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Cardio Command Assessment

a. 1)
– Cardio Command Assessment on FDA registered original equipment manufacturer
– Heavily regulated
– ISO certified (Internal Organization for Standardization)
– Must meet several requirements in order to maintain certification
– Regulatory requirements
– 2 kinds of concepts: Technology and Market driven
– Cardio Command is more on the technological side
– Research and Design team creates new technology i.e. pipeline into a funnel, not all products that go through come out. Some products fail along the way, others make it through and fail afterwards.
– Benchmark competition
– Reduce costs; cost saving activities, process improvements, commercialization process ties into improvements
b. 1)
– Regulated and certified
-There is a quality system in place to ensure requirements are met
– There are 4 levels: quality manual, policy manual, standard operating procedures (SOP): (document control, manufacturing and inspection), work instruction (more detailed than SOP).
– There is a matrix used to meet requirements. There are procedures used to map the requirements in different regions where products and customers are located
– There are management reviews every quarter that review everything in quality to make sure it complies with standards.
– Quality customer satisfaction, manufacturing quality
– Number of exits to look at before delivering product to customer
– Day-to day operations: production, quality, project team meetings to monitor status and determine the need for improvements
– Quality system procedures deal with the infrastructure of the business. It supports:
• day-to-day operations
• financial process and evaluation
• customer service and data entry
3) Management review and feedback given appropriately
– Weekly quality meetings, monthly team meetings
– CAPA (collective and productive action)
– Internal and external CAPA
– OJT (on the job training) improves performance
– 1 employee went to a leadership conference and other employees attend workshops
– 2 employees are getting OSHA -30 certified and 1 employee has received the certification
– Training is a key process
– looking at data
c) Contact no privy to innovation
– happens on an upper management level. They also search for new opportunities
– They are always seeking new opportunities
– Our contact is not always involved in the innovation process
– Refers to the “pipeline and funnel” technique with innovation
– Techniques and metrics to go through to funnel out products. The process has a number of gates to go through

6.2: Operational effectiveness
a. Look at labor content in terms of products to have adequate preparation
– Delivery and fill rate: percentage of product you can ship to a customer from the time a product is received. They try to fulfill fill rate within 1 day
– High fill rate: products on shelf ready to ship
– Higher inventory costs when fill rate is high and lower costs when fill rate is low
High inventory increases opportunity costs
– Monitor life of materials not conforming: materials are inspected and then accepted and they turn out to be defective when a product is ready to be built.
– The defective material then goes to a material review board  leads to corrective action or further investigation
– Look at date trends to see whether or not it is favorable
– Cycle counting to test if its accurate for auditing purposes: accurate inventory, if counting is wrong, operational costs will increase or decrease
b. SOP for supplier selection, qualification, and requalification
– Monitoring supplier performance
– Suppliers get requalified annually
– They can also be disqualified, or found inactive
1. Monitoring suppliers: any issues they try to consult with suppliers and address issues. This means looking at lead times, paperwork, etc. And then try to resolve the issue directly with the supplier
2. The alternative is to find another supplier. In terms of time is takes severable variables and is time consuming. This sometimes results in poor or mismatched employers.
Cyclical suppliers: change in ownership materials, people, etc. It’s easier to talk with the supplier then try to pursue a new one.
c. 1)
– Regulated by OSHA
– They comply with the rules and regulations
– Chemicals and other potential hazards are dealt with according to guidelines
OSHA-30 training
– Ongoing prevention: safety is addressed during management review and monthly team meetings. There is in specific safety committee
– If there is a an issue of safety, it gets reported to the immediate team leader and then follows the chain of command
– Stay up-to-date with communication
– There are on-site and off-site backups in place to prepare for any disasters
– Keep an updated record of supplier information in case of total wipe-out of information
– Sole sourcing items from suppliers which poses an issue. Sole sourcing: only one person on company that can provide the contractual services as needed. There is a list of such companies, so that is there is any such issue they have safety stock on hand in the event of a disaster.

7.1 (a.)
– 30-day return policy: no questions asked
– Customer service measured by a metric system
– There have been no issues with the system
– There is a complaint system in place: deals with the regulatory requirements
– All complaints are documented, investigated and then resolved
– To date there has not been a high volume of complaints
One of the product lines is proprietary
– it serves as an alternative pathway to drugs
– Not a direct comparison, there isn’t another business that does the exact same as other businesses in the industry. No direct competition
– (Surveillance) Market- trade shows, phone customers
– Management reviews the findings
– Company is not publicly traded, harder to benchmark
b. 1)
– Industry standards
– Fill rate, inventory accuracy and turnover
2) There have been no disasters to report on, just one instance of heavy rain
c. High level of customer satisfaction with rates, on-time delivery and turnaround time.
– High-level of increase in patient outcomes (satisfaction)
No formal survey
– conversing on the phone and at trade shows
2 parts: Design and Development
– small engineering staff on site
– supplemented with an offsite team to assist
– long term relationships
– keeps overhead low
– outsourced CPA
– Manufacturing and distribution: contract resources. During peak demand periods they use a staffing agency
Minimal resources and a lot of outsourcing of materials
– Skill sets: new process- skill sets are well defined
– Use the same criteria for hiring and training
– OJT, SOP, infrastructure training

Internal communication
– management review: mainly operational
– limited audience in attendance: just CEO, president and the president’s advisors
– discuss and handle formal infrastructure
– Topic of conversation depends upon the issue being addressed
– Corrective action with materials is monitored
– Milestones dictate process of corrective action
– Anything significant company wise: President and CEO will communicated directly to organization
– Departmental meetings: production meeting every other week regarding safety and communication
– Every week: production meetings to discuss goals and other staffing, production and materials issues. Also follow-ups from previous weeks to make sure goals were reached
– Other types of communication and engagement: problem-solving, regular one-on-one meetings, annual off-site company event and holiday party
– One or two trade shows a month
– campaign and publications
– Follow GAAP
– FDA regulated and ISO certified
– Internal quality system audits over the course of a year
– Training matrixes in places and documented
– Quality policy: serves the same purpose as corporate mission statement
– Results of independent auditors, FDA looking at quality and auditors for ISO: good standing with limited number of findings from time to time
– No formal ethical rules
– Decent year= Christmas bonus
– Only 1 incident of unethical behavior that resulted in employee being let go
– Good relationship with stakeholders
– Involved in a number of organizations including: Bay Area Manufacturing Association, Upper Tampa Bay Manufacturing Association, Medical Advocacy group, STEM Advisory board for local high schools, and St. Pete College Bioscience credentials committee
Increased sales
– Doing more with less
– Strengthen core competencies: do more without investing more money. Training properly and effectively ensures this
– Intelligent risks: minimal customer complaints and minimal patient risks. They are about managing these at Cardio Command
– Overall goal is to increase sales and remain viable
– Improve patient outcomes for people using products.


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