

    No partnership can flourish if one of the parties has ulterior motives or seeks advantage over the other.  This simple precept leads to effectively accomplished business and personal agreements.  The founders of Omnica came originally from Kansas and maintain the midwest values they grew up with.

    Logic and Common Sense

    None of the founders had business degrees or relied on published guides about running a business.  All the business processes have been internally developed including custom software for time tracking and personal calendars.  Everything was based on logic and common sense.   While in some cases these systems may seem antiquated,  they still function extraordinarily well.

    Orbiting the Giant Hairball

    Business is subject to a frustratingly wide variety of non-productive bureaucratic influences.  Gordon MacKenzie, in his book Orbiting the Giant Hairball, asserted that every business has internal procedural, reporting, approval, and organizational processes that comprise a virtual “hairball” that impedes progress.  Add to these the every present external hairballs like insurance, inspectors, HR, the IRS, FDA, the state board of equalization, Air Quality, EPA etc.  Its a wonder that anything useful ever gets done.  MacKenzie’s assertion is that to succeed in business, one must learn to “orbit”; high and fast enough to not be snagged by the morass below, but near and slow enough as to not reach escape velocity and lose sight of what the relationship really needs.  Omnica has learned to somewhat master this dynamic by eschewing non-productive internal processes and avoiding projects from companies that deem “process” is more important than progress.   Process never solved a problem.


    Leave your ego at the door.  Ego is usually a destructive force in a product development environment.  Engineers need to take constructive criticism well and in practice, solicit it.  Those that have not been able to do this are no longer employed here.

    Continuing Education

    Every Omnica employee has been given the opportunity to learn new skills and to take on as much responsibility as they wish.  Many have taken advantage and many are happy remaining in their comfort zone.

    Economic Responsibility

    The company puts its employees first and throughout the years during difficult periods has always sacrificed management compensation before that of the employees.

    Benefits Package and Profit Sharing

    Omnica provides a very generous benefits package including bonuses, company paid medical insurance and a profit sharing program through our private 401K plan.

    So what have been the results of operating in this way for so many years?

    Massive throughput capability.  Omnica is actively working on as many as 20 projects of different sizes simultaneously without sacrificing quality or schedule for any of them.   We complete 50 – 80 projects per year.

    As a company, we have almost zero turnover (average tenure of 17 years)  resulting in much lower costs.

    Greater efficiency allows us to do more with less and thus improve profitability.



  4. Non-invasive Breast Cancer Screening System

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    After more than fifty years of research, it is now recognized that virtually all breast cancers begin in the breast milk ducts. Clinical studies have also confirmed the ability to detect early cellular changes within the breast ducts — similar to the Pap test detection of early cervical cellular changes — through analysis of nipple aspirate fluid (NAF). Long-term clinical follow-up of patients has established the utility of NAF cytology to predict breast cancer risk. Additionally, NAF screening may detect a cancerous growth years before mammography or physical examination.

    NeoMatrix, LLC, was a virtual company who engaged Omnica during the initial concepting phase of their project. As the primary development group, we performed all of the industrial design, mechanical and electronic engineering for the Neomatrix HALO breast cancer screening device. The HALO NAF Collection System(TM) is the first fully automated, non-invasive Nipple Aspirate Fluid (NAF) Collection device, specifically designed for use in the OB/GYN office.

    The HALO System, which received FDA clearance in September 2002, is intended as a simple, reliable method for NAF collection. The collected fluid can be used in the determination and/or differentiation of normal versus pre-malignant versus malignant cells. NAF analysis may be used as an objective assessment of a patient’s breast health and may detect early warning signs of ductal cellular changes. Regular assessment and tracking of cellular changes in the milk ducts, where most breast cancer begins, enables clinicians and patients the ability to routinely evaluate and manage breast cancer risk. The HALO System allows a simple, five minute, reproducible test that, when performed routinely, can help in the monitoring and assessment of intraductal changes within the breast, before a palpable tumor forms.

  5. The Truth About Time and Materials Estimates

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    Earl Robinson

    There are two ways to contract for design and engineering services: fixed price and time and materials. The former can give the purchasing department an idyllic vision of security and control, while the latter offers a vision of mayhem and runaway costs. When competing product development firms use different methods to bid on the same project, uncertainty and false expectations can overshadow the real benefits of a well-considered time and materials estimate.

    Purchasing departments want to capture all project costs with fixed bids to avoid issues like budget overruns. It sounds like a worthy objective, but from the beginning we’ve known that it is in our customers’ best interest to specify a time and materials bid when developing a complex medical product. Here are four typical opinions purchasing and project managers have when choosing between fixed price bids and time and materials estimates:

    Myth 1:  “Time and materials contractors run amok, prolong the project, and hold us hostage.”

    Reality: Yes, it happens, but developers who routinely lengthen the duration of projects tend to not stay in business. Old fashioned word-of-mouth, the Internet, and social networking expose the reputations of unscrupulous contractors, warning-off new customers.

    Successful development companies deliver customer satisfaction by promoting a straightforward relationship with their clients. Frequent status meetings with the client, and weekly activity summaries are tried and true methods of sustaining this relationship. We work at the direction of our clients as a team, and communicate with checks and balances to insure we are on the right track to do what they hired us for.

    Myth 2: “Keeping a time and materials project on time and under budget is impossible.”

    Reality:  Staying within an agreed budget is important for both parties. Our customers don’t want un-planned bills, and we want to do business with them in the future. Monetary and time goals can be met if two key ingredients are addressed before starting a project: 1) A clear project definition with a description of what the bid actually does and does not cover, and 2) A realistic budget should be based on real world experience, not a sum of what needs to be done.

    Both key ingredients refer to the confusion and misunderstandings that can occur when either our team or our customer doesn’t fully appreciate the scope of the project. This is when bids from competing companies can be helpful. If two product developers bid on the same project, and there is a significant difference in their estimates, it’s a yellow flag: Someone doesn’t have a complete grasp on the overall scope, and it needs to be cleared up before anyone starts working (or paying).

    Myth 3:  “I need to know exactly what a program is going to cost to effectively manage it.”

    Reality: Accurately predicting a fixed price for something that has not been done before is nearly impossible. There are too many variables like erratic marketing mandates, patent revelations, unforeseen design opportunities, component obsolescence, and not the least of all, the limitations of physics. Each can significantly impact the cost of a development program.

    At best, a cost prediction is an educated guess based on available information, and things almost never go exactly as planned – that’s the nature of developing new and unique products. On the other hand, breaking a project down into logical phases and establishing working budgets for each, is both practical and useful. Bottom line, budgets need a level of flexibility.

    Myth 4: “If there are changes to the project scope, we’ll just ask for a re-quote for the new work.”     

    Reality:  Revisiting the project definition, recurrent  proposal writing, purchasing negotiations, and sorting new P.O.’s result in non-productive reporting overhead. Re-working activities like this don’t contribute to the task at hand and should not be an added burden for the people (the client and the contractor) who are trying to do the job. Of the two types of estimates only a T & M relationship allows for flexibility. If a new need arises, it is addressed and handled. It’s as simple as that.

    In summary, when working under a time and materials agreement, a simple process of weekly progress reviews, weekly billing reports, and close customer participation in the development process insures project transparency for all involved, and expediently allows the work to be completed in timely manner.

  6. Soft Tooling – Why do we use it?

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    In a past article, we featured a story on how we used 3D printing to construct complex appearance models. Another use for those accurate 3D printed parts is for producing original patterns when building silicone-rubber molds, also called “soft tools”. We use soft tooling for small parts and larger desktop-sized cases when we need multiples of less than twenty or thirty.

    The advantages of silicone molds over other tooling methods are low cost, speed, versatility, and accuracy.

    Costs for the molding materials and the 3D printed model/ pattern are usually measured in hundreds, rather than thousands of dollars. After the molds are built, duplicates can be cast in a matter of days. The flexible nature of a soft tool also allows the engineer to test different casting materials without changing draft angles. Best of all, the resultant  prototype parts are accurate within a few thousandths of an inch.

    We build molds that range from pea-sized to some the size of a large Microwave oven. 

    First a mold container is constructed using MDF or acrylic, then the original part is suspended within. See picture at right. (The yellow clay was inserted so that the original part would not be completely encased in the cured silicone mold. Before the top half of the mold is poured, the clay will be removed. This way, the two mold halves can be separated after they’re cured.)

    Liquid silicone is poured into the container, covering and completely encasing the original part. In a few hours, the silicone cures (this process can be accelerated with heat) and the hardened rubber block is removed from the mold box.

    The next challenge is to extract the original encased part without damaging either it or the new “soft tool”. An experienced and steady hand is needed to cut cured silicone in the right places so that the original model can be safely removed. The resulting flexible mold can be bent open to remove the original part. See picture at right which shows half of a two-piece mold. If the part is a complicated one, it may need to be sectioned.

    After re-assembly, the void where the original stereolithography part was originally located is filled (cast) with the material of choice, usually a two-component epoxy or urethane. The fill material is cured, and the new cast replica is removed from the soft tool. Depending on the material used, we can make a score of duplicates from one mold. Picture at left shows both mold halves with an actual cast part after it was removed.  A close look at the picture reveals “sprues” (they look like stalagmites) on the cast part. They are the result of holes that were added to the mold to inhibit bubble formation in the finished part. The sprues are removed during final finishing.

    We used this prototyping process for the Hampton lock housing project; one that required a lot of testing with snap-fits, crush ribs, and material selection. The accuracy of the resultant parts and the ability to test different production materials significantly impacted development time. It was the “soft-tooling” that made it possible for us to meet our customer’s time line.

  7. Miniature Bar Code Reader:

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    No Small Acheivement

    This diminutive scanner reads data matrix barcodes and was developed at Omnica for a special project. It weighs only a tenth of an ounce and is much smaller than any commercially available barcode reader.

    Today’s electronic devices gives us more design and engineering latitude. We pushed the size envelope when one of our clients engaged us to build a diagnostic device that would require a very small barcode reader. One which could, despite its small size, make the best use of existing data matrix barcode technology. In our prospective design, space was so tight, no barcode reader currently available would have suited our needs.

    The data matrix barcode contains a lot of information.

    The plan was to communicate the information in the barcode to a printer and to the assay detector in a tabletop diagnostic device we were developing.  We chose to use a NASA-developed scalable data matrix standard, which offered the possibility of including an extraordinary amount of data in a very small space (about the size of your little fingernail). There was a mitigating factor, however. If the barcode image was not properly printed and presented, the contained information could be easily corrupted. Our challenge was to build the smallest possible reader that correctly interpreted and relayed critical information even if the printed image of the code itself was somehow blemished or distorted.

    Specialized optics and error correction algorithms.

    We developed an optics design that included a special lens and a customized LED light source to supply consistent light intensity and uniformity as the coded image was being read. As importantly, our perseverance in advancing the state-of-the-art in barcode image processing allowed us to make the best use of effective and robust error correction algorithms.

    The tiny barcode contains a tremendous amount of data.
    Our miniature reader has to decode the data even if the
    printed image is not positioned perfectly on the plastic assay cassette.

    The end result was the successful development of a   miniature and easily manufacturable barcode reader, which improved usability of an existing technology. The diminutive device is used to read the data symbols on the assay cassette shown above. The reader (also called a scanner) is tiny, about the size of a postage stamp, and weighs only a tenth of an ounce. Compared to the smallest barcode reader commercially available, it is less than half the size.

    * We have had many readers inquire where they could purchase the barcode reader described in this article for use in other projects. It was developed for a client to be used in a specific application. It is not for sale or commercially available from us or our client.

  8. How to Recognize Project Managers Who Will Slow You Down

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    President – Earl Robinson

    Every successful product development program requires a “champion”, and a motivated, tech savvy PM. They can be, but usually are not the same person. The former is the visionary program leader and critical to the team. The second is the contact we will work with on a weekly basis, and the one who moves that vision from a wish into reality. For starters, if a project has a hope of succeeding, those two people have to be on the personnel list.

    The primary objective of the PM is to guide our efforts, answer our questions, insulate us from the politics and bureaucracy of their company, and accurately communicate our counsel to their internal decision makers. “We are only as good as our customers’ PM” is a truism. Their qualifications and experience are considered carefully during our proposal process.

    Project Managers, for the most part, do their job effectively. Some are better than others. If we are fortunate enough to work with a talent, work progresses smoothly, and everybody is happy. Generally, we are comfortable with PMs who are referrals or return customers since we have an idea what to expect. If they are a new customer, there are three types of PMs we try to avoid.

    Project Managers come to us with the best of intentions, but one particularly unsettling type has responsibility, but no authority.

    They are not uncommon, but unfortunately hard to identify until we are well into the development process. The way we develop projects affords us the ability to respond to PM suggestions and satisfy their astute out-of-scope activity requests – it is one of the reasons we work for time and materials.

    Problems arise when the PM asks us to proceed without knowing if their expanded budget will be approved.

    It is not a stretch to say these types may not even know they don’t have authority to request extra funds until they are challenged. When we do ask for P.O. extension, and it’s denied, they fear reprisal from their management and don’t step-up and ask for the extra funds. It really slows . . . things . . . down.

    Another untoward situation is when a corporate directive has divided the subsystems development responsibilities of a project among many managers.

    It is a common practice. Problems surface when it is not clear whose budget will be used to pay for our work. An example is the design and fabrication of a cable harness, where one PM is responsible for the design, and another for the fabrication. When it is time to assess charges, a job well done can be eclipsed by a turf battle.

    Only recently we discovered that some with the title “Project Manager” are not technical people at all. They are purchasing agents with a functional role to monitor budget and schedules. Yes, budget and schedules are important, but those whose expertise is mostly focused on arbitrary deadlines and Gantt charts are not good project managers. We experienced this during two recent large-scale programs where we never saw one of the active “PMs”, and only heard from the other when his bonus program was affected. It didn’t end well, and taught us to be suspicious of business card titles.

    Before a project begins we recognize that the Omnica/PM relationship is based on mutual trust and expectation. We depend on them to effectively oversee the project and make wise decisions, quickly. It’s our job to move the development program through to a successful conclusion and make them look good. Seasoned and experienced PMs are invaluable, and when we are working with one who knows his or her stuff, the results can be very rewarding.

    Earl Robinson is the President, and founder of Omnica.

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  9. Medical Devices Standards and Quality

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    Earl Robinson

    Earl Robinson
    Founder and President

    Sleek and shapely consumer products like cell phones, flat screen TVs, and some kitchen gadgets are celebrated and “sexy”. Medical devices are not so exalted. Some are elegant in their own way, but outside of a hospital or doctor’s office, most people don’t recognize the products we design. But that’s all right with us.

    Six reasons why medical device development meshes well with our design and engineering philosophy.

    1  Overall quality   As members of the medical device community, we pursue quality over quantity, which conflicts with the reality that drives the consumer industry, whose mantra is usually “faster, better, cheaper”. Our clients don’t ask us to use inferior materials or shortcut the design process to save money. They recognize that end-users depend on medical devices to exceed expectations, and not by narrow margins, especially for Class II and Class III devices.

    2  High product standards   Most of the products we design are controlled by the FDA and must pass special labeling requirements, performance standards, and post market monitoring. Consumer device manufacturers cut costs by setting their standards just high enough not to suffer too many returns or recalls. Legally they have minimum guideline standards, but other than UL (U.S.) and CE (in Europe), third party oversight is limited.

    3  Robust products   Medical products tend to stay on the market longer and are not necessarily replaced by new versions every 6 months to a year. It is another convincing reason that “just good enough” does not suit us or our customers. The extended life cycle prompts us to do a thorough job and produce devices that are built to last. Also, since we probably won’t revisit redesigns of the same product for many years, our employees are constantly motivated by the challenges of other new devices. The side effect is an ever changing environment, which ensures that our people continue to maintain interest in their work.

    4  Interesting materials and methods   Activities that involve cutting-edge technologies and fabrication methods are intellectually stimulating. Since medical devices are usually manufactured in smaller volumes, we find ourselves working with materials and methods that are usually ignored by other industries. As an example, we recently designed a handheld device which uses a Kevlar and memory wire drive chain integrated with rare earth magnets. It’s a slim chance a mainstream manufacturer would employ such exotic materials in a consumer product.

    5  We get to explore new technologies   Clients sometimes challenge our team to investigate projects that may involve an   unproven concept or idea. In these cases they frequently give us the latitude to explore every possible solution. That’s a good fit, too. Our R&D group is experienced in concept feasibility and testing, and they are particularly motivated when we’re hired to incorporate a core technology or IP into a new product.

    6  Customer benefits   Speaking from experience, we can tell you that medical device development requires more than the right tools and vendor connections. Workers in this arena are typically well experienced individuals who can appreciate a unique set of expectations. Their work is guided by well-defined time and cost sensitivities, performance thresholds, and attention to detail. And the rewards are quite different from those in the consumer industry. What we design and engineer may not be alluring or recognizable, but work in this field gives us the opportunity to develop new and complex devices and instruments that can benefit patients’ lives and the quality of care from their service providers.

  10. Introduction to Design Controls

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    FDA investigators will evaluate your design control process and procedures. Are you ready?

    Learn about Omnica

    Kathryn Kukulka,Regulatory Affairs

    Approximately 75% of our clients hire us to design and engineer medical devices. They represent companies that range from small start-ups to large Fortune 500 corporations and all have two things in common: to see their ideas realized and to overcome the challenges of incorporating the design and development process into their Quality Systems as defined by the FDA Quality Systems Regulation (QSR).

    Intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase yet, statistics show, a significant percentage of all medical device recalls are due to design problems. A device recall can result in unplanned development costs, lost revenue for the manufacturer, and can significantly affect the end-user. Considering the   relatively short life-cycle for market viability, it is in everyone’s interest to “do it right the first time”.

    In 1996, the Good Manufacturing Practice (cGMP) requirements were revised to include the area of  Design Control and have become a part of the Quality System Regulations (QSR) with which all medical device manufacturers must comply. It is incumbent on the manufacturer to demonstrate compliance with the QSR and (as of 1996) with Design Control requirements as well.

    Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied to control design activities while assessing quality and correcting errors through an iterative process of development. As a result, the end user benefits from a safe and effective product and the manufacturer benefits from a successful return on investment.

    Design controls should be in place for a new product prior to approval of the system-level requirements document and after completion of the feasibility phase. However, a pivotal debate ensues when trying to determine the end of feasibility and beginning of development. To alleviate confusion, a manufacturer should look back into their management practices and policies and their comprehensive Product Development Process to define specific milestones and development phases. Once they have determined the product is feasible and the decision has been made to transition into development, the Design Control process begins.

    At Omnica, our design and development team is highly experienced with this process and can provide guidance to ensure the transition from feasibility, through development, and into production while   following FDA guidelines.

    Design Controls are made up of ten elements with documented procedures. However, the FDA places great emphasis on Risk Management and, although it is woven into the validation process, this author believes it deserves its own category.

    These requirements affect most medical device manufacturers.

    The following are brief descriptions of the sections of Design Controls as they relate to requirements defined in the Code of Federal Regulations 21 CFR 820.30

    1) Design Control – States that when manufacturers or suppliers develop a product subject to design controls, they shall establish and maintain the proper documentation to ensure the specified design requirements are met.

    2) Design and Development Plan – Describes the overall development plan and defines design activities and responsibilities. It establishes roles of all contributors to the development process including marketing, purchasing, manufacturing, R&D, Regulatory Affairs, and others. The Plan also defines design elements, intended use, and interfaces associated with the overall design process.

    3) Design Input – Establishes the requirements that will ensure the device will meet the needs of the intended users. This is often in the form of a Product Requirements document or a Device Specification document; et al. Design input does not come in a box and is not a tangible entity, but is a process of gathering all available information about how a device might fulfill one or more user needs, while defining requirements which characterize the device. A requirements document is the tangible embodiment of user needs and is “the” document that comprises all fundamentals to help decide how to implement the design. Requirements should specify what is needed, not the solution, and act as a basis for verification of the design. It is not a trivial document and requires time and effort.

    4) Design Output – Applies to all stages of the design process. These are the final technical documents that constitute the Design History File (DHF). This information shows that the device was developed according to the Design Plan and Design Inputs. It ensures that the Design Output meets the Design Input requirements and specifications. Design output is the accumulated information and instructions for building and maintaining the product. If followed, the result will be a device that consistently meets specified user need(s).

    5) Design Review – These are planned, formal, and documented reviews of the design results conducted at appropriate stages of the device’s design development. Formal Design Reviews (minimum of two) require the participation of representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The formal reviews ensure that Design Outputs are meeting the Design Input requirements and are being recorded.

    6) Design Verification – Assesses conformance to the requirements and confirms and documents (in reports) that the design output has met design input requirements. It verifies that the product was “made right”.

    7) Design Validation –Validation follows successful Verification and is performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. It shall determine, by objective evidence, that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and *risk analysis, where appropriate. It confirms that only safe and effective devices are produced for their intended use and therefore validates the “right product” was made.

    8) Design Transfer – Ensures that the design specifications of the device is correctly translated into production specifications.

    9) Design Changes – Design Changes are to be documented and validated or where appropriate, verified (again). They are also to be reviewed and approved again before their implementation.

    10) Design History File (DHF) – Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate the design was developed in accordance with the approved design plan and the requirements of this part (21CFR820.30). It is a collection all outputs derived from the previous categories listed above.

    *Risk and Hazard Analysis activities are required during most phases of development.

    The standard for the application of risk management is ISO 14971 Medical devices – Application of risk management to medical devices. The extent of testing and evaluation is proportional to the risks associated with the product. If risks are unacceptable, the manufacturer may need to redesign the device or establish appropriate warnings for use. If the Risk and Hazard Analysis procedures are found unacceptable or incomplete, FDA reviewers will question the “safety and effectiveness” of the device. It is therefore essential that any risks and hazards are mitigated to “acceptable” levels. Literature review shows that appropriate risk analysis procedures are always a challenge and fall short in more than half the cases studied. For these reasons, this author suggests that manufacturers establish a specific Risk Management section of their Design Control system.

    When all these subjects have been addressed and documented, you have the makings of the Design History File which can support a company’s 510(k) Pre-Market Notification and / or Pre-Market Application (PMA).

    When reviewing the design control requirements, FDA investigators will not determine if a design is appropriate, or safe and effective. They will evaluate the design control process, make recommendations based on whether the manufacturer has the required checks and balances in place, and verify implementation of the design control guidelines.