By Robert Andrews, VP Business Development

Defining key product requirements for a new medical device is a critical first step in the product development process. This activity establishes a direction to guide the product development effort and is proven save time and money. Without definition, effort may potentially become wasted when engineering activities run astray are not clearly focused on contributing to the development goals.

The business opportunity and rationale is assessed for releasing a new product or significantly upgrading an existing product. Ideas for these efforts are initiated by various functional units within the company. Customer sales and marketing personnel base their inputs on market feedback or exploration or by competitive pressures.

Whatever the origin, the first step is the definition of the proposed new product (Phase 0). In this phase, the product is defined at a user and market level. It is important that the design input at this stage be as complete and consistent as possible, as there may be potential impacts to cost and time on subsequent development activities.

Product development phases begin with inputs, then the results of the development phases are defined in outputs. There are no required inputs to Phase 0, although new product or existing product initiatives are generally defined by the marketing and development teams. The outputs of the product definition phase should include an approved Product Opportunity Assessment (POA), a Product Requirements Document (PRD), Product Development Plan (PDP), and a Human Factors Engineering Plan (HFEP).

Product Opportunity Assessment (POA): This POA defines the business rationale, perceived market, and high-level definition of a new product or major upgrade to an existing product. Management approval should be required before design work is initiated on a new product or a major change to an existing product. This authorization can be in the form of the signed POA. Approval documentation becomes part of the Design History File. (DHF)

Product Requirements Document (PRD): A marketing PRD is developed based on the POA, user research, and input from the project team. The PRD should include all of the required product performance specifications as they are understood at the time. Not all requirements may be identified at this time. The PRD should specify all requirements at a level such that an engineering team designing to it would produce the desired product without additional input. It is during this time that the team must resolve incomplete, ambiguous or conflicting requirements.

Product Development Plan (PDP): The PDP defines the path to achieving the design requirements of the PRD by breaking the project into functional tasks and providing a road map to product release. The PDP specifies resource needs, milestone charts and contains an overall schedule. Certain activities defined in this procedure are required for every design project.

The PDP also determines project specific activities such as user human factors studies, interface reviews and testing activities that vary from project to project. It is the responsibility of the Program Manager to identify and plan for all activities to successfully complete the project. The PDP is updated periodically, at project phase reviews at a minimum, to reflect progress towards product release. The PDP is controlled by the Program Manager and each revision is archived in the DHF.

Human Factors Engineering Plan (HFEP): The HFEP is required per IEC 62366 and describes the planned human factors engineering activities. The HFEP also clarifies links to other engineering activities (e.g. risk analysis) and the end-products resulting from such technical activities. The plan will include the following activities:

• Research to understand the users and the use environment
• Analysis Activities
• Specification Activities
• Design Activities
• Activities
• Final Report

Summary
Developing a good product definition has several benefits to streamlining the product development process:

• Testing the business case for embarking on the program
• Refinement of the product concept
• Creating a clear direction to enable efficient use of product development resources
• Determination of program cost and timeline
• Alignment with FDA requirements for successful product approval
• Providing the foundation for manufacturing plan development

By Robert Andrews, VP Business Development

Prototyping is a valuable tool in the market research and product development processes. An effective prototype can rapidly convey design concepts to an end user, company management, or a potential investor.

Prototyping enables marketing to see the reactions of others in order to validate (or invalidate) the product idea or concept. It is a valuable tool to determine the usability of the device by observing customer interaction with it. The prototype can prove engineering feasibility of a design concept (or reveal technical hurdles).

Types of Prototypes

Presentation prototypes, are generally a “looks-like” prototype which is non-functional. This prototype can be used to get buy-in from Marketing to convey a concept to the user and obtain feedback.

Feasibility, or engineering “works like” prototypes, can be used to prove new design concepts and specific device functions. These prototypes, which can be in the form of breadboards (individual modules), often do not look like the product or are the size of the final product. This type of prototype can inform product development of the design direction to take and lends itself to fast iterations to make rapid progress.

Functional, or “works-like/looks like” prototypes, are generally in a self-contained package and provide the engineering group with a device to test design requirements. These prototypes are used in the iterative design cycle where the unit is tested and design revisions are made to achieve the design specification.

Production prototypes, or “works-like/looks-like/made like” prototypes, represent the device that will go to market. Components can be assembled with prototype tooling and low volume assembly methods can be utilized. The design is the final iteration that is going to production. Quantities are built that are sufficient for design verification, where the requirements can be tested to ensure compliance to the specifications.

Prototyping Methods

After determining the purpose and requirement for the prototype, the fabrication method(s) can be determined. Criteria for fabrication method can include piece part and tooling cost/lead time, finish, dimensional accuracy, and strength of the materials. Approaches include:

Conventional Machining

Machining is a well-established prototyping method. It allows the use of a variety of materials including many metals and plastics. It has the advantages of high accuracies and low tooling costs, but the cost of the part can be high due to labor content.

Casting

A model of the part is first constructed in order to cast a part using a liquid (usually a casting resin). The model is typically constructed by machining or 3D prototyping. A mold is formed in two halves over the model using flexible silicone or composite material. The casting material is then poured in to the mold and hardened.

This process has the disadvantage of producing only solid parts, and the mold life is limited. The process is moderate in accuracies, tooling, and piece costs.

Molding

Molding a part requires that a cavity to form the part be machined and incorporated into a mold frame. Methods include rotational, injection, compression, and blow molding. Molding prototypes have longer lead times than machining, and higher tooling costs.

The advantages include low piece price, high strength, good surface finish, consistent dimensions, and near production quality parts.

Thermoforming

Thermoforming utilizes a plastic sheet that is heated and formed on a two-dimensional mold using vacuum to draw the plastic into the mold where it cools and retains its final shape.
The process has the advantage of being able to form parts with different wall thickness by varying the sheet stock. The lead times and tooling costs are generally lower than molding.
Disadvantages include low dimensional accuracies, limitations on part geometries and surface finishes, and frequent requirements for post finishing operations.

3D Prototyping

3D prototyping also known as additive (or “digital”) manufacturing has become a preferred method of prototyping. The design is modeled in CAD and a 3D data file is produced. The file is used to produce a prototype using a variety of material deposition methods including stereolithography, selective laser melting, select laser sintering, laminated object manufacturing, fused deposition modeling, and digital light processing.

Additive manufacturing has a key advantage of short lead times. Components can typically be fabricated in a day or less. Adequate surface finish can often be achieved without post finishing depending on the method and material selected. The piece price can be high, but is usually acceptable for low quantity fabrication. Some processes can produce very high dimensional accuracies, and some can be extremely strong. More and more materials can be 3D printed, including a wide range of polymers (with and without additives that increase strength), elastomers, and a variety of metals.

Effective prototyping

Prototyping is a proven method of communication of the product concept and design to a wide range of stakeholders. Successful prototyping requires:

• Clear understanding of the purposes of the prototypes
• Identification of the audience intended to view and use the prototypes
• Robust definition of functional and/or appearance requirements of the prototypes
• Selection of the most suitable fabrication method for each component

When they make sense to bring to market—and when they don’t
By OTI Founder/CEO Randal Chinnock

Failure. It isn’t something most CEOs like to talk about. But I’ve found that I can learn a lot from failure—other people’s and my own. In fact, I have a habit of combing the Wall Street Journal, searching for spectacular screw-ups (there’s nothing like a touch of schadenfreude with my morning coffee).

That’s why I decided to tackle the subject of bringing disposable medical devices to market through the lens of failure, or, rather, what it takes to prevent it. It may seem obvious that disposables make sense. For one thing, they can prevent the kind of cross-contamination fiascos that led, among other things, to the infection of 32 patients at Johns Hopkins in 2002—and may have played a role in the death of three patients. (Substandard disinfecting of reusable endoscopes was issue here.) And, from a business perspective, the high margins that go along with disposables are definitely alluring.

But disposables don’t always make sense, even when it comes to issues of patient safety. (For instance, the need to keep the cost of disposables relatively low can compromise the instruments’ performance.) To achieve a level of success comparable to a disposable VideoLaryngoscope that we developed, or the “PillCam” developed by Given Imaging and now a Covidien product, it’s crucial, I’ve discovered over many years of disposable optics programs, to keep several key factors in mind. Find out what they are in this presentation I delivered at Biophotonics 2014.

by Robert  Andrews, VP Business Development

The highly competitive medical device industry requires OEMs to take advantage of every possible resource, both internal and external, to stay ahead of the curve. Many device firms have capitalized on the benefits of out-sourced labor and manufacturing for years. But recently upstream functions, such as product design and development, have become a major part of the outsourcing product development trend. OEMs are realizing that they can capitalize on external engineering expertise to gain several advantages without jeopardizing trade secrets or intellectual property (IP), and more effective technology transfers and training are allowing manufacturers to better internalize partnership- produced knowledge for long-term benefits.

There are many factors that must be considered to determine whether outsourcing product design and development is a strategic fit for a company. Here are 10 key benefits that medical device manufacturers may be able to realize by contracting product design and development functions.

1. Leverage Multidisciplinary Expertise
Two heads are better than one, as the adage goes. This is particularly true for product design and development. Truly innovative products rely on multiple concepts and theories for differentiation and leadership in the market. A design team with industry spanning expertise can efficiently apply the best possible technology to the product concept. A team of engineers confined to one product line often does not have this pool of knowledge to draw from, which can make it difficult to find the best solutions to complex problems in a timely way.

2. Expand Internal Engineering Capabilities
Some projects require rapid staffing scale-ups for short  term assignments, and not all OEMs are equipped to do so. Hiring full time employees is not always economical, and adding temporary help is time consuming and can present confidentiality risks. And in either case, finding the right people and getting them down the learning curve always takes longer than anticipated. Outsourcing allows OEMs to leverage their partner’s full-time staff to device development projects quickly and cost effectively. Then, the proper amount of the targeted expertise can be applied at the right time. Companies can therefore avoid paying for excess labor and engineering costs. Table I shows various staffing scale-up options.

However, it is important to note that it is difficult to make direct hourly rate comparisons of in-house design versus external engineering. Outsourced hourly rates include items that are hidden within the organization when design is conducted internally. Such internal costs include CAD work  stations, software licensing fees, office and laboratory space, tools, and equipment.

Lastly, be sure that an outsourced development project is placed into the hands of an outsourced development resource that has a thorough knowledge of applicable standards. Documentation from an outsourced development effort should be able to withstand scrutiny of such standards as ISO 13485, and designs should meet safety and EMI standards like IEC 60601-1. Interview the potential outsourcer. Ask to see their quality manual and some SOP’s and sample documentation. Get them to talk about some details of safety and/or EMI problems that they encountered in previous programs.

Table I. Various scale-up options are available to medical device manufacturers for product design and development projects.

3. Capitalize on Technology Forecasting
Experienced outsourcing partners should have a good grasp on up-and-coming technologies that could play a role in developing products. They should also know how these advances will affect a medical device company.

4. Manage Project Timeline
Many design projects fall victim to missed, or unmanaged timelines. With internal engineering and management resources stretched thin, it is often hard for OEMs to fully commit resources to product development projects. Outsourcing partnerships can offer an advantage, because the engineering firm not only assumes project time management responsibilities, but it can also assign and manage resources. It is a good idea for both parties to agree on a program time.

SHOULD I OUTSOURCE DESIGN?
How can device manufacturers determine whether their product design and development processes will benefit from outsourced engineering? Answer true or false to the following statements. If any are true, outsourcing product design and development may be the solution:

• Internal resources are stretched thin.
• Medical device development projects often run over budget.
• Product launches are often delayed, costing the company lost sales and additional expenses.
• The company has not released a market dominating product in several years.
• The R&D department has several new ideas, but it cannot develop cost-effective manufacturing processes to produce these concepts.
• It is difficult to keep up with the competition in terms of new product development.

5. Control Project Costs
Similar to providing project timeline management, outsourcing partners can help device OEMs keep product development costs within budgeted goals. At contract signing, the project budget should be set and resources allocated, with written approval required for any changes. Reports should be developed and delivered on an agreed-upon periodic basis to keep all parties abreast of current expenditures versus budgeted amounts.

Compared with internal product development, during which it can be difficult to account for time and resources, outsourcing relationships set costs for each project stage. In this way, OEMs can clearly identify the areas in which resources are invested and prevent costs from spiraling out of control. Table II shows an example of a project cost sheet.

Outsourcing design can have a positive effect on the bottom line, even if budget control is not an issue. Device manufacturers can often reduce project costs by working with external partners, because outsourcing design firms rely on past experience to optimize designs.

PROJECT STATUS REPORT FOR FY 2013, PERIOD 5

Project Number: GD00.005123        Status: Active
Project Name: Medical Device X      Period of Performance: 08/04/13-10/04/13
Customer: John Smith Inc                Project Manager: Jane Jones

Table II. A product development cost sheet clearly categorizes incurred expenses and explicitly states contract budgets.

6. Reduce Time to Market
External design firms can speed time to market. Engineering partners can provide end-to-end solutions, providing guidance from concept and product development through equipment design, build, and installation. Having one point of contact for all aspects of a project lends efficiency to it. Additionally, design firms can apply knowledge of similar projects and technologies thereby enhancing productivity. They can also overcome technical obstacles that can delay product introductions. External designers do not have the steep learning curves or resource limitations that internal designers often face.

7. Maintain Confidentiality
One of the major misconceptions about outsourcing product design and development is that it compromises corporate trade secrets. However, confidentiality can be protected through nondisclosure agreements. Companies should also insist on competitive exclusivity.

The anonymity of working with a third party engineering firm may even provide stronger protection for a company’s proprietary position than would internal development. One of the main benefits of doing so is that this option makes it difficult to track down engineers that are responsible for a design that was outsourced. Anonymity reduces the threat of a takeover by competitors and a subsequent information leak.

8. Create a Proprietary Market Position
To gain market ownership, a medical device must provide an innovative solution to an unsatisfied need. Partners that follow industry trends and keep up to date can gauge which market needs are currently unmet. Device manufacturers that specialize in one particular market segment often do not have the ability to perform those analyses. Development firms can also provide an objective analysis of a company’s strengths and weaknesses to determine which needs the company can most effectively meet. Perhaps even more valuable, a good development firm can also provide guidance on how to meet those needs.

Complete and lengthy market ownership also depends on a company’s products being difficult to replicate. External sources can help develop innovative products because they bring novel ideas and wide-ranging expertise to the table. But manufacturers should be wary of getting caught up in the process of making small changes to existing products and re-launching them. Those types of projects and resulting line extension products do not command price premiums.

9. Protect Intellectual Property Rights
Device manufacturers can outsource upstream product development functions without compromising IP. To do so, they must work with partners that agree to assign IP rights for IP that results from the program. This means that the outsourcer either cooperates in preparing patent applications or maintains the IP as a trade secret. Depending on the outsourcer and the breadth of the development, manufacturing process-related IP may be treated differently from design-related IP.

WHAT TO AVOID WHEN OUTSOURCING ENGINEERING

Incomplete Knowledge Transfer. Be sure that the initial agreement explicitly states that all designs and design files become the property of the OEM. If the outsourcing partner is also a CM, the agreement should also clearly state that all designs and design files become the property of the OEM, including ownership of the Device Master Record (DMR). It is imperative that an engineering partner provide training and support at the project’s completion so that the OEM can internalize the knowledge produced during the partnership. It is important to agree to specific training guidelines at the project’s onset.

Communication Problems. When working with off-shore partners, communication issues such as language barriers, cultural differences, and mismatched work schedules could snag product development. Evaluate potential partners’ compatibility with your firm. Other countries have very different, if any, IP laws. Don’t be afraid to talk to potential partners about concerns.

Gratuitous Engineering. Accepting free or discounted engineering from a contract manufacturer may seem to cost less than working with an engineering firm, but it may not produce the best possible product. Contract manufacturers have an incentive to develop products to fit their manufacturing equipment instead of choosing the best design for the product, which can jeopardize profitability. A breakthrough product is worth much more than savings derived from design engineering.

Discounted Engineering. With resources and product success at stake, it is unwise to choose an engineering partner strictly on price. It is important to extensively research potential partners and their qualifications before making a decision.

Oversimplified Programs. Vendors that propose overly simple design plans might not fully understand the project. Moreover, simple solutions are easy to copy and could prevent growth in market share. Visit engineering partners before and during the project and evaluate their capabilities.

10. Keep Up with the Competition
Device manufacturers are increasingly allocating funds to outsource product design and development functions. Whether their strategy is to maintain or gain market leadership, an increasing number of medical device companies are recognizing that outsourcing product design and development is a critical strategic tool. Companies that expect to compete in the device market may find that they have to outsource.

By Robert R. Andrews, VP of Business Development, Optimum Technologies Inc.

Part 2 of 2

Successful product development of a medical device does not insure market success.  The device must get to market in a cost effective and timely manner.  Rapid transition of a product from development to manufacturing requires analysis of the processes to be used for production in the development phase as well as production qualification planning and execution.  Neglecting these steps can lead to delays to market introduction, missing the mark for quality standards, and missing cost targets.

Given how innovative and unique most medical devices are, it is not surprising that many simply cannot be manufactured using standard equipment.  A customized solution can be developed by either modifying existing equipment or developing unique proprietary systems. In either case, planning for manufacturing should begin as soon as a product concept is developed.  Engineers will be able to assess whether standard equipment, a modified version of it, or a unique proprietary system is required as the project moves  from initial design to process validation.

Manufacturing Qualification

Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) provide opportunities to improve the product development process toward optimizing manufacturing.  As an integral part of any manufacturing operation, IQ, OQ and PQ should be considered as soon as a prototype is developed to ensure a seamless transition to full-scale production.  Whereas IQ and OQ focus on facility specifications and how the manufacturing equipment operates, PQ helps ensure that high-quality and high product yields are achieved at full-production conditions.

Proper execution of PQ involves running production to identify acceptable tolerances for a wide range of conditions, such as pressure, temperature, line speed, sealing strength in packaging applications, etc.  The best strategy is to test the full range of tolerances in the production process, including those for separate components.  For example, it is important to test the minimum pressure that will be exerted on a product all the way up to the maximum to ensure the most accurate representation of real-world manufacturing conditions. Failure to test the full range of tolerances at line speed can result in serious manufacturing issues at full-scale production.

Given how innovative and unique most medical devices are, it is not surprising that many simply cannot be manufactured using standard equipment.  A customized solution can be developed by either modifying existing equipment or developing unique proprietary systems.  In either case, planning for manufacturing should begin as soon as a product concept is developed.  Engineers will be able to assess whether standard equipment, a modified version of it, or a unique proprietary system is required as the project moves from initial design to process validation.

Design Tools

Medical device manufacturers should use all resources available to them to move a concept through to production faster and more efficiently.  One such resource is Design for Manufacture and Assembly (DFMA), which is a methodology and software toolset used to determine how to simplify a current or future product design and/or manufacturing process to achieve cost savings.  DFMA allows for improved supply chain cost management, product quality and manufacturing, and communication between Design, Manufacturing, Purchasing and Management.

Engineering firms familiar with the DFMA philosophy and software are open to a wide range of advanced technologies, and can help medical device manufacturers choose the techniques that will best drive product development and manufacturability.

From a manufacturability perspective, DFMA tools help avoid the “disconnect” that often occurs when the design team puts forth a product that cannot be manufactured.  DFMA benefits the design team by allowing them to explore alternatives in processes and materials, while showing the cost impact of each decision.   This allows designers to improve the manufacturability of their product through simplification and the selection of the process best suited to the design.

DFMA can also help remedy cost overruns, which are endemic in the product development world.  It not only helps medical device companies identify what the main contributors to cost are, but it also provides analytical data as to how much a product will actually cost to produce.  Further cost savings can be gained from the fact that DFMA helps internal and external teams work together better by serving as a communication tool and as a method to refine best design practices within an organization.

Process Failure Mode, Effects, and Criticality Analysis (PFMECA) is another resource that can be used to increase the reliability of the product and the manufacturing process.  By conducting this analysis, malfunctions in the designed manufacturing processes can be identified and improvements made before refined prototypes are produced.  The program considers overall design, operating, and service problems, while addressing process and safety problems.  As PFMECA is closely tied to the design process itself, it reinforces the need for communication and collaboration early in the process.  In fact, timeliness is probably the most important factor in differentiating between effective and ineffective implementation of the PFMECA.

New Opportunities, New Challenges

Manufacturing can function as either a gateway to success or an obstacle to realizing a final product.  As the pace of innovation quickens and regulatory requirements grow more complicated, device manufacturers will need to take special precautions to ensure a cohesive, efficient product development process and a seamless transition from design to manufacturing.

Since the choice of technology will influence the entire project from design to manufacturing, it is critical that medical device companies align themselves with the right scientific institutions and technology providers.  External engineering firms have the benefit of working with myriad technologies across multiple industries which empowers them to make recommendations from an informed and experienced standpoint.

For more information, call Bob Andrews, VP Business Development at (508) 765-8100

By Robert R. Andrews, Vice President of Business Development, Optimum Technologies, Inc.

Part 1 of 2

Medical device marketers face many challenges in bringing new innovations to market. Quality standards in the medical industry are formidable and the fast pace of innovation in this market makes the technology horizon unpredictable and places a large cost on even small delays in product launches. For these and other reasons, it is critical that medical device companies take manufacturing into account early in the process to speed breakthrough products through development to commercial market.

Collaboration at the outset of the project is perhaps the most important step toward realizing a successful end product.  By bringing together researchers, marketers, engineers, senior level executives and outside engineering and manufacturing experts, medical device companies can gain a wealth of interdependent information about regulatory and quality standards, unmet needs in the marketplace, emerging technologies and manufacturability.  If the various members of the product development team do not communicate early in the process, the device may soon not be capable of being manufactured, marketable, or doomed to regulatory failure.

Bringing Partners into the Fold

The more advanced medical devices become, the greater the need for outside expertise, which is generally sought in the areas of manufacturing and engineering.  If the engineering firm offers market research and technology forecasting capabilities as part of its portfolio of expertise, then it should be brought into the project development process before a concept has even been established.  The role of the engineering firm also includes helping identify manufacturing partners to join the development team.  Selection of manufacturing partners will depend largely on the technology planned for use in the device and the materials from which it will be constructed. In many cases, more than one manufacturing partner is required due to the complexity of the device.

Due to the intense collaboration required to bring a new medical innovation to market, synergy between internal teams and external partners is quintessential.  Medical device firms should consider characteristics like management style, reputation, problem-solving approach, workflow patterns, and personal compatibility when evaluating potential partners.

Some medical device companies may be tempted to turn to contract manufacturers that offer “free” or discounted engineering services.  However, because contract manufacturers are focused on production and not design, they have a tendency to “force fit” their capabilities, components, processes, or equipment into the manufacture of the product, and this could result in a suboptimal design.

From Beginning to End

Working with one partner that understands the entire product development process is central to ensuring a seamless transition from design to manufacturing.  Without a lead partner, projects become piecemeal and ultimately require rework.  Design firms that simply “pass” the project onto manufacturers once a prototype has been completed will find themselves often making major design adjustments later on.  Understanding the needs of the manufacturer during initial design can avoid “patching up” flaws in manufacturability, which are not only costly, but can also delay a product launch.

The following two examples illustrate what happens when external design firms do not consider manufacturing early in the development process.

Tasked with creating a design concept for a console used in clinical environments for direct patient care, the contracted design firm finalized the prototype and passed it to the manufacturing team.  By this time, significant funds and a large amount of time were dedicated to the console design.  The manufacturing team recognized that the concept as designed possessed numerous flaws and ergonomic issues, and would require costly assembly in the field.  Revamping the design concept in the manufacturing stage also proved costly.  Had the design firm and manufacturing team been one, design flaws would have been uncovered early in the design process, avoiding costly rework and continual product evolutions.

In the case of one diagnostic device development project, the external design firm did not consider what would be feasible in terms of manufacturing throughput.  To produce the product in the volumes desired, the contract manufacturer would need to employ more workers on the manufacturing line than physically possible.  This, too, could have been avoided by a cohesive product development team.

An example of a successful project  is when TearScience, Inc. came to Optimum Technologies, Inc. (OTI) a contract R&D firm to develop a quantitative instrument for the diagnosis of ocular tear film deficiencies and response to therapy.  OTI developed the device including optical design and engineering, measurement theory and algorithm development, prototype fabrication, extensive design verification protocol development and testing.  The device received 510K approval in 85 days. OTI partnered with the client who was the manufacturer early in the design process which ensured quick production ramp up and rapid product introduction.

External product development firms have the benefit of working with many technologies and manufacturing processes.  This not only empowers them to make recommendations from an informed and experienced standpoint, but it also allows for an efficient transfer from development to manufacturing.  This will avoid costly delays in ramping up production to meet market needs.

For more information, call Bob Andrews, VP Business Development at (508) 765-8100