Bringing a medical device to market is no small feat. It’s not uncommon for an established device company to pour millions of dollars into a novel device concept, only to have an unsuccessful market launch after spending years of development and millions of dollars. Or, to see a device come to market and flop, even after years of development with millions more poured into the concept after launch.
In medical device development, ideas are abundant, while the expertise to develop devices is much harder to come by. Hence the millions of dollars and years invested into taking an idea from the back of a napkin to the operating room.
Here are two typical development and manufacturing scenarios:
Scenario 1
The company has an idea and perhaps an early prototype. It goes to a design and development firm to formalize the design of the product. These firms can take your concept from simple drawings to production ready.
Scenario 2
The company has a much larger and more robust team or has already worked with a design and development firm. The device is ready for manufacturing but needs a contract manufacturer to bring it to life. The drawings are done, the design is final, all the boxes checked, and a product ready to be made and sold.
Each scenario calls for a different type of organization to partner with at a different part of the process–design and development on the front end, and contract manufacturing on the back end. But how do you maximize the value of each of these partners?
Design and Development
- Channel the Customer
- Always come back to the customer needs and inputs. This should guide the process.
- Lean on Partner Expertise
- You hired them for a reason. Understand what they are great at and then utilize that.
- Meet the Team
- In person meetings are invaluable. Determine how best to work with the team, tour their facilities, see products they have made that are similar, and understand their processes and capabilities.
- Don’t Outsource Everything
- Bring your experience and expertise to the table, but don’t be afraid to ask questions about the process and requirements. Do your research and homework on the regulations and requirements so you are not blindly entering into the process.
- Be Cost Conscious
- Design and development “scope creep” can quickly get out of hand. Finding trendy materials or slick components may be great, but there are tradeoffs between what is necessary while staying within budget. Price and cost should be at the forefront of the discussion and adhered to throughout the process.
- Be Even More Value Conscious
- You can make a device for free and still have no one who wants to buy it. It can be easy to make assumptions about solutions, so make sure there is value in what you are making. Leverage rapid prototyping and iterative processes to ensure functionality and usability.
Contract Manufacturer
In theory you bring a product to a contract manufacturer that is ready to be made. Assuming that’s the case, focus on the following:
- Ask the Right Questions Up Front
- Understand lead times, production timelines, and where you fall in the order of their operations, etc. It can cause problems when you move into production only to learn that there are 8 customers ahead of you on one machine and orders are due.
- Ask About Other Capabilities
- Aside from manufacturing, are inventory management, logistics, or continuous improvement programs something you could partner on? You may be missing all your contract manufacturer has to offer.
- Understand Their Regulatory and Quality Systems
- A medical device is only as good as its compliance. Understand where your contract manufacturer falls on the regulatory and quality continuum. Vet the QMS with their compliance team, and make sure to ask even the most basic questions and get explanations for everything so there are no surprises.
- Plan for the Unexpected
- With medical devices, understanding contingencies may be more important than initial production. What happens if there is a recall, defect, something is out of spec, or a component is backordered? Ask all the scary scenario questions up front and develop plans.
- Think Long-Term
- One of the bigger challenges is moving the manufacturing operation once a product is in production. Understand how you can grow within the contract manufacturer, or if you can grow together. What does that look like?
- Keep the End User In the Conversation
- It’s not uncommon for contract manufacturers to make widgets for the sake of production, and not fully understand how they will be used or the impact they can have on a person’s life. Always level set and remind your partner teams, and frontline operators, if possible, what they are making and why. It can have a meaningful impact on quality.
- Continuous Improvement
- Is your organization or partner driven by key internal metrics to improve their process? Understand what they value and how they achieve continuous improvement to ensure you receive the highest quality products.
Bonus Scenario
While it may seem typical to find separate partners for the front end and the backend of the process, respectively, the optimal path may be to find an organization that can do both. One that can design, develop, and then manufacture.
Here are a few of the benefits of a full-service partner:
- Ability to Establish Deeper, Long-term Relationships
- When you start a new project from inception through production, you can grow together, creating a deeper alignment, and a stronger working relationship.
- Speed to Market
- Because of the depth of relationship and understanding how to work well together, your future projects will go much smoother and faster. You understand them and they understand you.
- Cost Benefits in the Project and Product
- Engineers in a full-service design, development, and manufacturing partner can help reduce costs significantly. Not only in the product by designing for manufacturing, selecting the optimal materials, and ensuring functionality, but also in the project by limiting the need to go back to the drawing board for redesigns, failed design freezes, etc.
- Broader Expertise
- You are not just getting a single point of service. When your partner offers a range of services such as regulatory, supply chain management, and manufacturing, your risk goes down. You also have access to more experts in materials, design expertise, custom manufacturing equipment, etc.
- Higher Quality Output
- Because a full-service partner has experience in developing products with manufacturing in mind, often they will have better output. Designing products without manufacturing in mind can make manufacturing challenging and expensive. It can also lead to higher rates of defect.
While there are plenty of great design and development organizations, and plenty of great contract manufacturers, having a partner with deep expertise in both areas can be invaluable now, and for the future for your company. To learn more about UFP MedTech’s full service development through manufacturing capabilities, contact our team to get started.
