Working with Providence Enterprise
From initial assessment to project kick-off: What to expect in the first few weeks.
Stages
Are we a good fit for you?
Our process is straightforward, honed over decades of successful partnerships. Will it work for you
This guide outlines our approach, explaining what typically happens when a customer first shows interest and the stages that lead to project kick-off.
As you review the stages you will come to understand the built-in efficiencies and commitment to communication that help all teams move onto actual work as soon as possible… sometimes in as little as 30 days.
Stage 1: Project Assessment
(2-4 business days)
Customer deliverables: Project overview
Providence Enterprise deliverables: Transparent assessment regarding project fit
In order to ensure that we are the right fit for your project, let’s start with assessing the project.
This initial conversation will cover details about your project, including desired timeline, volumes, regulatory requirements, and manufacturing needs.
Are you a fit for Providence? The quick-glance test
- We can support production of electromechanical products at volumes of 10,000 to 10,000,000+ units.
- If your product involves the following, we are a great fit:
- Pump or motors
- Complex electronics
- High volume disposables
- If you just need to manufacture 10 units a year, we are not the right fit for this particular project.
We will share all relevant information with you about our capabilities, facilities, certifications, product experience, our team, process, and more. This will further demonstrate our ability to fulfill your project requirements.
Together, we will determine whether we are the right manufacturing partner for your project.
Full-Service Capabilities: See The Providence approach in action
Stage 2: Review & Sign a Non Disclosure Agreement (NDA)
(5 business days)
Customer deliverables: Your mutual NDA template
Providence Enterprise deliverables: Alternatively, we can provide a mutual NDA template and will work towards mutually agreed terms.
We engage in a mutual NDA in an effort to protect both parties.
In the spirit of partnership, we look to be open and transparent throughout the project. We will be sharing confidential information with you about our processes and technology, just as you are sharing confidential information with us about your product.
You can expect a thorough review and, if any suggested edits, a tracked version with proposed changes. We also have non disclosure agreements in place with our suppliers to allow for open collaboration with them.
As a starting point, you can provide us with your mutual NDA template or we can provide a template as well.
Stage 3: Request For Quotation Review
(2-3 weeks)
Customer deliverables: Request For Quotation Package
Providence Enterprise deliverables: Proposal including Unit Pricing and Non-Recurring Expenses
Now it’s your turn to share. This is where we are provided information such as:
- 2D/3D Drawings
- Bill of Material
- Electronic Files
- Test requirements
- Packaging requirements
- 2-3 golden samples
The more complete and detailed your RFQ, the faster and more accurate our proposal turnaround will be.
What’s a Golden Sample?
If your product has been produced before, we would appreciate receiving 2-3 golden samples. These would be samples that meet specifications and requirements. Having such samples will enable us to more quickly process the information in the RFQ. It will also enable us to better understand the fit, form, and function of the product.
This information you share will allow us to start our Design for Excellence (DfX) process & checklist. We need to determine, as of right now, the state of your product:
- How manufacturable is it?
- Are the materials and components all still available?
- What are the lead times of those materials and are the costs within budget?
- What does the testing and QA process require?
- What possible supply chain disruptions should we prepare for?
- Do you have designated suppliers and are you open to us suggesting suppliers?
This will inspire a discussion to map out the best path forward. A call between your engineering team and ours may provide relevant context to accompany all the assets shared from the list above.
We talk a lot about DfX and look forward to sharing more with you about our approach. In the meantime, you can read more here about our approach to creating successful medical devices.
Our multidisciplinary team will review your request for proposal and prepare a quotation and project timeline.
Stage 4: Proposal submission
(2-3 weeks)
Customer deliverables: RFQ Proposal Review
Providence Enterprise deliverables: RFQ Proposal
Depending on the project’s complexity, you will receive either a standard quotation or a detailed proposal complete with a timeline and project team breakdown.
We will itemize costs to help you evaluate the unit price and any non-recurring expenses, such as development costs, tooling, and fixtures. Included in our proposal might be suggestions for cost reduction via alternate materials, enhanced manufacturing processes, methods to increase quality consistency, or strategies for working with local suppliers to reduce supply chain complexity.
This will also outline both parties’ responsibilities, for Providence and for you, the customer. It will help to define critical milestones and stages in order to reach these milestones.
Stage 5: Proposal discussion
(0 – 21 days)
Customer deliverables: RFQ Proposal Review
Providence Enterprise deliverables: RFQ Proposal
Should any of your stakeholders have questions about the proposal, the project or our process, we welcome in-person, video or phone discussions to provide more clarity in the proposed approach.
Such discussions could be with your Supply Chain, Engineering, Operations, Quality, and Senior Management teams.
If adjustments to the project are requested, we would address those as well.
Stage 6: Site visit
(Timeline TBD)
Customer deliverables: Confirmation on the location to be visited and quality audit requirements, if applicable
Providence Enterprise deliverables: Set up site visits and support quality audits, as requested
Though we welcome site visits to any of our manufacturing locations, a site visit may become essential at this stage. We have factory locations in Haiphong, Vietnam, as well as Shenzhen and Ganzhou, China that are worth visiting. As a starting point, we have provided a slide show below to illustrate the various points of interest within one of our factories.
In the past, we have supported both on-site visits and virtual visits. Potential and current customers are encouraged to visit us. In the event that a visit cannot be made in person, we can support a walk-through visit via mobile video.
A tour of our facility can take up to 3 hours, but can be expedited based on visiting specific areas.
We’re no stranger to scrutiny
Additionally, a Quality System audit may take place at one of our manufacturing locations.
Providence participates in and passes over 100 diverse audits each year. We are ready to show your team what we’re capable of.
- Our documentation is in place and readily available.
- We have extensive experience with the FDA to make this a seamless experience.
- Audits can be conducted onsite or remote.
- First audit pass rates are in excess of 99%.
- Audits can include FDA audits, SMETA audits, and Quality System audits.
- We have a dedicated Audit Support Team.
- We have supported audits that take from 2-4 days, depending on the type of audit.
Our Factory At A Glance
Pick The Factory Site You Would Like To Visit
Stage 7: Review & Sign Business/Quality Agreement
(2-4 weeks)
Customer deliverables: Business & Quality Agreement template
Providence Enterprise deliverables: A tracked change version with edits to the agreement
A business and quality agreement may be established based on terms mutually agreed upon by both parties and are typically recommended.
Similar to the NDA, we can use your template or we can provide a template as a starting point.
Agreements are typically multi-year and have an option to be renewed. The timing for this process depends on the complexity of the agreement and the resources involved.
Stage 8: Release Purchase Orders & Conduct Kick-off
(1-2 weeks)
Customer deliverables: Issuance of Purchase Order & provide timing regarding project kick-off
Providence Enterprise deliverables: Acceptance of PO and providing project kick-off support
A business and quality agreement may be established based on terms mutually agreed upon by both parties and are typically recommended.
Similar to the NDA, we can use your template or we can provide a template as a starting point.
Agreements are typically multi-year and have an option to be renewed. The timing for this process depends on the complexity of the agreement and the resources involved.
Other Featured Resources
About Providence Enterprise
Providence Enterprise is a Hong Kong medical device contract manufacturer of Class I and II medical devices with manufacturing in China & Vietnam. We specialize in electro-mechanical assemblies and high-volume disposables. We are FDA registered and ISO 13485, ISO 14971, ISO 14001, ISO 27001 certified. Our capabilities include fabricating tooling for silicone rubber and injection molded plastics, clean room injection molding, electronics, clean room assembly, and sterilization.