Question

In: Operations Management

You are the Operations and Supply Chain Manager for the ACME Medical Device Manufacturing Company, LLC....

You are the Operations and Supply Chain Manager for the ACME Medical Device Manufacturing Company, LLC. (ACME). Superior Medical Devices, Inc. (SMD) has approached ACME about contract manufacturing a new medical device. The device will be assembled and tested by ACME and then ACME will maintain a consigned inventory for direct shipment to medical facilities upon demand. Some of the components you will include in the product are: Microprocessor & Printed Circuit Assembly Rechargeable Battery Injectable Pharmaceuticals Custom Case

You will have to:

Subcontract some of the assembly and fabrication to suppliers.

complete the production engineering process

verify you quality assurance and processes meet the requirements plan and schedule both materials and resources

The items below are what you should address in your report:

What are your concerns? Prioritize them.

Define the flows of information and connections between ACME and your suppliers.

Define the flows of information and connections between ACME and SMD.

What teams (internal and integrated with the supply chain) will you establish?

What are the most critical attributes of the relationships? For instance, Trust, Cooperation, Reliability, etc. How do you foster them? Don't just repeat the words that I listed or add a new one, define why they are critical.

Expert Solution

1. Conerns in Priority Order

Priority	Concerns
1	Is the design of the Product ready
2	Will SMD share the design and specifications or just the concept?
3	Can ACME suggest alterantions in design to ease manufacturability
4	What are the testing requirements
5	What is the procedure to do assembly
6	Whats the production volume SMD is looking at
7	Whats the lead time for prototype development
8	When is the likely schedule for production start?
9	Does this product require FDA approval? Whose responsibility is that?
10	What are the payment terms from SMD
11	What will be the program life?
12	Is SME ready to carry inventory or ACME should carry it to esure on time delivery?
13	Who are the potential vendors ACME for this program?
14	What shuld be the selection criteria for vendors
15	For the PCBs, will SMD be doinf the program flashing or is it in ACME's scope?
16	What are the uncertainities and risks involved in execution?
17	How will the risks be mitigated?
18	How much buffer should be considered in the Project schedule

2. Flow of Information between ACME & Suppliers

Requirements & Specifications from ACME for suppliers to quote price

Purchase Order to selected suppliers from ACME

Sharing of Final documents for manufacturing from Supplier

Schedule for progress monitoring from ACME

A risk register to monitor actions on identified risks from ACME

Engineering review document from ACME

Frequent progress update from supplier

Inspection reports and process documents for completed parts from supplier

Invoice and packing list for dispatched parts from Supplier

Payment from ACME as per agreed terms

3. Flow of Information between SMD & ACME

Purchase order from SMD

Final documents for manufacturing from SMD

Schedule for progress monitoring from SMD

Frequent progress update from SMD

Assembly Procedures from SMD

Testing Procedures from SMD

Test reports from SMD for prototypes

Production Clearance from SMD

Production Schedule and inventory requirements from SMD

Inspection reports and process documents for completed parts from ACME

Invoice and packing list for dispatched parts from ACME

Payment from SMD as per agreed terms

4. Team

Project Manager

Engineering Representative

Procurement / Supply Chain Engineer

QA & QC Engineer

Assembly Engineer

Testing Engineer

Logistics Representative

5. Critical aspects of relationship would be reliability of Supplier, Open Communication, Being Pro Active, and Responsiveness

How to Foster them:

a. Reliability of Supplier

By communicating with Supplier, evaluating the supplier’s processes and systems, supporting them in understanding requirements, ensuring that everyone is in same platform, evaluating the critical parameters and make them understand the functionality of the product etc.

b. Open Communication

Being transparent, communicate early, follow up for requirements if not received on time, let the other party know about good and bad events early enough so that they can plan their actions.

c. Being proactive

Plan in advance and track the plan, track risks and ensure they are not happening. In case of a risk occurrence, be early to act with the mitigation plan

d. Responsiveness

Respond to any requirements, emails or other modes of communications or request immediately, don’t procrastinate or postpone it. Sharing information in time helps advancing faster.

keosha answered 3 months ago

how you think economics impacts a manufacturing medical device company?

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