So, you’ve settled on a concept for your next orthopedic device. Great! Now it’s time to embark on myriad feasibility, development and commercialization actions. We’ve compiled best practices for six critical steps – from patent opinions to manufacturing decisions – to assist you through your process.
1. SEEK PATENT OPINIONS
Intellectual property (IP) opinions can help you determine whether moving forward with a product patent is the right choice. There are several types of opinions, depending on what you’re seeking to determine.
Patentability Opinion: Perhaps the most foundational opinion to obtain, a patentability opinion digs deep into public records to determine whether it’s worth the money to seek a patent. Meaning, is your invention new, useful and not obvious, or has someone already come up with it? A registered patent attorney can conduct the search, review the results and provide you with an opinion on whether or not your idea is patentable. This can help you determine the likelihood of success in obtaining a patent, while at the same time shedding light on existing inventions that may be similar.
Freedom to Operate (FTO), or Clearance Opinion: This one is a must, and you have to obtain an FTO before you make a significant investment to consider the risk of moving forward without infringing on another company’s IP. Providing a registered patent attorney with a complete, clear description of your invention will help them develop comprehensive search criteria and strategy, review the results, and identify any patent applications that may be infringed upon by your technology/product/process. Ideally, the process will present a clear path to patent, but if it indicates infringement, it will help you determine whether to redesign your invention or abandon it altogether. The final opinion should be a complete, formal written opinion to evidence the conclusion of non-infringement – this is an important step in the event that a judge needs to review the FTO to determine whether it is competent or not engaged in an infringement case.
Validity Opinion: Validity opinions are a good way to determine whether an identified existing patent is valid and enforceable. It’s also worth obtaining if you plan to buy or license a specific patent — if the patent is invalid, a license isn’t needed for the invention. Validity opinions are also useful during mergers and acquisitions to determine an accurate IP portfolio. They are different from the other patent opinions in that they can be used very effectively either offensively or defensively, depending on the business circumstances.
2. THINK BIG PICTURE WITH YOUR DESIGN
Designing a product can often feel rushed, fall flat or just be an adequate solution to a problem. But starting with a bigger-picture mindset and looking beyond the obvious can help to create truly amazing products.
To take an entrepreneurial engineer approach to design, look at the full problem in context at a high level to think through an elegant solution. Gather ideas by asking yourself questions such as, “Is this a symptom of a bigger problem?” or “What’s happening in the overall system?” Talk with the people who are most affected by the problem (usually a medical provider or surgeon) to find out precisely what they need. Observe the problem in practice. Interview other stakeholders. Brainstorm with other engineers, and bounce ideas off of one another.
Next, create a rough prototype to test and explore your concepts in a physical space. This will help you see what does and doesn’t work and iterate before spending a lot of time and money on a CAD design. Keep stakeholders like sales, marketing and machinists involved in the process and get feedback and buy-in throughout.
Save your CAD designing for (almost) last – you should already have a complete idea of what you’re modeling before you put time into a CAD program. When you create the CAD models, start with everything you know (sequence of components, shape constraints, etc.) before figuring out the final unknowns. If your product has range of motion or configuration changes, look at various snapshots at various points of time to learn and iterate.
The very last thing you do before presenting your design is analyze it. Use standard engineering calculations to verify your fine element analysis (FEA) after your CAD design is complete.
3. DEVELOP A REGULATORY STRATEGY
Regulatory requirements are constantly evolving and becoming more complex. If you go into product development with a robust regulatory strategy, it can maximize your chances of achieving your goal and potentially give you a competitive advantage.
Start by involving internal stakeholders to brainstorm which aspects of your invention have regulatory impact. This team should include regulatory, R&D/engineering, marketing and medical/clinical affairs, at the minimum. Together, identify aspects such as intended use of the product, its design and features, proposed claims, similar products, target markets, anticipated supportive data, anticipated regulatory concerns, jurisdictional concerns, postmarket concerns and the potential need for post-approval studies.
Next, conduct regulatory intelligence on possible precedents. You can often find analogies in other products, even in areas outside of orthopedics, that could help to inform your strategy. Start with FDA’s website for guidelines on requirements and necessary tests/studies for clearance, and use the databases on MDRs and recalls to gain insight into postmarket concerns. The clinicaltrials.gov website is also helpful in identifying which products are in clinical investigation.
Then, it’s time to document the strategy. Triangulate the various precedents you’ve researched to determine what regulatory issues there may be for your product and ways that your strategy can address them. Document the following:
- Advantages and disadvantages of various pathways to regulatory compliance or approval
- For a 510(k) device, a comparison between your proposed device and predicate devices
- Anticipated preclinical testing requirements
- Whether clinical data may be required
- How available existing data can be leveraged
- Likely concerns of regulatory authority representatives
- Proposed timelines
Finally, verify the strategy’s viability by seeking input from internal stakeholders and a regulatory authority (if deemed necessary). Understand that the strategy evolves along with regulatory requirements and internal changes, so it will need to be revisited often and adjusted as needed.
4. DESIGN FOR MANUFACTURABILITY (AND OTHER FACTORS)
Design for Manufacturability (DFM) is an essential step to provide manufacturing input during the design process. A successful product needs to meet a market need at a price the market is willing to pay at a time when the market wants it, and DFM can influence all three of these areas.
But the concept can also expand to several other factors, including designing for assembly, inspection, low cost, manufacturing efficiency, business needs, manufacturing throughput, packaging/transportation, etc. All of these factors and any additional ones are collectively referred to as DF(x).
The key is to start early in the process when first evaluating design inputs (informed by user need). You can leverage DFM by keeping in mind design, material, product launch, throughput, datum structure, material removal and additional DF(x) considerations.
In general, the keys to unlocking the benefits of DFM include:
• Change the approach from DFM to DF(x)
• Start early
• Define the priority of customer and business needs
• Trace outputs back to needs to evaluate design alternatives and avoid costly options
• Be careful of parametric designs – the time saved upfront could be lost down the line
• Be mindful of potential conflicts of interest – would a supplier be motivated to manufacture a costly design to increase revenue?
5. FOCUS ON USABILITY ENGINEERING
Emphasis on product design safety and competitiveness in the orthopedic space are driving the need for an increased focus on the human factor and usability engineering. Human factors/usability engineering intentions, risk and testing are part of FDA’s premarket approval process and are sometimes required for a 510(k). The release of new guidelines and increased international attention on human factors should drive manufacturers to demonstrate the value of human factors to their organization.
It’s not just necessary because of regulations — it’s also just good business practice to do good human factors. You’ll likely be more competitive, have higher sales and fewer complaints, returns and recalls. And if it’s an easy-to-use product, you’ll spend less time training people.
One of the best ways to incorporate usability engineering is to have a person dedicated to that role at your organization. If that’s not possible, the engineer should be specifically trained in human factors engineering. It’s imperative to include input from several departments as well as stakeholders on the clinical side from the very beginning of the design process.
Understanding what tests will be performed to collect user expectations and clinical outcomes data is crucial for manufacturers. While clinical trials focus on effectiveness and safety, usability studies focus on user expectations and safety, which is an important distinction.
The biggest factor in usability engineering is how intuitive the design is for the person who will be using it. Manufacturers that consider usability from the onset may have a greater grasp of human factors requirements as well as the ability to measure their device’s viability and lifespan in the market.
6. SELECT YOUR SUPPLIER WISELY
Before outsourcing, it’s important to consider several factors. To outsource or not to outsource … that is the first question. Do you need to outsource or can you handle production in-house? Consider all of your internal solutions first and note where efficiencies can be improved, including overtime, planning and forecasting, internal operator efficiency, equipment layout and bottlenecks and communication.
If you determine that outsourcing is the right approach, the next step is to determine exactly what components, processes and/or services you are outsourcing. That will help you determine the right supplier. Evaluate potential suppliers’ manufacturing methods, testing and inspection requirements, assembly techniques, complex programming, specialty materials and other critical features to make sure that they stand up to your capability requirements.
The final question you should ask yourself is, are you prepared for outsourcing? Take a look at the following elements to determine if your team is ready to send out RFQs:
• Determine whether all of your stakeholders are in agreement on the decision to outsource.
• Review drawings and specifications for clarity, and look for missing details.
• Review documented inspection requirements and techniques to make sure they are clear.
• Outline acceptable alternate manufacturing techniques.
• Include the impact on overhead absorption.
• Outline any alternate strategies for core and outlier sizes or items.
Following the six best practices outlined above will help put you on a solid path to product development and commercialization. Though some steps seem to be common sense, it’s always important to thoroughly review and document your protocol, design, tests, feedback and iterations to make sure that nothing is missed to cause issues later in the process.
Heather Tunstall is an ORTHOWORLD Contributing Editor.