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The quality route to market for the world’s best medical devices “There’s a lot of risk associated with manufacturing a medical device, so we need to feel confident that we’ve entrusted this work to people who are capable of getting it done. Synecco gives us that confidence.” Jack Griffis, Vice President, R&D MedShape, Inc


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The quality route to market for the world’s best medical devices Trusted partnerships are the key to driving out cost and meeting rigorous safety requirements. Leading medical device brands trust Synecco to deliver services across the product lifecycle: from concept and prototyping to manufacturing and worldwide logistics. From our global headquarters in Ireland and our Asian headquarters in Ningbo, China, we help deliver on your vision: – Design services deliver completed, compliant devices that blend intuitive function and aesthetics – Global supply chain solutions permanently reduce your cost base and accelerate time to market – Commercialization of novel concepts working with clinicians and entrepreneurs

A simple solution to the challenges of Asia Synecco services span the full lifecycle of medical devices, from ideation and concept generation to high-quality manufacturing and logistics at the lowest total cost. Embedded in China for nearly a decade, Synecco’s Asian headquarters gets you to market faster, utilizing our network of partnerships with high-quality manufacturers and our unrivalled skill in optimizing and managing global supply chains. Learn more about our global supply chain solutions.


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Introduction to our services Design services

Global supply chain solutions

Discover the di rence Synecco can make to your competitiveness and time to market. Our design engineers help you develop innovative medical device concepts that answer genuine end-user needs, and rapidly transform your concept into functional and visual prototypes. Our experience in managing the full product lifecycle of design, manufacture and logistics allows us to transfer your design into coste ve manufacturing solutions. We can also help you explore enhancements or applications for existing products. More

Synecco is setting the standard in supply chain ve, streamlined excellence, delivering highly e manufacturing processes to create value. Our customers are empowered to meet rigorous quality requirements at the total lowest cost, thanks to our exibility, continuous process improvement and leaner operations across the full supply chain. Our track record in optimising complex supply chains and successfully challenging traditional business models has earned us our reputation as innovators in medical device manufacturing. More

Commercialization Services Bringing a new medical device or product to market can be a daunting and costly exercise. Synecco’s commercialization service is a comprehensive and logical sequence of steps to help you on this journey, including advisory services, commercial acumen, business know how, design services and supply chain management solutions. More


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Contents and quick links


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Design services for medical devices

6

Global supply chain solutions

8

Commercialization of new medical devices

10

Medical device design, manufacture and logistics: a single point of contact

12

Our people

14

About Synecco

18


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Design services for medical devices Discover the difference Synecco can make to your competitiveness and time to market. Our design engineers help you develop innovative medical device concepts that answer genuine end-user needs, and rapidly transform your concept into functional and visual prototypes. Our experience in managing the full product lifecycle of design, manufacture and logistics allows us to transfer your design into costeffective manufacturing solutions. We can also help you explore enhancements or applications for existing products.

Enhance your brand through distinctive design We believe in hard-working products which are intuitively and attractively designed, are ambassadors for your brand and are robust for end-users. Our design engineers challenge you and themselves to develop desirable, user-centred designs that communicate quality, workmanship and usability, moving your product beyond a functional to a highperformance medical device. Maximum control, with minimized time to market

Synecco brings an unrivalled, holistic outlook to product design, balancing strong product aesthetics and ergonomics with the demands of manufacturing and assembly. Our design control process takes account of all critical factors from the start, through design definition, verification, validation and transfer, to production. Learn more about our proven track record in medical device design. Our knowledge of the complete path to market means that our designs are manufacturing-aware, and lets us offer targeted assistance with design for cost-reduction, design for regulation and design for packaging.

Locating our design team in Ireland allows customers to deal with the convenient GMT timezone for the design process; our design engineers also draw on a global network of subject matter experts to support design, development, prototyping, tooling, testing and evaluation. Seamless transfer of your design to production via our Asian headquarters in China ensures continuity of control through to manufacture, where our local engineers can deliver final refinements in response to production line requirements. The Synecco teams in Europe and Asia work as a unit to deliver 24/7 progress on your product, to minimize your time to market.


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Contact us to learn more about our services for medical device design, prototyping and testing:

– Design thinking platform – Product definition – Inventive problem solving

“The design capability Synecco has here in Ireland is very good. I was very confident in their capabilities to help me to deliver on the vision of what we needed to do with the design for version 2 of our product.”

– Concept generation – Industrial design – Design for manufacture and assembly (DFMA) – Engineering and development – Prototyping – Verification and validation – Product testing – Design transfer to manufacturing

“Synecco bring design expertise, and they understand our business and our needs. We trust them because they always deliver what they say they will.”


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Global supply chain solutions Synecco is setting the standard in supply chain excellence, delivering highly effective, streamlined manufacturing processes to create value. Our customers are empowered to meet rigorous quality requirements at the total lowest cost, thanks to our constant drive to deliver flexibility, continuous process improvement and leaner operations across the full supply chain. Our track record in optimising complex supply chains and successfully challenging traditional models has earned us our reputation as innovators in medical device manufacturing.

Your guaranteed route to lowest total cost, at the required quality A reliable, well-managed supply chain helps you achieve the customer satisfaction levels that your reputation depends on. An unreliable supply chain, or one that relies on unknown players, can introduce unacceptable risk to your operations. At Synecco, our partner network and expertise in supply chain management help you deliver on your commitments. At Synecco we draw on our unrivalled network of reputable partners in tooling, manufacturing and global logistics to create your ideal supply chain: with the shortest supply leadtime, lowest order leadtime, minimal stock and work in progress, to the lowest total cost and expected highest quality. Our Asian headquarters in China allows you to tap into our embedded team of skilled engineers, quality and logistics experts. And because we are technology and process agnostic, we’re able to connect you with the best platform to deliver on your requirements, cost-effectively. The end result for you is significantly reduced risk and lower capital investment in bringing your medical device to market.


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Contact us to learn about our manufacturing and global supply chain solutions:

– Bringing a ‘frozen design’ through tooling preparation – Validation and testing – Injection moulding – Tooling – Extrusion – Sterilization – Pilot test and full scale manufacturing – Production ramp up – Global logistics: shipping and warehousing

“We’ve worked closely with the local team in Synecco’s Asian location, and they have been very responsive and very helpful. It’s not just their engineering capability and their manufacturing awareness, but also their appreciation of the criticality of medical products. This is a matter of health and human safety, and there’s no room for error. They treat this with the level of quality focus and risk management that we expect.”


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Commercialization of new medical devices Bringing a new medical device or product to market can be a daunting and costly exercise. Synecco’s commercialization service is a comprehensive and logical sequence of steps to help you on this journey, including advisory services, commercial acumen, business know how, design services and global supply chain solutions. Our commercialization service is an ideal resource for funded start-ups, SMEs, clinicians, academics and business incubators needing to make product ideas a reality. Synecco’s pedigree in design, development, regulatory approval and manufacturing of medical devices allows you to jump from concept to production to delivery, in the most cost-e way. We draw on a broad base of commercial, product development and regulatory experience, to deliver focussed, productive assistance working with a range of professionals, from medical device subject matter experts, designers, clinicians and business professionals to practicing doctors. Learn more about Synecco’s management team.

Fast track your medical device idea to seize the market opportunity Our support, guidance and direction will fast track the commercialization of your new product to take advantage of current, unmet or poorly met clinical needs. Our shared-risk approach means that Synecco helps reduce the risk traditionally associated with all new product development (NPD); this innovative approach and our sector expertise ensures the greatest potential of success for your product. We can also oversee regulatory approval, advising nancial, management and other resources required to take your concept through the complete process.


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Contact us to learn about our services for bringing your medical device concept to market:

– We o r immediate access to a network of support systems – Research and product viability services –

cation of commercial opportunities

– Design services (initial product concept and branding through to manufacture and physical delivery of products) – Regulatory environment process management – Global supply chain solutions – Access to a global network of expert teams in the US, Europe and Asia – Commercial acumen and business know how

“For us, timelines and budget are critical: we know we can trust Synecco to design and prototype within those parameters, and do it well.”


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Step 1 Definition

Step 2 Concept generation and selection

Step 3 Development

Step 4 Prototyping

Step 5 Verification and validation

Medical device design, manufacture and logistics: a single point of contact Our real-world expertise in critical areas like ideation, regulatory approval, transfer to production, and manufacturing and logistics allows you to simplify and focus on your core business.

Synecco offers a fully comprehensive service that spans the full process of developing and bringing a medical device to the end customer: 1

Our design team works with your in-house resources to define the product.

2

The team uses advanced, proven design techniques to develop genuinely innovative concepts.

3

Our engineering team develops the concept through DFMA, adhering to ISO13485 design control process.

4

We provide a full prototyping service from early concept evaluation to soft tooling.

5

We fulfill Design Verification Protocol requirements, ensuring the process is verified, the product is validated and production ready.


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k Cp

PQ /OQ/ 1Q

Step 6 Tool design and manufacture

Step 7 Quality control and quality assurance

Step 8 Production pilot and full scale assembly

6

We provide full tool design, analysis, testing and manufacturing services.

7

Our QA/RA personnel ensure that client validation requirements are satisfied. We fully support your regulatory needs.

8

We deliver extensive production capabilities, built through a network of suppliers and approved channel partners.

9

We ensure packaging, labelling and sterilization requirements are met.

10 We provide extensive logistical capabilities, up to and including product fulfillment.

Contact us to learn about our complete process for bringing your medical device to market

Step 9 Assembly packaging and sterilization

Step 10 Logistics

“Synecco has done a fantastic job of simplifying our first-generation product. We now have a better presentation to the practitioner, which gives more intuitive functionality. It is infinitely aesthetically more pleasing, it’s more comfortable for the patient, and it takes a major amount of complexity and cost out of the manufacturing process.”


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Our People

Bernard Flynn Executive Chairman

Tony Doherty Chieff O Chi Operations i Officer

Bernard can advise you on: – Driving innovation in business models

Tony can advise you on: – Getting your product to market faster

– ‘Out of the box’ thinking for your business

– Optimizing your supply chain at the lowest total cost

– Linking knowledge from academia, business and clinical areas to create value View bio

– Incorporating Asia into your business model View bio


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Gary Yu Quality Manager

Mark Costello Design

Gary can advise you on: – Quality management and risk mitigation for medical devices

Mark can advise you on: – Maximizing product potential through design

– Design verification requirements – Product and process validation View bio

– Getting the best value out of the NPD process – Optimizing outputs from multi-disciplinary teams View bio


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Our People

Vanessa Ryan Finance Manager

Luo Xianyong Operations O i M Manager

Vanessa can advise you on: – Optimizing supply chain through multicurrency environments

Luo can advise you on: – All aspects of engineering, quality control and logistics for medical devices

– Financial impact of logistics and importing

– Designing the most efficient supply chain to meet project requirements

– Global perspective on transactional activity View bio

– Expediting time to market whilst minimizing costs View bio


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Dr Declan Bogan Head of Ideation and Strategy

Louis O’Neill CFO

Declan can advise you on: – Managing your design and manufacture outsourcing needs

Louis can advise you on: – Project feasibility, structuring and financing to assess potential

– Creating new product opportunities through collaborative networks

– Business model development to maximize returns

– Best practices in innovation for the medical device sector View bio

– Working capital and supply chain management to minimize cash investment View bio


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About Synecco Founded in 2004, Synecco was established with a vision of helping companies meet market demand for well-designed, efficiently manufactured medical devices. We established our Asian headquarters in China and our global headquarters in Galway, Ireland, to provide an ideal East-West team that spans the complete product lifecycle, from original concept through to high-quality manufacturing at the lowest total cost. Medical device companies trust Synecco as their single point of contact for our full range of services, from concept development through pre-prototype and prototype fabrication, to manufacturing and global logistics.

Synecco’s management team features a unique combination of commercial expertise, ideation and design strength, along with supply chain and logistics experience, grounded in a strong comprehension of the medical devices and plastics sectors. Learn more about Synecco’s leadership


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Why choose Synecco?

– wide portfolio of customer experiences including the world’s top medical device companies

“There’s a lot of risk associated with manufacturing a medical device, so we need to feel confident that we’ve entrusted this work to people who are capable of getting it done. Synecco gives us that confidence.”

– skill in managing and optimizing your supply chain, to deliver the highest expected quality at the lowest risk and cost. More

Jack Griffis, Vice President, R&D MedShape, Inc

Our unique combination of product design and proven supply chain management, centered on manufacturing in China, offers you the single most powerful route to market for new or existing products needing to add value and drive out cost. Learn more about our:

– delivering on the need for speed, with rapid prototyping and 24/7 project turnaround for your design. More – shared accountability approach for medical device entrepreneurs, which protects your investment and minimizes NPD risk. More – ISO 13485 quality-controlled process for design, manufacture and logistics. More


Contact Us Please contact our team at Synecco if you need any further information or if you would like to arrange a consultation: info@synecco.com www.synecco.com

“Synecco have handled all aspects of developing the accessory kit — that’s important to us because we need to focus our resources on our core technology. A lot of work goes into commercializing a medical device, regardless of whether it’s an accessory or a permanent implant. Synecco were able to take on the responsibility of doing all that.”


Synecco corporate brochure