Top Ten Most Important Considerations for Outsourcing Medical Design

Outsourcing medical design and development is extremely beneficial if the right design firm is selected. External creative input typically provides an in-house design team with a different perspective, new ideas and specialized expertise. 

If the right design firm is chosen, project costs can be more easily controlled, overhead can be reduced, and schedules can be met. Outsourcing also motivates in-house designers and engineers to be more productive on their own projects.

The key underlying challenge is identifying the “right” firm or partner. This paper will hopefully provide you with some insightful parameters to consider next time you are selecting a design and development firm, especially for medical products.

1. Scope of Work vs. The Design Firm’s Core competency

Project planning, scheduling and budgeting requires an extensive amount of time as well as thought. Product specifications and performance criteria are defined during this critical stage of product development. 

That’s why it’s so essential for project managers to remain objective when delegating responsibilities to staff. You want to be confident that everyone has the skills, knowledge and experience to fulfill his or her duties throughout the entire project. Since the staffs of most medical device companies are often comprised of individuals with expertise relevant to that company’s products, there are often gaps in the human resources versus project requirements. 

Therefore, it’s not uncommon for project managers to recruit design firms or individual consultants to full these voids which can include human factors expertise, aesthetics/product branding, plastics design expertise, or simply a complete turnkey design. 

In addition, design firms should be rated based on an evaluation system which quantitatively ranks them based on their total score to comply with your top five or ten project criteria. If they don’t meet ALL of your criteria, choose another one. Don’t settle for inferiority when so much is as stake.

2. Size of firm and Resources vs. Project Requirements

The question of “Does size matter?” often comes up when selecting the optimum design firm for a project. The correct answer is, “it depends on your project requirements”. 

Large medical device companies often retain large firms with hundreds of designers primarily because of security in numbers and the perception that bigger is better. The truth is, quality is not necessarily proportional to quantity. 

Projects requiring a wide range of expertise in optics, chemistry, electrical engineering, human factors, GUI and plastics engineering will require a large staff of highly skilled specialist typically employed at large firms. These projects are usually turnkey programs which are wholly subcontracted to contract manufacturers. 

However, most medical design projects typically require smaller sections of a much larger project to be subcontracted out, in which case a smaller firm would be much better suited. After all, a well-qualified smaller firm is more nimble, personable, cost-effective and most importantly, better qualified. 

Smaller firms are typically staffed with highly experienced and qualified personal with a broad range of skills. They are best suited for start-ups, mid-sized corporations or larger corporations seeking specific skill sets.

3. Budgetary Considerations

Establishing a financially sensible project development budget is always challenging. Budgetary considerations must account for risk, return on investment, amortization, cash flow and available resources. In fact, budgets allocated for outsourced design and development are always the most challenging since the quality of service is not always directly proportional to cost. 

Project managers must estimate the man-hours and costs for completing a set of tasks within a project and identify the best possible fit for a design firm to fulfill their commitments within that budget in a timely manner. 

Since every project always deviates from its original plan, typically requiring additional time, cost control is extremely challenging when you outsource design and development. The best cost control solution is to work with a design firm willing to commit to a fixed budget based on a detailed scope of work. 

In addition, you should assess a firm’s ethics and business philosophy to be assured that every minor change won’t amount to an added charge. Changes in the scope of work should always be pre-agreed upon based on an estimated cost from your design firm. 

4. Timeframe and Scheduling

Every new medical product design project is based on a planned schedule and forecast production launch date. These dates are often based on competition, market conditions, technological trends, cash flow or regulatory changes.

It’s therefore imperative that products are introduced into the market on time, especially of major tradeshows are critical to a major launch. Your outsourced partner is always critical to the project plan and must be fully committed to adhering to the schedule. 

Determining what firm will provide you with the best chances of meeting your scheduling objectives is purely based on only one critical attribute: competency. A knowledgeable firm is well managed, has a proven track record, and is comprised of highly experienced and intelligent individuals who are not afraid of committing to your objectives. 

Firms such as these are typically smaller companies comprised of a hand-picked group of exceptional individuals who can think quickly, be resourceful, work efficiently and communicate effectively within a network of project contributors. 

5. Proximity and Communication

“Location, location, location.” 

Everyone has heard that phrase at one time or another. Although it may be true for storefront businesses, it is not necessarily true for design and development firms. 

The proximity between a medical device manufacturer and an outsourced design firm is undoubtedly beneficial for convenient impromptu visitations, but not necessary for successfully developing a new medical device or a long-term medical product designer/client relationship.

As a matter of fact, most projects require less than two or three face-to-face meetings between a client and outside resource. Since the most important activity in any project is excellent communication, physical location is not as relevant as efficiently sharing updates on project activities between all contributing parties. 

Prospective design firms being considered for a project should be evaluated based on their proven ability to provide timely reports, formal presentations, daily online meetings, emails and comprehensive project history to any level of corporate personnel. 

6. Compatibility of Corporate Cultures

Every manager knows the importance of assembling a team of people who can productively work together toward a common set of objectives. This is undoubtedly the most challenging task for any project leader and is especially difficult when you are faced with contracting with an outsourced design firm. 

Companies, like people, have personalities which is labeled with the term “corporate culture”, which is derived from the top management, corporate policies, financial policies, goodwill and type of business in which a company is based. 

Larger design firms will interact with their clients based on a highly structured set of formal guidelines and policies which are necessary when managing many people. These policies are best suited for very big budget projects issued by large corporations but are totally inappropriate for smaller projects or companies. 

Typically, smaller companies are seeking a highly interactive design firm which can respond quickly and efficiently. They are best suited for a small group of highly talented and experienced individuals with a broad knowledge base who can quickly solve problems. 

Another very important, but difficult characteristic to determine its integrity. A design firm’s integrity is essential for the successful outcome of any medical product development project. Integrity affects the cost, ability to comply with contractual obligations and most importantly cooperating with a client’s team to achieve a set of objectives. 

7. Experience and Reputation

Experience and reputation should never be overestimated. A critical part of due diligence is verifying the reputation and experience of the design firm you are evaluating for your next medical device development project. 

Requesting the names of two to three references who would be willing to be interviewed is an excellent method of penetrating beneath the surface of a sales pitch. Preparing a brief provocative list of questions is highly recommended. 

Key representatives at the design firm should be subjected to two or more rigorous interviews with your best personnel to evaluate their firm’s strengths and weaknesses. The design firm should demonstrate its capabilities by presenting case studies of related projects. These presentations should offer a Q&A exchange during or after the presentation. Benefits of these exchanges are only as good as the questions asked and your ability to critique the answers.

8. Responsiveness and Cooperation

Every project manager requires a team of individuals who are highly competent, intelligent, respectful, able to follow instructions and cooperative. These traits are difficult to find in individuals and even more difficult to find in outsourced design firms comprised of many individuals. 

It’s essential for project managers to trust the design firm they selected to share his / her vision and cooperate with the in-house development team throughout the project. Typically, smaller design firms are easier to integrate into a project because of the limited number of people to manage. 

In addition, smaller firms are far less bureaucratic, more informal and extremely nimble, which enables them to react much quicker to changes in project direction. A design firm’s willingness to cooperate and respond to a client’s needs is embedded in its business philosophy. It is an essential quality which should be tested and verified during the interview process. 

Medical companies and project managers don’t want to be continually subjected to change orders and ballooning costs every time a minor change is encountered during a development program. Although these situations are not binary with an absolute answer, both parties should agree on some basic mutually acceptable terms and conditions to determine when added costs through change orders should be applied to a project.

9. Commitment or Guarantee to Deliver

Every initial meeting with a design firm is oversaturated with countless promises and endless commitments to satisfy every requirement for a given project. Design firms will promise to do whatever is required to win your RFQ. This is typical for most sales calls. However, the commitments tend to become diluted after a formal contract is submitted with numerous terms and conditions. 

Ultimately, most product design contracts are laden with so many exceptions and conditions that there are little to no responsibilities, commitments or deliverables. Design firms should be willing to provide certain guarantees and assume responsibilities for their work. 

Furthermore, if a design firm has been retained by a medical device manufacturer to develop a product to look and function in accordance with a set of written specifications, it should be held accountable for those commitments. It is not unreasonable for both parties to arrive at a list of expectations which must be completed successfully by the design firm. If the accepted list is not fulfilled or work has been incorrectly completed, the design firm should be held accountable and has defaulted on its contractual obligations.  

10. Integrity, Honesty and Ethics

Three words which don’t often appear in business print are “honesty”, “integrity” and “ethics”. Ironically, these three simple words represent the cornerstones of all business relationships and are essential for all profitable business transactions. 

Every design and development project revolves around trust, which encourages all contributors to freely exchange ideas and concentrate creative energies toward solving problems. Mutual trust is essential for designers and developers to have confidence in each other, maintain control of intellectual property and be assured accrued design fees are paid. 

These same traits affect the quality of design work, project costs and project scheduling. Trust and integrity of a prospective design firm can be determined by carefully analyzing a contract, in-depth personal interviews and thoroughly checking references. A trustworthy firm will submit a clearly written contract with concisely defined tasks, terms and conditions which are consistent with a client’s objectives. 

Interviews with one or more members of the firm should answer questions with confidence and clarity. Long, complex explanations are an indication of inadequacy and trouble. Requesting one or two randomly chosen references that were selected from a firm’s portfolio will provide a more accurate review versus handpicked references chosen by the firm.