Outsourcing development is a strategic approach that can accelerate product development and expedite time to market. However, it requires careful planning and management to ensure project success, especially for those new to product development. The six themes below are critical as you consider engaging with a company to help you get to market.
Requirement #1: Build the right team
So much of what you have done and will be doing hinges on judgment calls by people who have done this before, the people who you have already turned to for advice and who you trust have experience that you can learn from. You also need to acknowledge that expertise has its place; the best people to optimize the path to market are the ones who have walked the path enough to know the shortcuts.
Bringing a medical device to market requires a lot of different people with specialized skill sets working together toward a common goal. Building your core team thoughtfully is the most important thing you can do to increase your odds of a successful journey. Be sure your trusted inner team collectively has a full breadth of experience and the time to devote to directing the activities.
Checklist for building the right team
Do you have the right team at your company to interface with your development partner to make judgement calls and understand the implications of questions?
Have you planned how much time it will take to interact with your partner, and can your timeline and resources support that?
Who is responsible for the overall project schedule, you or your partner?
Are there other people your partner will need to interact with on your behalf? Who is going to watch out for your interests during those conversations?
Requirement #2: Fully validate your science
You have an idea for a new thing—a new instrument, a diagnostic tool, an improved treatment—something that is at the heart of why you are doing what you are doing. But before you jump into making that idea into a product you need to really demonstrate “the science.”
Do you understand the limits of what makes your core idea work or not work? Have you been able to prove that it works, or is it still just a theory or idea? If you don’t know for sure it works, the problem you need to solve first is answering that question.
This is not to imply that you can’t take a calculated risk to start product development early, but understand that the more developed and proven your science is (as evaluated by the experienced engineers who will be implementing it) the less risky and costly any new learnings will be to your company.
Checklist for validating your science
Can you write down your key differentiator such that a knowledgeable person not affiliated with your project can logically follow it?
Can you write a process document or requirements document that precisely describes the steps for your “science”?
What areas have you only been able to simulate or prototype because of lead time or expense limitations? Do you understand the risks of not being done?
Solving the wrong problem can cost you your business
Requirement #3: Vet your business plan and product strategy
In addition to nailing your “science” you also need to make sure your end-to-end value proposition and business model have been vetted and all the assumptions are solid before you seriously invest in product development.
Vetting all parts of your business and product strategy becomes just as important as vetting your science: your investment strategy, regulatory strategy, reimbursement model, your marketing. Do what you can to make sure your whole plan is solid before investing in developing your product.
Solving the wrong problem can cost you your business, as one of our clients learned when they invested in new development without realizing they first should have been fully vetting their go-to-market strategy.
Checklist for vetting your business model and product strategy
Did you spend enough time to vet all aspects of your business model?
Have you found experts in the field who agree that the product you are trying to develop is actually needed at the price point you can deliver?
Does your regulatory strategy have any unknowns in how or what you need to submit?
Does your reimbursement strategy align with your expected ROI?
Requirement #4: Select the right partner
Successful outsourcing begins with careful planning. It’s crucial to clearly define project needs and set early expectations for quality, standards, and documentation. Understanding the product’s immediate and future uses will aid in effective communication with potential partners. Selecting the right development partner is influenced by management style, technology compatibility, maturity needs, and cultural fit.
Considerations for selecting the right partner
Clearly outline project requirements and potential changes. Be clear about the maturity of your product requirements and where you need help to make sure they are solid.
Choose a partner whose expertise matches the project’s technical needs—do you have a preference for the technical tool chain used? Do you need specialized engineering services, and does your potential partner have them?
Align the partner’s maturity expectations with the project’s requirements. For example, if you are expecting a company to help with setting up for manufacturing, make sure they are experienced in doing exactly that.
Talk about your expectations for Quality Management System integration and make sure that is something your partner is comfortable with.
Selecting the right development partner is influenced by management style, technology compatibility, maturity needs, and cultural fit.
Requirement #5: Managing Change
Managing changes in requirements is essential to keep the project on track. Requirement changes, if not managed well, can lead to increased costs, delays, and project risks. To minimize disruptions, employ strategies such as prototyping, effective communication, and careful planning.
Strategies for successfully managing change
Use prototypes to establish a clear understanding of user interfaces and product features.
Communicate critical decisions and changes promptly to adjust project plans accordingly.
Anticipate potential changes and inform your development partner to mitigate risks.
Requirement #6: Defining “done”
As the project concludes, ensuring that the deliverables meet the predefined expectations is vital. Miscommunication or assumptions can lead to dissatisfaction with the delivered product. Set clear completion metrics and involve your development partner in defining these endpoints during the planning phase.
Considerations for project completion
Define and communicate test and quality expectations early in the project.
Agree on issue-tracking methods to prevent misunderstandings.
Plan for post-project support and transitions, discussing expectations with your partner well in advance.
In summary, successful product development outsourcing hinges on meticulous planning, selecting a compatible partner, managing requirement changes effectively, and ensuring a smooth completion process. By adhering to these six principles, you can set the foundation for a positive and productive collaboration with your development partner, and ultimately succeed in delivering
