Coghlin Companies Blog

Working at a client services organization such as DCI is often exhilarating, sometimes exasperating, but always challenging. We wanted to explore creative analogues to the work environment at DCI and asked DCI employees to share their mental images of working at DCI. The following are three representative examples. Not surprisingly, the common themes were teamwork and a sense of accomplishment.

Professional Football
Every part of a pro football organization must play their role well to ensure success. It starts with the ownership, then the coaches, the players and right on down to the fans.
The team owners are like our customers. At the end of the day, they have the most to lose if we fail and the most to gain if we succeed. Ownership changes from time to time but it is their interests we must have in mind to guide our overall actions. Without customers, we don’t have a business.
The head coaches are best represented by our management staff. It is their guidance that must find a way to make our team work together as a whole, to put together successful drives when we need a score, or defend against other teams, i.e., our competitors. To “get a win” they must figure out a way for us to rise above our competition and do what is necessary to make our owners happy and our fans cheer; the fans being our potential customers.
Project Management can probably best be summed up by comparison to position coaches. They have to apply upper management’s vision to execute that game plan; each game being a separate project. It is their job to make sure they have the proper players in place to execute the game plan. Frequently, they are stuck between the interests of the owners, coaches and players.
Engineering would be best described as being the offensive/defensive skill positions such as quarterbacks, running backs, defensive backs, etc. Some take the ball and run with it, others go over the middle for a tough catch. The team has its stars but they can’t do it on their own.
The linemen are our technicians and support staff. They get the work done in the trenches – building machines, getting parts, collecting money and paying the bills. These players may not be as visible to our fans but their importance is paramount. They do the thankless work to keep things moving.
Our Sales force is the face of the organization to the public so they are the cheerleaders. Their job is to get the morale of the fans up and get them cheering. If they get our potential customers excited enough about our capabilities, they will want to be more involved with us and even want to become owners.
Many players in our organization play multiple positions so these comparisons can shift from player to player on any given day but the bottom line is that we are a team. No position is unimportant and every player has an opportunity to make a play. Success follows those who are aware enough on the field to recognize where they are, what role they play, and how their actions affect the team as a whole.
John Bettencourt
Mechanical Engineer, DCI

The Band
My idea of the DCI business model is remarkably similar to the band where I play the saxophone on weekends. Our ultimate goal is the same as DCI – customer satisfaction and the feeling of personal accomplishment.
Our band consists of people from all disciplines – an auto body mechanic, a senior manager for a large medical company, professional sales personnel and me. DCI consists of senior management, sales, engineers and of course the people that build the products every day.
We practice every week and discuss what potential and existing customers want to hear from us as a band. We all have input in the music selection and our approach to playing the chosen repertoire. At DCI there are weekly meetings to discuss and review customer requirements and all disciplines have input as to how the product should be designed and built. All suggestions are welcome, all inputs are important to build the very best product we can for our customers and achieve total customer satisfaction.
There are occasions when disagreements and tensions arise in the band but our intentions are always to be the best we can and deliver a top notch show for our customers. The same can occur at DCI but always with respect and on a professional level, to listen to all sides of the debate and realize that everyone has the same goals – personal satisfaction for a job well done and a happy customer.
In closing, both DCI and my band are about the people. No one person in DCI or the band can achieve the goals without all of us contributing. Both require dedicated team effort and the realization that the challenges we face are worth the effort. It is not easy but we can have fun and at the end of the day we can all look back and say thanks for the help and good job.
Vincent Provenzano
Director of Purchasing, DCI

Hiking trip
Working at DCI reminds me of a hiking trip. Good hikers always seek to improve their basic skills in map reading and first aid, and have the tools such as boots and gear that enable them to scale more challenging peaks. Similarly at DCI, the engineers learn the best practices in design tools and methodologies that enable them to solve the most challenging problems.
A successful hike requires good preparation and it starts with an understanding of the park regulations and planning what trail you are going to take, how long it is, the terrain, elevation and points of interest along the way. I am always hiking with friends and we divide up the tasks of procuring the food, updating our gear and carrying the food, water and gear between us. Similarly, a successful project starts with understanding the customer requirements for design and build, and developing a project plan that partitions the tasks among the available resources, and sets key milestones.
During the hike we follow our plan but make adjustments along the way if the trail is not what we expected or if we find a shorter path, or how we are doing on time if we decide to stay longer at one place. Similarly, execution is the key to success on a development project and we follow the plan but make modifications depending on challenges encountered in meeting the specifications or cost or schedule.
The hike ends with a feeling of satisfaction, some nice pictures and journal entry for future reference. At the end of the project, there is a feeling of accomplishment, once again, as we deliver the product and documentation to a happy customer.
Rich Strazdas
Software Engineer, DCI

Good Documentation Practices have been a hot topic in the medical device industry for a long time. It appears simple and straight forward but for some reason it remains a critical topic in the industry. I have seen it in Good Laboratory Practices (GLP’s), current Good Manufacturing Practices (cGMP’s), Good Clinical Practices (GCP’s) and the Quality System Regulation (QSR). It is a common theme….documentation that is illegible, not attributable, incomplete, inaccurate or backdated. The FDA has written 483’s, warning letters, and has taken official action against organizations as a result of poor documentation. Poor documentation has cost organizations millions of dollars and the real key to GDP is simply the ability to enable ”Document Reconstruction”. Document reconstruction is the single most important aspect of GDP. If your documents could stand on their own and tell a true and accurate story of what took place 10 or 20 year from now you are on the right track. I think they should call it Good Business Practices, because it is so critical to the success of any organization. The key principles that I like to remember about GDP are “ALCOA”…Attributable, Legible, Contemporaneous, Original and Accurate. These simple concepts can make a world of difference if you are trying to reconstruct any documentation that would allow you to make critical decisions. A former FDA investigator/reviewer once said to me ”Can you imagine what it would be like to have the responsibility to make a decision that could impact millions of people and all you have in front of you is documentation that someone created 5 to 10 years ago? How confident would you be if you could not clearly reconstruct the documentation?” Remember, your documents could play an important role in someone’s life.

By Scott Cook — Director of Quality and Compliance — Cogmedix

Completing a design for a product intended for volume production includes many trade-offs not necessarily considered for prototype development or low volume development projects.  Not to be confused with Design for Manufacturability (DFM) which concerns component producibility and ease of manufacture or assembly, design for volume production is primarily focused on Cost of Goods Sold (COGS).

There are multiple design solutions for obtaining a given function.  These can vary as widely as purchasing a commercially available modular subassembly, to creating the same functionality from a custom and unique “from scratch” design.  A commercial solution can be quickly obtained, integrated, and utilized, which helps time to market considerations and helps keep development (engineering) costs down, but typically carries a higher component cost.  This higher component cost versus development cost can be alluring as customers strive for functionality and time to market, but can be detrimental as supply chain pressure for cost of the component will only yield so much once in volume production.  The issue quickly turns into a margin problem as the demand for the product may be high, but the cost can’t be driven down any further by typical supply chain management.   This issue will remain for the life of the product or until a redesign effort is expended to replace these higher cost commercial solutions.  If you can choose a commercial component that is used across multiple industries and is produced in very large quantities, the issue will be diminished and should be part of the trade-off analysis.

An alternative to commercial solutions are custom designs.  A good example would be purchasing a commercially available motor controller versus a developing a custom printed circuit board design.  Custom component design will be more expensive up front and generally takes longer to implement than a commercial solution, but often gives customers a margin advantage due to lower Cost of Goods once in volume production.  A custom design can also allow the development team to provide the exact functionality required, where a commercial solution may have additional features built-in that are not needed in a particular application.

When faced with a product development project to be produced in medium to high volume, a discussion of product cost targets, time to market goals, development cost objectives, and performance is required before proceeding with the design.  Properly set expectations between the customer and the development team are paramount to being successful.  Trade-offs between market needs and development costs early in the development may be the deciding factor to a long term win.

Bill Johnson – Vice President of Programs and Operations for DCI Engineering Services Email: bjohnson@dciengineeringservices.com

Over the last decade, there has been a great push to move the assembly of printed circuit boards from the United States to Asia and Eastern Europe to reduce cost.  However, this may not make sense for a low to medium volume product, as there are many hidden costs with manufacturing off shore.

The end customer must take the following into account:

1. Labor cost vs. material cost
2. Cost of shipping the product, including duties
3. Language barrier
4. Time zone difference
5. Time to implement product changes (ECO’s)
6. Distance between the end customer and the manufacturing site

There are significant advantages to sourcing a product with a local, highly skilled contract manufacturer, like Columbia Tech, with a strong supply chain since labor is a small percentage of the total cost of a complex product that has a high percentage of its parts equipment-placed.  These advantages include:

1. Flexibility to build small runs of product with significant change traffic
2. The ability to meet with the contract manufacturer as needed, without significant cost and planning
3. Clear, concise communications with production management and staff, without the need of a translator
4. Reduced cycle times between product completion and receipt, without significant shipping costs

The End Customer must take all of the previously listed items into account when deciding whether or not to outsource printed circuit board assembly to other markets, as all items can have significant implications which will affect bottom line profitability.

Phil Provencal

VP PCB Operations

Certainty and Speed
With little room for delays due to management, technical or budget shortfalls, product development and transition to manufacturing have to be done right the first time and on time. In a rapidly growing market, with a product life cycle of three years, a six-month delay can reduce financial return on the product by a third. Due to the overarching importance of market penetration, doubling of the development budget or an increase in the cost of goods in this scenario will impact return by only a few percent. Conversely, in a stable market with long life cycles, increased cost of goods can compromise return on innovation (ROI) significantly.

The clash of development and manufacturing objectives, the ambitions and measures of success for each, puts return on innovation at risk: the growth and strengthening of financial and professional assets factor richly into every subsequent run at innovation, individually and as a team.

Roles and Goals
The goal of Research (R) is discovery; of Development (D) reduction to practice; and of Manufacturing (M) is stable, consistent and high quality replication at reduced cost. The interface of greatest potential conflict is where development (D) meets manufacturing (M). Development and manufacturing are specialized with their own skills, language and culture. All companies are structured to support development and manufacturing as distinct with unique success factors and measures.

Development
• Acceleration and value imperative
• Rate of change is high, steadily convergent
• ECR/ECO’s being processed on the fly
• Assembly workflow partially, informally defined
• BOM in constant flux & varying structure
• Material supply and tracking variably out of phase
• Lowest volume, variable demand
• Adaptive process, distributed teams, methods, tools
• Quality: appropriate workmanship, fit and finish

Manufacturing
• Cost & stability imperative
• Cost of change is high, fully converged
• ECO’s systematic in advance of ship dates
• Fully defined flow, provisioned in advance
• Defined and complete in every respect
• Fully developed, synchronized supply chain
• Higher volume demand, ability to forecast
• Fixed process, centralized control, uniform tools
• Quality: specified, measured verified, adhered to

Indeed D and M attract professionals of differing makeup. Clarity on roles within the Development and Manufacturing teams becomes critically important when integrating these key capabilities. Given a void in the team – an unfilled role – it is always better to respect that the role is not yet filled while seeking the right professional, rather than to ascribe responsibility to a professional from outside the domain. Why violate nature? The D-M transition is uncertain enough without challenges of on-the-job training, the inefficiencies, and added stress on all.

Accelerating Success
Everyone within D and M strives to be successful individually and as a team. Thus the D-M clash naturally rears its head. Return on innovation depends on transition planning in advance of kickoff of the Development, balancing as best understood the matters of speed, design maturity, and manufacturing cost.

It’s meant to be strengthening and rewarding. It builds muscle! Always remember to agree in advance that return on innovation includes both financial return and top quality professional experience for strategic innovation capability. And with each new program, individual and organizational capability is better prepared to maximize ROI!

Central ideas expressed in this article:
Return on innovation (ROI): innovation nets financial, professional and organizational returns
Cultural impact on ROI: integrating cultures of Research, Development and Manufacturing increases ROI
Accelerated ROI: special advance planning and integration are key to accelerated development and ROI
Professional maturity: respect for and learning from colleagues in adjacent specialties add certainty to ROI
Innovation is naturally challenging: change is hard, yet improves capability, ROI and professional rewards.

Matt Haggerty

President, DCI Engineering

As Columbia Tech, DCI and Cogmedix (wholly owned subsidiaries of The Coghlin Companies) have recently completed the selection process for a new ERP system, the entire financial, quality, materials management, manufacturing and operations teams are enthusiastically waiting for the implementation plan to be published. As stated in a recent announcement from the Board of Directors, this new ERP system represents “a major leap forward in capability, functionality and technology” and enables us to again raise the bar and maintain our status as a leading contract manufacturer.

As an engineering design and contract manufacturing entity assisting technology companies with their time to market strategy, it is imperative that we continually explore ways to enhance our internal processes in an effort to create a superior, higher yielding, more efficient model in areas of cost and quality. As part of this system conversion, we will continue this practice using a Business Process Modeling approach to optimize our organization’s processes to the benefit of both internal and external customers. Everyone will take an active part and no single area will be exempt from our project.

In an environment where we have grown accustomed to continuous improvement initiatives (The “Coghlin Culture”), the ERP system conversion and Business Process Modeling will continue to energize our key department leaders and their valued associates and allow for a deeper dive into continuous improvement efforts in every area of our company enabling world class quality, pricing and customer satisfaction.

Bob Brunelle
VP Operations and Technology Advancement
Columbia Tech

There are many differences in working in a compliant, finished medical device manufacturing facility when compared to a non medical device manufacturing organization. I have been fortunate enough in my career to have worked in both types of organizations within Coghlin Companies. Coghlin Companies has two manufacturing companies under its umbrella; one of which is a broad market based contract manufacturing (CM) environment, Columbia Tech, and the other is Coghlin’s FDA compliant medical device manufacturing company, Cogmedix. Currently working in the medical device manufacturing field as a Project Manager, I have learned the importance in the differentiating factors driven by compliance between the two types of service providers.

As a finished medical device contract manufacturer and specifically according to the Cogmedix Quality System, we take exception to design related activities. We collaborate very closely with our customers and assembly personnel and provide the experience to offer manufacturing simplicity recommendations, but in the end it is our customer, the design specifier and manufacturer of record with the FDA, who owns the complete design and documentation package. We rely on our customers to release changes to Cogmedix through a controlled ECO process. However, with any release of such product packages we will review and perform documentation validation and report our findings, as well as feeding back those suggestions for improved manufacturability to our customer. Our experience and ability to provide this service is essential to maintaining superior quality and reducing costs to our customers.

As a Project Manager at Cogmedix, a lot of the compliance work is done “behind the scenes” in preparation for production. From maintaining and developing complete Device History Record (DHR) work order routing documentation, to designating and sending the “critical components” through our incoming inspection process, it is important that we have complete traceability of the products we manufacture, most times all the way down to the component level, and the human resources that performed each task along the way. Other compliant activities that need to take place before we go into production are the creation of the Device Master Record (DMR), contract review, and NPI (New Product Introduction). During the NPI process, we capture any and all special requirements needed for production. It could be something as simple as a tool or something more complex such as environmental conditions, but it is important that all these items are outlined at this stage of the project in order to make a smooth, compliant transition to the floor. Other topics covered and documented in the NPI process that are very specific to medical device manufacturing include:

• Serialization/tracking requirements – Cogmedix maintains serial number traceability documents for all units manufactured for each individual customer.

• Routing setup for the Device History Record (DHR) – an internal word document is created for each level of assembly that captures revisions of all documents used in the assembly, checks and balances for each step of the process, and sign-offs for each operation by each operator.

• Assuring suppliers are on the Approved Vendor List (AVL) – customer required suppliers or any new suppliers that are not on the existing AVL will be added according to the appropriate internal processes and procedures.

• Life of product and retention time determination – Cogmedix maintains all product records for the length of time directed by the customer, which is no shorter than the expected life of the product and in accordance with all FDA requirements.

• Risk analysis – all processes and procedures of the product are outlined to determine potential risks and hazards from the kitting process right through to the packaging of the finished device.

• Device History Record (DHR) checklist – all documents essential to the final, finished device are outlined and verified by both the Project Manager and Quality Manager before the product leaves the facility.

• Creation of torque verification sheets – any customer defined torque requirements are captured on an internal document which travels with each unit for sign-off at the appropriate stages of the process.

• Critical component traceability – any item or component that is deemed by the customer as critical, Cogmedix will determine the best way to document the serial number of such components in the DHR package. This could be a simple photocopy of a serial label or a defined sequence in the work order routing document, but any recording is required before installation into the final product.

• Process Validation Report – in conjunction with the Director of Quality and Compliance, the process validation report is documented using a defined number of units that captures all documents required for the build as well as any discrepancies or uncertainties in those documents.

These are just some of the activities that set Cogmedix apart from a non-medically focused contract manufacturer.

Joshua Paquette
Project Manager
Cogmedix