Martin Dowd, EU general manager, and Emmett McArdle, R&D manager, Avery Dennison Medical, share best practises based on its new product collaborations with device developers.
David Cantwell
Partnering on design and product development is a desirable path for many medical device companies. Why work with a partner? For some, it is a means to accelerate product development. In-house teams can focus on one launch whilst a partner manages another. In other cases, original equipment manufacturers (OEM) may need specific R&D, manufacturing, materials sourcing or other capabilities they do not have internally. Whatever the drivers, there are best practises applicable to any collaborative medical device design and development project
1. Understand your partner’s capabilities
It is important to know the scope of potential partners’ capabilities. For example, some contractors excel in device manufacturing but do not engage in design or regulatory reviews. Some specialise in converting components but do not manufacture finished devices. Others focus on design and prototyping but not mass production. If you need a one-stop shop from design to finished product, look for a partner who has experience handling all processes, internally and in coordination with third parties. Be sure to ask about material customisation, sterilisation, packaging and biocompatibility testing. Also bear in mind that some contractors will only entertain orders that meet a large revenue threshold, whereas others will work with customers on small- to mid-sized jobs.
2. Expect an in-depth discovery phase
A successful collaboration begins with mutual understanding of end goals. A product development partner should invest ample time in the early conceptualisation stage — asking detailed questions and listening. Look for findings to be presented in a term sheet, a document detailing expectations, potential timetables and costs for every product development and manufacturing activity. Alignment on design inputs (requirements) is a precursor to obtaining successful design outputs (finished devices).
3. Prepare to make choices and trade-offs
After the discovery phase, your design and development partner will go into matchmaking mode. This means evaluating different materials, design approaches, manufacturing methods and other variables — searching for solutions to match your product’s performance and price parameters. Inevitably, there will be trade-offs. For example, the perfect material for your application may have a minimum order requirement (MOR) exceeding your forecasted volume. Or the material supplier may lack medical-grade certification, and it will take time and resources for testing. At such junctions, your development partner should offer you choices. Perhaps the desired material can be procured in the lot size you need at a price premium. Will your business model support the cost? Maybe an alternate material will meet most, but not all, performance requirements, such as for breathability, exudate absorption or adhesion. Will it be sufficient? A successful partnership involves continual adaptation to arrive at workable solutions.
4. Keep multidisciplinary communication flowing
From early conceptualisation to device delivery, communication must be a constant priority. To head off misunderstandings and misalignment, it is important to have engagement from multidisciplinary teams from both “sides.” For example, there should be regular, frequent communication between professionals in procurement, R&D, regulatory affairs, sales, marketing and supply chain management, from both the OEM and contracting partner
In conclusion, there are benefits to joining forces with a reliable partner on medical device design, development and manufacturing. In the ideal scenario, your partner will offer flexibility to do as little or as much as you need, depending on your project and product lifecycle — delivering the right product with the right performance at the right price, coupled with commitment to a lasting business relationship.
