Medical device manufacturers that attempt to handle too many tasks in the product development process without the sufficient level of competency are simply setting themselves up for failure. It is vital for them to maintain a strong expertise in those core competencies and look outside for strategic partners who can aid them. This article examines that for the product design process.

Working closely with an outside partner can offer valuable insights and advantages to technical product development. This collaborative relationship has the advantage of bringing an outside perspective; an external partner can bring additional expertise to a team and the experience gained working across numerous projects and industries. Traditional outsourcing is sometimes viewed simply as hiring contract help to execute specific tasks. However, a strategic development partner can bring much higher value to an organization, including generating fresh concepts and fostering innovative ideas. This partner can offer an experienced, proven team that knows how to plan and execute a medical device project. Having the flexibility to use the team only when needed enables growth and the ability to bring new products to market even during challenging economic times. In addition, many companies have become more focused on their core competencies, often creating the need to partner with an external group to meet the company’s product goals.

Shifting from “Outsourcing” to “Partnership”
When should a company turn to external product development help? How is the shift made from simply outsourcing to utilizing a partner effectively? Following are two scenarios with which the answers to these questions can best be explained.

Scenario 1: Company A has a new drug that needs a delivery device. Or, it has a new detection method or assay and needs instrumentation developed. Or, it has a new algorithm using the body’s electrical signals, but developing a body-worn or implantable device to implement the science is a daunting task.

Case in Point #1
Angiotech’s Atrieve Vascular Snare

For Angiotech to meet the optimal market window for its vascular snare kit, time was a key problem. Angiotech came to Stratos with an aggressive, 10-month project schedule. Stratos quickly integrated into Angiotech’s product development core team and helped identify a design solution that cut months from the project schedule, reduced costs, and greatly simplified the regulatory strategy. In addition, Stratos identified a manufacturing method (direct metal laser sintering, or DMLS) for creating prototype heat treat fixtures that enabled rapid evaluation of prototypes and identified techniques for in vitro prototype evaluation. Stratos managed feasibility and GLP animal studies and authored project documents, including Product Requirements Specification, Project Plan and Verification, and IQ/OQ/PQ Protocols. All this enabled Angiotech to deliver the Atrieve Vascular Snare to market on time and to stay focused on other projects.

“This is the second time I have chosen to use Stratos to augment Angiotech’s Product Development resources. Organizationally, they are able to bring to bear key technical resources to help drive projects to successful conclusion in a timely and cost effective manner.” –Senior VP, R&D, Angiotech Pharmaceuticals Inc.


Scenario 2: Manager B is in a bind. He manages the development group for a larger company and doesn’t have the necessary resources. Or, the software team is lacking the experience in a new technology, such as wireless communications. Or, there is an important deadline looming for a clinical trial and he doesn’t have the available personnel or expertise to complete the development. Or, Manager B is embarking on a development effort and could use some technical investigation, preliminary architecture concepts, or an interdisciplinary team to offer new technology ideas and a fresh perspective on the redesign of an existing product.

Scenario 1 illustrates companies where science or biochemistry is the IP and internal expertise. Here, it may not make business sense to build an internal team to execute the device development. Experienced talent will almost certainly be difficult to find or may not be a part of long-term core needs. Add the time, expense, and risk involved and an external development partner may be the best path.

For Manager B, an outside partner can make the difference between major technical problems—with accompanying schedule delays—and meeting deadlines with a quality product. In addition, a strong product development firm has the advantage of more numerous design cycles and a wider variety of products than a company’s internal team sees. This can result in some innovative product ideas and solutions. An external development partner can augment an existing internal team by providing individualized services, such as applied research or electrical engineering only, or they can provide fully outsourced integrated services for an entire product development effort.

Aligning Culture and Expertise for Optimal Collaboration
A number of factors are important in choosing the right development partner. The most important is finding a partner who has the technical expertise that is critical to the product. Some groups have experience in one or more product areas, such as implantables, low-cost disposables, or patient monitoring software. A product segment, such as body-worn or portable devices, can encompass a wide range of technical areas, including biocompatible materials, low-power analog and digital electronics, battery technology, and embedded software for everything from power management to a graphical user interface to wireless communications.

Even if outsourcing only a portion of the design, a development firm with on-staff expertise in other disciplines can prove to be an important advantage. Integrated product designs are complex and understanding the product from a holistic standpoint results in more innovative ideas and robust solutions.

Case in Point #2
AcelRx Pharmaceuticals’ Drug Delivery System

AcelRx Pharmaceuticals is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain. AcelRx was founded to solve the problems of post-operative intravenous patient-controlled analgesia (IV PCA) by addressing the unmet medical need to reduce the side effects of morphine, address the invasive IV route of delivery, and eliminate the inherent potential for programming and delivery errors associated with the complexity of IV PCA pumps. The company had a strong mechanical engineering team but had limited software and hardware technical resources to respond to the product development challenges associated with programming and delivery errors. AcelRx turned to Stratos, who represented a similarly creative approach and technical depth, to respond to the challenges of electrical and software engineering solution development.

“From the outset, we knew that we had a strong internal mechanical team, but would need a flexible and experienced electrical and software partner. Stratos was selected after conducting diligence on several firms. They have become an extension of our engineering group whereby they design and solve problems in real time alongside our team throughout the development process.”–VP, Engineering, AcelRx Pharmaceuticals Inc.


Take the example of using a partner to design the embedded software and electronics for a hand-held product. If additional individuals with mechanical, acoustic, and user interface design expertise (plus a quality engineering team versed in medical design process requirements) surround this external team, they will be more aware of the important design and development considerations. The team hired can then bring that experience to bear and the development partner can also supply additional short-term expertise to the project as needed.

Culture and fit between organizations are also important. Whether outsourcing the device development entirely, or just using a partner for a portion of the design, good lines of communication between the external partner with the internal team will be necessary, at a minimum. However, the right collaboration can create a synergy that results in a fuller understanding of the product goals and requirements, more informed and innovative concepts, and, ultimately, the right product.

Navigating the rigorous FDA and ISO design requirements is a major challenge, even for industry veterans. Medical devices need to be developed in accordance with the required design controls under a compliant quality system. A development partner with a mature ISO 13485 compliant design control system—particularly one with a long record of success with past products—can allow a fledgling company to undertake device development under the design controls of its outsourcing partner, avoiding or postponing the significant time, expense, and uncertainty of developing some aspects of its own quality system.

The phase of development is another consideration. The project may be at the stage of moving from the lab bench to a proof-of-concept prototype. In this case, the partner will need to have applied research skills and the ability to understand the science in the context and within the constraints of device development. The company may need help with cost engineering and manufacturing transition; a group is needed that has a background in manufacturing process and DFM, as well as strategic relationships with contract manufacturers. A partner could also be the best option for a full product development cycle, from initial research and preliminary concepts through architecture, design, verification, and manufacturing transition. Here, an integrated development firm with a full range of disciplines and services can be the virtual team.

Combining Forces to Deliver the Right Product
A good product development partner will understand that while it is being brought in for its existing expertise, it still has much to learn from the client, including product research and history, IP technical due diligence, user scenarios, specific technology, previous prototypes, and more. Ideally, the individual contributors on the partner’s team should be largely senior-level professionals, with not only proven industry experience but also a successful history of working together as a team.

A partner must have a clear, robust development process that fits the scope and intent of the product, as well as the strategic design goals. While this is essential for the development of all products, it is even more critical in the world of medical devices. Medical product development is complex and multidisciplinary, from the technologies involved to the clinical-use scenarios to the demanding performance requirements, with changes and hurdles to be expected along the way. It is beneficial to find a design partner who can work in a consultative manner and offer insights from the number of diverse projects it has seen and be responsive and adaptive to specific needs.

By using the criteria outlined here as a guide, medical device OEMs can collaborate effectively with an outside development partner to deliver the right product to market.

John Havard is VP of Engineering at Stratos Product Development. He oversees the multi-discipline team of Stratos engineers. Havard can be reached at 206-448-1388 or